<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01714817</url>
  </required_header>
  <id_info>
    <org_study_id>IM101-291</org_study_id>
    <secondary_id>2012-000714-11</secondary_id>
    <nct_id>NCT01714817</nct_id>
  </id_info>
  <brief_title>Efficacy and Safety Study of Abatacept to Treat Lupus Nephritis</brief_title>
  <official_title>A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of BMS-188667 (Abatacept) or Placebo on a Background of Mycophenolate Mofetil and Corticosteroids in the Treatment of Subjects With Active Class III or IV Lupus Nephritis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bristol-Myers Squibb</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Bristol-Myers Squibb</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate (Abatacept) for treatment of lupus nephritis when&#xD;
      used on a background of Cellcept (mycophenolate) and prednisone (corticosteroids)&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Inability to meet protocol objectives.&#xD;
  </why_stopped>
  <start_date type="Actual">January 22, 2013</start_date>
  <completion_date type="Actual">May 30, 2018</completion_date>
  <primary_completion_date type="Actual">November 21, 2016</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Participants in Complete Renal Response (CR) of Lupus Glomerulonephritis at Day 365 of the Double-blind Period</measure>
    <time_frame>Day 365</time_frame>
    <description>Number of participants achieving CR was divided by the total number of participants in that arm and expressed as a percentage. CR defined as: eGFR is normal or no &lt;85% of the baseline; eGFR based on mean creatinine value from day 358 and 365. Proteinuria: UPCR&lt;0.5 mg/mg. Urine sediment: No cellular casts. Corticosteroid dose: Daily dose must be no &gt;10 mg prednisone or equiv. for at least 28 days prior to assessment. Participants with &gt;10mg/day prednisone or equivalent for non-renal disease within 28 days prior to day 365 will be imputed as having achieved CR if the following are true: Met all criteria for CR at day 337 and all criteria for CR except corticosteroid dose at day 365; Investigator confirms increase in steroid dose is not related to renal disease. Adjusted odds ratio is estimated from logistic regression model which includes treatment group, baseline ACEi/ARBs use (Yes/No), race (Asian/ Black/Caucasian/Other) and baseline UPCR as a continuous variable.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Nephrotic Participants in Complete Renal Response of Lupus Glomerulonephritis at Day 365 of the Double-blind Period</measure>
    <time_frame>Day 365</time_frame>
    <description>Number of participants achieving CR was divided by total participants in that arm, expressed as a percentage. CR is defined the following criteria: eGFR is normal or no &lt;85% of the baseline value; eGFR is based on mean creatinine value from day 358 and 365. Proteinuria: UPCR&lt;0.5 mg/mg. Urine sediment: No cellular casts. Corticosteroid dose: Daily dose must be no &gt;10 mg prednisone or equivalent for at least 28 days prior. Subjects with &gt;10mg/day prednisone or equivalent for non-renal disease within 28 days prior to day 365 will be imputed as CR if the following are true: Met all criteria for CR at day 337 and all criteria for CR except corticosteroid dose at day 365; Investigator confirms increase in steroid dose is not related to renal disease. Adjusted odds ratio is estimated from logistic regression model which includes treatment group, baseline ACEi/ARBs use, race and baseline UPCR as a continuous variable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adjusted Mean Change From Baseline in Urine Protein/Creatinine Ratio (UPCR) at Day 365 of the Double-blind Period in Nephrotic Participants</measure>
    <time_frame>Baseline and Day 365</time_frame>
    <description>Adjusted Mean Change from Baseline in UPCR at Day 365 of the double-blind period in nephrotic participants</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adjusted Mean Change From Baseline in UPCR at Day 365 of the Double-blind Period in Overall Population</measure>
    <time_frame>Day 1 and Day 365</time_frame>
    <description>Adjusted Mean Change from Baseline in Urine protein/creatinine ratio (UPCR) at Day 365 of the double-blind period in the overall population</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adjusted Mean Change From Baseline in Disease Activity as Measured by BILAG 2004 Over Time During Year 1 of the Double-blind Period</measure>
    <time_frame>Day 1 to Day 365</time_frame>
    <description>Adjusted mean change from baseline in British Isles Lupus Assessment Group (BILAG) score over time during Year 1 of the double-blind period based on a repeated measure mixed model and presented at each visit in the first 12-month of the double-blind period. BILAG index measures disease activity in different organs/systems separately. BILAG score is calculated for each of 9 systems depending on the clinical features present and whether they are new (4 points), worse (3 points), the same (2 points), improving (1 point) or not present (0 points) in the last 4 weeks compared with previously. BILAG &quot;A&quot; represents the presence of serious features of lupus. BILAG &quot;B&quot; represents more moderate features of the disease. BILAG &quot;C&quot; includes only mild symptomatic features. BILAG &quot;D&quot; represents prior activity with no current symptoms due to active lupus. BILAG &quot;E&quot; represents an organ that has never been involved. Overall BILAG score ranges from 0-108, with higher scores reflecting a worse outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Any Adverse Events (AEs) During Year 1 of the Double-blind Period</measure>
    <time_frame>From Day 1 up to 56 days post last dose in Year 1 of the double-blind period</time_frame>
    <description>All AEs were coded and grouped into preferred terms (PT) by system organ class (SOC), using the Medical Dictionary for Regulatory Activities (MedDRA, version 21.0). Investigators determined the intensity of each AE as mild, moderate, severe, or very severe and assessed the relationship to study drug.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Ranked Outcome of Complete Renal Response, Partial Renal Response (PR), and No Renal Response (NR) During the Double-blind Period</measure>
    <time_frame>Day 365, Day 729</time_frame>
    <description>Complete Renal Response or Complete Response (CR): defined as meeting ALL of the following criteria: eGFR normal OR no less than 85% of the baseline value; UPCR &lt; 0.5; Urine sediment: No cellular casts; Daily corticosteroid dose must be no greater than 10 mg prednisone or equivalent for at least 28 days prior to assessment. Partial Renal Response or Partial Response (PR): defined as meeting ALL of the following criteria: Participant does not meet criteria for CR; eGFR no less than 85% of the lesser of the values at screening or randomization (Day 1); UPCR &lt; 0.5 OR 50% reduced from baseline and &lt; 1 if baseline value was &lt; 3, OR 50% reduced from baseline and &lt; 3 if baseline value was greater than or equal to 3; Urine sediment: no cellular casts; daily corticosteroid dose no greater than 10 mg/day prednisone or prednisone equivalent for at least 28 days prior to assessment. No Renal Response or No Response (NR): defined as not meeting criteria for CR or PR or withdrawn</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Median Time to Complete Renal Response During the Double-blind Period in All Participants</measure>
    <time_frame>Day 365, Day 729</time_frame>
    <description>The estimate of median time to Complete Renal Response is based on Kaplan-Meier analysis. Complete renal response (CR): defined as meeting ALL of the following criteria: eGFR normal OR no less than 85% of the baseline value; Urine protein/creatinine ratio (UPCR) &lt; 0.5; Urine sediment: No cellular casts; Daily corticosteroid dose must be no greater than 10 mg prednisone or equivalent for at least 28 days prior to assessment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Median Time to Complete Renal Response During the Double-blind Period in Nephrotic Participants</measure>
    <time_frame>Day 365, Day 729</time_frame>
    <description>The estimate of median time to Complete Renal Response in nephrotic participants is based on Kaplan-Meier analysis. Complete renal response (CR): defined as meeting ALL of the following criteria: eGFR normal OR no less than 85% of the baseline value; Urine protein/creatinine ratio (UPCR) &lt; 0.5; Urine sediment: No cellular casts; Daily corticosteroid dose must be no greater than 10 mg prednisone or equivalent for at least 28 days prior to assessment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Median Time to Partial Renal Response During the Double-blind Period in All Participants</measure>
    <time_frame>Day 365, Day 729</time_frame>
    <description>The estimate of median time to Partial Response (PR) is based on Kaplan-Meier analysis. Partial renal response (PR): defined as meeting ALL of the following criteria: Participant does not meet criteria for CR; eGFR no less than 85% of the lesser of the values at screening or randomization (Day 1); UPCR &lt; 0.5 OR 50% reduced from baseline and &lt; 1 if baseline value was &lt; 3, OR 50% reduced from baseline and &lt; 3 if baseline value was 3; Urine sediment: no cellular casts; daily corticosteroid dose no greater than 10 mg/day prednisone or prednisone equivalent for at least 28 days prior to assessment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Median Time to Partial Renal Response During the Double-blind Period in Nephrotic Participants</measure>
    <time_frame>Day 365, Day 729</time_frame>
    <description>The estimate of median time to Partial Response (PR) in nephrotic participants is based on Kaplan-Meier analysis. Partial renal response (PR): defined as meeting ALL of the following criteria: Participant does not meet criteria for CR; eGFR no less than 85% of the lesser of the values at screening or randomization (Day 1); UPCR &lt; 0.5 OR 50% reduced from baseline and &lt; 1 if baseline value was &lt; 3, OR 50% reduced from baseline and &lt; 3 if baseline value was 3; Urine sediment: no cellular casts; daily corticosteroid dose no greater than 10 mg/day prednisone or prednisone equivalent for at least 28 days prior to assessment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adjusted Mean Change From Baseline in UPCR Over Time</measure>
    <time_frame>Day 365; Day 729, includes data up to July 1st 2017 when double-blind therapy ended</time_frame>
    <description>A repeated measure mixed model that included the baseline UPCR value, randomization stratification factors, time, and time by treatment interaction as fixed effects and subject as a random effect was used.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Median Percent Change From Baseline in UPCR Over Time</measure>
    <time_frame>Day 365, Day 729</time_frame>
    <description>A repeated measure mixed model that included the baseline UPCR value, randomization stratification factors, time, and time by treatment interaction as fixed effects and subject as a random effect was used.&#xD;
% Change from Baseline = (post baseline - baseline value) / baseline value x 100</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adjusted Mean Change From Baseline in eGFR Over Time</measure>
    <time_frame>Day 365, Day 729</time_frame>
    <description>Estimated glomerular filtration rate(eGFR), will be calculated by the CKD-EPI formula shown below.50 eGFR is expressed as mL/min per 1.73m2. For the purpose of this study lower limit of normal eGFR is defined as 90mL/min per 1.73m2 eGFR = 141 X min (Scr/k, 1)α X max (Scr/k, 1)-1.209 X 0.993Age X (1.018 [if female]) X (1.159 [if black]) Where Scr is serum creatinine (mg/dL), k is 0.7 for females and 0.9 for males, α is -0.329 for females and -0.411 for males, min indicates the minimum of Scr/k or 1, and max indicates the maximum of Scr/k or 1, age in years.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Median Time to First Sustained Change to No Response During the Double-blind Period</measure>
    <time_frame>Day 365, Day 729</time_frame>
    <description>Sustained response defined as response present at 2 consecutive visits approximately 4 weeks apart. No renal response (NR): defined as not meeting criteria for CR or PR or withdrawn&#xD;
The estimate of median time is based on Kaplan-Meier analysis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Sustained Change From Higher Level of Response to no Response During the Double-blind Period</measure>
    <time_frame>Day 365, Day 729</time_frame>
    <description>Sustained change to no response is defined as going from CR (or PR) to NR and remaining in NR for at least 2 consecutive visits; visits should be approximately 4 weeks apart. This analysis will be based on time from response CR (or PR) to the first visit in which the no response (NR) was achieved and sustained to the next visit.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adjusted Mean Change From Baseline in Disease Activity as Measured by BILAG 2004 Over Time During the Double-blind Period</measure>
    <time_frame>Day 1 to Day 729; Day 365 to Day 729</time_frame>
    <description>BILAG index measures and reports disease activity in different organs/systems separately. The BILAG score is calculated for each of nine systems depending on the clinical features present and whether they are new (4 points), worse (3 points), the same (2 points), improving (1 point) or not present (0 points) in the last 4 weeks compared with previously. A BILAG &quot;A&quot; represents the presence of one or more serious features of lupus. A BILAG &quot;B&quot; represents more moderate features of the disease. A BILAG &quot;C&quot; includes only mild symptomatic features. A BILAG &quot;D&quot; represents only prior activity with no current symptoms due to active lupus. A BILAG &quot;E&quot; represents an organ that has never been involved. Overall BILAG score ranges from 0-108, with higher scores reflecting a worse outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cmin (ug/mL): Trough Level Serum Concentration of Abatacept Prior to the Administration of the IV Infusion</measure>
    <time_frame>Days 1 to 365</time_frame>
    <description>Trough level serum concentration of abatacept prior to the administration of the IV infusion on Days 1 to 365</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cmax: Maximum Observed Serum Concentration Following Participants Receiving Active Abatacept IV</measure>
    <time_frame>at 1 hour post Day 1 dose and 30 minutes post Day 337 dose</time_frame>
    <description>Cmax: Maximum observed serum concentration following participants receiving active abatacept IV</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AUC (TAU): Area Under the Serum Concentration Time Curve Over a Dosing Interval</measure>
    <time_frame>Days 337 to 365</time_frame>
    <description>AUC (TAU): Area under the serum concentration time curve over a dosing interval between Days 337 to 365.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Summary Statistics for Systolic Blood Pressure</measure>
    <time_frame>Day 1 to Day 729</time_frame>
    <description>Summary statistics for systolic blood pressure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Summary Statistics for Diastolic Blood Pressure</measure>
    <time_frame>Day 1 to Day 729</time_frame>
    <description>Summary statistics for diastolic blood pressure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Summary Statistics for Heart Rate</measure>
    <time_frame>Day 1 to Day 729</time_frame>
    <description>Summary statistics for Heart Rate</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Change From Baseline in Laboratory Analytes During the Double-blind Period (U/L)</measure>
    <time_frame>Day 729</time_frame>
    <description>Laboratory assessments were analyzed centrally, with the exception of pregnancy testing. Blood draws and urine collections were performed at visits specified in the protocol.&#xD;
Change from Baseline = Post-baseline - Baseline value.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Change From Baseline in Laboratory Analytes During the Double-blind Period (g/L)</measure>
    <time_frame>Day 729</time_frame>
    <description>Laboratory assessments were analyzed centrally, with the exception of pregnancy testing. Blood draws and urine collections were performed at visits specified in the protocol.&#xD;
Change from Baseline = Post-baseline - Baseline value.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Change From Baseline in Laboratory Analytes During the Double-blind Period (Percentage of Blood)</measure>
    <time_frame>Day 729</time_frame>
    <description>Laboratory assessments were analyzed centrally, with the exception of pregnancy testing. Blood draws and urine collections were performed at visits specified in the protocol.&#xD;
Change from Baseline = Post-baseline - Baseline value.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Change From Baseline in Laboratory Analytes During the Double-blind Period (Umol/L)</measure>
    <time_frame>Day 729</time_frame>
    <description>Laboratory assessments were analyzed centrally, with the exception of pregnancy testing. Blood draws and urine collections were performed at visits specified in the protocol.&#xD;
Change from Baseline = Post-baseline - Baseline value.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Change From Baseline in Laboratory Analytes During the Double-blind Period (mmol/L)</measure>
    <time_frame>Day 729</time_frame>
    <description>Laboratory assessments were analyzed centrally, with the exception of pregnancy testing. Blood draws and urine collections were performed at visits specified in the protocol.&#xD;
Change from Baseline = Post-baseline - Baseline value.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Change From Baseline in Laboratory Analytes During the Double-blind Period (x10^9 Cells/L)</measure>
    <time_frame>Day 729</time_frame>
    <description>Laboratory assessments were analyzed centrally, with the exception of pregnancy testing. Blood draws and urine collections were performed at visits specified in the protocol.&#xD;
Change from Baseline = Post-baseline - Baseline value.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Marked Hematology Laboratory Abnormalities During Year 1 of the Double Blind Period</measure>
    <time_frame>Day 1 to Day 365; includes data up to 56 days post last dose in year 1 of double-blind period or first dose date in the year 2 of double-blind period, whichever is earlier</time_frame>
    <description>LLN= Lower limit of normals ULN= Upper limit of normals Pre RX = Baseline value HEMOGLOBIN g/L 4.0 HB &gt;3 G/DL DECREASE FROM PRE RX HEMATOCRIT vol 6.3 HCT &lt;0.75X PRE RX ERYTHROCYTES x10*12 c/L 5.2 RBC &lt;0.75X PRE RX PLATELET COUNT x10*9 c/L 5.0 PLAT &lt;0.67X LLN OR &gt;1.5X ULN, OR IF PRE RX&lt;LLN THEN USE 0.5X PRE RX AND &lt;100,000/MM3 LEUKOCYTES x10*9 c/L 6.2 WBC &lt;0.75X LLN OR &gt;1.25X ULN, OR IF PRE RX&lt;LLN THEN USE &lt;0.8X PRE RX OR &gt;ULN, OR IF PRE RX&gt;ULN THEN USE &gt;1.2X PRE RX OR &lt;LLN EOSINOPHILS (ABSOLUTE) x10*9 c/L 8.3 EOSA IF VALUE &gt; .750 X10*3 c/uL BASOPHILS (ABSOLUTE) x10*9 c/L 8.3 BASOA IF VALUE &gt; 400/MM3 MONOCYTES (ABSOLUTE) x10*9 c/L 8.3 MONOA IF VALUE &gt; 2000/MM3 LYMPHOCYTES (ABSOLUTE) x10*9 c/L 8.3 LYMPA IF VALUE &lt; .750 X10*3 c/uL OR IF VALUE &gt; 7.50 X10*3 c/uL&#xD;
N = the number of participants with at least 1 on treatment lab result for each analyte</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Marked Liver and Kidney Function Laboratory Abnormalities During Year 1 of the Double Blind Period</measure>
    <time_frame>Day 1 to Day 365; includes data up to 56 days post last dose in year 1 of double-blind period or first dose date in the year 2 of double-blind period, whichever is earlier</time_frame>
    <description>LLN= Lower limit of normals ULN= Upper limit of normals Pre RX = Baseline value ALKALINE PHOSPHATASE (ALP) U/L 5.0 ALP &gt;2X ULN, OR IF PRE RX&gt;ULN THEN USE &gt;3X PRE RX ASPARTATE AMINOTRANSFERASE (AST) U/L 5.0 AST &gt;3X ULN, OR IF PRE RX&gt;ULN THEN USE &gt;4X PRE RX ALANINE AMINOTRANSFERASE (ALT) U/L 5.0 ALT &gt;3X ULN, OR IF PRE RX&gt;ULN THEN USE &gt;4X PRE RX G-GLUTAMYL TRANSFERASE (GGT) U/L 5.0 GGT &gt;2X ULN, OR IF PRE RX&gt;ULN THEN USE &gt;3X PRE RX BILIRUBIN, TOTAL umol/L 5.1 TBILI &gt;2X ULN, OR IF PRE RX&gt;ULN THEN USE &gt;4X PRE RX BILIRUBIN, DIRECT umol/L 5.1 DBILI &gt;1.5X ULN, OR IF PRE RX&gt;ULN THEN USE &gt;2X PRE RX BLOOD UREA NITROGEN mmol/L 5.1 BUN &gt;2X PRE RX CREATININE umol/L 5.0 CREAT &gt;1.5X PRE RX&#xD;
N = the number of participants with at least 1 on treatment lab result for each analyte</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Marked Electrolyte Laboratory Abnormalities During Year 1 of the Double Blind Period</measure>
    <time_frame>Day 1 to Day 365; includes data up to 56 days post last dose in year 1 of double-blind period or first dose date in the year 2 of double-blind period, whichever is earlier</time_frame>
    <description>LLN= Lower limit of normals ULN= Upper limit of normals Pre RX = Baseline value SODIUM, SERUM mmol/L 4.0 NA &lt;0.95X LLN OR &gt;1.05X ULN, OR IF PRE RX&lt;LLN THEN USE &lt;0.95X PRE RX OR &gt;ULN, OR IF PRE RX&gt;ULN THEN USE &gt;1.05X PRE RX OR &lt;LLN POTASSIUM, SERUM mmol/L 4.1 K &lt;0.9X LLN OR &gt;1.1X ULN, OR IF PRE RX&lt;LLN THEN USE &lt;0.9X PRE RX OR &gt;ULN, OR IF PRE RX&gt;ULN THEN USE &gt;1.1X PRE RX OR &lt;LLN CHLORIDE, SERUM mmol/L 5.0 CL &lt;0.9X LLN OR &gt;1.1X ULN, OR IF PRE RX&lt;LLN THEN USE &lt;0.9X PRE RX OR &gt;ULN, OR IF PRE RX&gt;ULN THEN USE &gt;1.1X PRE RX OR &lt;LLN&#xD;
N = the number of participants with at least 1 on treatment lab result for each analyte</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Marked Urinalysis Laboratory Abnormalities During Year 1 of the Double Blind Period</measure>
    <time_frame>Day 1 to Day 365; includes data up to 56 days post last dose in year 1 of double-blind period or first dose date in the year 2 of double-blind period, whichever is earlier</time_frame>
    <description>LLN= Lower limit of normals ULN= Upper limit of normals Pre RX = Baseline value PROTEIN, URINE Unknown UPRO IF MISSING PRE THEN USE &gt;=2, OR IF VALUE &gt;=4, OR IF PRE RX =0 OR 0.5 THEN USE &gt;=2, OR IF PRE RX =1 THEN USE &gt;=3, OR IF PRE RX =2 OR 3 THEN USE &gt;=4 GLUCOSE, URINE N/A UGLU IF MISSING PRE THEN USE &gt;=2, OR IF VALUE &gt;=4, OR IF PRE RX =0 OR 0.5 THEN USE &gt;=2, OR IF PRE RX =1 THEN USE &gt;=3, OR IF PRE RX =2 OR 3 THEN USE &gt;=4 BLOOD, URINE N/A UBLD IF MISSING PRE THEN USE &gt;=2, OR IF VALUE &gt;=4, OR IF PRE RX =0 OR 0.5 THEN USE &gt;=2, OR IF PRE RX =1 THEN USE &gt;=3, OR IF PRE RX =2 OR 3 THEN USE &gt;=4 RBC, URINE hpf 5.0 URBC IF MISSING PRE THEN USE &gt;=2, OR IF VALUE &gt;=4, OR IF PRE RX =0 OR 0.5 THEN USE &gt;=2, OR IF PRE RX =1 THEN USE &gt;=3, OR IF PRE RX =2 OR 3 THEN USE &gt;=4 WBC, URINE hpf 5.0 UWBC IF MISSING PRE THEN USE &gt;=2, OR IF VALUE &gt;=4, OR IF PRE RX =0 OR 0.5 THEN USE &gt;=2, OR IF PRE RX =1 THEN USE &gt;=3, OR IF PRE RX =2 OR 3 THEN USE &gt;=4</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Other Marked Chemistry Laboratory Abnormalities During Year 1 of the Double Blind Period</measure>
    <time_frame>Day 1 to Day 365; includes data up to 56 days post last dose in year 1 of double-blind period or first dose date in the year 2 of double-blind period, whichever is earlier</time_frame>
    <description>LLN= Lower limit of normals ULN= Upper limit of normals Pre RX = Baseline value CALCIUM, TOTAL mmol/L 5.2 CA &lt;0.8X LLN OR &gt;1.2X ULN, OR IF PRE RX&lt;LLN THEN USE &lt;0.75X PRE RX OR &gt;ULN, OR IF PRE RX&gt;ULN THEN USE &gt;1.25X PRE RX OR &lt;LLN PHOSPHORUS, INORGANIC mmol/L 5.2 PHOS &lt;0.75X LLN OR &gt;1.25X ULN, OR IF PRE RX&lt;LLN THEN USE &lt;0.67X PRE RX OR &gt;ULN GLUCOSE, SERUM mmol/L 4.1 GLUC &lt;65 mg/dL, OR &gt;220 mg/dL PROTEIN, TOTAL g/L 5.0 TPRO &lt;0.9X LLN OR &gt;1.1X ULN, OR IF PRE RX&lt;LLN THEN USE 0.9X PRE RX OR &gt;ULN, OR IF PRE RX&gt;ULN THEN USE 1.1X PRE RX OR &lt;LLN ALBUMIN g/L 3.0 ALB &lt;0.9X LLN, OR IF PRE RX&lt;LLN THEN USE &lt;0.75X PRE RX CHOLESTEROL, TOTAL (TC) mmol/L 5.2 CHOL &gt;2X PRE R&#xD;
N = the number of participants with at least 1 on treatment lab result for each analyte</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Any Adverse Events (AEs) During Year 2 of the Double-blind Period and Long-term Extension</measure>
    <time_frame>From the first dose in Year 2 of the double-blind period up to 56 days post last dose</time_frame>
    <description>All AEs were coded and grouped into preferred terms (PT) by system organ class (SOC), using the Medical Dictionary for Regulatory Activities (MedDRA, version 21.0). Investigators determined the intensity of each AE as mild, moderate, severe, or very severe and assessed the relationship to study drug.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants in Treatment Failure Over Time During the Double-blind Period</measure>
    <time_frame>Day 365, Day 729</time_frame>
    <description>Lupus treatment failure is defined as any of the following: Death, unless due to physical trauma or violence; Renal Flare; sustained doubling of creatinine from baseline (greater of Screening or Study Day 1 value); initiation of rescue therapy for treatment of active lupus nephritis after Study Week 20.&#xD;
Overall treatment failure is defined as lupus treatment failure plus discontinuation of study drug for any reason except death due to physical trauma or violence, pregnancy or administrative decision by Sponsor.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Median Time to First Treatment Failure and Overall Treatment Failure During the Double-blind Period</measure>
    <time_frame>Day 365, Day 729</time_frame>
    <description>First treatment failure (or Lupus treatment failure) is defined as any of the following: Death, unless due to physical trauma or violence; Renal Flare; sustained doubling of creatinine from baseline (greater of Screening or Study Day 1 value); initiation of rescue therapy for treatment of active lupus nephritis after Study Week 20.&#xD;
Overall treatment failure is defined as lupus treatment failure plus discontinuation of study drug for any reason except death due to physical trauma or violence, pregnancy or administrative decision by Sponsor.&#xD;
The hazard ratio is estimated using the Cox proportional hazards model which includes treatment group, stratification variables (baseline ACEis/ARBs use, RACE) and baseline UPCR.&#xD;
The estimate of median time is based on Kaplan-Meier analysis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Nephrotic Participants in Complete Renal Response of Lupus Glomerulonephritis at Day 729 of the Double-blind Period</measure>
    <time_frame>Day 729</time_frame>
    <description>Number of participants achieving CR was divided by total participants in that arm, expressed as a percentage. CR is defined the following criteria: eGFR is normal or no &lt;85% of the baseline value; eGFR is based on mean creatinine value from day 358 and 365. Proteinuria: UPCR&lt;0.5 mg/mg. Urine sediment: No cellular casts. Corticosteroid dose: Daily dose must be no &gt;10 mg prednisone or equivalent for at least 28 days prior. Subjects with &gt;10mg/day prednisone or equivalent for non-renal disease within 28 days prior to day 365 will be imputed as CR if the following are true: Met all criteria for CR at day 337 and all criteria for CR except corticosteroid dose at day 365; Investigator confirms increase in steroid dose is not related to renal disease. Adjusted odds ratio is estimated from logistic regression model which includes treatment group, baseline ACEi/ARBs use, race and baseline UPCR as a continuous variable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants in Overall Population in Complete Renal Response of Lupus Glomerulonephritis at Day 729 of the Double-blind Period</measure>
    <time_frame>Day 729</time_frame>
    <description>Number of participants achieving CR was divided by total participants in that arm, expressed as a percentage. CR is defined the following criteria: eGFR is normal or no &lt;85% of the baseline value; eGFR is based on mean creatinine value from day 358 and 365. Proteinuria: UPCR&lt;0.5 mg/mg. Urine sediment: No cellular casts. Corticosteroid dose: Daily dose must be no &gt;10 mg prednisone or equivalent for at least 28 days prior. Subjects with &gt;10mg/day prednisone or equivalent for non-renal disease within 28 days prior to day 365 will be imputed as CR if the following are true: Met all criteria for CR at day 337 and all criteria for CR except corticosteroid dose at day 365; Investigator confirms increase in steroid dose is not related to renal disease. Adjusted odds ratio is estimated from logistic regression model which includes treatment group, baseline ACEi/ARBs use, race and baseline UPCR as a continuous variable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Marked Hematology Laboratory Abnormalities in the Double Blind Period</measure>
    <time_frame>Day 1 to Day 729</time_frame>
    <description>LLN= Lower limit of normals ULN= Upper limit of normals Pre RX = Baseline value HEMOGLOBIN g/L 4.0 HB &gt;3 G/DL DECREASE FROM PRE RX HEMATOCRIT vol 6.3 HCT &lt;0.75X PRE RX ERYTHROCYTES x10*12 c/L 5.2 RBC &lt;0.75X PRE RX PLATELET COUNT x10*9 c/L 5.0 PLAT &lt;0.67X LLN OR &gt;1.5X ULN, OR IF PRE RX&lt;LLN THEN USE 0.5X PRE RX AND &lt;100,000/MM3 LEUKOCYTES x10*9 c/L 6.2 WBC &lt;0.75X LLN OR &gt;1.25X ULN, OR IF PRE RX&lt;LLN THEN USE &lt;0.8X PRE RX OR &gt;ULN, OR IF PRE RX&gt;ULN THEN USE &gt;1.2X PRE RX OR &lt;LLN EOSINOPHILS (ABSOLUTE) x10*9 c/L 8.3 EOSA IF VALUE &gt; .750 X10*3 c/uL BASOPHILS (ABSOLUTE) x10*9 c/L 8.3 BASOA IF VALUE &gt; 400/MM3 MONOCYTES (ABSOLUTE) x10*9 c/L 8.3 MONOA IF VALUE &gt; 2000/MM3 LYMPHOCYTES (ABSOLUTE) x10*9 c/L 8.3 LYMPA IF VALUE &lt; .750 X10*3 c/uL OR IF VALUE &gt; 7.50 X10*3 c/uL&#xD;
N = the number of participants with at least 1 on treatment lab result for each analyte</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Marked Liver and Kidney Function Laboratory Abnormalities in the Double Blind Period</measure>
    <time_frame>Day 1 to Day 729</time_frame>
    <description>LLN= Lower limit of normals ULN= Upper limit of normals Pre RX = Baseline value ALKALINE PHOSPHATASE (ALP) U/L 5.0 ALP &gt;2X ULN, OR IF PRE RX&gt;ULN THEN USE &gt;3X PRE RX ASPARTATE AMINOTRANSFERASE (AST) U/L 5.0 AST &gt;3X ULN, OR IF PRE RX&gt;ULN THEN USE &gt;4X PRE RX ALANINE AMINOTRANSFERASE (ALT) U/L 5.0 ALT &gt;3X ULN, OR IF PRE RX&gt;ULN THEN USE &gt;4X PRE RX G-GLUTAMYL TRANSFERASE (GGT) U/L 5.0 GGT &gt;2X ULN, OR IF PRE RX&gt;ULN THEN USE &gt;3X PRE RX BILIRUBIN, TOTAL umol/L 5.1 TBILI &gt;2X ULN, OR IF PRE RX&gt;ULN THEN USE &gt;4X PRE RX BILIRUBIN, DIRECT umol/L 5.1 DBILI &gt;1.5X ULN, OR IF PRE RX&gt;ULN THEN USE &gt;2X PRE RX BLOOD UREA NITROGEN mmol/L 5.1 BUN &gt;2X PRE RX CREATININE umol/L 5.0 CREAT &gt;1.5X PRE RX&#xD;
N = the number of participants with at least 1 on treatment lab result for each analyte</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Marked Electrolyte Laboratory Abnormalities in the Double Blind Period</measure>
    <time_frame>Day 1 to Day 729</time_frame>
    <description>LLN= Lower limit of normals ULN= Upper limit of normals Pre RX = Baseline value SODIUM, SERUM mmol/L 4.0 NA &lt;0.95X LLN OR &gt;1.05X ULN, OR IF PRE RX&lt;LLN THEN USE &lt;0.95X PRE RX OR &gt;ULN, OR IF PRE RX&gt;ULN THEN USE &gt;1.05X PRE RX OR &lt;LLN POTASSIUM, SERUM mmol/L 4.1 K &lt;0.9X LLN OR &gt;1.1X ULN, OR IF PRE RX&lt;LLN THEN USE &lt;0.9X PRE RX OR &gt;ULN, OR IF PRE RX&gt;ULN THEN USE &gt;1.1X PRE RX OR &lt;LLN CHLORIDE, SERUM mmol/L 5.0 CL &lt;0.9X LLN OR &gt;1.1X ULN, OR IF PRE RX&lt;LLN THEN USE &lt;0.9X PRE RX OR &gt;ULN, OR IF PRE RX&gt;ULN THEN USE &gt;1.1X PRE RX OR &lt;LLN&#xD;
N = the number of participants with at least 1 on treatment lab result for each analyte</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Marked Urinalysis Laboratory Abnormalities in the Double Blind Period</measure>
    <time_frame>Day 1 to Day 729</time_frame>
    <description>LLN= Lower limit of normals ULN= Upper limit of normals Pre RX = Baseline value PROTEIN, URINE Unknown UPRO IF MISSING PRE THEN USE &gt;=2, OR IF VALUE &gt;=4, OR IF PRE RX =0 OR 0.5 THEN USE &gt;=2, OR IF PRE RX =1 THEN USE &gt;=3, OR IF PRE RX =2 OR 3 THEN USE &gt;=4 GLUCOSE, URINE N/A UGLU IF MISSING PRE THEN USE &gt;=2, OR IF VALUE &gt;=4, OR IF PRE RX =0 OR 0.5 THEN USE &gt;=2, OR IF PRE RX =1 THEN USE &gt;=3, OR IF PRE RX =2 OR 3 THEN USE &gt;=4 BLOOD, URINE N/A UBLD IF MISSING PRE THEN USE &gt;=2, OR IF VALUE &gt;=4, OR IF PRE RX =0 OR 0.5 THEN USE &gt;=2, OR IF PRE RX =1 THEN USE &gt;=3, OR IF PRE RX =2 OR 3 THEN USE &gt;=4 RBC, URINE hpf 5.0 URBC IF MISSING PRE THEN USE &gt;=2, OR IF VALUE &gt;=4, OR IF PRE RX =0 OR 0.5 THEN USE &gt;=2, OR IF PRE RX =1 THEN USE &gt;=3, OR IF PRE RX =2 OR 3 THEN USE &gt;=4 WBC, URINE hpf 5.0 UWBC IF MISSING PRE THEN USE &gt;=2, OR IF VALUE &gt;=4, OR IF PRE RX =0 OR 0.5 THEN USE &gt;=2, OR IF PRE RX =1 THEN USE &gt;=3, OR IF PRE RX =2 OR 3 THEN USE &gt;=4</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Other Marked Chemistry Laboratory Abnormalities in the Double Blind Period</measure>
    <time_frame>Day 1 to Day 729</time_frame>
    <description>LLN= Lower limit of normals ULN= Upper limit of normals Pre RX = Baseline value CALCIUM, TOTAL mmol/L 5.2 CA &lt;0.8X LLN OR &gt;1.2X ULN, OR IF PRE RX&lt;LLN THEN USE &lt;0.75X PRE RX OR &gt;ULN, OR IF PRE RX&gt;ULN THEN USE &gt;1.25X PRE RX OR &lt;LLN PHOSPHORUS, INORGANIC mmol/L 5.2 PHOS &lt;0.75X LLN OR &gt;1.25X ULN, OR IF PRE RX&lt;LLN THEN USE &lt;0.67X PRE RX OR &gt;ULN GLUCOSE, SERUM mmol/L 4.1 GLUC &lt;65 mg/dL, OR &gt;220 mg/dL PROTEIN, TOTAL g/L 5.0 TPRO &lt;0.9X LLN OR &gt;1.1X ULN, OR IF PRE RX&lt;LLN THEN USE 0.9X PRE RX OR &gt;ULN, OR IF PRE RX&gt;ULN THEN USE 1.1X PRE RX OR &lt;LLN ALBUMIN g/L 3.0 ALB &lt;0.9X LLN, OR IF PRE RX&lt;LLN THEN USE &lt;0.75X PRE RX CHOLESTEROL, TOTAL (TC) mmol/L 5.2 CHOL &gt;2X PRE R&#xD;
N = the number of participants with at least 1 on treatment lab result for each analyte</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Abatacept Induced Antibody Response Over Time in the Double-blind Period</measure>
    <time_frame>Day 365, Day 729</time_frame>
    <description>Participants who experienced a positive antibody response relative to baseline (ECL Assay)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">695</enrollment>
  <condition>Lupus Nephritis</condition>
  <arm_group>
    <arm_group_label>BMS-188667 + Mycophenolate mofetil + Prednisone</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>BMS-188667 30 mg/kg injection by intravenous on Days 1,15, 29, and 57, followed by a weight-tiered dose approximating 10mg/kg injection by intravenous every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo + Mycophenolate mofetil + Prednisone</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo matching with BMS-188667 injection by intravenous on Days 1,15, 29, and 57, followed by every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 Weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>BMS-188667</intervention_name>
    <arm_group_label>BMS-188667 + Mycophenolate mofetil + Prednisone</arm_group_label>
    <other_name>Abatacept</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Mycophenolate mofetil</intervention_name>
    <arm_group_label>BMS-188667 + Mycophenolate mofetil + Prednisone</arm_group_label>
    <arm_group_label>Placebo + Mycophenolate mofetil + Prednisone</arm_group_label>
    <other_name>Cellcept</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Prednisone</intervention_name>
    <arm_group_label>BMS-188667 + Mycophenolate mofetil + Prednisone</arm_group_label>
    <arm_group_label>Placebo + Mycophenolate mofetil + Prednisone</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Placebo matching with BMS-188667</intervention_name>
    <arm_group_label>Placebo + Mycophenolate mofetil + Prednisone</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        For additional information please contact the BMS Lupus Nephritis Clinical Trial Matching&#xD;
        Service at 855-56-LUPUS. Please visit www.BMSStudyConnect.com for more information on&#xD;
        clinical trial participation.&#xD;
&#xD;
        Note: Subjects &gt; 16 are eligible for enrollment at selected centers&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          -  Potential subjects must have active lupus nephritis&#xD;
&#xD;
          -  Biopsy within 12 months prior to screening visit indicating active Class 3 or 4&#xD;
             proliferative lupus glomerulonephritis (lupus effecting your kidney)&#xD;
&#xD;
          -  Urine protein creatinine ratio (UPCR) ≥ 1 at Screening&#xD;
&#xD;
          -  Serum creatinine ≤ 3 mg/dL (ie, ≤ 265 micromol/L)&#xD;
&#xD;
          -  There must also be evidence of active disease within 3 months of Screening, based on&#xD;
             at least one of the following:&#xD;
&#xD;
               -  Worsening of lupus nephritis OR&#xD;
&#xD;
               -  UPCR ≥ 3 at Screening OR&#xD;
&#xD;
               -  Active urine sediment OR&#xD;
&#xD;
               -  Biopsy within 3 months prior to screening visit indicating active Class 3 or&#xD;
                  Class 4 active proliferative lupus glomerulonephritis&#xD;
&#xD;
        Inclusion Criteria for the Long-Term Extension Period:&#xD;
&#xD;
          -  Signed Written Informed Consent&#xD;
&#xD;
          -  Subjects who achieve a complete or partial renal response after completing 2 years of&#xD;
             double-blind treatment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Systemic Lupus Erythematosus (SLE) must be the primary/main autoimmune diagnosis&#xD;
&#xD;
          -  Current symptoms of severe, progressive, or uncontrolled non-SLE related renal,&#xD;
             hepatic, hematological, gastrointestinal, pulmonary, cardiac, neurological, or&#xD;
             cerebral disease, or other concomitant medical conditions that, in the opinion of the&#xD;
             Investigator, might place the subject at unacceptable risk for participation in this&#xD;
             study&#xD;
&#xD;
          -  Significant active Central nervous system (CNS) lupus with the exception of fatigue or&#xD;
             mild stable cognitive&#xD;
&#xD;
          -  Subjects who are diagnosed as end-stage renal disease or whose kidney damage is too&#xD;
             significant and irreversible&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bristol-Myers Squibb</last_name>
    <role>Study Director</role>
    <affiliation>Bristol-Myers Squibb</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Of Alabama At Birmingham (Uab)</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35294</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Valerius Med Group &amp; Res Ctr Of Greater Long Beach, Inc.</name>
      <address>
        <city>Long Beach</city>
        <state>California</state>
        <zip>90806</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>East Bay Rheumatology Medical Group, Inc.</name>
      <address>
        <city>San Leandro</city>
        <state>California</state>
        <zip>94578</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Of Connecticut Health Center</name>
      <address>
        <city>Farmington</city>
        <state>Connecticut</state>
        <zip>06030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Of Miami Miller School Of Medicine</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33136</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Integral Rheumatology &amp; Immunology Specialists</name>
      <address>
        <city>Plantation</city>
        <state>Florida</state>
        <zip>33324</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Emory University.</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30303</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rush University Medical Center</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ochsner Clinic Foundation</name>
      <address>
        <city>Baton Rouge</city>
        <state>Louisiana</state>
        <zip>70809</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tulane University School Of Medicine</name>
      <address>
        <city>New Orleans</city>
        <state>Louisiana</state>
        <zip>70112</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Brigham &amp; Women'S Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Boston University Medical Center</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02118</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Camden</city>
        <state>New Jersey</state>
        <zip>08103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Suny Downstate Medical Center</name>
      <address>
        <city>Brooklyn</city>
        <state>New York</state>
        <zip>11203-2056</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northshore Lij Health System</name>
      <address>
        <city>Great Neck</city>
        <state>New York</state>
        <zip>11021</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Feinstein Institute For Medical Research</name>
      <address>
        <city>Manhasset</city>
        <state>New York</state>
        <zip>11030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital For Special Surgery</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10021-4892</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10032</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Of North Carolina At Chapel Hill</name>
      <address>
        <city>Chapel Hill</city>
        <state>North Carolina</state>
        <zip>27599</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shanahan Rheum &amp; Immunotherapy, PLLC</name>
      <address>
        <city>Raleigh</city>
        <state>North Carolina</state>
        <zip>27617</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MetroHealth Medical Center</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Paramount Medical Research &amp; Consulting, Llc</name>
      <address>
        <city>Middleburg Heights</city>
        <state>Ohio</state>
        <zip>44130</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rheumatology Consultants Pllc</name>
      <address>
        <city>Knoxville</city>
        <state>Tennessee</state>
        <zip>37909-1907</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UT Southwestern Medical Center</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75390</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Of Utah Hospital</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84112</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Charlottesville</city>
        <state>Virginia</state>
        <zip>22908</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Organizacion Medica De Investigacion S.A. (Omi)</name>
      <address>
        <city>Capital Federal</city>
        <state>Buenos Aires</state>
        <zip>1015</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Capital Federal</city>
        <state>Buenos Aires</state>
        <zip>1431</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Buenos Aires</city>
        <zip>1181</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Privado-Centro Medico De Cordoba S.A.</name>
      <address>
        <city>Cordoba</city>
        <zip>5016</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Adelaide</city>
        <state>South Australia</state>
        <zip>5000</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Parkville</city>
        <state>Victoria</state>
        <zip>3050</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Perth</city>
        <state>Western Australia</state>
        <zip>6009</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Savaldor</city>
        <state>Bahia</state>
        <zip>40150-150</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Goiania</city>
        <state>Goias</state>
        <zip>74110-120</zip>
        <country>Brazil</country>
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    </facility>
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  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Belo Horizonte</city>
        <state>Minas Gerais</state>
        <zip>30150-320</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Juiz De Fora</city>
        <state>Minas Gerais</state>
        <zip>36010-570</zip>
        <country>Brazil</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Uberlandia</city>
        <state>Minas Gerais</state>
        <zip>38400-902</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Porto Alegre</city>
        <state>Rio Grande Do Sul</state>
        <zip>91610000</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Sao Paulo</city>
        <zip>01323-900</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Mississauga</city>
        <state>Ontario</state>
        <zip>L5M 2V8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5T 2S8</zip>
        <country>Canada</country>
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    </facility>
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  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Santiago De Chile</city>
        <state>Metropolitana</state>
        <zip>8360156</zip>
        <country>Chile</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Santiago</city>
        <state>Metropolitana</state>
        <zip>8330024</zip>
        <country>Chile</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Independencia</city>
        <state>Santiago</state>
        <country>Chile</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Vina Del Mar</city>
        <state>Valparaiso</state>
        <zip>2570017</zip>
        <country>Chile</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100034</zip>
        <country>China</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100044</zip>
        <country>China</country>
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    </facility>
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  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510080</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Haikou</city>
        <state>Hainan</state>
        <zip>570311</zip>
        <country>China</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Wuhan</city>
        <state>Hebei</state>
        <zip>430030</zip>
        <country>China</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Harbin</city>
        <state>Heilongjiang</state>
        <zip>150001</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Zhengzhou</city>
        <state>Henan</state>
        <zip>450004</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Wuxi</city>
        <state>Jiangsu</state>
        <zip>214023</zip>
        <country>China</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Nanchang</city>
        <state>Jiangxi</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Xian</city>
        <state>Shan1xi</state>
        <zip>710054</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200032</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Chengdu</city>
        <state>Sichuan</state>
        <zip>610041</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <zip>310003</zip>
        <country>China</country>
      </address>
    </facility>
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  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Beijing</city>
        <zip>100029</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Chong Qing</city>
        <zip>400010</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Guangzhou</city>
        <country>China</country>
      </address>
    </facility>
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  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Nanchang</city>
        <zip>330006</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Nanning</city>
        <zip>530000</zip>
        <country>China</country>
      </address>
    </facility>
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  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Shanghai</city>
        <zip>200001</zip>
        <country>China</country>
      </address>
    </facility>
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  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Shanghai</city>
        <zip>200025</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Shanghai</city>
        <country>China</country>
      </address>
    </facility>
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  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Xi'An</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Riesgo De Fractura S.A. Cayre Ips</name>
      <address>
        <city>Bogota</city>
        <state>Cundinamarca</state>
        <country>Colombia</country>
      </address>
    </facility>
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  <location>
    <facility>
      <name>Servimed E.U</name>
      <address>
        <city>Bucaramanga</city>
        <state>Santander</state>
        <country>Colombia</country>
      </address>
    </facility>
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  <location>
    <facility>
      <name>Clinica De La Costa</name>
      <address>
        <city>Barranquilla</city>
        <zip>XXXXXX</zip>
        <country>Colombia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Circaribe S.A.S</name>
      <address>
        <city>Barranquilla</city>
        <country>Colombia</country>
      </address>
    </facility>
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  <location>
    <facility>
      <name>Hospital Universitario San Ignacio</name>
      <address>
        <city>Bogota</city>
        <country>Colombia</country>
      </address>
    </facility>
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  <location>
    <facility>
      <name>Hospital Pablo Tobon Uribe</name>
      <address>
        <city>Medellin</city>
        <zip>MEDELLIN</zip>
        <country>Colombia</country>
      </address>
    </facility>
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  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Praha 2</city>
        <zip>128 50</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Hong Kong</city>
        <country>Hong Kong</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Secunderabad</city>
        <state>Andhra Pradesh</state>
        <zip>500003</zip>
        <country>India</country>
      </address>
    </facility>
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  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Ahmedabad</city>
        <state>Gujrat</state>
        <zip>380052</zip>
        <country>India</country>
      </address>
    </facility>
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  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Gurgaon</city>
        <zip>122001</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Hyderabad</city>
        <zip>500004</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Lucknow-</city>
        <zip>226018</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>New Delhi</city>
        <zip>110029</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Haifa</city>
        <zip>31048</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Haifa</city>
        <zip>31096</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Ramat-gan</city>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Tel Aviv</city>
        <zip>64239</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Brescia</city>
        <zip>25123</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Milano</city>
        <zip>20122</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Padova</city>
        <zip>35128</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Reggio Emilia</city>
        <zip>42100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Torino</city>
        <zip>10128</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Nagakute-shi</city>
        <state>Aichi</state>
        <zip>4801195</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Nagoya-shi</city>
        <state>Aichi</state>
        <zip>4668560</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Chiba-shi</city>
        <state>Chiba</state>
        <zip>2608677</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Fukuoka-shi</city>
        <state>Fukuoka</state>
        <zip>8108563</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Kitakyushu-shi</city>
        <state>Fukuoka</state>
        <zip>8078555</zip>
        <country>Japan</country>
      </address>
    </facility>
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  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Maebashi-shi</city>
        <state>Gunma</state>
        <zip>3718511</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Sapporo-shi</city>
        <state>Hokkaido</state>
        <zip>0608604</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Sapporo-shi</city>
        <state>Hokkaido</state>
        <country>Japan</country>
      </address>
    </facility>
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  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Kanazawa-shi</city>
        <state>Ishikawa</state>
        <zip>9208641</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Yokohama-shi</city>
        <state>Kanagawa</state>
        <zip>2360004</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Sendai-shi</city>
        <state>Miyagi</state>
        <zip>9808574</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Nagasaki-shi</city>
        <state>Nagasaki</state>
        <zip>8528501</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Niigata-shi</city>
        <state>Niigata</state>
        <zip>9518520</zip>
        <country>Japan</country>
      </address>
    </facility>
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  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Okayama-shi</city>
        <state>Okayama</state>
        <zip>7008558</zip>
        <country>Japan</country>
      </address>
    </facility>
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  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Iruma-gun</city>
        <state>Saitama</state>
        <zip>3500495</zip>
        <country>Japan</country>
      </address>
    </facility>
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  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Shimotsuke-shi</city>
        <state>Tochigi</state>
        <zip>3290498</zip>
        <country>Japan</country>
      </address>
    </facility>
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  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Bunkyo-ku</city>
        <state>Tokyo</state>
        <zip>1138431</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Bunkyo-ku</city>
        <state>Tokyo</state>
        <zip>1138519</zip>
        <country>Japan</country>
      </address>
    </facility>
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  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Chuo-ku</city>
        <state>Tokyo</state>
        <zip>1048560</zip>
        <country>Japan</country>
      </address>
    </facility>
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  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Fuchu</city>
        <state>Tokyo</state>
        <zip>1838524</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Ota-ku</city>
        <state>Tokyo</state>
        <zip>1438541</zip>
        <country>Japan</country>
      </address>
    </facility>
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  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Shinjuku-Ku</city>
        <state>Tokyo</state>
        <zip>1608582</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Kita-gun</city>
        <zip>7610793</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Osaka</city>
        <zip>5308480</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Daegu</city>
        <zip>41944</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Seoul</city>
        <zip>06591</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Seoul</city>
        <zip>07345</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
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  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Mexico City</city>
        <state>Distrito Fededral</state>
        <zip>11850</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital De Jesus</name>
      <address>
        <city>Mexico City</city>
        <state>Distrito Federal</state>
        <zip>06090</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital General De Mexico O.D.</name>
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        <city>Mexico City</city>
        <state>Distrito Federal</state>
        <zip>06726</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Guadalajara, Jalisco</city>
        <state>Jalisco</state>
        <zip>44160</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro De Est D Inv. Basica Y Clinica</name>
      <address>
        <city>Guadalajara</city>
        <state>Jalisco</state>
        <zip>44690</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro Medico De Las Americas</name>
      <address>
        <city>Merida</city>
        <state>Yucatan</state>
        <zip>97000</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Instituto Nacional De Ciencias Medicas Y Nutricion S.Z.</name>
      <address>
        <city>Distrito Federal</city>
        <zip>14080</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro Potosino de Inv Clinica</name>
      <address>
        <city>San Luis Potosi</city>
        <zip>78200</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hosp Central I.Morones Prieto</name>
      <address>
        <city>San Luis Potosi</city>
        <zip>78240</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Nacional Guillermo Almenara Irigoyen</name>
      <address>
        <city>Lima</city>
        <zip>13</zip>
        <country>Peru</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Nacional Cayetano Heredia</name>
      <address>
        <city>Lima</city>
        <zip>LIMA 31</zip>
        <country>Peru</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Instituto De Ginecologia Y Reproduccion Inv. Clinical Sac</name>
      <address>
        <city>Lima</city>
        <zip>LIMA 33</zip>
        <country>Peru</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>San Juan</city>
        <zip>00927</zip>
        <country>Puerto Rico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Bucharest</city>
        <zip>011192</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Bucuresti</city>
        <zip>010976</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Bucuresti</city>
        <zip>020125</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Cluj-napoca</city>
        <zip>400006</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Iasi</city>
        <zip>700503</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Moscow</city>
        <zip>115522</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>St. Petersburg</city>
        <zip>197341</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Ufa</city>
        <zip>450005</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Madrid</city>
        <zip>28007</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Madrid</city>
        <zip>28041</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Kaohsiung</city>
        <zip>80756</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Kaohsiung</city>
        <zip>833</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Taichung</city>
        <zip>40447</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Taichung</city>
        <zip>40705</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Taipei</city>
        <zip>10051</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Taoyuan</city>
        <zip>333</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Antalya</city>
        <zip>07070</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Edirne</city>
        <zip>22030</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Argentina</country>
    <country>Australia</country>
    <country>Brazil</country>
    <country>Canada</country>
    <country>Chile</country>
    <country>China</country>
    <country>Colombia</country>
    <country>Czechia</country>
    <country>Hong Kong</country>
    <country>India</country>
    <country>Israel</country>
    <country>Italy</country>
    <country>Japan</country>
    <country>Korea, Republic of</country>
    <country>Mexico</country>
    <country>Peru</country>
    <country>Puerto Rico</country>
    <country>Romania</country>
    <country>Russian Federation</country>
    <country>Spain</country>
    <country>Taiwan</country>
    <country>Turkey</country>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>Czech Republic</country>
  </removed_countries>
  <link>
    <url>https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html</url>
    <description>BMS Clinical Trial Information</description>
  </link>
  <link>
    <url>https://www.bmsstudyconnect.com/s/US/English/USenHome</url>
    <description>BMS Clinical Trial Patient Recruiting</description>
  </link>
  <link>
    <url>https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm</url>
    <description>FDA Safety Alerts and Recalls</description>
  </link>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>October 24, 2012</study_first_submitted>
  <study_first_submitted_qc>October 24, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 26, 2012</study_first_posted>
  <results_first_submitted>November 20, 2017</results_first_submitted>
  <results_first_submitted_qc>November 20, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">December 21, 2017</results_first_posted>
  <last_update_submitted>February 24, 2021</last_update_submitted>
  <last_update_submitted_qc>February 24, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 26, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Nephritis</mesh_term>
    <mesh_term>Lupus Nephritis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Mycophenolic Acid</mesh_term>
    <mesh_term>Prednisone</mesh_term>
    <mesh_term>Abatacept</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>Overall, 695 participants were enrolled; 406 randomized; and 405 received treatment. 289 participants were screen failures and never treated with study medication; 233 were due to no longer meeting study criteria; 19 withdrew consent; 4 due to Adverse Events; 1 due to death; 1 due to poor/non-compliance; 1 was lost to follow up; and 30 were other.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Abatacept IV</title>
          <description>Abatacept 30 mg/kg injection by intravenous on Days 1,15, 29, and 57, followed by a weight-tiered dose approximating 10mg/kg injection by intravenous every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 weeks</description>
        </group>
        <group group_id="P2">
          <title>Placebo IV</title>
          <description>Placebo matching with Abatacept injection by intravenous on Days 1,15, 29, and 57, followed by every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 Weeks</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Year 1 Period</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="203"/>
                <participants group_id="P2" count="203"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Treated</title>
              <participants_list>
                <participants group_id="P1" count="202"/>
                <participants group_id="P2" count="203"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="155">Completed = continued study through Year 1</participants>
                <participants group_id="P2" count="161">Completed = continued study through Year 1</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="48"/>
                <participants group_id="P2" count="42"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lack of Efficacy</title>
              <participants_list>
                <participants group_id="P1" count="11"/>
                <participants group_id="P2" count="9"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
                <participants group_id="P2" count="17"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="7"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Poor / non-compliance</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Pregnancy</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Participant no longer meets criteria</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Not treated- received ACE inhibition</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Change in Concomitant Medication</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Need of use of Prohibited Medications</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Antiproteinuric changed/dose increased</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Hypersensitivity to the medication</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Year 2 Period</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="155">Started = Completed Year 1</participants>
                <participants group_id="P2" count="161">Started = Completed Year 1</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="129">Completed = Continued study through Year 2</participants>
                <participants group_id="P2" count="123">Completed = Continued study through Year 2</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="26"/>
                <participants group_id="P2" count="38"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lack of Efficacy</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="12"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="6"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Participant request to stop treatment</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Administrative reason by Sponsor</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Participant withdrew consent</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="5"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Participant no longer meets criteria</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Participant went to US stopped treatment</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Pregnancy</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Completed Year 1, did not enter Year 2</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Given cyclophosphamide, corticosteroids</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Long-Term Extension (LTE) Period</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="129">Started = Completed Year 2</participants>
                <participants group_id="P2" count="123">Started = Completed Year 2</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="62">Completed = Continued study through LTE</participants>
                <participants group_id="P2" count="53">Completed = Continued study through LTE</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="67"/>
                <participants group_id="P2" count="70"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Administrative reason by Sponsor</title>
              <participants_list>
                <participants group_id="P1" count="27"/>
                <participants group_id="P2" count="21"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Disease progression</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Not effective</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Participant request to stop treatment</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Participant withdrew consent</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event unrelated to study drug</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Pregnancy</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Study drug toxicity</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Participant no longer meets criteria</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Completed Year 2, did not enter LTE</title>
              <participants_list>
                <participants group_id="P1" count="33"/>
                <participants group_id="P2" count="38"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Absence of renal response</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Investigator decision, study termination</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Study was terminated</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>All Randomized and Treated Subjects</population>
      <group_list>
        <group group_id="B1">
          <title>Abatacept IV</title>
          <description>Abatacept 30 mg/kg injection by intravenous on Days 1,15, 29, and 57, followed by a weight-tiered dose approximating 10mg/kg injection by intravenous every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 weeks</description>
        </group>
        <group group_id="B2">
          <title>Placebo IV</title>
          <description>Placebo matching with Abatacept injection by intravenous on Days 1,15, 29, and 57, followed by every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 Weeks</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="202"/>
            <count group_id="B2" value="203"/>
            <count group_id="B3" value="405"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="33.1" spread="10.75" lower_limit="17" upper_limit="65"/>
                    <measurement group_id="B2" value="33.2" spread="10.48" lower_limit="18" upper_limit="72"/>
                    <measurement group_id="B3" value="33.1" spread="10.60" lower_limit="17" upper_limit="72"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="182"/>
                    <measurement group_id="B2" value="178"/>
                    <measurement group_id="B3" value="360"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="25"/>
                    <measurement group_id="B3" value="45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Asian</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="71"/>
                    <measurement group_id="B2" value="74"/>
                    <measurement group_id="B3" value="145"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>African American</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Caucasian</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="85"/>
                    <measurement group_id="B2" value="71"/>
                    <measurement group_id="B3" value="156"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="31"/>
                    <measurement group_id="B2" value="43"/>
                    <measurement group_id="B3" value="74"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants in Complete Renal Response (CR) of Lupus Glomerulonephritis at Day 365 of the Double-blind Period</title>
        <description>Number of participants achieving CR was divided by the total number of participants in that arm and expressed as a percentage. CR defined as: eGFR is normal or no &lt;85% of the baseline; eGFR based on mean creatinine value from day 358 and 365. Proteinuria: UPCR&lt;0.5 mg/mg. Urine sediment: No cellular casts. Corticosteroid dose: Daily dose must be no &gt;10 mg prednisone or equiv. for at least 28 days prior to assessment. Participants with &gt;10mg/day prednisone or equivalent for non-renal disease within 28 days prior to day 365 will be imputed as having achieved CR if the following are true: Met all criteria for CR at day 337 and all criteria for CR except corticosteroid dose at day 365; Investigator confirms increase in steroid dose is not related to renal disease. Adjusted odds ratio is estimated from logistic regression model which includes treatment group, baseline ACEi/ARBs use (Yes/No), race (Asian/ Black/Caucasian/Other) and baseline UPCR as a continuous variable.</description>
        <time_frame>Day 365</time_frame>
        <population>All randomized and treated participants</population>
        <group_list>
          <group group_id="O1">
            <title>Abatacept IV</title>
            <description>Abatacept 30 mg/kg injection by intravenous on Days 1,15, 29, and 57, followed by a weight-tiered dose approximating 10mg/kg injection by intravenous every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 weeks</description>
          </group>
          <group group_id="O2">
            <title>Placebo IV</title>
            <description>Placebo matching with Abatacept injection by intravenous on Days 1,15, 29, and 57, followed by every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 Weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants in Complete Renal Response (CR) of Lupus Glomerulonephritis at Day 365 of the Double-blind Period</title>
          <description>Number of participants achieving CR was divided by the total number of participants in that arm and expressed as a percentage. CR defined as: eGFR is normal or no &lt;85% of the baseline; eGFR based on mean creatinine value from day 358 and 365. Proteinuria: UPCR&lt;0.5 mg/mg. Urine sediment: No cellular casts. Corticosteroid dose: Daily dose must be no &gt;10 mg prednisone or equiv. for at least 28 days prior to assessment. Participants with &gt;10mg/day prednisone or equivalent for non-renal disease within 28 days prior to day 365 will be imputed as having achieved CR if the following are true: Met all criteria for CR at day 337 and all criteria for CR except corticosteroid dose at day 365; Investigator confirms increase in steroid dose is not related to renal disease. Adjusted odds ratio is estimated from logistic regression model which includes treatment group, baseline ACEi/ARBs use (Yes/No), race (Asian/ Black/Caucasian/Other) and baseline UPCR as a continuous variable.</description>
          <population>All randomized and treated participants</population>
          <units>Percentage</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="202"/>
                <count group_id="O2" value="203"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35.1" lower_limit="0.8967" upper_limit="1.5726"/>
                    <measurement group_id="O2" value="33.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>0.7264</p_value>
            <method>Stratified logistic regression</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.08</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.7077</ci_lower_limit>
            <ci_upper_limit>1.6421</ci_upper_limit>
            <estimate_desc>Abatacept IV:Placebo IV 95%CI for Odds Ratio</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Nephrotic Participants in Complete Renal Response of Lupus Glomerulonephritis at Day 365 of the Double-blind Period</title>
        <description>Number of participants achieving CR was divided by total participants in that arm, expressed as a percentage. CR is defined the following criteria: eGFR is normal or no &lt;85% of the baseline value; eGFR is based on mean creatinine value from day 358 and 365. Proteinuria: UPCR&lt;0.5 mg/mg. Urine sediment: No cellular casts. Corticosteroid dose: Daily dose must be no &gt;10 mg prednisone or equivalent for at least 28 days prior. Subjects with &gt;10mg/day prednisone or equivalent for non-renal disease within 28 days prior to day 365 will be imputed as CR if the following are true: Met all criteria for CR at day 337 and all criteria for CR except corticosteroid dose at day 365; Investigator confirms increase in steroid dose is not related to renal disease. Adjusted odds ratio is estimated from logistic regression model which includes treatment group, baseline ACEi/ARBs use, race and baseline UPCR as a continuous variable.</description>
        <time_frame>Day 365</time_frame>
        <population>All randomized and treated nephrotic participants. Nephrotic is defined as screening UPCR &gt;= 3.0mg/mg (&gt;=339mg/mmol)</population>
        <group_list>
          <group group_id="O1">
            <title>Abatacept IV</title>
            <description>Abatacept 30 mg/kg injection by intravenous on Days 1,15, 29, and 57, followed by a weight-tiered dose approximating 10mg/kg injection by intravenous every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 weeks</description>
          </group>
          <group group_id="O2">
            <title>Placebo IV</title>
            <description>Placebo matching with Abatacept injection by intravenous on Days 1,15, 29, and 57, followed by every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 Weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Nephrotic Participants in Complete Renal Response of Lupus Glomerulonephritis at Day 365 of the Double-blind Period</title>
          <description>Number of participants achieving CR was divided by total participants in that arm, expressed as a percentage. CR is defined the following criteria: eGFR is normal or no &lt;85% of the baseline value; eGFR is based on mean creatinine value from day 358 and 365. Proteinuria: UPCR&lt;0.5 mg/mg. Urine sediment: No cellular casts. Corticosteroid dose: Daily dose must be no &gt;10 mg prednisone or equivalent for at least 28 days prior. Subjects with &gt;10mg/day prednisone or equivalent for non-renal disease within 28 days prior to day 365 will be imputed as CR if the following are true: Met all criteria for CR at day 337 and all criteria for CR except corticosteroid dose at day 365; Investigator confirms increase in steroid dose is not related to renal disease. Adjusted odds ratio is estimated from logistic regression model which includes treatment group, baseline ACEi/ARBs use, race and baseline UPCR as a continuous variable.</description>
          <population>All randomized and treated nephrotic participants. Nephrotic is defined as screening UPCR &gt;= 3.0mg/mg (&gt;=339mg/mmol)</population>
          <units>Percentage</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="100"/>
                <count group_id="O2" value="88"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27" lower_limit="0.8967" upper_limit="1.5726"/>
                    <measurement group_id="O2" value="29.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.81</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.4148</ci_lower_limit>
            <ci_upper_limit>1.5956</ci_upper_limit>
            <estimate_desc>Abatacept IV:Placebo IV</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Adjusted Mean Change From Baseline in Urine Protein/Creatinine Ratio (UPCR) at Day 365 of the Double-blind Period in Nephrotic Participants</title>
        <description>Adjusted Mean Change from Baseline in UPCR at Day 365 of the double-blind period in nephrotic participants</description>
        <time_frame>Baseline and Day 365</time_frame>
        <population>All randomized and treated nephrotic participants with both post-baseline and baseline measurements</population>
        <group_list>
          <group group_id="O1">
            <title>Abatacept IV</title>
            <description>Abatacept 30 mg/kg injection by intravenous on Days 1,15, 29, and 57, followed by a weight-tiered dose approximating 10mg/kg injection by intravenous every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 weeks</description>
          </group>
          <group group_id="O2">
            <title>Placebo IV</title>
            <description>Placebo matching with Abatacept injection by intravenous on Days 1,15, 29, and 57, followed by every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 Weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Adjusted Mean Change From Baseline in Urine Protein/Creatinine Ratio (UPCR) at Day 365 of the Double-blind Period in Nephrotic Participants</title>
          <description>Adjusted Mean Change from Baseline in UPCR at Day 365 of the double-blind period in nephrotic participants</description>
          <population>All randomized and treated nephrotic participants with both post-baseline and baseline measurements</population>
          <units>UPCR (mg/mg)</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="76"/>
                <count group_id="O2" value="68"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-5.01" spread="0.33"/>
                    <measurement group_id="O2" value="-4.84" spread="0.35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>0.571</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Adjusted mean difference</param_type>
            <param_value>-0.17</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.76</ci_lower_limit>
            <ci_upper_limit>0.42</ci_upper_limit>
            <estimate_desc>Adjusted mean difference from placebo</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Adjusted Mean Change From Baseline in UPCR at Day 365 of the Double-blind Period in Overall Population</title>
        <description>Adjusted Mean Change from Baseline in Urine protein/creatinine ratio (UPCR) at Day 365 of the double-blind period in the overall population</description>
        <time_frame>Day 1 and Day 365</time_frame>
        <population>All randomized and treated participants with both post-baseline and baseline measurements</population>
        <group_list>
          <group group_id="O1">
            <title>Abatacept IV</title>
            <description>Abatacept 30 mg/kg injection by intravenous on Days 1,15, 29, and 57, followed by a weight-tiered dose approximating 10mg/kg injection by intravenous every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 weeks</description>
          </group>
          <group group_id="O2">
            <title>Placebo IV</title>
            <description>Placebo matching with Abatacept injection by intravenous on Days 1,15, 29, and 57, followed by every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 Weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Adjusted Mean Change From Baseline in UPCR at Day 365 of the Double-blind Period in Overall Population</title>
          <description>Adjusted Mean Change from Baseline in Urine protein/creatinine ratio (UPCR) at Day 365 of the double-blind period in the overall population</description>
          <population>All randomized and treated participants with both post-baseline and baseline measurements</population>
          <units>UPCR (mg/mg)</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="157"/>
                <count group_id="O2" value="163"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.99" spread="0.17"/>
                    <measurement group_id="O2" value="-2.90" spread="0.16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>0.561</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Adjusted mean difference</param_type>
            <param_value>-0.09</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.41</ci_lower_limit>
            <ci_upper_limit>0.22</ci_upper_limit>
            <estimate_desc>Adjusted mean difference from placebo</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Adjusted Mean Change From Baseline in Disease Activity as Measured by BILAG 2004 Over Time During Year 1 of the Double-blind Period</title>
        <description>Adjusted mean change from baseline in British Isles Lupus Assessment Group (BILAG) score over time during Year 1 of the double-blind period based on a repeated measure mixed model and presented at each visit in the first 12-month of the double-blind period. BILAG index measures disease activity in different organs/systems separately. BILAG score is calculated for each of 9 systems depending on the clinical features present and whether they are new (4 points), worse (3 points), the same (2 points), improving (1 point) or not present (0 points) in the last 4 weeks compared with previously. BILAG &quot;A&quot; represents the presence of serious features of lupus. BILAG &quot;B&quot; represents more moderate features of the disease. BILAG &quot;C&quot; includes only mild symptomatic features. BILAG &quot;D&quot; represents prior activity with no current symptoms due to active lupus. BILAG &quot;E&quot; represents an organ that has never been involved. Overall BILAG score ranges from 0-108, with higher scores reflecting a worse outcome.</description>
        <time_frame>Day 1 to Day 365</time_frame>
        <population>All randomized and treated participants with both post-baseline and baseline measurements</population>
        <group_list>
          <group group_id="O1">
            <title>Abatacept IV</title>
            <description>Abatacept 30 mg/kg injection by intravenous on Days 1,15, 29, and 57, followed by a weight-tiered dose approximating 10mg/kg injection by intravenous every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 weeks</description>
          </group>
          <group group_id="O2">
            <title>Placebo IV</title>
            <description>Placebo matching with Abatacept injection by intravenous on Days 1,15, 29, and 57, followed by every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 Weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Adjusted Mean Change From Baseline in Disease Activity as Measured by BILAG 2004 Over Time During Year 1 of the Double-blind Period</title>
          <description>Adjusted mean change from baseline in British Isles Lupus Assessment Group (BILAG) score over time during Year 1 of the double-blind period based on a repeated measure mixed model and presented at each visit in the first 12-month of the double-blind period. BILAG index measures disease activity in different organs/systems separately. BILAG score is calculated for each of 9 systems depending on the clinical features present and whether they are new (4 points), worse (3 points), the same (2 points), improving (1 point) or not present (0 points) in the last 4 weeks compared with previously. BILAG &quot;A&quot; represents the presence of serious features of lupus. BILAG &quot;B&quot; represents more moderate features of the disease. BILAG &quot;C&quot; includes only mild symptomatic features. BILAG &quot;D&quot; represents prior activity with no current symptoms due to active lupus. BILAG &quot;E&quot; represents an organ that has never been involved. Overall BILAG score ranges from 0-108, with higher scores reflecting a worse outcome.</description>
          <population>All randomized and treated participants with both post-baseline and baseline measurements</population>
          <units>Scores on a Scale</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="157"/>
                <count group_id="O2" value="161"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-8.22" lower_limit="-9.29" upper_limit="-7.16"/>
                    <measurement group_id="O2" value="-7.60" lower_limit="-8.66" upper_limit="-6.54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Any Adverse Events (AEs) During Year 1 of the Double-blind Period</title>
        <description>All AEs were coded and grouped into preferred terms (PT) by system organ class (SOC), using the Medical Dictionary for Regulatory Activities (MedDRA, version 21.0). Investigators determined the intensity of each AE as mild, moderate, severe, or very severe and assessed the relationship to study drug.</description>
        <time_frame>From Day 1 up to 56 days post last dose in Year 1 of the double-blind period</time_frame>
        <population>All treated participants</population>
        <group_list>
          <group group_id="O1">
            <title>Abatacept IV</title>
            <description>Abatacept 30 mg/kg injection by intravenous on Days 1,15, 29, and 57, followed by a weight-tiered dose approximating 10mg/kg injection by intravenous every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 weeks</description>
          </group>
          <group group_id="O2">
            <title>Placebo IV</title>
            <description>Placebo matching with Abatacept injection by intravenous on Days 1,15, 29, and 57, followed by every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 Weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Any Adverse Events (AEs) During Year 1 of the Double-blind Period</title>
          <description>All AEs were coded and grouped into preferred terms (PT) by system organ class (SOC), using the Medical Dictionary for Regulatory Activities (MedDRA, version 21.0). Investigators determined the intensity of each AE as mild, moderate, severe, or very severe and assessed the relationship to study drug.</description>
          <population>All treated participants</population>
          <units>Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="202"/>
                <count group_id="O2" value="203"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Participants with Adverse Events</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="188"/>
                    <measurement group_id="O2" value="194"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Participants with Serious Adverse Events</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="49"/>
                    <measurement group_id="O2" value="39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Participants with infection Adverse Events</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="150"/>
                    <measurement group_id="O2" value="147"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Participants with malignancies</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Participants with autoimmune events</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Participants with peri-infusional Adverse Events</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Participants with acute infusional Adverse Events</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Ranked Outcome of Complete Renal Response, Partial Renal Response (PR), and No Renal Response (NR) During the Double-blind Period</title>
        <description>Complete Renal Response or Complete Response (CR): defined as meeting ALL of the following criteria: eGFR normal OR no less than 85% of the baseline value; UPCR &lt; 0.5; Urine sediment: No cellular casts; Daily corticosteroid dose must be no greater than 10 mg prednisone or equivalent for at least 28 days prior to assessment. Partial Renal Response or Partial Response (PR): defined as meeting ALL of the following criteria: Participant does not meet criteria for CR; eGFR no less than 85% of the lesser of the values at screening or randomization (Day 1); UPCR &lt; 0.5 OR 50% reduced from baseline and &lt; 1 if baseline value was &lt; 3, OR 50% reduced from baseline and &lt; 3 if baseline value was greater than or equal to 3; Urine sediment: no cellular casts; daily corticosteroid dose no greater than 10 mg/day prednisone or prednisone equivalent for at least 28 days prior to assessment. No Renal Response or No Response (NR): defined as not meeting criteria for CR or PR or withdrawn</description>
        <time_frame>Day 365, Day 729</time_frame>
        <population>All randomized and treated participants.&#xD;
Year 1 data based on all elements of clinical response definition: UPCR, eGFR and cellular casts.&#xD;
Study terminated and Year 2 data based on only two clinical response definition elements: UPCR and eGFR. Data presented for the &quot;as observed&quot; population (those that completed Day 729).</population>
        <group_list>
          <group group_id="O1">
            <title>Abatacept IV</title>
            <description>Abatacept 30 mg/kg injection by intravenous on Days 1,15, 29, and 57, followed by a weight-tiered dose approximating 10mg/kg injection by intravenous every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 weeks</description>
          </group>
          <group group_id="O2">
            <title>Placebo IV</title>
            <description>Placebo matching with Abatacept injection by intravenous on Days 1,15, 29, and 57, followed by every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 Weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Ranked Outcome of Complete Renal Response, Partial Renal Response (PR), and No Renal Response (NR) During the Double-blind Period</title>
          <description>Complete Renal Response or Complete Response (CR): defined as meeting ALL of the following criteria: eGFR normal OR no less than 85% of the baseline value; UPCR &lt; 0.5; Urine sediment: No cellular casts; Daily corticosteroid dose must be no greater than 10 mg prednisone or equivalent for at least 28 days prior to assessment. Partial Renal Response or Partial Response (PR): defined as meeting ALL of the following criteria: Participant does not meet criteria for CR; eGFR no less than 85% of the lesser of the values at screening or randomization (Day 1); UPCR &lt; 0.5 OR 50% reduced from baseline and &lt; 1 if baseline value was &lt; 3, OR 50% reduced from baseline and &lt; 3 if baseline value was greater than or equal to 3; Urine sediment: no cellular casts; daily corticosteroid dose no greater than 10 mg/day prednisone or prednisone equivalent for at least 28 days prior to assessment. No Renal Response or No Response (NR): defined as not meeting criteria for CR or PR or withdrawn</description>
          <population>All randomized and treated participants.&#xD;
Year 1 data based on all elements of clinical response definition: UPCR, eGFR and cellular casts.&#xD;
Study terminated and Year 2 data based on only two clinical response definition elements: UPCR and eGFR. Data presented for the &quot;as observed&quot; population (those that completed Day 729).</population>
          <units>Percentage</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="202"/>
                <count group_id="O2" value="203"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>CR - Day 365</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="202"/>
                    <count group_id="O2" value="203"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35.1"/>
                    <measurement group_id="O2" value="33.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PR - Day 365</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="202"/>
                    <count group_id="O2" value="203"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.8"/>
                    <measurement group_id="O2" value="21.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>NR - Day 365</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="202"/>
                    <count group_id="O2" value="203"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="44.1"/>
                    <measurement group_id="O2" value="44.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CR - Day 729</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="112"/>
                    <count group_id="O2" value="110"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="60.7"/>
                    <measurement group_id="O2" value="53.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PR - Day 729</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="112"/>
                    <count group_id="O2" value="110"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25.9"/>
                    <measurement group_id="O2" value="22.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>NR - Day 729</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="112"/>
                    <count group_id="O2" value="110"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.4"/>
                    <measurement group_id="O2" value="23.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>CR - Day 365</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Estimate of Difference</param_type>
            <param_value>1.6510</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-7.595828</ci_lower_limit>
            <ci_upper_limit>10.897784</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>PR - Day 365</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Estimate of Difference</param_type>
            <param_value>-0.8828</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-8.848056</ci_lower_limit>
            <ci_upper_limit>7.082461</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>NR - Day 365</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Estimate of Difference</param_type>
            <param_value>-0.7682</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-10.446714</ci_lower_limit>
            <ci_upper_limit>8.910353</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Median Time to Complete Renal Response During the Double-blind Period in All Participants</title>
        <description>The estimate of median time to Complete Renal Response is based on Kaplan-Meier analysis. Complete renal response (CR): defined as meeting ALL of the following criteria: eGFR normal OR no less than 85% of the baseline value; Urine protein/creatinine ratio (UPCR) &lt; 0.5; Urine sediment: No cellular casts; Daily corticosteroid dose must be no greater than 10 mg prednisone or equivalent for at least 28 days prior to assessment.</description>
        <time_frame>Day 365, Day 729</time_frame>
        <population>All randomized and treated participants, as observed, calculated per modified criteria (UPCR and eGFR only)</population>
        <group_list>
          <group group_id="O1">
            <title>Abatacept IV</title>
            <description>Abatacept 30 mg/kg injection by intravenous on Days 1,15, 29, and 57, followed by a weight-tiered dose approximating 10mg/kg injection by intravenous every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Placebo IV</title>
            <description>Placebo matching with Abatacept injection by intravenous on Days 1,15, 29, and 57, followed by every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 Weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Median Time to Complete Renal Response During the Double-blind Period in All Participants</title>
          <description>The estimate of median time to Complete Renal Response is based on Kaplan-Meier analysis. Complete renal response (CR): defined as meeting ALL of the following criteria: eGFR normal OR no less than 85% of the baseline value; Urine protein/creatinine ratio (UPCR) &lt; 0.5; Urine sediment: No cellular casts; Daily corticosteroid dose must be no greater than 10 mg prednisone or equivalent for at least 28 days prior to assessment.</description>
          <population>All randomized and treated participants, as observed, calculated per modified criteria (UPCR and eGFR only)</population>
          <units>Days</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="202"/>
                <count group_id="O2" value="203"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 365</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="100"/>
                    <count group_id="O2" value="98"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="280.0" lower_limit="198.0" upper_limit="365.0"/>
                    <measurement group_id="O2" value="309.0" lower_limit="280.0" upper_limit="365.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 729</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="134"/>
                    <count group_id="O2" value="131"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="170.0" lower_limit="141.0" upper_limit="225.0"/>
                    <measurement group_id="O2" value="282.0" lower_limit="225.0" upper_limit="357.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Median Time to Complete Renal Response During the Double-blind Period in Nephrotic Participants</title>
        <description>The estimate of median time to Complete Renal Response in nephrotic participants is based on Kaplan-Meier analysis. Complete renal response (CR): defined as meeting ALL of the following criteria: eGFR normal OR no less than 85% of the baseline value; Urine protein/creatinine ratio (UPCR) &lt; 0.5; Urine sediment: No cellular casts; Daily corticosteroid dose must be no greater than 10 mg prednisone or equivalent for at least 28 days prior to assessment.</description>
        <time_frame>Day 365, Day 729</time_frame>
        <population>All randomized and treated nephrotic participants, as observed, calculated per modified criteria (UPCR and eGFR only); Nephrotic is defined as screening UPCR &gt;= 3.0 mg/mg (&gt;=339mg/mmol)</population>
        <group_list>
          <group group_id="O1">
            <title>Abatacept IV</title>
            <description>Abatacept 30 mg/kg injection by intravenous on Days 1,15, 29, and 57, followed by a weight-tiered dose approximating 10mg/kg injection by intravenous every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 weeks</description>
          </group>
          <group group_id="O2">
            <title>Placebo IV</title>
            <description>Placebo matching with Abatacept injection by intravenous on Days 1,15, 29, and 57, followed by every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 Weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Median Time to Complete Renal Response During the Double-blind Period in Nephrotic Participants</title>
          <description>The estimate of median time to Complete Renal Response in nephrotic participants is based on Kaplan-Meier analysis. Complete renal response (CR): defined as meeting ALL of the following criteria: eGFR normal OR no less than 85% of the baseline value; Urine protein/creatinine ratio (UPCR) &lt; 0.5; Urine sediment: No cellular casts; Daily corticosteroid dose must be no greater than 10 mg prednisone or equivalent for at least 28 days prior to assessment.</description>
          <population>All randomized and treated nephrotic participants, as observed, calculated per modified criteria (UPCR and eGFR only); Nephrotic is defined as screening UPCR &gt;= 3.0 mg/mg (&gt;=339mg/mmol)</population>
          <units>Days</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="100"/>
                <count group_id="O2" value="88"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 365</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="37"/>
                    <count group_id="O2" value="32"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="366.0" lower_limit="337.0" upper_limit="NA">Study terminated, upper limit not met</measurement>
                    <measurement group_id="O2" value="368.0" lower_limit="311.0" upper_limit="368.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 729</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="62"/>
                    <count group_id="O2" value="51"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="365.0" lower_limit="197.0" upper_limit="644.0"/>
                    <measurement group_id="O2" value="368.0" lower_limit="308.0" upper_limit="505.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Median Time to Partial Renal Response During the Double-blind Period in All Participants</title>
        <description>The estimate of median time to Partial Response (PR) is based on Kaplan-Meier analysis. Partial renal response (PR): defined as meeting ALL of the following criteria: Participant does not meet criteria for CR; eGFR no less than 85% of the lesser of the values at screening or randomization (Day 1); UPCR &lt; 0.5 OR 50% reduced from baseline and &lt; 1 if baseline value was &lt; 3, OR 50% reduced from baseline and &lt; 3 if baseline value was 3; Urine sediment: no cellular casts; daily corticosteroid dose no greater than 10 mg/day prednisone or prednisone equivalent for at least 28 days prior to assessment</description>
        <time_frame>Day 365, Day 729</time_frame>
        <population>All randomized and treated participants, as observed, calculated per modified criteria (UPCR and eGFR only)</population>
        <group_list>
          <group group_id="O1">
            <title>Abatacept IV</title>
            <description>Abatacept 30 mg/kg injection by intravenous on Days 1,15, 29, and 57, followed by a weight-tiered dose approximating 10mg/kg injection by intravenous every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Placebo IV</title>
            <description>Placebo matching with Abatacept injection by intravenous on Days 1,15, 29, and 57, followed by every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 Weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Median Time to Partial Renal Response During the Double-blind Period in All Participants</title>
          <description>The estimate of median time to Partial Response (PR) is based on Kaplan-Meier analysis. Partial renal response (PR): defined as meeting ALL of the following criteria: Participant does not meet criteria for CR; eGFR no less than 85% of the lesser of the values at screening or randomization (Day 1); UPCR &lt; 0.5 OR 50% reduced from baseline and &lt; 1 if baseline value was &lt; 3, OR 50% reduced from baseline and &lt; 3 if baseline value was 3; Urine sediment: no cellular casts; daily corticosteroid dose no greater than 10 mg/day prednisone or prednisone equivalent for at least 28 days prior to assessment</description>
          <population>All randomized and treated participants, as observed, calculated per modified criteria (UPCR and eGFR only)</population>
          <units>Days</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="202"/>
                <count group_id="O2" value="203"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 365</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="105"/>
                    <count group_id="O2" value="105"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="226.0" lower_limit="198.0" upper_limit="313.0"/>
                    <measurement group_id="O2" value="253.0" lower_limit="198.0" upper_limit="358.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 729</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="134"/>
                    <count group_id="O2" value="131"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="59.0" lower_limit="56.0" upper_limit="85.0"/>
                    <measurement group_id="O2" value="58.0" lower_limit="57.0" upper_limit="85.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Median Time to Partial Renal Response During the Double-blind Period in Nephrotic Participants</title>
        <description>The estimate of median time to Partial Response (PR) in nephrotic participants is based on Kaplan-Meier analysis. Partial renal response (PR): defined as meeting ALL of the following criteria: Participant does not meet criteria for CR; eGFR no less than 85% of the lesser of the values at screening or randomization (Day 1); UPCR &lt; 0.5 OR 50% reduced from baseline and &lt; 1 if baseline value was &lt; 3, OR 50% reduced from baseline and &lt; 3 if baseline value was 3; Urine sediment: no cellular casts; daily corticosteroid dose no greater than 10 mg/day prednisone or prednisone equivalent for at least 28 days prior to assessment</description>
        <time_frame>Day 365, Day 729</time_frame>
        <population>All randomized and treated nephrotic participants, as observed, calculated per modified criteria (UPCR and eGFR only); Nephrotic is defined as screening UPCR &gt;= 3.0 mg/mg (&gt;=339mg/mmol)</population>
        <group_list>
          <group group_id="O1">
            <title>Abatacept IV</title>
            <description>Abatacept 30 mg/kg injection by intravenous on Days 1,15, 29, and 57, followed by a weight-tiered dose approximating 10mg/kg injection by intravenous every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Placebo IV</title>
            <description>Placebo matching with Abatacept injection by intravenous on Days 1,15, 29, and 57, followed by every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 Weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Median Time to Partial Renal Response During the Double-blind Period in Nephrotic Participants</title>
          <description>The estimate of median time to Partial Response (PR) in nephrotic participants is based on Kaplan-Meier analysis. Partial renal response (PR): defined as meeting ALL of the following criteria: Participant does not meet criteria for CR; eGFR no less than 85% of the lesser of the values at screening or randomization (Day 1); UPCR &lt; 0.5 OR 50% reduced from baseline and &lt; 1 if baseline value was &lt; 3, OR 50% reduced from baseline and &lt; 3 if baseline value was 3; Urine sediment: no cellular casts; daily corticosteroid dose no greater than 10 mg/day prednisone or prednisone equivalent for at least 28 days prior to assessment</description>
          <population>All randomized and treated nephrotic participants, as observed, calculated per modified criteria (UPCR and eGFR only); Nephrotic is defined as screening UPCR &gt;= 3.0 mg/mg (&gt;=339mg/mmol)</population>
          <units>Days</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="100"/>
                <count group_id="O2" value="88"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 365</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="55"/>
                    <count group_id="O2" value="51"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="225.0" lower_limit="196.0" upper_limit="311.0"/>
                    <measurement group_id="O2" value="196.0" lower_limit="170.0" upper_limit="225.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 729</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="62"/>
                    <count group_id="O2" value="51"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="58.5" lower_limit="29.0" upper_limit="86.0"/>
                    <measurement group_id="O2" value="56.0" lower_limit="29.0" upper_limit="58.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Adjusted Mean Change From Baseline in UPCR Over Time</title>
        <description>A repeated measure mixed model that included the baseline UPCR value, randomization stratification factors, time, and time by treatment interaction as fixed effects and subject as a random effect was used.</description>
        <time_frame>Day 365; Day 729, includes data up to July 1st 2017 when double-blind therapy ended</time_frame>
        <population>All randomized and treated participants with both post-baseline and baseline measurements</population>
        <group_list>
          <group group_id="O1">
            <title>Abatacept IV</title>
            <description>Abatacept 30 mg/kg injection by intravenous on Days 1,15, 29, and 57, followed by a weight-tiered dose approximating 10mg/kg injection by intravenous every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Placebo IV</title>
            <description>Placebo matching with Abatacept injection by intravenous on Days 1,15, 29, and 57, followed by every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 Weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Adjusted Mean Change From Baseline in UPCR Over Time</title>
          <description>A repeated measure mixed model that included the baseline UPCR value, randomization stratification factors, time, and time by treatment interaction as fixed effects and subject as a random effect was used.</description>
          <population>All randomized and treated participants with both post-baseline and baseline measurements</population>
          <units>UPCR (mg/mg)</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="157"/>
                <count group_id="O2" value="163"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 365</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="157"/>
                    <count group_id="O2" value="163"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.95" spread="0.17"/>
                    <measurement group_id="O2" value="-2.68" spread="0.17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 729</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="112"/>
                    <count group_id="O2" value="110"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.13" spread="0.18"/>
                    <measurement group_id="O2" value="-2.72" spread="0.18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Median Percent Change From Baseline in UPCR Over Time</title>
        <description>A repeated measure mixed model that included the baseline UPCR value, randomization stratification factors, time, and time by treatment interaction as fixed effects and subject as a random effect was used.&#xD;
% Change from Baseline = (post baseline - baseline value) / baseline value x 100</description>
        <time_frame>Day 365, Day 729</time_frame>
        <population>All randomized and treated participants with both post-baseline and baseline measurements</population>
        <group_list>
          <group group_id="O1">
            <title>Abatacept IV</title>
            <description>Abatacept 30 mg/kg injection by intravenous on Days 1,15, 29, and 57, followed by a weight-tiered dose approximating 10mg/kg injection by intravenous every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Placebo IV</title>
            <description>Placebo matching with Abatacept injection by intravenous on Days 1,15, 29, and 57, followed by every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 Weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Median Percent Change From Baseline in UPCR Over Time</title>
          <description>A repeated measure mixed model that included the baseline UPCR value, randomization stratification factors, time, and time by treatment interaction as fixed effects and subject as a random effect was used.&#xD;
% Change from Baseline = (post baseline - baseline value) / baseline value x 100</description>
          <population>All randomized and treated participants with both post-baseline and baseline measurements</population>
          <units>Percent</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="202"/>
                <count group_id="O2" value="203"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 365</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="157"/>
                    <count group_id="O2" value="163"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-83.77" lower_limit="-92.42" upper_limit="-64.18"/>
                    <measurement group_id="O2" value="-84.12" lower_limit="-94.03" upper_limit="-59.98"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 729</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="112"/>
                    <count group_id="O2" value="110"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-89.83" lower_limit="-95.41" upper_limit="-77.95"/>
                    <measurement group_id="O2" value="-87.28" lower_limit="-93.78" upper_limit="-66.43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Adjusted Mean Change From Baseline in eGFR Over Time</title>
        <description>Estimated glomerular filtration rate(eGFR), will be calculated by the CKD-EPI formula shown below.50 eGFR is expressed as mL/min per 1.73m2. For the purpose of this study lower limit of normal eGFR is defined as 90mL/min per 1.73m2 eGFR = 141 X min (Scr/k, 1)α X max (Scr/k, 1)-1.209 X 0.993Age X (1.018 [if female]) X (1.159 [if black]) Where Scr is serum creatinine (mg/dL), k is 0.7 for females and 0.9 for males, α is -0.329 for females and -0.411 for males, min indicates the minimum of Scr/k or 1, and max indicates the maximum of Scr/k or 1, age in years.</description>
        <time_frame>Day 365, Day 729</time_frame>
        <population>All randomized and treated participants with both post-baseline and baseline measurements</population>
        <group_list>
          <group group_id="O1">
            <title>Abatacept IV</title>
            <description>Abatacept 30 mg/kg injection by intravenous on Days 1,15, 29, and 57, followed by a weight-tiered dose approximating 10mg/kg injection by intravenous every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 weeks</description>
          </group>
          <group group_id="O2">
            <title>Placebo IV</title>
            <description>Placebo matching with Abatacept injection by intravenous on Days 1,15, 29, and 57, followed by every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 Weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Adjusted Mean Change From Baseline in eGFR Over Time</title>
          <description>Estimated glomerular filtration rate(eGFR), will be calculated by the CKD-EPI formula shown below.50 eGFR is expressed as mL/min per 1.73m2. For the purpose of this study lower limit of normal eGFR is defined as 90mL/min per 1.73m2 eGFR = 141 X min (Scr/k, 1)α X max (Scr/k, 1)-1.209 X 0.993Age X (1.018 [if female]) X (1.159 [if black]) Where Scr is serum creatinine (mg/dL), k is 0.7 for females and 0.9 for males, α is -0.329 for females and -0.411 for males, min indicates the minimum of Scr/k or 1, and max indicates the maximum of Scr/k or 1, age in years.</description>
          <population>All randomized and treated participants with both post-baseline and baseline measurements</population>
          <units>mL/min per 1.73m2</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="202"/>
                <count group_id="O2" value="203"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 365</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="158"/>
                    <count group_id="O2" value="162"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.85" lower_limit="3.47" upper_limit="10.23"/>
                    <measurement group_id="O2" value="5.85" lower_limit="2.51" upper_limit="9.20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 729</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="112"/>
                    <count group_id="O2" value="109"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.20" lower_limit="3.40" upper_limit="11.00"/>
                    <measurement group_id="O2" value="7.91" lower_limit="4.14" upper_limit="11.68"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Median Time to First Sustained Change to No Response During the Double-blind Period</title>
        <description>Sustained response defined as response present at 2 consecutive visits approximately 4 weeks apart. No renal response (NR): defined as not meeting criteria for CR or PR or withdrawn&#xD;
The estimate of median time is based on Kaplan-Meier analysis</description>
        <time_frame>Day 365, Day 729</time_frame>
        <population>All randomized and treated participants</population>
        <group_list>
          <group group_id="O1">
            <title>Abatacept IV</title>
            <description>Abatacept 30 mg/kg injection by intravenous on Days 1,15, 29, and 57, followed by a weight-tiered dose approximating 10mg/kg injection by intravenous every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 weeks</description>
          </group>
          <group group_id="O2">
            <title>Placebo IV</title>
            <description>Placebo matching with Abatacept injection by intravenous on Days 1,15, 29, and 57, followed by every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 Weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Median Time to First Sustained Change to No Response During the Double-blind Period</title>
          <description>Sustained response defined as response present at 2 consecutive visits approximately 4 weeks apart. No renal response (NR): defined as not meeting criteria for CR or PR or withdrawn&#xD;
The estimate of median time is based on Kaplan-Meier analysis</description>
          <population>All randomized and treated participants</population>
          <units>Days</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="202"/>
                <count group_id="O2" value="203"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 365</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="23"/>
                    <count group_id="O2" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" lower_limit="392.0" upper_limit="NA">Due to &lt; 50% event occurrence, the median is not evaluable</measurement>
                    <measurement group_id="O2" value="NA" lower_limit="NA" upper_limit="NA">Due to &lt; 50% event occurrence, the median is not evaluable</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 729</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="202"/>
                    <count group_id="O2" value="203"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" lower_limit="NA" upper_limit="NA">Due to &lt; 50% event occurrence, the median is not evaluable</measurement>
                    <measurement group_id="O2" value="NA" lower_limit="672.0" upper_limit="NA">Due to &lt; 50% event occurrence, the median is not evaluable</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Sustained Change From Higher Level of Response to no Response During the Double-blind Period</title>
        <description>Sustained change to no response is defined as going from CR (or PR) to NR and remaining in NR for at least 2 consecutive visits; visits should be approximately 4 weeks apart. This analysis will be based on time from response CR (or PR) to the first visit in which the no response (NR) was achieved and sustained to the next visit.</description>
        <time_frame>Day 365, Day 729</time_frame>
        <population>All randomized and treated participants, as observed, calculated per modified criteria (UPCR and eGFR only)</population>
        <group_list>
          <group group_id="O1">
            <title>Abatacept IV</title>
            <description>Abatacept 30 mg/kg injection by intravenous on Days 1,15, 29, and 57, followed by a weight-tiered dose approximating 10mg/kg injection by intravenous every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 weeks</description>
          </group>
          <group group_id="O2">
            <title>Placebo IV</title>
            <description>Placebo matching with Abatacept injection by intravenous on Days 1,15, 29, and 57, followed by every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 Weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Sustained Change From Higher Level of Response to no Response During the Double-blind Period</title>
          <description>Sustained change to no response is defined as going from CR (or PR) to NR and remaining in NR for at least 2 consecutive visits; visits should be approximately 4 weeks apart. This analysis will be based on time from response CR (or PR) to the first visit in which the no response (NR) was achieved and sustained to the next visit.</description>
          <population>All randomized and treated participants, as observed, calculated per modified criteria (UPCR and eGFR only)</population>
          <units>Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="202"/>
                <count group_id="O2" value="203"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 365</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="110"/>
                    <count group_id="O2" value="98"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 729</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="134"/>
                    <count group_id="O2" value="131"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="52"/>
                    <measurement group_id="O2" value="56"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Day 365</non_inferiority_desc>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>1.43</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.3251</ci_lower_limit>
            <ci_upper_limit>6.2849</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Day 729</non_inferiority_desc>
            <param_type>Estimate of Difference vs Drug</param_type>
            <param_value>3.4</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-8.4</ci_lower_limit>
            <ci_upper_limit>15.1</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Adjusted Mean Change From Baseline in Disease Activity as Measured by BILAG 2004 Over Time During the Double-blind Period</title>
        <description>BILAG index measures and reports disease activity in different organs/systems separately. The BILAG score is calculated for each of nine systems depending on the clinical features present and whether they are new (4 points), worse (3 points), the same (2 points), improving (1 point) or not present (0 points) in the last 4 weeks compared with previously. A BILAG &quot;A&quot; represents the presence of one or more serious features of lupus. A BILAG &quot;B&quot; represents more moderate features of the disease. A BILAG &quot;C&quot; includes only mild symptomatic features. A BILAG &quot;D&quot; represents only prior activity with no current symptoms due to active lupus. A BILAG &quot;E&quot; represents an organ that has never been involved. Overall BILAG score ranges from 0-108, with higher scores reflecting a worse outcome.</description>
        <time_frame>Day 1 to Day 729; Day 365 to Day 729</time_frame>
        <population>All randomized and treated participants with both post-baseline and baseline measurements</population>
        <group_list>
          <group group_id="O1">
            <title>Abatacept IV</title>
            <description>Abatacept 30 mg/kg injection by intravenous on Days 1,15, 29, and 57, followed by a weight-tiered dose approximating 10mg/kg injection by intravenous every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 weeks</description>
          </group>
          <group group_id="O2">
            <title>Placebo IV</title>
            <description>Placebo matching with Abatacept injection by intravenous on Days 1,15, 29, and 57, followed by every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 Weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Adjusted Mean Change From Baseline in Disease Activity as Measured by BILAG 2004 Over Time During the Double-blind Period</title>
          <description>BILAG index measures and reports disease activity in different organs/systems separately. The BILAG score is calculated for each of nine systems depending on the clinical features present and whether they are new (4 points), worse (3 points), the same (2 points), improving (1 point) or not present (0 points) in the last 4 weeks compared with previously. A BILAG &quot;A&quot; represents the presence of one or more serious features of lupus. A BILAG &quot;B&quot; represents more moderate features of the disease. A BILAG &quot;C&quot; includes only mild symptomatic features. A BILAG &quot;D&quot; represents only prior activity with no current symptoms due to active lupus. A BILAG &quot;E&quot; represents an organ that has never been involved. Overall BILAG score ranges from 0-108, with higher scores reflecting a worse outcome.</description>
          <population>All randomized and treated participants with both post-baseline and baseline measurements</population>
          <units>Scores on a Scale</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="202"/>
                <count group_id="O2" value="203"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 1 to Day 729</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="109"/>
                    <count group_id="O2" value="108"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-9.31" spread="0.56"/>
                    <measurement group_id="O2" value="-8.53" spread="0.56"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 365 to Day 729</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="129"/>
                    <count group_id="O2" value="127"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.95" spread="0.538"/>
                    <measurement group_id="O2" value="-0.40" spread="0.530"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Cmin (ug/mL): Trough Level Serum Concentration of Abatacept Prior to the Administration of the IV Infusion</title>
        <description>Trough level serum concentration of abatacept prior to the administration of the IV infusion on Days 1 to 365</description>
        <time_frame>Days 1 to 365</time_frame>
        <population>All participants who received at least 1 Abatacept Infusion and have at least 1 Cmin value during Year 1 of the double-blind period.</population>
        <group_list>
          <group group_id="O1">
            <title>Abatacept IV</title>
            <description>Abatacept 30 mg/kg injection by intravenous on Days 1,15, 29, and 57, followed by a weight-tiered dose approximating 10mg/kg injection by intravenous every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 weeks</description>
          </group>
          <group group_id="O2">
            <title>Placebo IV</title>
            <description>Placebo matching with Abatacept injection by intravenous on Days 1,15, 29, and 57, followed by every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 Weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Cmin (ug/mL): Trough Level Serum Concentration of Abatacept Prior to the Administration of the IV Infusion</title>
          <description>Trough level serum concentration of abatacept prior to the administration of the IV infusion on Days 1 to 365</description>
          <population>All participants who received at least 1 Abatacept Infusion and have at least 1 Cmin value during Year 1 of the double-blind period.</population>
          <units>ug/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="189"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 15</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="189"/>
                    <count group_id="O2" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="69.97" spread="91.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 29</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="177"/>
                    <count group_id="O2" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="90.46" spread="56.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 57</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="177"/>
                    <count group_id="O2" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="36.43" spread="84.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 85</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="172"/>
                    <count group_id="O2" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="34.46" spread="55.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 113</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="164"/>
                    <count group_id="O2" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.42" spread="69.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 169</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="157"/>
                    <count group_id="O2" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.98" spread="64.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 281</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="152"/>
                    <count group_id="O2" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.44" spread="54.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 337</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="139"/>
                    <count group_id="O2" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.99" spread="73.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 365</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="133"/>
                    <count group_id="O2" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.62" spread="51.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Cmax: Maximum Observed Serum Concentration Following Participants Receiving Active Abatacept IV</title>
        <description>Cmax: Maximum observed serum concentration following participants receiving active abatacept IV</description>
        <time_frame>at 1 hour post Day 1 dose and 30 minutes post Day 337 dose</time_frame>
        <population>All participants who received at least 1 Abatacept Infusion and have at least 1 Cmin value during Year 1 of the double-blind period</population>
        <group_list>
          <group group_id="O1">
            <title>Abatacept IV</title>
            <description>Abatacept 30 mg/kg injection by intravenous on Days 1,15, 29, and 57, followed by a weight-tiered dose approximating 10mg/kg injection by intravenous every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 weeks</description>
          </group>
          <group group_id="O2">
            <title>Placebo IV</title>
            <description>Placebo matching with Abatacept injection by intravenous on Days 1,15, 29, and 57, followed by every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 Weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Cmax: Maximum Observed Serum Concentration Following Participants Receiving Active Abatacept IV</title>
          <description>Cmax: Maximum observed serum concentration following participants receiving active abatacept IV</description>
          <population>All participants who received at least 1 Abatacept Infusion and have at least 1 Cmin value during Year 1 of the double-blind period</population>
          <units>ug/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="185"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="185"/>
                    <count group_id="O2" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="527.43" spread="59.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 337</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="135"/>
                    <count group_id="O2" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="203.51" spread="30.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>AUC (TAU): Area Under the Serum Concentration Time Curve Over a Dosing Interval</title>
        <description>AUC (TAU): Area under the serum concentration time curve over a dosing interval between Days 337 to 365.</description>
        <time_frame>Days 337 to 365</time_frame>
        <population>All participants who received at least 1 Abatacept Infusion and have at least 1 Cmin value during Year 1 of the double-blind period</population>
        <group_list>
          <group group_id="O1">
            <title>Abatacept IV</title>
            <description>Abatacept 30 mg/kg injection by intravenous on Days 1,15, 29, and 57, followed by a weight-tiered dose approximating 10mg/kg injection by intravenous every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 weeks</description>
          </group>
          <group group_id="O2">
            <title>Placebo IV</title>
            <description>Placebo matching with Abatacept injection by intravenous on Days 1,15, 29, and 57, followed by every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 Weeks</description>
          </group>
        </group_list>
        <measure>
          <title>AUC (TAU): Area Under the Serum Concentration Time Curve Over a Dosing Interval</title>
          <description>AUC (TAU): Area under the serum concentration time curve over a dosing interval between Days 337 to 365.</description>
          <population>All participants who received at least 1 Abatacept Infusion and have at least 1 Cmin value during Year 1 of the double-blind period</population>
          <units>ug*h/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="106"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="36480.24" spread="29.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Summary Statistics for Systolic Blood Pressure</title>
        <description>Summary statistics for systolic blood pressure</description>
        <time_frame>Day 1 to Day 729</time_frame>
        <population>All treated participants</population>
        <group_list>
          <group group_id="O1">
            <title>Abatacept IV</title>
            <description>Abatacept 30 mg/kg injection by intravenous on Days 1,15, 29, and 57, followed by a weight-tiered dose approximating 10mg/kg injection by intravenous every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 weeks</description>
          </group>
          <group group_id="O2">
            <title>Placebo IV</title>
            <description>Placebo matching with Abatacept injection by intravenous on Days 1,15, 29, and 57, followed by every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 Weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Summary Statistics for Systolic Blood Pressure</title>
          <description>Summary statistics for systolic blood pressure</description>
          <population>All treated participants</population>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="202"/>
                <count group_id="O2" value="203"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 1, end of observation</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="199"/>
                    <count group_id="O2" value="200"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="122.0" spread="15.48"/>
                    <measurement group_id="O2" value="122.6" spread="15.31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 365, end of observation</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="112.3" spread="18.45"/>
                    <measurement group_id="O2" value="115.0" spread="7.07"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 729, end of observation</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="81"/>
                    <count group_id="O2" value="73"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="108.6" spread="13.29"/>
                    <measurement group_id="O2" value="114.2" spread="14.51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Summary Statistics for Diastolic Blood Pressure</title>
        <description>Summary statistics for diastolic blood pressure</description>
        <time_frame>Day 1 to Day 729</time_frame>
        <population>All treated participants</population>
        <group_list>
          <group group_id="O1">
            <title>Abatacept IV</title>
            <description>Abatacept 30 mg/kg injection by intravenous on Days 1,15, 29, and 57, followed by a weight-tiered dose approximating 10mg/kg injection by intravenous every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 weeks</description>
          </group>
          <group group_id="O2">
            <title>Placebo IV</title>
            <description>Placebo matching with Abatacept injection by intravenous on Days 1,15, 29, and 57, followed by every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 Weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Summary Statistics for Diastolic Blood Pressure</title>
          <description>Summary statistics for diastolic blood pressure</description>
          <population>All treated participants</population>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="202"/>
                <count group_id="O2" value="203"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 1, end of observation</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="199"/>
                    <count group_id="O2" value="200"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="76.5" spread="11.49"/>
                    <measurement group_id="O2" value="77.0" spread="11.19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 365, end of observation</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="73.5" spread="10.75"/>
                    <measurement group_id="O2" value="77.5" spread="10.61"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 729, end of observation</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="81"/>
                    <count group_id="O2" value="73"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="67.5" spread="9.60"/>
                    <measurement group_id="O2" value="72.7" spread="9.45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Summary Statistics for Heart Rate</title>
        <description>Summary statistics for Heart Rate</description>
        <time_frame>Day 1 to Day 729</time_frame>
        <population>All treated participants</population>
        <group_list>
          <group group_id="O1">
            <title>Abatacept IV</title>
            <description>Abatacept 30 mg/kg injection by intravenous on Days 1,15, 29, and 57, followed by a weight-tiered dose approximating 10mg/kg injection by intravenous every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 weeks</description>
          </group>
          <group group_id="O2">
            <title>Placebo IV</title>
            <description>Placebo matching with Abatacept injection by intravenous on Days 1,15, 29, and 57, followed by every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 Weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Summary Statistics for Heart Rate</title>
          <description>Summary statistics for Heart Rate</description>
          <population>All treated participants</population>
          <units>beats per minute</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="202"/>
                <count group_id="O2" value="203"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 1, end of observation</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="199"/>
                    <count group_id="O2" value="200"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="80.6" spread="10.91"/>
                    <measurement group_id="O2" value="81.4" spread="10.64"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 365, end of observation</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="78.5" spread="9.57"/>
                    <measurement group_id="O2" value="70.0" spread="14.14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 729, end of observation</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="81"/>
                    <count group_id="O2" value="72"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="76.2" spread="11.69"/>
                    <measurement group_id="O2" value="76.7" spread="10.36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Change From Baseline in Laboratory Analytes During the Double-blind Period (U/L)</title>
        <description>Laboratory assessments were analyzed centrally, with the exception of pregnancy testing. Blood draws and urine collections were performed at visits specified in the protocol.&#xD;
Change from Baseline = Post-baseline - Baseline value.</description>
        <time_frame>Day 729</time_frame>
        <population>All treated participants with both post-baseline and baseline measurements</population>
        <group_list>
          <group group_id="O1">
            <title>Abatacept IV</title>
            <description>Abatacept 30 mg/kg injection by intravenous on Days 1,15, 29, and 57, followed by a weight-tiered dose approximating 10mg/kg injection by intravenous every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 weeks</description>
          </group>
          <group group_id="O2">
            <title>Placebo IV</title>
            <description>Placebo matching with Abatacept injection by intravenous on Days 1,15, 29, and 57, followed by every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 Weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change From Baseline in Laboratory Analytes During the Double-blind Period (U/L)</title>
          <description>Laboratory assessments were analyzed centrally, with the exception of pregnancy testing. Blood draws and urine collections were performed at visits specified in the protocol.&#xD;
Change from Baseline = Post-baseline - Baseline value.</description>
          <population>All treated participants with both post-baseline and baseline measurements</population>
          <units>U/L</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="153"/>
                <count group_id="O2" value="160"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>ALANINE AMINOTRANSFERASE (ALT) (U/L)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="133"/>
                    <count group_id="O2" value="116"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.2" lower_limit="-4.834" upper_limit="0.382"/>
                    <measurement group_id="O2" value="-3.4" lower_limit="-6.462" upper_limit="-0.435"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ALKALINE PHOSPHATASE (ALP) (U/L)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="133"/>
                    <count group_id="O2" value="116"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.2" lower_limit="4.514" upper_limit="11.967"/>
                    <measurement group_id="O2" value="11.7" lower_limit="7.125" upper_limit="16.202"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ASPARTATE AMINOTRANSFERASE (AST) (U/L)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="133"/>
                    <count group_id="O2" value="116"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.3" lower_limit="-1.747" upper_limit="2.288"/>
                    <measurement group_id="O2" value="0.3" lower_limit="-1.326" upper_limit="1.947"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>G-GLUTAMYL TRANSFERASE (GGT) (U/L)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="133"/>
                    <count group_id="O2" value="116"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-5.3" lower_limit="-11.020" upper_limit="0.509"/>
                    <measurement group_id="O2" value="-4.1" lower_limit="-11.419" upper_limit="3.143"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Change From Baseline in Laboratory Analytes During the Double-blind Period (g/L)</title>
        <description>Laboratory assessments were analyzed centrally, with the exception of pregnancy testing. Blood draws and urine collections were performed at visits specified in the protocol.&#xD;
Change from Baseline = Post-baseline - Baseline value.</description>
        <time_frame>Day 729</time_frame>
        <population>All treated participants with both post-baseline and baseline measurements</population>
        <group_list>
          <group group_id="O1">
            <title>Abatacept IV</title>
            <description>Abatacept 30 mg/kg injection by intravenous on Days 1,15, 29, and 57, followed by a weight-tiered dose approximating 10mg/kg injection by intravenous every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 weeks</description>
          </group>
          <group group_id="O2">
            <title>Placebo IV</title>
            <description>Placebo matching with Abatacept injection by intravenous on Days 1,15, 29, and 57, followed by every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 Weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change From Baseline in Laboratory Analytes During the Double-blind Period (g/L)</title>
          <description>Laboratory assessments were analyzed centrally, with the exception of pregnancy testing. Blood draws and urine collections were performed at visits specified in the protocol.&#xD;
Change from Baseline = Post-baseline - Baseline value.</description>
          <population>All treated participants with both post-baseline and baseline measurements</population>
          <units>g/L</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="153"/>
                <count group_id="O2" value="160"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>ALBUMIN (g/L)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="133"/>
                    <count group_id="O2" value="116"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.2" lower_limit="8.040" upper_limit="10.336"/>
                    <measurement group_id="O2" value="8.1" lower_limit="6.917" upper_limit="9.308"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>HEMOGLOBIN (g/L)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="129"/>
                    <count group_id="O2" value="113"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.8" lower_limit="5.977" upper_limit="11.574"/>
                    <measurement group_id="O2" value="9.0" lower_limit="5.480" upper_limit="12.449"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PROTEIN, TOTAL (g/L)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="153"/>
                    <count group_id="O2" value="160"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.9" lower_limit="8.135" upper_limit="11.579"/>
                    <measurement group_id="O2" value="10.1" lower_limit="8.438" upper_limit="11.786"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Change From Baseline in Laboratory Analytes During the Double-blind Period (Percentage of Blood)</title>
        <description>Laboratory assessments were analyzed centrally, with the exception of pregnancy testing. Blood draws and urine collections were performed at visits specified in the protocol.&#xD;
Change from Baseline = Post-baseline - Baseline value.</description>
        <time_frame>Day 729</time_frame>
        <population>All treated participants with both post-baseline and baseline measurements</population>
        <group_list>
          <group group_id="O1">
            <title>Abatacept IV</title>
            <description>Abatacept 30 mg/kg injection by intravenous on Days 1,15, 29, and 57, followed by a weight-tiered dose approximating 10mg/kg injection by intravenous every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 weeks</description>
          </group>
          <group group_id="O2">
            <title>Placebo IV</title>
            <description>Placebo matching with Abatacept injection by intravenous on Days 1,15, 29, and 57, followed by every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 Weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change From Baseline in Laboratory Analytes During the Double-blind Period (Percentage of Blood)</title>
          <description>Laboratory assessments were analyzed centrally, with the exception of pregnancy testing. Blood draws and urine collections were performed at visits specified in the protocol.&#xD;
Change from Baseline = Post-baseline - Baseline value.</description>
          <population>All treated participants with both post-baseline and baseline measurements</population>
          <units>Percentage</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="153"/>
                <count group_id="O2" value="160"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0328" lower_limit="0.023873" upper_limit="0.041658"/>
                    <measurement group_id="O2" value="0.0325" lower_limit="0.021813" upper_limit="0.043160"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Change From Baseline in Laboratory Analytes During the Double-blind Period (Umol/L)</title>
        <description>Laboratory assessments were analyzed centrally, with the exception of pregnancy testing. Blood draws and urine collections were performed at visits specified in the protocol.&#xD;
Change from Baseline = Post-baseline - Baseline value.</description>
        <time_frame>Day 729</time_frame>
        <population>All treated participants with both post-baseline and baseline measurements</population>
        <group_list>
          <group group_id="O1">
            <title>Abatacept IV</title>
            <description>Abatacept 30 mg/kg injection by intravenous on Days 1,15, 29, and 57, followed by a weight-tiered dose approximating 10mg/kg injection by intravenous every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 weeks</description>
          </group>
          <group group_id="O2">
            <title>Placebo IV</title>
            <description>Placebo matching with Abatacept injection by intravenous on Days 1,15, 29, and 57, followed by every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 Weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change From Baseline in Laboratory Analytes During the Double-blind Period (Umol/L)</title>
          <description>Laboratory assessments were analyzed centrally, with the exception of pregnancy testing. Blood draws and urine collections were performed at visits specified in the protocol.&#xD;
Change from Baseline = Post-baseline - Baseline value.</description>
          <population>All treated participants with both post-baseline and baseline measurements</population>
          <units>umol/L</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="153"/>
                <count group_id="O2" value="160"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>BILIRUBIN, TOTAL (umol/L)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="133"/>
                    <count group_id="O2" value="116"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.77" lower_limit="1.0751" upper_limit="2.4633"/>
                    <measurement group_id="O2" value="1.00" lower_limit="0.5112" upper_limit="1.4922"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CREATININE (umol/L)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="133"/>
                    <count group_id="O2" value="116"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-5.6" lower_limit="-9.306" upper_limit="-1.912"/>
                    <measurement group_id="O2" value="-6.2" lower_limit="-10.764" upper_limit="-1.598"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Change From Baseline in Laboratory Analytes During the Double-blind Period (mmol/L)</title>
        <description>Laboratory assessments were analyzed centrally, with the exception of pregnancy testing. Blood draws and urine collections were performed at visits specified in the protocol.&#xD;
Change from Baseline = Post-baseline - Baseline value.</description>
        <time_frame>Day 729</time_frame>
        <population>All treated participants with both post-baseline and baseline measurements</population>
        <group_list>
          <group group_id="O1">
            <title>Abatacept IV</title>
            <description>Abatacept 30 mg/kg injection by intravenous on Days 1,15, 29, and 57, followed by a weight-tiered dose approximating 10mg/kg injection by intravenous every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 weeks</description>
          </group>
          <group group_id="O2">
            <title>Placebo IV</title>
            <description>Placebo matching with Abatacept injection by intravenous on Days 1,15, 29, and 57, followed by every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 Weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change From Baseline in Laboratory Analytes During the Double-blind Period (mmol/L)</title>
          <description>Laboratory assessments were analyzed centrally, with the exception of pregnancy testing. Blood draws and urine collections were performed at visits specified in the protocol.&#xD;
Change from Baseline = Post-baseline - Baseline value.</description>
          <population>All treated participants with both post-baseline and baseline measurements</population>
          <units>mmol/L</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="153"/>
                <count group_id="O2" value="160"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>BLOOD UREA NITROGEN (mmol/L)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="133"/>
                    <count group_id="O2" value="116"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.31" lower_limit="-2.9879" upper_limit="-1.6241"/>
                    <measurement group_id="O2" value="-2.25" lower_limit="-2.8370" upper_limit="-1.6682"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CALCIUM, TOTAL (mmol/L)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="133"/>
                    <count group_id="O2" value="116"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.097" lower_limit="0.06893" upper_limit="0.12566"/>
                    <measurement group_id="O2" value="0.108" lower_limit="0.07754" upper_limit="0.13850"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CHLORIDE, SERUM (mmol/L)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="133"/>
                    <count group_id="O2" value="116"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.1" lower_limit="-1.675" upper_limit="-0.461"/>
                    <measurement group_id="O2" value="-0.5" lower_limit="-1.244" upper_limit="0.192"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GLUCOSE, SERUM (mmol/L)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="116"/>
                    <count group_id="O2" value="101"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.23" lower_limit="-0.4924" upper_limit="0.0424"/>
                    <measurement group_id="O2" value="-0.58" lower_limit="-0.9623" upper_limit="-0.1902"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PHOSPHORUS, INORGANIC (mmol/L)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="133"/>
                    <count group_id="O2" value="116"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.077" lower_limit="-0.12699" upper_limit="-0.02654"/>
                    <measurement group_id="O2" value="-0.037" lower_limit="-0.08152" upper_limit="0.00807"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>POTASSIUM, SERUM (mmol/L)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="153"/>
                    <count group_id="O2" value="160"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.02" lower_limit="-0.0947" upper_limit="0.0646"/>
                    <measurement group_id="O2" value="-0.10" lower_limit="-0.2115" upper_limit="0.0029"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SODIUM, SERUM (mmol/L)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="153"/>
                    <count group_id="O2" value="160"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.2" lower_limit="-0.762" upper_limit="0.280"/>
                    <measurement group_id="O2" value="-0.5" lower_limit="-1.060" upper_limit="0.078"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Change From Baseline in Laboratory Analytes During the Double-blind Period (x10^9 Cells/L)</title>
        <description>Laboratory assessments were analyzed centrally, with the exception of pregnancy testing. Blood draws and urine collections were performed at visits specified in the protocol.&#xD;
Change from Baseline = Post-baseline - Baseline value.</description>
        <time_frame>Day 729</time_frame>
        <population>All treated participants with both post-baseline and baseline measurements</population>
        <group_list>
          <group group_id="O1">
            <title>Abatacept IV</title>
            <description>Abatacept 30 mg/kg injection by intravenous on Days 1,15, 29, and 57, followed by a weight-tiered dose approximating 10mg/kg injection by intravenous every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 weeks</description>
          </group>
          <group group_id="O2">
            <title>Placebo IV</title>
            <description>Placebo matching with Abatacept injection by intravenous on Days 1,15, 29, and 57, followed by every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 Weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change From Baseline in Laboratory Analytes During the Double-blind Period (x10^9 Cells/L)</title>
          <description>Laboratory assessments were analyzed centrally, with the exception of pregnancy testing. Blood draws and urine collections were performed at visits specified in the protocol.&#xD;
Change from Baseline = Post-baseline - Baseline value.</description>
          <population>All treated participants with both post-baseline and baseline measurements</population>
          <units>x10^9 cells/L</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="153"/>
                <count group_id="O2" value="160"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>EOSINOPHILS (ABSOLUTE) (x10^9 cells/L)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="126"/>
                    <count group_id="O2" value="113"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.034" lower_limit="0.01182" upper_limit="0.05611"/>
                    <measurement group_id="O2" value="0.010" lower_limit="-0.01781" upper_limit="0.03781"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>LYMPHOCYTES (ABSOLUTE) (x10^9 cells/L)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="126"/>
                    <count group_id="O2" value="113"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.141" lower_limit="-0.01315" upper_limit="0.29584"/>
                    <measurement group_id="O2" value="-0.149" lower_limit="-0.29961" upper_limit="0.00138"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>MONOCYTES (ABSOLUTE) (x10^9 cells/L)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="126"/>
                    <count group_id="O2" value="113"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.018" lower_limit="-0.05220" upper_limit="0.01649"/>
                    <measurement group_id="O2" value="-0.050" lower_limit="-0.09264" upper_limit="-0.00772"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>NEUTROPHILS (ABSOLUTE) (x10^9 cells/L)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="126"/>
                    <count group_id="O2" value="113"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.259" lower_limit="-2.78568" upper_limit="-1.73210"/>
                    <measurement group_id="O2" value="-2.289" lower_limit="-2.95652" upper_limit="-1.62118"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PLATELET COUNT (x10^9 cells/L)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="129"/>
                    <count group_id="O2" value="112"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.9" lower_limit="-16.962" upper_limit="7.148"/>
                    <measurement group_id="O2" value="-9.1" lower_limit="-24.094" upper_limit="5.951"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Marked Hematology Laboratory Abnormalities During Year 1 of the Double Blind Period</title>
        <description>LLN= Lower limit of normals ULN= Upper limit of normals Pre RX = Baseline value HEMOGLOBIN g/L 4.0 HB &gt;3 G/DL DECREASE FROM PRE RX HEMATOCRIT vol 6.3 HCT &lt;0.75X PRE RX ERYTHROCYTES x10*12 c/L 5.2 RBC &lt;0.75X PRE RX PLATELET COUNT x10*9 c/L 5.0 PLAT &lt;0.67X LLN OR &gt;1.5X ULN, OR IF PRE RX&lt;LLN THEN USE 0.5X PRE RX AND &lt;100,000/MM3 LEUKOCYTES x10*9 c/L 6.2 WBC &lt;0.75X LLN OR &gt;1.25X ULN, OR IF PRE RX&lt;LLN THEN USE &lt;0.8X PRE RX OR &gt;ULN, OR IF PRE RX&gt;ULN THEN USE &gt;1.2X PRE RX OR &lt;LLN EOSINOPHILS (ABSOLUTE) x10*9 c/L 8.3 EOSA IF VALUE &gt; .750 X10*3 c/uL BASOPHILS (ABSOLUTE) x10*9 c/L 8.3 BASOA IF VALUE &gt; 400/MM3 MONOCYTES (ABSOLUTE) x10*9 c/L 8.3 MONOA IF VALUE &gt; 2000/MM3 LYMPHOCYTES (ABSOLUTE) x10*9 c/L 8.3 LYMPA IF VALUE &lt; .750 X10*3 c/uL OR IF VALUE &gt; 7.50 X10*3 c/uL&#xD;
N = the number of participants with at least 1 on treatment lab result for each analyte</description>
        <time_frame>Day 1 to Day 365; includes data up to 56 days post last dose in year 1 of double-blind period or first dose date in the year 2 of double-blind period, whichever is earlier</time_frame>
        <population>All treated participants&#xD;
NA (not available) indicates not-calculated as it was not a relevant pre-specified marked abnormality.</population>
        <group_list>
          <group group_id="O1">
            <title>Abatacept IV</title>
            <description>Abatacept 30 mg/kg injection by intravenous on Days 1,15, 29, and 57, followed by a weight-tiered dose approximating 10mg/kg injection by intravenous every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 weeks</description>
          </group>
          <group group_id="O2">
            <title>Placebo IV</title>
            <description>Placebo matching with Abatacept injection by intravenous on Days 1,15, 29, and 57, followed by every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 Weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Marked Hematology Laboratory Abnormalities During Year 1 of the Double Blind Period</title>
          <description>LLN= Lower limit of normals ULN= Upper limit of normals Pre RX = Baseline value HEMOGLOBIN g/L 4.0 HB &gt;3 G/DL DECREASE FROM PRE RX HEMATOCRIT vol 6.3 HCT &lt;0.75X PRE RX ERYTHROCYTES x10*12 c/L 5.2 RBC &lt;0.75X PRE RX PLATELET COUNT x10*9 c/L 5.0 PLAT &lt;0.67X LLN OR &gt;1.5X ULN, OR IF PRE RX&lt;LLN THEN USE 0.5X PRE RX AND &lt;100,000/MM3 LEUKOCYTES x10*9 c/L 6.2 WBC &lt;0.75X LLN OR &gt;1.25X ULN, OR IF PRE RX&lt;LLN THEN USE &lt;0.8X PRE RX OR &gt;ULN, OR IF PRE RX&gt;ULN THEN USE &gt;1.2X PRE RX OR &lt;LLN EOSINOPHILS (ABSOLUTE) x10*9 c/L 8.3 EOSA IF VALUE &gt; .750 X10*3 c/uL BASOPHILS (ABSOLUTE) x10*9 c/L 8.3 BASOA IF VALUE &gt; 400/MM3 MONOCYTES (ABSOLUTE) x10*9 c/L 8.3 MONOA IF VALUE &gt; 2000/MM3 LYMPHOCYTES (ABSOLUTE) x10*9 c/L 8.3 LYMPA IF VALUE &lt; .750 X10*3 c/uL OR IF VALUE &gt; 7.50 X10*3 c/uL&#xD;
N = the number of participants with at least 1 on treatment lab result for each analyte</description>
          <population>All treated participants&#xD;
NA (not available) indicates not-calculated as it was not a relevant pre-specified marked abnormality.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="202"/>
                <count group_id="O2" value="203"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>HEMOGLOBIN, low</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="202"/>
                    <count group_id="O2" value="203"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>HEMOGLOBIN, high</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="202"/>
                    <count group_id="O2" value="203"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA">Pre-specified marked lab abnormalities criteria do not include this low/high end value</measurement>
                    <measurement group_id="O2" value="NA">Pre-specified marked lab abnormalities criteria do not include this low/high end value</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>HEMATOCRIT, low</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="201"/>
                    <count group_id="O2" value="203"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                    <measurement group_id="O2" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>HEMATOCRIT, high</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="201"/>
                    <count group_id="O2" value="203"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA">Pre-specified marked lab abnormalities criteria do not include this low/high end value</measurement>
                    <measurement group_id="O2" value="NA">Pre-specified marked lab abnormalities criteria do not include this low/high end value</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ERYTHROCYTES, low</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="201"/>
                    <count group_id="O2" value="203"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ERYTHROCYTES, high</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="201"/>
                    <count group_id="O2" value="203"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA">Pre-specified marked lab abnormalities criteria do not include this low/high end value</measurement>
                    <measurement group_id="O2" value="NA">Pre-specified marked lab abnormalities criteria do not include this low/high end value</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PLATELET COUNT, low</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="201"/>
                    <count group_id="O2" value="203"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PLATELET COUNT, high</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="201"/>
                    <count group_id="O2" value="203"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>LEUKOCYTES, low</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="202"/>
                    <count group_id="O2" value="203"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35"/>
                    <measurement group_id="O2" value="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>LEUKOCYTES, high</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="202"/>
                    <count group_id="O2" value="203"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29"/>
                    <measurement group_id="O2" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>EOSINOPHILS (ABSOLUTE), low</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="202"/>
                    <count group_id="O2" value="203"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA">Pre-specified marked lab abnormalities criteria do not include this low/high end value</measurement>
                    <measurement group_id="O2" value="NA">Pre-specified marked lab abnormalities criteria do not include this low/high end value</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>EOSINOPHILS (ABSOLUTE), high</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="202"/>
                    <count group_id="O2" value="203"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>BASOPHILS (ABSOLUTE), low</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="202"/>
                    <count group_id="O2" value="203"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA">Pre-specified marked lab abnormalities criteria do not include this low/high end value</measurement>
                    <measurement group_id="O2" value="NA">Pre-specified marked lab abnormalities criteria do not include this low/high end value</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>BASOPHILS (ABSOLUTE), high</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="202"/>
                    <count group_id="O2" value="203"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>MONOCYTES (ABSOLUTE), low</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="202"/>
                    <count group_id="O2" value="203"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA">Pre-specified marked lab abnormalities criteria do not include this low/high end value</measurement>
                    <measurement group_id="O2" value="NA">Pre-specified marked lab abnormalities criteria do not include this low/high end value</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>MONOCYTES (ABSOLUTE), high</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="202"/>
                    <count group_id="O2" value="203"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>LYMPHOCYTES (ABSOLUTE), low</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="202"/>
                    <count group_id="O2" value="203"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="81"/>
                    <measurement group_id="O2" value="104"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>LYMPHOCYTES (ABSOLUTE), high</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="202"/>
                    <count group_id="O2" value="203"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Marked Liver and Kidney Function Laboratory Abnormalities During Year 1 of the Double Blind Period</title>
        <description>LLN= Lower limit of normals ULN= Upper limit of normals Pre RX = Baseline value ALKALINE PHOSPHATASE (ALP) U/L 5.0 ALP &gt;2X ULN, OR IF PRE RX&gt;ULN THEN USE &gt;3X PRE RX ASPARTATE AMINOTRANSFERASE (AST) U/L 5.0 AST &gt;3X ULN, OR IF PRE RX&gt;ULN THEN USE &gt;4X PRE RX ALANINE AMINOTRANSFERASE (ALT) U/L 5.0 ALT &gt;3X ULN, OR IF PRE RX&gt;ULN THEN USE &gt;4X PRE RX G-GLUTAMYL TRANSFERASE (GGT) U/L 5.0 GGT &gt;2X ULN, OR IF PRE RX&gt;ULN THEN USE &gt;3X PRE RX BILIRUBIN, TOTAL umol/L 5.1 TBILI &gt;2X ULN, OR IF PRE RX&gt;ULN THEN USE &gt;4X PRE RX BILIRUBIN, DIRECT umol/L 5.1 DBILI &gt;1.5X ULN, OR IF PRE RX&gt;ULN THEN USE &gt;2X PRE RX BLOOD UREA NITROGEN mmol/L 5.1 BUN &gt;2X PRE RX CREATININE umol/L 5.0 CREAT &gt;1.5X PRE RX&#xD;
N = the number of participants with at least 1 on treatment lab result for each analyte</description>
        <time_frame>Day 1 to Day 365; includes data up to 56 days post last dose in year 1 of double-blind period or first dose date in the year 2 of double-blind period, whichever is earlier</time_frame>
        <population>All treated participants&#xD;
NA (not available) indicates not-calculated as it was not a relevant pre-specified marked abnormality.</population>
        <group_list>
          <group group_id="O1">
            <title>Abatacept IV</title>
            <description>Abatacept 30 mg/kg injection by intravenous on Days 1,15, 29, and 57, followed by a weight-tiered dose approximating 10mg/kg injection by intravenous every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 weeks</description>
          </group>
          <group group_id="O2">
            <title>Placebo IV</title>
            <description>Placebo matching with Abatacept injection by intravenous on Days 1,15, 29, and 57, followed by every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 Weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Marked Liver and Kidney Function Laboratory Abnormalities During Year 1 of the Double Blind Period</title>
          <description>LLN= Lower limit of normals ULN= Upper limit of normals Pre RX = Baseline value ALKALINE PHOSPHATASE (ALP) U/L 5.0 ALP &gt;2X ULN, OR IF PRE RX&gt;ULN THEN USE &gt;3X PRE RX ASPARTATE AMINOTRANSFERASE (AST) U/L 5.0 AST &gt;3X ULN, OR IF PRE RX&gt;ULN THEN USE &gt;4X PRE RX ALANINE AMINOTRANSFERASE (ALT) U/L 5.0 ALT &gt;3X ULN, OR IF PRE RX&gt;ULN THEN USE &gt;4X PRE RX G-GLUTAMYL TRANSFERASE (GGT) U/L 5.0 GGT &gt;2X ULN, OR IF PRE RX&gt;ULN THEN USE &gt;3X PRE RX BILIRUBIN, TOTAL umol/L 5.1 TBILI &gt;2X ULN, OR IF PRE RX&gt;ULN THEN USE &gt;4X PRE RX BILIRUBIN, DIRECT umol/L 5.1 DBILI &gt;1.5X ULN, OR IF PRE RX&gt;ULN THEN USE &gt;2X PRE RX BLOOD UREA NITROGEN mmol/L 5.1 BUN &gt;2X PRE RX CREATININE umol/L 5.0 CREAT &gt;1.5X PRE RX&#xD;
N = the number of participants with at least 1 on treatment lab result for each analyte</description>
          <population>All treated participants&#xD;
NA (not available) indicates not-calculated as it was not a relevant pre-specified marked abnormality.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="202"/>
                <count group_id="O2" value="203"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>ALKALINE PHOSPHATASE (ALP), low</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="201"/>
                    <count group_id="O2" value="203"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA">Pre-specified marked lab abnormalities criteria do not include this low/high end value</measurement>
                    <measurement group_id="O2" value="NA">Pre-specified marked lab abnormalities criteria do not include this low/high end value</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ALKALINE PHOSPHATASE (ALP), high</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="201"/>
                    <count group_id="O2" value="203"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ASPARTATE AMINOTRANSFERASE (AST), low</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="201"/>
                    <count group_id="O2" value="203"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA">Pre-specified marked lab abnormalities criteria do not include this low/high end value</measurement>
                    <measurement group_id="O2" value="NA">Pre-specified marked lab abnormalities criteria do not include this low/high end value</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ASPARTATE AMINOTRANSFERASE (AST), high</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="201"/>
                    <count group_id="O2" value="203"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ALANINE AMINOTRANSFERASE (ALT), low</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="201"/>
                    <count group_id="O2" value="203"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA">Pre-specified marked lab abnormalities criteria do not include this low/high end value</measurement>
                    <measurement group_id="O2" value="NA">Pre-specified marked lab abnormalities criteria do not include this low/high end value</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ALANINE AMINOTRANSFERASE (ALT), high</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="201"/>
                    <count group_id="O2" value="203"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>G-GLUTAMYL TRANSFERASE (GGT), low</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="202"/>
                    <count group_id="O2" value="203"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA">Pre-specified marked lab abnormalities criteria do not include this low/high end value</measurement>
                    <measurement group_id="O2" value="NA">Pre-specified marked lab abnormalities criteria do not include this low/high end value</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>G-GLUTAMYL TRANSFERASE (GGT), high</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="202"/>
                    <count group_id="O2" value="203"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17"/>
                    <measurement group_id="O2" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>BILIRUBIN, TOTAL, low</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="202"/>
                    <count group_id="O2" value="203"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA">Pre-specified marked lab abnormalities criteria do not include this low/high end value</measurement>
                    <measurement group_id="O2" value="NA">Pre-specified marked lab abnormalities criteria do not include this low/high end value</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>BILIRUBIN, TOTAL, high</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="202"/>
                    <count group_id="O2" value="203"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>BILIRUBIN, DIRECT, low</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="200"/>
                    <count group_id="O2" value="203"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA">Pre-specified marked lab abnormalities criteria do not include this low/high end value</measurement>
                    <measurement group_id="O2" value="NA">Pre-specified marked lab abnormalities criteria do not include this low/high end value</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>BILIRUBIN, DIRECT, high</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="200"/>
                    <count group_id="O2" value="203"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>BLOOD UREA NITROGEN, low</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="201"/>
                    <count group_id="O2" value="203"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA">Pre-specified marked lab abnormalities criteria do not include this low/high end value</measurement>
                    <measurement group_id="O2" value="NA">Pre-specified marked lab abnormalities criteria do not include this low/high end value</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>BLOOD UREA NITROGEN, high</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="201"/>
                    <count group_id="O2" value="203"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20"/>
                    <measurement group_id="O2" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CREATININE, low</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="202"/>
                    <count group_id="O2" value="203"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA">Pre-specified marked lab abnormalities criteria do not include this low/high end value</measurement>
                    <measurement group_id="O2" value="NA">Pre-specified marked lab abnormalities criteria do not include this low/high end value</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CREATININE, high</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="202"/>
                    <count group_id="O2" value="203"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24"/>
                    <measurement group_id="O2" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Marked Electrolyte Laboratory Abnormalities During Year 1 of the Double Blind Period</title>
        <description>LLN= Lower limit of normals ULN= Upper limit of normals Pre RX = Baseline value SODIUM, SERUM mmol/L 4.0 NA &lt;0.95X LLN OR &gt;1.05X ULN, OR IF PRE RX&lt;LLN THEN USE &lt;0.95X PRE RX OR &gt;ULN, OR IF PRE RX&gt;ULN THEN USE &gt;1.05X PRE RX OR &lt;LLN POTASSIUM, SERUM mmol/L 4.1 K &lt;0.9X LLN OR &gt;1.1X ULN, OR IF PRE RX&lt;LLN THEN USE &lt;0.9X PRE RX OR &gt;ULN, OR IF PRE RX&gt;ULN THEN USE &gt;1.1X PRE RX OR &lt;LLN CHLORIDE, SERUM mmol/L 5.0 CL &lt;0.9X LLN OR &gt;1.1X ULN, OR IF PRE RX&lt;LLN THEN USE &lt;0.9X PRE RX OR &gt;ULN, OR IF PRE RX&gt;ULN THEN USE &gt;1.1X PRE RX OR &lt;LLN&#xD;
N = the number of participants with at least 1 on treatment lab result for each analyte</description>
        <time_frame>Day 1 to Day 365; includes data up to 56 days post last dose in year 1 of double-blind period or first dose date in the year 2 of double-blind period, whichever is earlier</time_frame>
        <population>All treated participants</population>
        <group_list>
          <group group_id="O1">
            <title>Abatacept IV</title>
            <description>Abatacept 30 mg/kg injection by intravenous on Days 1,15, 29, and 57, followed by a weight-tiered dose approximating 10mg/kg injection by intravenous every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 weeks</description>
          </group>
          <group group_id="O2">
            <title>Placebo IV</title>
            <description>Placebo matching with Abatacept injection by intravenous on Days 1,15, 29, and 57, followed by every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 Weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Marked Electrolyte Laboratory Abnormalities During Year 1 of the Double Blind Period</title>
          <description>LLN= Lower limit of normals ULN= Upper limit of normals Pre RX = Baseline value SODIUM, SERUM mmol/L 4.0 NA &lt;0.95X LLN OR &gt;1.05X ULN, OR IF PRE RX&lt;LLN THEN USE &lt;0.95X PRE RX OR &gt;ULN, OR IF PRE RX&gt;ULN THEN USE &gt;1.05X PRE RX OR &lt;LLN POTASSIUM, SERUM mmol/L 4.1 K &lt;0.9X LLN OR &gt;1.1X ULN, OR IF PRE RX&lt;LLN THEN USE &lt;0.9X PRE RX OR &gt;ULN, OR IF PRE RX&gt;ULN THEN USE &gt;1.1X PRE RX OR &lt;LLN CHLORIDE, SERUM mmol/L 5.0 CL &lt;0.9X LLN OR &gt;1.1X ULN, OR IF PRE RX&lt;LLN THEN USE &lt;0.9X PRE RX OR &gt;ULN, OR IF PRE RX&gt;ULN THEN USE &gt;1.1X PRE RX OR &lt;LLN&#xD;
N = the number of participants with at least 1 on treatment lab result for each analyte</description>
          <population>All treated participants</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="202"/>
                <count group_id="O2" value="203"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>SODIUM, SERUM, low</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SODIUM, SERUM, high</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>POTASSIUM, SERUM, low</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>POTASSIUM, SERUM, high</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CHLORIDE, SERUM, low</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CHLORIDE, SERUM, high</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CALCIUM, TOTAL, low</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CALCIUM, TOTAL, high</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PHOSPHORUS, INORGANIC, low</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PHOSPHORUS, INORGANIC, high</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                    <measurement group_id="O2" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Marked Urinalysis Laboratory Abnormalities During Year 1 of the Double Blind Period</title>
        <description>LLN= Lower limit of normals ULN= Upper limit of normals Pre RX = Baseline value PROTEIN, URINE Unknown UPRO IF MISSING PRE THEN USE &gt;=2, OR IF VALUE &gt;=4, OR IF PRE RX =0 OR 0.5 THEN USE &gt;=2, OR IF PRE RX =1 THEN USE &gt;=3, OR IF PRE RX =2 OR 3 THEN USE &gt;=4 GLUCOSE, URINE N/A UGLU IF MISSING PRE THEN USE &gt;=2, OR IF VALUE &gt;=4, OR IF PRE RX =0 OR 0.5 THEN USE &gt;=2, OR IF PRE RX =1 THEN USE &gt;=3, OR IF PRE RX =2 OR 3 THEN USE &gt;=4 BLOOD, URINE N/A UBLD IF MISSING PRE THEN USE &gt;=2, OR IF VALUE &gt;=4, OR IF PRE RX =0 OR 0.5 THEN USE &gt;=2, OR IF PRE RX =1 THEN USE &gt;=3, OR IF PRE RX =2 OR 3 THEN USE &gt;=4 RBC, URINE hpf 5.0 URBC IF MISSING PRE THEN USE &gt;=2, OR IF VALUE &gt;=4, OR IF PRE RX =0 OR 0.5 THEN USE &gt;=2, OR IF PRE RX =1 THEN USE &gt;=3, OR IF PRE RX =2 OR 3 THEN USE &gt;=4 WBC, URINE hpf 5.0 UWBC IF MISSING PRE THEN USE &gt;=2, OR IF VALUE &gt;=4, OR IF PRE RX =0 OR 0.5 THEN USE &gt;=2, OR IF PRE RX =1 THEN USE &gt;=3, OR IF PRE RX =2 OR 3 THEN USE &gt;=4</description>
        <time_frame>Day 1 to Day 365; includes data up to 56 days post last dose in year 1 of double-blind period or first dose date in the year 2 of double-blind period, whichever is earlier</time_frame>
        <population>All treated participants&#xD;
N = the number of participants with at least 1 on treatment lab result for each analyte&#xD;
NA (not available) indicates not-calculated as it was not a relevant pre-specified marked abnormality.</population>
        <group_list>
          <group group_id="O1">
            <title>Abatacept IV</title>
            <description>Abatacept 30 mg/kg injection by intravenous on Days 1,15, 29, and 57, followed by a weight-tiered dose approximating 10mg/kg injection by intravenous every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 weeks</description>
          </group>
          <group group_id="O2">
            <title>Placebo IV</title>
            <description>Placebo matching with Abatacept injection by intravenous on Days 1,15, 29, and 57, followed by every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 Weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Marked Urinalysis Laboratory Abnormalities During Year 1 of the Double Blind Period</title>
          <description>LLN= Lower limit of normals ULN= Upper limit of normals Pre RX = Baseline value PROTEIN, URINE Unknown UPRO IF MISSING PRE THEN USE &gt;=2, OR IF VALUE &gt;=4, OR IF PRE RX =0 OR 0.5 THEN USE &gt;=2, OR IF PRE RX =1 THEN USE &gt;=3, OR IF PRE RX =2 OR 3 THEN USE &gt;=4 GLUCOSE, URINE N/A UGLU IF MISSING PRE THEN USE &gt;=2, OR IF VALUE &gt;=4, OR IF PRE RX =0 OR 0.5 THEN USE &gt;=2, OR IF PRE RX =1 THEN USE &gt;=3, OR IF PRE RX =2 OR 3 THEN USE &gt;=4 BLOOD, URINE N/A UBLD IF MISSING PRE THEN USE &gt;=2, OR IF VALUE &gt;=4, OR IF PRE RX =0 OR 0.5 THEN USE &gt;=2, OR IF PRE RX =1 THEN USE &gt;=3, OR IF PRE RX =2 OR 3 THEN USE &gt;=4 RBC, URINE hpf 5.0 URBC IF MISSING PRE THEN USE &gt;=2, OR IF VALUE &gt;=4, OR IF PRE RX =0 OR 0.5 THEN USE &gt;=2, OR IF PRE RX =1 THEN USE &gt;=3, OR IF PRE RX =2 OR 3 THEN USE &gt;=4 WBC, URINE hpf 5.0 UWBC IF MISSING PRE THEN USE &gt;=2, OR IF VALUE &gt;=4, OR IF PRE RX =0 OR 0.5 THEN USE &gt;=2, OR IF PRE RX =1 THEN USE &gt;=3, OR IF PRE RX =2 OR 3 THEN USE &gt;=4</description>
          <population>All treated participants&#xD;
N = the number of participants with at least 1 on treatment lab result for each analyte&#xD;
NA (not available) indicates not-calculated as it was not a relevant pre-specified marked abnormality.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="202"/>
                <count group_id="O2" value="203"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>PROTEIN, URINE, low</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="198"/>
                    <count group_id="O2" value="195"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA">Pre-specified marked lab abnormalities criteria do not include this low/high end value</measurement>
                    <measurement group_id="O2" value="NA">Pre-specified marked lab abnormalities criteria do not include this low/high end value</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PROTEIN, URINE, high</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="198"/>
                    <count group_id="O2" value="195"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GLUCOSE, URINE, low</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="193"/>
                    <count group_id="O2" value="194"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA">Pre-specified marked lab abnormalities criteria do not include this low/high end value</measurement>
                    <measurement group_id="O2" value="NA">Pre-specified marked lab abnormalities criteria do not include this low/high end value</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GLUCOSE, URINE, high</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="193"/>
                    <count group_id="O2" value="194"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>BLOOD, URINE, low</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="200"/>
                    <count group_id="O2" value="200"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA">Pre-specified marked lab abnormalities criteria do not include this low/high end value</measurement>
                    <measurement group_id="O2" value="NA">Pre-specified marked lab abnormalities criteria do not include this low/high end value</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>BLOOD, URINE, high</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="200"/>
                    <count group_id="O2" value="200"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Red blood cells (RBC), URINE, low</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="201"/>
                    <count group_id="O2" value="201"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA">Pre-specified marked lab abnormalities criteria do not include this low/high end value</measurement>
                    <measurement group_id="O2" value="NA">Pre-specified marked lab abnormalities criteria do not include this low/high end value</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Red blood cells (RBC), URINE, high</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="201"/>
                    <count group_id="O2" value="201"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="93"/>
                    <measurement group_id="O2" value="103"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>White blood cells (WBC), URINE, low</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="201"/>
                    <count group_id="O2" value="201"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA">Pre-specified marked lab abnormalities criteria do not include this low/high end value</measurement>
                    <measurement group_id="O2" value="NA">Pre-specified marked lab abnormalities criteria do not include this low/high end value</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>White blood cells (WBC), URINE, high</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="201"/>
                    <count group_id="O2" value="201"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="91"/>
                    <measurement group_id="O2" value="98"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Other Marked Chemistry Laboratory Abnormalities During Year 1 of the Double Blind Period</title>
        <description>LLN= Lower limit of normals ULN= Upper limit of normals Pre RX = Baseline value CALCIUM, TOTAL mmol/L 5.2 CA &lt;0.8X LLN OR &gt;1.2X ULN, OR IF PRE RX&lt;LLN THEN USE &lt;0.75X PRE RX OR &gt;ULN, OR IF PRE RX&gt;ULN THEN USE &gt;1.25X PRE RX OR &lt;LLN PHOSPHORUS, INORGANIC mmol/L 5.2 PHOS &lt;0.75X LLN OR &gt;1.25X ULN, OR IF PRE RX&lt;LLN THEN USE &lt;0.67X PRE RX OR &gt;ULN GLUCOSE, SERUM mmol/L 4.1 GLUC &lt;65 mg/dL, OR &gt;220 mg/dL PROTEIN, TOTAL g/L 5.0 TPRO &lt;0.9X LLN OR &gt;1.1X ULN, OR IF PRE RX&lt;LLN THEN USE 0.9X PRE RX OR &gt;ULN, OR IF PRE RX&gt;ULN THEN USE 1.1X PRE RX OR &lt;LLN ALBUMIN g/L 3.0 ALB &lt;0.9X LLN, OR IF PRE RX&lt;LLN THEN USE &lt;0.75X PRE RX CHOLESTEROL, TOTAL (TC) mmol/L 5.2 CHOL &gt;2X PRE R&#xD;
N = the number of participants with at least 1 on treatment lab result for each analyte</description>
        <time_frame>Day 1 to Day 365; includes data up to 56 days post last dose in year 1 of double-blind period or first dose date in the year 2 of double-blind period, whichever is earlier</time_frame>
        <population>All treated participants&#xD;
NA (not available) indicates not-calculated as it was not a relevant pre-specified marked abnormality.</population>
        <group_list>
          <group group_id="O1">
            <title>Abatacept IV</title>
            <description>Abatacept 30 mg/kg injection by intravenous on Days 1,15, 29, and 57, followed by a weight-tiered dose approximating 10mg/kg injection by intravenous every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 weeks</description>
          </group>
          <group group_id="O2">
            <title>Placebo IV</title>
            <description>Placebo matching with Abatacept injection by intravenous on Days 1,15, 29, and 57, followed by every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 Weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Other Marked Chemistry Laboratory Abnormalities During Year 1 of the Double Blind Period</title>
          <description>LLN= Lower limit of normals ULN= Upper limit of normals Pre RX = Baseline value CALCIUM, TOTAL mmol/L 5.2 CA &lt;0.8X LLN OR &gt;1.2X ULN, OR IF PRE RX&lt;LLN THEN USE &lt;0.75X PRE RX OR &gt;ULN, OR IF PRE RX&gt;ULN THEN USE &gt;1.25X PRE RX OR &lt;LLN PHOSPHORUS, INORGANIC mmol/L 5.2 PHOS &lt;0.75X LLN OR &gt;1.25X ULN, OR IF PRE RX&lt;LLN THEN USE &lt;0.67X PRE RX OR &gt;ULN GLUCOSE, SERUM mmol/L 4.1 GLUC &lt;65 mg/dL, OR &gt;220 mg/dL PROTEIN, TOTAL g/L 5.0 TPRO &lt;0.9X LLN OR &gt;1.1X ULN, OR IF PRE RX&lt;LLN THEN USE 0.9X PRE RX OR &gt;ULN, OR IF PRE RX&gt;ULN THEN USE 1.1X PRE RX OR &lt;LLN ALBUMIN g/L 3.0 ALB &lt;0.9X LLN, OR IF PRE RX&lt;LLN THEN USE &lt;0.75X PRE RX CHOLESTEROL, TOTAL (TC) mmol/L 5.2 CHOL &gt;2X PRE R&#xD;
N = the number of participants with at least 1 on treatment lab result for each analyte</description>
          <population>All treated participants&#xD;
NA (not available) indicates not-calculated as it was not a relevant pre-specified marked abnormality.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="202"/>
                <count group_id="O2" value="203"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>GLUCOSE, SERUM, low</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="202"/>
                    <count group_id="O2" value="203"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="33"/>
                    <measurement group_id="O2" value="29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GLUCOSE, SERUM, high</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="202"/>
                    <count group_id="O2" value="203"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PROTEIN, TOTAL, low</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="201"/>
                    <count group_id="O2" value="203"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="44"/>
                    <measurement group_id="O2" value="26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PROTEIN, TOTAL, high</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="201"/>
                    <count group_id="O2" value="203"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ALBUMIN, low</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="202"/>
                    <count group_id="O2" value="203"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ALBUMIN, high</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="202"/>
                    <count group_id="O2" value="203"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA">Pre-specified marked lab abnormalities criteria do not include this low/high end value</measurement>
                    <measurement group_id="O2" value="NA">Pre-specified marked lab abnormalities criteria do not include this low/high end value</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Any Adverse Events (AEs) During Year 2 of the Double-blind Period and Long-term Extension</title>
        <description>All AEs were coded and grouped into preferred terms (PT) by system organ class (SOC), using the Medical Dictionary for Regulatory Activities (MedDRA, version 21.0). Investigators determined the intensity of each AE as mild, moderate, severe, or very severe and assessed the relationship to study drug.</description>
        <time_frame>From the first dose in Year 2 of the double-blind period up to 56 days post last dose</time_frame>
        <population>All treated participants in Year 2</population>
        <group_list>
          <group group_id="O1">
            <title>Abatacept IV</title>
            <description>Abatacept 30 mg/kg injection by intravenous on Days 1,15, 29, and 57, followed by a weight-tiered dose approximating 10mg/kg injection by intravenous every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 weeks</description>
          </group>
          <group group_id="O2">
            <title>Placebo IV</title>
            <description>Placebo matching with Abatacept injection by intravenous on Days 1,15, 29, and 57, followed by every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 Weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Any Adverse Events (AEs) During Year 2 of the Double-blind Period and Long-term Extension</title>
          <description>All AEs were coded and grouped into preferred terms (PT) by system organ class (SOC), using the Medical Dictionary for Regulatory Activities (MedDRA, version 21.0). Investigators determined the intensity of each AE as mild, moderate, severe, or very severe and assessed the relationship to study drug.</description>
          <population>All treated participants in Year 2</population>
          <units>Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="153"/>
                <count group_id="O2" value="160"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Participants with Adverse Events</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="127"/>
                    <measurement group_id="O2" value="137"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Participants with Serious Adverse Events</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                    <measurement group_id="O2" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Participants with infection Adverse Events</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100"/>
                    <measurement group_id="O2" value="107"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Participants with malignancies</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Participants with autoimmune events</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants in Treatment Failure Over Time During the Double-blind Period</title>
        <description>Lupus treatment failure is defined as any of the following: Death, unless due to physical trauma or violence; Renal Flare; sustained doubling of creatinine from baseline (greater of Screening or Study Day 1 value); initiation of rescue therapy for treatment of active lupus nephritis after Study Week 20.&#xD;
Overall treatment failure is defined as lupus treatment failure plus discontinuation of study drug for any reason except death due to physical trauma or violence, pregnancy or administrative decision by Sponsor.</description>
        <time_frame>Day 365, Day 729</time_frame>
        <population>All randomized and treated participants</population>
        <group_list>
          <group group_id="O1">
            <title>Abatacept IV</title>
            <description>Abatacept 30 mg/kg injection by intravenous on Days 1,15, 29, and 57, followed by a weight-tiered dose approximating 10mg/kg injection by intravenous every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 weeks</description>
          </group>
          <group group_id="O2">
            <title>Placebo IV</title>
            <description>Placebo matching with Abatacept injection by intravenous on Days 1,15, 29, and 57, followed by every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 Weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants in Treatment Failure Over Time During the Double-blind Period</title>
          <description>Lupus treatment failure is defined as any of the following: Death, unless due to physical trauma or violence; Renal Flare; sustained doubling of creatinine from baseline (greater of Screening or Study Day 1 value); initiation of rescue therapy for treatment of active lupus nephritis after Study Week 20.&#xD;
Overall treatment failure is defined as lupus treatment failure plus discontinuation of study drug for any reason except death due to physical trauma or violence, pregnancy or administrative decision by Sponsor.</description>
          <population>All randomized and treated participants</population>
          <units>Percentage</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="202"/>
                <count group_id="O2" value="203"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Lupus treatment failure (LTF) - Day 365</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="202"/>
                    <count group_id="O2" value="203"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.5" lower_limit="0.943" upper_limit="5.988"/>
                    <measurement group_id="O2" value="4.4" lower_limit="1.602" upper_limit="7.265"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Overall treatment failure (OTF) - Day 365</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="202"/>
                    <count group_id="O2" value="203"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.5" lower_limit="1.610" upper_limit="7.301"/>
                    <measurement group_id="O2" value="4.9" lower_limit="1.949" upper_limit="7.903"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>LTF - Day 729</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="134"/>
                    <count group_id="O2" value="131"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.5" lower_limit="1.0" upper_limit="8.0"/>
                    <measurement group_id="O2" value="5.3" lower_limit="1.5" upper_limit="9.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>OTF - Day 729</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="134"/>
                    <count group_id="O2" value="131"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.2" lower_limit="1.5" upper_limit="9.0"/>
                    <measurement group_id="O2" value="8.4" lower_limit="3.6" upper_limit="13.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Lupus treatment failure - Day 365</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Estimate of Difference</param_type>
            <param_value>-0.9682</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-4.760178</ci_lower_limit>
            <ci_upper_limit>2.823876</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Overall treatment failure - Day 365</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Estimate of Difference</param_type>
            <param_value>-0.4707</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-4.588691</ci_lower_limit>
            <ci_upper_limit>3.647365</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Lupus treatment failure - Day 729</non_inferiority_desc>
            <param_type>Estimate of Difference</param_type>
            <param_value>0.8</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-4.5</ci_lower_limit>
            <ci_upper_limit>6.1</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Overall treatment failure - Day 729</non_inferiority_desc>
            <param_type>Estimate of Difference</param_type>
            <param_value>2.7</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.3</ci_lower_limit>
            <ci_upper_limit>8.8</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Median Time to First Treatment Failure and Overall Treatment Failure During the Double-blind Period</title>
        <description>First treatment failure (or Lupus treatment failure) is defined as any of the following: Death, unless due to physical trauma or violence; Renal Flare; sustained doubling of creatinine from baseline (greater of Screening or Study Day 1 value); initiation of rescue therapy for treatment of active lupus nephritis after Study Week 20.&#xD;
Overall treatment failure is defined as lupus treatment failure plus discontinuation of study drug for any reason except death due to physical trauma or violence, pregnancy or administrative decision by Sponsor.&#xD;
The hazard ratio is estimated using the Cox proportional hazards model which includes treatment group, stratification variables (baseline ACEis/ARBs use, RACE) and baseline UPCR.&#xD;
The estimate of median time is based on Kaplan-Meier analysis</description>
        <time_frame>Day 365, Day 729</time_frame>
        <population>All randomized and treated participants</population>
        <group_list>
          <group group_id="O1">
            <title>Abatacept IV</title>
            <description>Abatacept 30 mg/kg injection by intravenous on Days 1,15, 29, and 57, followed by a weight-tiered dose approximating 10mg/kg injection by intravenous every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 weeks</description>
          </group>
          <group group_id="O2">
            <title>Placebo IV</title>
            <description>Placebo matching with Abatacept injection by intravenous on Days 1,15, 29, and 57, followed by every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 Weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Median Time to First Treatment Failure and Overall Treatment Failure During the Double-blind Period</title>
          <description>First treatment failure (or Lupus treatment failure) is defined as any of the following: Death, unless due to physical trauma or violence; Renal Flare; sustained doubling of creatinine from baseline (greater of Screening or Study Day 1 value); initiation of rescue therapy for treatment of active lupus nephritis after Study Week 20.&#xD;
Overall treatment failure is defined as lupus treatment failure plus discontinuation of study drug for any reason except death due to physical trauma or violence, pregnancy or administrative decision by Sponsor.&#xD;
The hazard ratio is estimated using the Cox proportional hazards model which includes treatment group, stratification variables (baseline ACEis/ARBs use, RACE) and baseline UPCR.&#xD;
The estimate of median time is based on Kaplan-Meier analysis</description>
          <population>All randomized and treated participants</population>
          <units>Days</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="202"/>
                <count group_id="O2" value="203"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>First treatment failure (FTF) - Day 365</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="56"/>
                    <count group_id="O2" value="50"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" lower_limit="NA" upper_limit="NA">Due to &lt; 50% event occurrence, the median is not evaluable</measurement>
                    <measurement group_id="O2" value="NA" lower_limit="NA" upper_limit="NA">Due to &lt; 50% event occurrence, the median is not evaluable</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Overall treatment failure (OTF) - Day 365</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="74"/>
                    <count group_id="O2" value="71"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" lower_limit="NA" upper_limit="NA">Due to &lt; 50% event occurrence, the median is not evaluable</measurement>
                    <measurement group_id="O2" value="NA" lower_limit="NA" upper_limit="NA">Due to &lt; 50% event occurrence, the median is not evaluable</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>FTF - Day 729</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="202"/>
                    <count group_id="O2" value="203"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" lower_limit="NA" upper_limit="NA">Due to &lt; 50% event occurrence, the median is not evaluable</measurement>
                    <measurement group_id="O2" value="NA" lower_limit="NA" upper_limit="NA">Due to &lt; 50% event occurrence, the median is not evaluable</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>OTF - Day 729</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="202"/>
                    <count group_id="O2" value="203"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" lower_limit="NA" upper_limit="NA">Due to &lt; 50% event occurrence, the median is not evaluable</measurement>
                    <measurement group_id="O2" value="NA" lower_limit="NA" upper_limit="NA">Due to &lt; 50% event occurrence, the median is not evaluable</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Nephrotic Participants in Complete Renal Response of Lupus Glomerulonephritis at Day 729 of the Double-blind Period</title>
        <description>Number of participants achieving CR was divided by total participants in that arm, expressed as a percentage. CR is defined the following criteria: eGFR is normal or no &lt;85% of the baseline value; eGFR is based on mean creatinine value from day 358 and 365. Proteinuria: UPCR&lt;0.5 mg/mg. Urine sediment: No cellular casts. Corticosteroid dose: Daily dose must be no &gt;10 mg prednisone or equivalent for at least 28 days prior. Subjects with &gt;10mg/day prednisone or equivalent for non-renal disease within 28 days prior to day 365 will be imputed as CR if the following are true: Met all criteria for CR at day 337 and all criteria for CR except corticosteroid dose at day 365; Investigator confirms increase in steroid dose is not related to renal disease. Adjusted odds ratio is estimated from logistic regression model which includes treatment group, baseline ACEi/ARBs use, race and baseline UPCR as a continuous variable.</description>
        <time_frame>Day 729</time_frame>
        <population>All randomized and treated nephrotic participants, as observed, calculated per modified criteria (UPCR and eGFR only). Nephrotic is defined as screening UPCR &gt;= 3.0mg/mg (&gt;=339mg/mmol)</population>
        <group_list>
          <group group_id="O1">
            <title>Abatacept IV</title>
            <description>Abatacept 30 mg/kg injection by intravenous on Days 1,15, 29, and 57, followed by a weight-tiered dose approximating 10mg/kg injection by intravenous every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 weeks</description>
          </group>
          <group group_id="O2">
            <title>Placebo IV</title>
            <description>Placebo matching with Abatacept injection by intravenous on Days 1,15, 29, and 57, followed by every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 Weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Nephrotic Participants in Complete Renal Response of Lupus Glomerulonephritis at Day 729 of the Double-blind Period</title>
          <description>Number of participants achieving CR was divided by total participants in that arm, expressed as a percentage. CR is defined the following criteria: eGFR is normal or no &lt;85% of the baseline value; eGFR is based on mean creatinine value from day 358 and 365. Proteinuria: UPCR&lt;0.5 mg/mg. Urine sediment: No cellular casts. Corticosteroid dose: Daily dose must be no &gt;10 mg prednisone or equivalent for at least 28 days prior. Subjects with &gt;10mg/day prednisone or equivalent for non-renal disease within 28 days prior to day 365 will be imputed as CR if the following are true: Met all criteria for CR at day 337 and all criteria for CR except corticosteroid dose at day 365; Investigator confirms increase in steroid dose is not related to renal disease. Adjusted odds ratio is estimated from logistic regression model which includes treatment group, baseline ACEi/ARBs use, race and baseline UPCR as a continuous variable.</description>
          <population>All randomized and treated nephrotic participants, as observed, calculated per modified criteria (UPCR and eGFR only). Nephrotic is defined as screening UPCR &gt;= 3.0mg/mg (&gt;=339mg/mmol)</population>
          <units>Percentage</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="62"/>
                <count group_id="O2" value="51"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="50.0"/>
                    <measurement group_id="O2" value="49.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants in Overall Population in Complete Renal Response of Lupus Glomerulonephritis at Day 729 of the Double-blind Period</title>
        <description>Number of participants achieving CR was divided by total participants in that arm, expressed as a percentage. CR is defined the following criteria: eGFR is normal or no &lt;85% of the baseline value; eGFR is based on mean creatinine value from day 358 and 365. Proteinuria: UPCR&lt;0.5 mg/mg. Urine sediment: No cellular casts. Corticosteroid dose: Daily dose must be no &gt;10 mg prednisone or equivalent for at least 28 days prior. Subjects with &gt;10mg/day prednisone or equivalent for non-renal disease within 28 days prior to day 365 will be imputed as CR if the following are true: Met all criteria for CR at day 337 and all criteria for CR except corticosteroid dose at day 365; Investigator confirms increase in steroid dose is not related to renal disease. Adjusted odds ratio is estimated from logistic regression model which includes treatment group, baseline ACEi/ARBs use, race and baseline UPCR as a continuous variable.</description>
        <time_frame>Day 729</time_frame>
        <population>All randomized and treated participants, as observed, calculated per modified criteria (UPCR and eGFR only)</population>
        <group_list>
          <group group_id="O1">
            <title>Abatacept IV</title>
            <description>Abatacept 30 mg/kg injection by intravenous on Days 1,15, 29, and 57, followed by a weight-tiered dose approximating 10mg/kg injection by intravenous every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 weeks</description>
          </group>
          <group group_id="O2">
            <title>Placebo IV</title>
            <description>Placebo matching with Abatacept injection by intravenous on Days 1,15, 29, and 57, followed by every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 Weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants in Overall Population in Complete Renal Response of Lupus Glomerulonephritis at Day 729 of the Double-blind Period</title>
          <description>Number of participants achieving CR was divided by total participants in that arm, expressed as a percentage. CR is defined the following criteria: eGFR is normal or no &lt;85% of the baseline value; eGFR is based on mean creatinine value from day 358 and 365. Proteinuria: UPCR&lt;0.5 mg/mg. Urine sediment: No cellular casts. Corticosteroid dose: Daily dose must be no &gt;10 mg prednisone or equivalent for at least 28 days prior. Subjects with &gt;10mg/day prednisone or equivalent for non-renal disease within 28 days prior to day 365 will be imputed as CR if the following are true: Met all criteria for CR at day 337 and all criteria for CR except corticosteroid dose at day 365; Investigator confirms increase in steroid dose is not related to renal disease. Adjusted odds ratio is estimated from logistic regression model which includes treatment group, baseline ACEi/ARBs use, race and baseline UPCR as a continuous variable.</description>
          <population>All randomized and treated participants, as observed, calculated per modified criteria (UPCR and eGFR only)</population>
          <units>Percentage</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="134"/>
                <count group_id="O2" value="131"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="61.9"/>
                    <measurement group_id="O2" value="52.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Marked Hematology Laboratory Abnormalities in the Double Blind Period</title>
        <description>LLN= Lower limit of normals ULN= Upper limit of normals Pre RX = Baseline value HEMOGLOBIN g/L 4.0 HB &gt;3 G/DL DECREASE FROM PRE RX HEMATOCRIT vol 6.3 HCT &lt;0.75X PRE RX ERYTHROCYTES x10*12 c/L 5.2 RBC &lt;0.75X PRE RX PLATELET COUNT x10*9 c/L 5.0 PLAT &lt;0.67X LLN OR &gt;1.5X ULN, OR IF PRE RX&lt;LLN THEN USE 0.5X PRE RX AND &lt;100,000/MM3 LEUKOCYTES x10*9 c/L 6.2 WBC &lt;0.75X LLN OR &gt;1.25X ULN, OR IF PRE RX&lt;LLN THEN USE &lt;0.8X PRE RX OR &gt;ULN, OR IF PRE RX&gt;ULN THEN USE &gt;1.2X PRE RX OR &lt;LLN EOSINOPHILS (ABSOLUTE) x10*9 c/L 8.3 EOSA IF VALUE &gt; .750 X10*3 c/uL BASOPHILS (ABSOLUTE) x10*9 c/L 8.3 BASOA IF VALUE &gt; 400/MM3 MONOCYTES (ABSOLUTE) x10*9 c/L 8.3 MONOA IF VALUE &gt; 2000/MM3 LYMPHOCYTES (ABSOLUTE) x10*9 c/L 8.3 LYMPA IF VALUE &lt; .750 X10*3 c/uL OR IF VALUE &gt; 7.50 X10*3 c/uL&#xD;
N = the number of participants with at least 1 on treatment lab result for each analyte</description>
        <time_frame>Day 1 to Day 729</time_frame>
        <population>All treated participants&#xD;
NA (not available) indicates not-calculated as it was not a relevant pre-specified marked abnormality.</population>
        <group_list>
          <group group_id="O1">
            <title>Abatacept IV</title>
            <description>Abatacept 30 mg/kg injection by intravenous on Days 1,15, 29, and 57, followed by a weight-tiered dose approximating 10mg/kg injection by intravenous every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 weeks</description>
          </group>
          <group group_id="O2">
            <title>Placebo IV</title>
            <description>Placebo matching with Abatacept injection by intravenous on Days 1,15, 29, and 57, followed by every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 Weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Marked Hematology Laboratory Abnormalities in the Double Blind Period</title>
          <description>LLN= Lower limit of normals ULN= Upper limit of normals Pre RX = Baseline value HEMOGLOBIN g/L 4.0 HB &gt;3 G/DL DECREASE FROM PRE RX HEMATOCRIT vol 6.3 HCT &lt;0.75X PRE RX ERYTHROCYTES x10*12 c/L 5.2 RBC &lt;0.75X PRE RX PLATELET COUNT x10*9 c/L 5.0 PLAT &lt;0.67X LLN OR &gt;1.5X ULN, OR IF PRE RX&lt;LLN THEN USE 0.5X PRE RX AND &lt;100,000/MM3 LEUKOCYTES x10*9 c/L 6.2 WBC &lt;0.75X LLN OR &gt;1.25X ULN, OR IF PRE RX&lt;LLN THEN USE &lt;0.8X PRE RX OR &gt;ULN, OR IF PRE RX&gt;ULN THEN USE &gt;1.2X PRE RX OR &lt;LLN EOSINOPHILS (ABSOLUTE) x10*9 c/L 8.3 EOSA IF VALUE &gt; .750 X10*3 c/uL BASOPHILS (ABSOLUTE) x10*9 c/L 8.3 BASOA IF VALUE &gt; 400/MM3 MONOCYTES (ABSOLUTE) x10*9 c/L 8.3 MONOA IF VALUE &gt; 2000/MM3 LYMPHOCYTES (ABSOLUTE) x10*9 c/L 8.3 LYMPA IF VALUE &lt; .750 X10*3 c/uL OR IF VALUE &gt; 7.50 X10*3 c/uL&#xD;
N = the number of participants with at least 1 on treatment lab result for each analyte</description>
          <population>All treated participants&#xD;
NA (not available) indicates not-calculated as it was not a relevant pre-specified marked abnormality.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="153"/>
                <count group_id="O2" value="160"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>HEMOGLOBIN, low</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>HEMOGLOBIN, high</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA">Pre-specified marked lab abnormalities criteria do not include this low/high end value</measurement>
                    <measurement group_id="O2" value="NA">Pre-specified marked lab abnormalities criteria do not include this low/high end value</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>HEMATOCRIT, low</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>HEMATOCRIT, high</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA">Pre-specified marked lab abnormalities criteria do not include this low/high end value</measurement>
                    <measurement group_id="O2" value="NA">Pre-specified marked lab abnormalities criteria do not include this low/high end value</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ERYTHROCYTES, low</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ERYTHROCYTES, high</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA">Pre-specified marked lab abnormalities criteria do not include this low/high end value</measurement>
                    <measurement group_id="O2" value="NA">Pre-specified marked lab abnormalities criteria do not include this low/high end value</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PLATELET COUNT, low</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PLATELET COUNT, high</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>LEUKOCYTES, low</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19"/>
                    <measurement group_id="O2" value="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>LEUKOCYTES, high</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>EOSINOPHILS (ABSOLUTE), low</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA">Pre-specified marked lab abnormalities criteria do not include this low/high end value</measurement>
                    <measurement group_id="O2" value="NA">Pre-specified marked lab abnormalities criteria do not include this low/high end value</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>EOSINOPHILS (ABSOLUTE), high</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>BASOPHILS (ABSOLUTE), low</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA">Pre-specified marked lab abnormalities criteria do not include this low/high end value</measurement>
                    <measurement group_id="O2" value="NA">Pre-specified marked lab abnormalities criteria do not include this low/high end value</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>BASOPHILS (ABSOLUTE), high</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>MONOCYTES (ABSOLUTE), low</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA">Pre-specified marked lab abnormalities criteria do not include this low/high end value</measurement>
                    <measurement group_id="O2" value="NA">Pre-specified marked lab abnormalities criteria do not include this low/high end value</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>MONOCYTES (ABSOLUTE), high</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>LYMPHOCYTES (ABSOLUTE), low</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="43"/>
                    <measurement group_id="O2" value="62"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>LYMPHOCYTES (ABSOLUTE), high</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Marked Liver and Kidney Function Laboratory Abnormalities in the Double Blind Period</title>
        <description>LLN= Lower limit of normals ULN= Upper limit of normals Pre RX = Baseline value ALKALINE PHOSPHATASE (ALP) U/L 5.0 ALP &gt;2X ULN, OR IF PRE RX&gt;ULN THEN USE &gt;3X PRE RX ASPARTATE AMINOTRANSFERASE (AST) U/L 5.0 AST &gt;3X ULN, OR IF PRE RX&gt;ULN THEN USE &gt;4X PRE RX ALANINE AMINOTRANSFERASE (ALT) U/L 5.0 ALT &gt;3X ULN, OR IF PRE RX&gt;ULN THEN USE &gt;4X PRE RX G-GLUTAMYL TRANSFERASE (GGT) U/L 5.0 GGT &gt;2X ULN, OR IF PRE RX&gt;ULN THEN USE &gt;3X PRE RX BILIRUBIN, TOTAL umol/L 5.1 TBILI &gt;2X ULN, OR IF PRE RX&gt;ULN THEN USE &gt;4X PRE RX BILIRUBIN, DIRECT umol/L 5.1 DBILI &gt;1.5X ULN, OR IF PRE RX&gt;ULN THEN USE &gt;2X PRE RX BLOOD UREA NITROGEN mmol/L 5.1 BUN &gt;2X PRE RX CREATININE umol/L 5.0 CREAT &gt;1.5X PRE RX&#xD;
N = the number of participants with at least 1 on treatment lab result for each analyte</description>
        <time_frame>Day 1 to Day 729</time_frame>
        <population>All treated participants&#xD;
NA (not available) indicates not-calculated as it was not a relevant pre-specified marked abnormality.</population>
        <group_list>
          <group group_id="O1">
            <title>Abatacept IV</title>
            <description>Abatacept 30 mg/kg injection by intravenous on Days 1,15, 29, and 57, followed by a weight-tiered dose approximating 10mg/kg injection by intravenous every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 weeks</description>
          </group>
          <group group_id="O2">
            <title>Placebo IV</title>
            <description>Placebo matching with Abatacept injection by intravenous on Days 1,15, 29, and 57, followed by every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 Weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Marked Liver and Kidney Function Laboratory Abnormalities in the Double Blind Period</title>
          <description>LLN= Lower limit of normals ULN= Upper limit of normals Pre RX = Baseline value ALKALINE PHOSPHATASE (ALP) U/L 5.0 ALP &gt;2X ULN, OR IF PRE RX&gt;ULN THEN USE &gt;3X PRE RX ASPARTATE AMINOTRANSFERASE (AST) U/L 5.0 AST &gt;3X ULN, OR IF PRE RX&gt;ULN THEN USE &gt;4X PRE RX ALANINE AMINOTRANSFERASE (ALT) U/L 5.0 ALT &gt;3X ULN, OR IF PRE RX&gt;ULN THEN USE &gt;4X PRE RX G-GLUTAMYL TRANSFERASE (GGT) U/L 5.0 GGT &gt;2X ULN, OR IF PRE RX&gt;ULN THEN USE &gt;3X PRE RX BILIRUBIN, TOTAL umol/L 5.1 TBILI &gt;2X ULN, OR IF PRE RX&gt;ULN THEN USE &gt;4X PRE RX BILIRUBIN, DIRECT umol/L 5.1 DBILI &gt;1.5X ULN, OR IF PRE RX&gt;ULN THEN USE &gt;2X PRE RX BLOOD UREA NITROGEN mmol/L 5.1 BUN &gt;2X PRE RX CREATININE umol/L 5.0 CREAT &gt;1.5X PRE RX&#xD;
N = the number of participants with at least 1 on treatment lab result for each analyte</description>
          <population>All treated participants&#xD;
NA (not available) indicates not-calculated as it was not a relevant pre-specified marked abnormality.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="153"/>
                <count group_id="O2" value="160"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>ALKALINE PHOSPHATASE (ALP), low</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA">Pre-specified marked lab abnormalities criteria do not include this low/high end value</measurement>
                    <measurement group_id="O2" value="NA">Pre-specified marked lab abnormalities criteria do not include this low/high end value</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ALKALINE PHOSPHATASE (ALP), high</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ASPARTATE AMINOTRANSFERASE (AST), low</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA">Pre-specified marked lab abnormalities criteria do not include this low/high end value</measurement>
                    <measurement group_id="O2" value="NA">Pre-specified marked lab abnormalities criteria do not include this low/high end value</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ASPARTATE AMINOTRANSFERASE (AST), high</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ALANINE AMINOTRANSFERASE (ALT), low</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA">Pre-specified marked lab abnormalities criteria do not include this low/high end value</measurement>
                    <measurement group_id="O2" value="NA">Pre-specified marked lab abnormalities criteria do not include this low/high end value</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ALANINE AMINOTRANSFERASE (ALT), high</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>G-GLUTAMYL TRANSFERASE (GGT), low</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA">Pre-specified marked lab abnormalities criteria do not include this low/high end value</measurement>
                    <measurement group_id="O2" value="NA">Pre-specified marked lab abnormalities criteria do not include this low/high end value</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>G-GLUTAMYL TRANSFERASE (GGT), high</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17"/>
                    <measurement group_id="O2" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>BILIRUBIN, TOTAL, low</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA">Pre-specified marked lab abnormalities criteria do not include this low/high end value</measurement>
                    <measurement group_id="O2" value="NA">Pre-specified marked lab abnormalities criteria do not include this low/high end value</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>BILIRUBIN, TOTAL, high</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>BILIRUBIN, DIRECT, low</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA">Pre-specified marked lab abnormalities criteria do not include this low/high end value</measurement>
                    <measurement group_id="O2" value="NA">Pre-specified marked lab abnormalities criteria do not include this low/high end value</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>BILIRUBIN, DIRECT, high</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>BLOOD UREA NITROGEN, low</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA">Pre-specified marked lab abnormalities criteria do not include this low/high end value</measurement>
                    <measurement group_id="O2" value="NA">Pre-specified marked lab abnormalities criteria do not include this low/high end value</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>BLOOD UREA NITROGEN, high</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CREATININE, low</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA">Pre-specified marked lab abnormalities criteria do not include this low/high end value</measurement>
                    <measurement group_id="O2" value="NA">Pre-specified marked lab abnormalities criteria do not include this low/high end value</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CREATININE, high</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17"/>
                    <measurement group_id="O2" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Marked Electrolyte Laboratory Abnormalities in the Double Blind Period</title>
        <description>LLN= Lower limit of normals ULN= Upper limit of normals Pre RX = Baseline value SODIUM, SERUM mmol/L 4.0 NA &lt;0.95X LLN OR &gt;1.05X ULN, OR IF PRE RX&lt;LLN THEN USE &lt;0.95X PRE RX OR &gt;ULN, OR IF PRE RX&gt;ULN THEN USE &gt;1.05X PRE RX OR &lt;LLN POTASSIUM, SERUM mmol/L 4.1 K &lt;0.9X LLN OR &gt;1.1X ULN, OR IF PRE RX&lt;LLN THEN USE &lt;0.9X PRE RX OR &gt;ULN, OR IF PRE RX&gt;ULN THEN USE &gt;1.1X PRE RX OR &lt;LLN CHLORIDE, SERUM mmol/L 5.0 CL &lt;0.9X LLN OR &gt;1.1X ULN, OR IF PRE RX&lt;LLN THEN USE &lt;0.9X PRE RX OR &gt;ULN, OR IF PRE RX&gt;ULN THEN USE &gt;1.1X PRE RX OR &lt;LLN&#xD;
N = the number of participants with at least 1 on treatment lab result for each analyte</description>
        <time_frame>Day 1 to Day 729</time_frame>
        <population>All treated participants</population>
        <group_list>
          <group group_id="O1">
            <title>Abatacept IV</title>
            <description>Abatacept 30 mg/kg injection by intravenous on Days 1,15, 29, and 57, followed by a weight-tiered dose approximating 10mg/kg injection by intravenous every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 weeks</description>
          </group>
          <group group_id="O2">
            <title>Placebo IV</title>
            <description>Placebo matching with Abatacept injection by intravenous on Days 1,15, 29, and 57, followed by every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 Weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Marked Electrolyte Laboratory Abnormalities in the Double Blind Period</title>
          <description>LLN= Lower limit of normals ULN= Upper limit of normals Pre RX = Baseline value SODIUM, SERUM mmol/L 4.0 NA &lt;0.95X LLN OR &gt;1.05X ULN, OR IF PRE RX&lt;LLN THEN USE &lt;0.95X PRE RX OR &gt;ULN, OR IF PRE RX&gt;ULN THEN USE &gt;1.05X PRE RX OR &lt;LLN POTASSIUM, SERUM mmol/L 4.1 K &lt;0.9X LLN OR &gt;1.1X ULN, OR IF PRE RX&lt;LLN THEN USE &lt;0.9X PRE RX OR &gt;ULN, OR IF PRE RX&gt;ULN THEN USE &gt;1.1X PRE RX OR &lt;LLN CHLORIDE, SERUM mmol/L 5.0 CL &lt;0.9X LLN OR &gt;1.1X ULN, OR IF PRE RX&lt;LLN THEN USE &lt;0.9X PRE RX OR &gt;ULN, OR IF PRE RX&gt;ULN THEN USE &gt;1.1X PRE RX OR &lt;LLN&#xD;
N = the number of participants with at least 1 on treatment lab result for each analyte</description>
          <population>All treated participants</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="153"/>
                <count group_id="O2" value="160"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>SODIUM, SERUM, low</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SODIUM, SERUM, high</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>POTASSIUM, SERUM, low</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>POTASSIUM, SERUM, high</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CHLORIDE, SERUM, low</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CHLORIDE, SERUM, high</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CALCIUM, TOTAL, low</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CALCIUM, TOTAL, high</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PHOSPHORUS, INORGANIC, low</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PHOSPHORUS, INORGANIC, high</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Marked Urinalysis Laboratory Abnormalities in the Double Blind Period</title>
        <description>LLN= Lower limit of normals ULN= Upper limit of normals Pre RX = Baseline value PROTEIN, URINE Unknown UPRO IF MISSING PRE THEN USE &gt;=2, OR IF VALUE &gt;=4, OR IF PRE RX =0 OR 0.5 THEN USE &gt;=2, OR IF PRE RX =1 THEN USE &gt;=3, OR IF PRE RX =2 OR 3 THEN USE &gt;=4 GLUCOSE, URINE N/A UGLU IF MISSING PRE THEN USE &gt;=2, OR IF VALUE &gt;=4, OR IF PRE RX =0 OR 0.5 THEN USE &gt;=2, OR IF PRE RX =1 THEN USE &gt;=3, OR IF PRE RX =2 OR 3 THEN USE &gt;=4 BLOOD, URINE N/A UBLD IF MISSING PRE THEN USE &gt;=2, OR IF VALUE &gt;=4, OR IF PRE RX =0 OR 0.5 THEN USE &gt;=2, OR IF PRE RX =1 THEN USE &gt;=3, OR IF PRE RX =2 OR 3 THEN USE &gt;=4 RBC, URINE hpf 5.0 URBC IF MISSING PRE THEN USE &gt;=2, OR IF VALUE &gt;=4, OR IF PRE RX =0 OR 0.5 THEN USE &gt;=2, OR IF PRE RX =1 THEN USE &gt;=3, OR IF PRE RX =2 OR 3 THEN USE &gt;=4 WBC, URINE hpf 5.0 UWBC IF MISSING PRE THEN USE &gt;=2, OR IF VALUE &gt;=4, OR IF PRE RX =0 OR 0.5 THEN USE &gt;=2, OR IF PRE RX =1 THEN USE &gt;=3, OR IF PRE RX =2 OR 3 THEN USE &gt;=4</description>
        <time_frame>Day 1 to Day 729</time_frame>
        <population>All treated participants&#xD;
N = the number of participants with at least 1 on treatment lab result for each analyte&#xD;
NA (not available) indicates not-calculated as it was not a relevant pre-specified marked abnormality.</population>
        <group_list>
          <group group_id="O1">
            <title>Abatacept IV</title>
            <description>Abatacept 30 mg/kg injection by intravenous on Days 1,15, 29, and 57, followed by a weight-tiered dose approximating 10mg/kg injection by intravenous every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 weeks</description>
          </group>
          <group group_id="O2">
            <title>Placebo IV</title>
            <description>Placebo matching with Abatacept injection by intravenous on Days 1,15, 29, and 57, followed by every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 Weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Marked Urinalysis Laboratory Abnormalities in the Double Blind Period</title>
          <description>LLN= Lower limit of normals ULN= Upper limit of normals Pre RX = Baseline value PROTEIN, URINE Unknown UPRO IF MISSING PRE THEN USE &gt;=2, OR IF VALUE &gt;=4, OR IF PRE RX =0 OR 0.5 THEN USE &gt;=2, OR IF PRE RX =1 THEN USE &gt;=3, OR IF PRE RX =2 OR 3 THEN USE &gt;=4 GLUCOSE, URINE N/A UGLU IF MISSING PRE THEN USE &gt;=2, OR IF VALUE &gt;=4, OR IF PRE RX =0 OR 0.5 THEN USE &gt;=2, OR IF PRE RX =1 THEN USE &gt;=3, OR IF PRE RX =2 OR 3 THEN USE &gt;=4 BLOOD, URINE N/A UBLD IF MISSING PRE THEN USE &gt;=2, OR IF VALUE &gt;=4, OR IF PRE RX =0 OR 0.5 THEN USE &gt;=2, OR IF PRE RX =1 THEN USE &gt;=3, OR IF PRE RX =2 OR 3 THEN USE &gt;=4 RBC, URINE hpf 5.0 URBC IF MISSING PRE THEN USE &gt;=2, OR IF VALUE &gt;=4, OR IF PRE RX =0 OR 0.5 THEN USE &gt;=2, OR IF PRE RX =1 THEN USE &gt;=3, OR IF PRE RX =2 OR 3 THEN USE &gt;=4 WBC, URINE hpf 5.0 UWBC IF MISSING PRE THEN USE &gt;=2, OR IF VALUE &gt;=4, OR IF PRE RX =0 OR 0.5 THEN USE &gt;=2, OR IF PRE RX =1 THEN USE &gt;=3, OR IF PRE RX =2 OR 3 THEN USE &gt;=4</description>
          <population>All treated participants&#xD;
N = the number of participants with at least 1 on treatment lab result for each analyte&#xD;
NA (not available) indicates not-calculated as it was not a relevant pre-specified marked abnormality.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="153"/>
                <count group_id="O2" value="160"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>PROTEIN, URINE, low</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="143"/>
                    <count group_id="O2" value="150"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA">Pre-specified marked lab abnormalities criteria do not include this low/high end value</measurement>
                    <measurement group_id="O2" value="NA">Pre-specified marked lab abnormalities criteria do not include this low/high end value</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PROTEIN, URINE, high</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="143"/>
                    <count group_id="O2" value="150"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GLUCOSE, URINE, low</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="142"/>
                    <count group_id="O2" value="152"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA">Pre-specified marked lab abnormalities criteria do not include this low/high end value</measurement>
                    <measurement group_id="O2" value="NA">Pre-specified marked lab abnormalities criteria do not include this low/high end value</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GLUCOSE, URINE, high</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="142"/>
                    <count group_id="O2" value="152"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>BLOOD, URINE, low</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="147"/>
                    <count group_id="O2" value="154"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA">Pre-specified marked lab abnormalities criteria do not include this low/high end value</measurement>
                    <measurement group_id="O2" value="NA">Pre-specified marked lab abnormalities criteria do not include this low/high end value</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>BLOOD, URINE, high</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="147"/>
                    <count group_id="O2" value="154"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Red blood cells (RBC), URINE, low</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="152"/>
                    <count group_id="O2" value="156"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA">Pre-specified marked lab abnormalities criteria do not include this low/high end value</measurement>
                    <measurement group_id="O2" value="NA">Pre-specified marked lab abnormalities criteria do not include this low/high end value</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Red blood cells (RBC), URINE, high</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="152"/>
                    <count group_id="O2" value="156"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="58"/>
                    <measurement group_id="O2" value="55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>White blood cells (WBC), URINE, low</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="152"/>
                    <count group_id="O2" value="156"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA">Pre-specified marked lab abnormalities criteria do not include this low/high end value</measurement>
                    <measurement group_id="O2" value="NA">Pre-specified marked lab abnormalities criteria do not include this low/high end value</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>White blood cells (WBC), URINE, high</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="152"/>
                    <count group_id="O2" value="156"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="46"/>
                    <measurement group_id="O2" value="59"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Other Marked Chemistry Laboratory Abnormalities in the Double Blind Period</title>
        <description>LLN= Lower limit of normals ULN= Upper limit of normals Pre RX = Baseline value CALCIUM, TOTAL mmol/L 5.2 CA &lt;0.8X LLN OR &gt;1.2X ULN, OR IF PRE RX&lt;LLN THEN USE &lt;0.75X PRE RX OR &gt;ULN, OR IF PRE RX&gt;ULN THEN USE &gt;1.25X PRE RX OR &lt;LLN PHOSPHORUS, INORGANIC mmol/L 5.2 PHOS &lt;0.75X LLN OR &gt;1.25X ULN, OR IF PRE RX&lt;LLN THEN USE &lt;0.67X PRE RX OR &gt;ULN GLUCOSE, SERUM mmol/L 4.1 GLUC &lt;65 mg/dL, OR &gt;220 mg/dL PROTEIN, TOTAL g/L 5.0 TPRO &lt;0.9X LLN OR &gt;1.1X ULN, OR IF PRE RX&lt;LLN THEN USE 0.9X PRE RX OR &gt;ULN, OR IF PRE RX&gt;ULN THEN USE 1.1X PRE RX OR &lt;LLN ALBUMIN g/L 3.0 ALB &lt;0.9X LLN, OR IF PRE RX&lt;LLN THEN USE &lt;0.75X PRE RX CHOLESTEROL, TOTAL (TC) mmol/L 5.2 CHOL &gt;2X PRE R&#xD;
N = the number of participants with at least 1 on treatment lab result for each analyte</description>
        <time_frame>Day 1 to Day 729</time_frame>
        <population>All treated participants&#xD;
NA (not available) indicates not-calculated as it was not a relevant pre-specified marked abnormality.</population>
        <group_list>
          <group group_id="O1">
            <title>Abatacept IV</title>
            <description>Abatacept 30 mg/kg injection by intravenous on Days 1,15, 29, and 57, followed by a weight-tiered dose approximating 10mg/kg injection by intravenous every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 weeks</description>
          </group>
          <group group_id="O2">
            <title>Placebo IV</title>
            <description>Placebo matching with Abatacept injection by intravenous on Days 1,15, 29, and 57, followed by every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 Weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Other Marked Chemistry Laboratory Abnormalities in the Double Blind Period</title>
          <description>LLN= Lower limit of normals ULN= Upper limit of normals Pre RX = Baseline value CALCIUM, TOTAL mmol/L 5.2 CA &lt;0.8X LLN OR &gt;1.2X ULN, OR IF PRE RX&lt;LLN THEN USE &lt;0.75X PRE RX OR &gt;ULN, OR IF PRE RX&gt;ULN THEN USE &gt;1.25X PRE RX OR &lt;LLN PHOSPHORUS, INORGANIC mmol/L 5.2 PHOS &lt;0.75X LLN OR &gt;1.25X ULN, OR IF PRE RX&lt;LLN THEN USE &lt;0.67X PRE RX OR &gt;ULN GLUCOSE, SERUM mmol/L 4.1 GLUC &lt;65 mg/dL, OR &gt;220 mg/dL PROTEIN, TOTAL g/L 5.0 TPRO &lt;0.9X LLN OR &gt;1.1X ULN, OR IF PRE RX&lt;LLN THEN USE 0.9X PRE RX OR &gt;ULN, OR IF PRE RX&gt;ULN THEN USE 1.1X PRE RX OR &lt;LLN ALBUMIN g/L 3.0 ALB &lt;0.9X LLN, OR IF PRE RX&lt;LLN THEN USE &lt;0.75X PRE RX CHOLESTEROL, TOTAL (TC) mmol/L 5.2 CHOL &gt;2X PRE R&#xD;
N = the number of participants with at least 1 on treatment lab result for each analyte</description>
          <population>All treated participants&#xD;
NA (not available) indicates not-calculated as it was not a relevant pre-specified marked abnormality.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="153"/>
                <count group_id="O2" value="160"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>GLUCOSE, SERUM, low</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="151"/>
                    <count group_id="O2" value="159"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                    <measurement group_id="O2" value="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GLUCOSE, SERUM, high</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="151"/>
                    <count group_id="O2" value="159"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GLUCOSE, FASTING SERUM, low</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="137"/>
                    <count group_id="O2" value="124"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GLUCOSE, FASTING SERUM, high</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="137"/>
                    <count group_id="O2" value="124"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PROTEIN, TOTAL, low</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="153"/>
                    <count group_id="O2" value="160"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PROTEIN, TOTAL, high</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="153"/>
                    <count group_id="O2" value="160"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ALBUMIN, low</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="153"/>
                    <count group_id="O2" value="160"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ALBUMIN, high</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="153"/>
                    <count group_id="O2" value="160"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA">Pre-specified marked lab abnormalities criteria do not include this low/high end value</measurement>
                    <measurement group_id="O2" value="NA">Pre-specified marked lab abnormalities criteria do not include this low/high end value</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Abatacept Induced Antibody Response Over Time in the Double-blind Period</title>
        <description>Participants who experienced a positive antibody response relative to baseline (ECL Assay)</description>
        <time_frame>Day 365, Day 729</time_frame>
        <population>All treated participants in the immunogenicity analysis population for Year 1.&#xD;
Note: Study terminated, Year 2 data not collected</population>
        <group_list>
          <group group_id="O1">
            <title>Abatacept IV</title>
            <description>Abatacept 30 mg/kg injection by intravenous on Days 1,15, 29, and 57, followed by a weight-tiered dose approximating 10mg/kg injection by intravenous every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 weeks</description>
          </group>
          <group group_id="O2">
            <title>Placebo IV</title>
            <description>Placebo matching with Abatacept injection by intravenous on Days 1,15, 29, and 57, followed by every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 Weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Abatacept Induced Antibody Response Over Time in the Double-blind Period</title>
          <description>Participants who experienced a positive antibody response relative to baseline (ECL Assay)</description>
          <population>All treated participants in the immunogenicity analysis population for Year 1.&#xD;
Note: Study terminated, Year 2 data not collected</population>
          <units>Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="202"/>
                <count group_id="O2" value="203"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 365, overall</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="199"/>
                    <count group_id="O2" value="176"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 729, overall</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Abatacept IV</title>
          <description>Abatacept 30 mg/kg injection by intravenous on Days 1,15, 29, and 57, followed by a weight-tiered dose approximating 10mg/kg injection by intravenous every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 weeks</description>
        </group>
        <group group_id="E2">
          <title>Placebo IV</title>
          <description>Placebo matching with Abatacept injection by intravenous on Days 1,15, 29, and 57, followed by every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 Weeks</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 21.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="202"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="203"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="62" subjects_at_risk="202"/>
                <counts group_id="E2" subjects_affected="58" subjects_at_risk="203"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="202"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="203"/>
              </event>
              <event>
                <sub_title>Anaemia of chronic disease</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="203"/>
              </event>
              <event>
                <sub_title>Febrile neutropenia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="202"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="203"/>
              </event>
              <event>
                <sub_title>Histiocytosis haematophagic</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="202"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="203"/>
              </event>
              <event>
                <sub_title>Neutropenia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="202"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="203"/>
              </event>
              <event>
                <sub_title>Thrombocytopenia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="202"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="203"/>
              </event>
              <event>
                <sub_title>Thrombotic thrombocytopenic purpura</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="203"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Lupus myocarditis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="202"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="203"/>
              </event>
              <event>
                <sub_title>Tachycardia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="203"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Cataract</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="203"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="203"/>
              </event>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="203"/>
              </event>
              <event>
                <sub_title>Chronic gastritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="203"/>
              </event>
              <event>
                <sub_title>Enteritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="203"/>
              </event>
              <event>
                <sub_title>Food poisoning</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="202"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="203"/>
              </event>
              <event>
                <sub_title>Gastritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="203"/>
              </event>
              <event>
                <sub_title>Haematochezia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="203"/>
              </event>
              <event>
                <sub_title>Intestinal perforation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="202"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="203"/>
              </event>
              <event>
                <sub_title>Intussusception</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="203"/>
              </event>
              <event>
                <sub_title>Upper gastrointestinal haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="203"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Chest pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="202"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="203"/>
              </event>
              <event>
                <sub_title>Generalised oedema</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="203"/>
              </event>
              <event>
                <sub_title>Multiple organ dysfunction syndrome</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="202"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="203"/>
              </event>
              <event>
                <sub_title>Oedema peripheral</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="202"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="203"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="202"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="203"/>
              </event>
              <event>
                <sub_title>Serositis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="202"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="203"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Hypogammaglobulinaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="202"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="203"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Anal abscess</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="202"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="203"/>
              </event>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="203"/>
              </event>
              <event>
                <sub_title>Candida infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="203"/>
              </event>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="202"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="203"/>
              </event>
              <event>
                <sub_title>Disseminated tuberculosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="203"/>
              </event>
              <event>
                <sub_title>Encephalitis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="202"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="203"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="202"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="203"/>
              </event>
              <event>
                <sub_title>Genital herpes</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="202"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="203"/>
              </event>
              <event>
                <sub_title>Herpes zoster</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="202"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="203"/>
              </event>
              <event>
                <sub_title>Lower respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="202"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="203"/>
              </event>
              <event>
                <sub_title>Lung infection</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="202"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="203"/>
              </event>
              <event>
                <sub_title>Periorbital cellulitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="203"/>
              </event>
              <event>
                <sub_title>Peritonitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="202"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="203"/>
              </event>
              <event>
                <sub_title>Pneumocystis jirovecii pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="202"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="203"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="15" subjects_at_risk="202"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="203"/>
              </event>
              <event>
                <sub_title>Pyelonephritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="203"/>
              </event>
              <event>
                <sub_title>Respiratory syncytial virus bronchiolitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="203"/>
              </event>
              <event>
                <sub_title>Salmonella bacteraemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="202"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="203"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="202"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="203"/>
              </event>
              <event>
                <sub_title>Septic shock</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="202"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="203"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="202"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="203"/>
              </event>
              <event>
                <sub_title>Subcutaneous abscess</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="202"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="203"/>
              </event>
              <event>
                <sub_title>Tooth abscess</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="203"/>
              </event>
              <event>
                <sub_title>Toxoplasmosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="202"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="203"/>
              </event>
              <event>
                <sub_title>Tuberculosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="202"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="203"/>
              </event>
              <event>
                <sub_title>Tuberculous pleurisy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="203"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="202"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="203"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="202"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="203"/>
              </event>
              <event>
                <sub_title>Urinary tract infection bacterial</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="202"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="203"/>
              </event>
              <event>
                <sub_title>Viral infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="202"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="203"/>
              </event>
              <event>
                <sub_title>Viral upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="203"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Contusion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="203"/>
              </event>
              <event>
                <sub_title>Overdose</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="202"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="203"/>
              </event>
              <event>
                <sub_title>Radius fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="203"/>
              </event>
              <event>
                <sub_title>Tendon rupture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="203"/>
              </event>
              <event>
                <sub_title>Traumatic fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="203"/>
              </event>
              <event>
                <sub_title>Ulna fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="203"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Gamma-glutamyltransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="203"/>
              </event>
              <event>
                <sub_title>Liver function test abnormal</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="203"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Hyperkalaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="203"/>
              </event>
              <event>
                <sub_title>Hypokalaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="202"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="203"/>
              </event>
              <event>
                <sub_title>Metabolic acidosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="203"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Foot deformity</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="203"/>
              </event>
              <event>
                <sub_title>Myopathy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="203"/>
              </event>
              <event>
                <sub_title>Osteonecrosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="202"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="203"/>
              </event>
              <event>
                <sub_title>Systemic lupus erythematosus</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="202"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="203"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Adenocarcinoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="203"/>
              </event>
              <event>
                <sub_title>Basal cell carcinoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="203"/>
              </event>
              <event>
                <sub_title>Hypergammaglobulinaemia benign monoclonal</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="202"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="203"/>
              </event>
              <event>
                <sub_title>Malignant neoplasm of conjunctiva</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="202"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="203"/>
              </event>
              <event>
                <sub_title>Myelofibrosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="202"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="203"/>
              </event>
              <event>
                <sub_title>Thyroid cancer</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="202"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="203"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Cerebral infarction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="203"/>
              </event>
              <event>
                <sub_title>Embolic stroke</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="203"/>
              </event>
              <event>
                <sub_title>Encephalopathy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="203"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="202"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="203"/>
              </event>
              <event>
                <sub_title>Idiopathic intracranial hypertension</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="203"/>
              </event>
              <event>
                <sub_title>Lupus encephalitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="202"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="203"/>
              </event>
              <event>
                <sub_title>Presyncope</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="203"/>
              </event>
              <event>
                <sub_title>Seizure</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="202"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="203"/>
              </event>
              <event>
                <sub_title>Sensory loss</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="203"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Pregnancy, puerperium and perinatal conditions</title>
            <event_list>
              <event>
                <sub_title>Pregnancy</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="202"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="203"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="202"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="203"/>
              </event>
              <event>
                <sub_title>Psychogenic seizure</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="203"/>
              </event>
              <event>
                <sub_title>Substance-induced psychotic disorder</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="202"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="203"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Acute kidney injury</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="202"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="203"/>
              </event>
              <event>
                <sub_title>Azotaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="203"/>
              </event>
              <event>
                <sub_title>Chronic kidney disease</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="203"/>
              </event>
              <event>
                <sub_title>Lupus nephritis</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="202"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="203"/>
              </event>
              <event>
                <sub_title>Renal failure</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="202"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="203"/>
              </event>
              <event>
                <sub_title>Renal impairment</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="202"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="203"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Cervical dysplasia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="203"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Acute pulmonary oedema</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="203"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="202"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="203"/>
              </event>
              <event>
                <sub_title>Interstitial lung disease</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="203"/>
              </event>
              <event>
                <sub_title>Pleural effusion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="202"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="203"/>
              </event>
              <event>
                <sub_title>Pneumothorax</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="202"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="203"/>
              </event>
              <event>
                <sub_title>Pulmonary alveolar haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="203"/>
              </event>
              <event>
                <sub_title>Respiratory failure</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="202"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="203"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Skin necrosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="203"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Deep vein thrombosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="203"/>
              </event>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="203"/>
              </event>
              <event>
                <sub_title>Vasculitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="203"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 21.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="164" subjects_at_risk="202"/>
                <counts group_id="E2" subjects_affected="179" subjects_at_risk="203"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" subjects_affected="20" subjects_at_risk="202"/>
                <counts group_id="E2" subjects_affected="23" subjects_at_risk="203"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="202"/>
                <counts group_id="E2" subjects_affected="14" subjects_at_risk="203"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="47" subjects_at_risk="202"/>
                <counts group_id="E2" subjects_affected="46" subjects_at_risk="203"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="13" subjects_at_risk="202"/>
                <counts group_id="E2" subjects_affected="17" subjects_at_risk="203"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="202"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="203"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Oedema peripheral</sub_title>
                <counts group_id="E1" subjects_affected="15" subjects_at_risk="202"/>
                <counts group_id="E2" subjects_affected="13" subjects_at_risk="203"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="202"/>
                <counts group_id="E2" subjects_affected="13" subjects_at_risk="203"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" subjects_affected="18" subjects_at_risk="202"/>
                <counts group_id="E2" subjects_affected="26" subjects_at_risk="203"/>
              </event>
              <event>
                <sub_title>Conjunctivitis</sub_title>
                <counts group_id="E1" subjects_affected="14" subjects_at_risk="202"/>
                <counts group_id="E2" subjects_affected="15" subjects_at_risk="203"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="202"/>
                <counts group_id="E2" subjects_affected="17" subjects_at_risk="203"/>
              </event>
              <event>
                <sub_title>Herpes zoster</sub_title>
                <counts group_id="E1" subjects_affected="20" subjects_at_risk="202"/>
                <counts group_id="E2" subjects_affected="18" subjects_at_risk="203"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="202"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="203"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="40" subjects_at_risk="202"/>
                <counts group_id="E2" subjects_affected="44" subjects_at_risk="203"/>
              </event>
              <event>
                <sub_title>Pharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="20" subjects_at_risk="202"/>
                <counts group_id="E2" subjects_affected="24" subjects_at_risk="203"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="43" subjects_at_risk="202"/>
                <counts group_id="E2" subjects_affected="42" subjects_at_risk="203"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="45" subjects_at_risk="202"/>
                <counts group_id="E2" subjects_affected="38" subjects_at_risk="203"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" subjects_affected="21" subjects_at_risk="202"/>
                <counts group_id="E2" subjects_affected="19" subjects_at_risk="203"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="202"/>
                <counts group_id="E2" subjects_affected="16" subjects_at_risk="203"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="202"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="203"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="24" subjects_at_risk="202"/>
                <counts group_id="E2" subjects_affected="23" subjects_at_risk="203"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" subjects_affected="13" subjects_at_risk="202"/>
                <counts group_id="E2" subjects_affected="20" subjects_at_risk="203"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" subjects_affected="25" subjects_at_risk="202"/>
                <counts group_id="E2" subjects_affected="24" subjects_at_risk="203"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Alopecia</sub_title>
                <counts group_id="E1" subjects_affected="13" subjects_at_risk="202"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="203"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="202"/>
                <counts group_id="E2" subjects_affected="20" subjects_at_risk="203"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="202"/>
                <counts group_id="E2" subjects_affected="12" subjects_at_risk="203"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="202"/>
                <counts group_id="E2" subjects_affected="13" subjects_at_risk="203"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.</restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>Study terminated early after review of Year 1 data. Only Year 2/LTE data captured within blind was analyzed. Outcomes related to renal responses were not calculated due to lack of data caused by the early termination.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Bristol-Myers Squibb Study Director</name_or_title>
      <organization>Bristol-Myers Squibb</organization>
      <phone>Please email:</phone>
      <email>Clinical.Trials@bms.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01714817
org study id: IM101-291
secondary id: 2012-000714-11
nct id: NCT01714817
lead sponsor: 
has dmc: Yes
The purpose of this study is to evaluate (Abatacept) for treatment of lupus nephritis when
      used on a background of Cellcept (mycophenolate) and prednisone (corticosteroids)
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Percentage of Participants in Complete Renal Response (CR) of Lupus Glomerulonephritis at Day 365 of the Double-blind Period
time frame: Day 365
description: Number of participants achieving CR was divided by the total number of participants in that arm and expressed as a percentage. CR defined as: eGFR is normal or no <85% of the baseline; eGFR based on mean creatinine value from day 358 and 365. Proteinuria: UPCR<0.5 mg/mg. Urine sediment: No cellular casts. Corticosteroid dose: Daily dose must be no >10 mg prednisone or equiv. for at least 28 days prior to assessment. Participants with >10mg/day prednisone or equivalent for non-renal disease within 28 days prior to day 365 will be imputed as having achieved CR if the following are true: Met all criteria for CR at day 337 and all criteria for CR except corticosteroid dose at day 365; Investigator confirms increase in steroid dose is not related to renal disease. Adjusted odds ratio is estimated from logistic regression model which includes treatment group, baseline ACEi/ARBs use (Yes/No), race (Asian/ Black/Caucasian/Other) and baseline UPCR as a continuous variable.
measure: Percentage of Nephrotic Participants in Complete Renal Response of Lupus Glomerulonephritis at Day 365 of the Double-blind Period
time frame: Day 365
description: Number of participants achieving CR was divided by total participants in that arm, expressed as a percentage. CR is defined the following criteria: eGFR is normal or no <85% of the baseline value; eGFR is based on mean creatinine value from day 358 and 365. Proteinuria: UPCR<0.5 mg/mg. Urine sediment: No cellular casts. Corticosteroid dose: Daily dose must be no >10 mg prednisone or equivalent for at least 28 days prior. Subjects with >10mg/day prednisone or equivalent for non-renal disease within 28 days prior to day 365 will be imputed as CR if the following are true: Met all criteria for CR at day 337 and all criteria for CR except corticosteroid dose at day 365; Investigator confirms increase in steroid dose is not related to renal disease. Adjusted odds ratio is estimated from logistic regression model which includes treatment group, baseline ACEi/ARBs use, race and baseline UPCR as a continuous variable.
measure: Adjusted Mean Change From Baseline in Urine Protein/Creatinine Ratio (UPCR) at Day 365 of the Double-blind Period in Nephrotic Participants
time frame: Baseline and Day 365
description: Adjusted Mean Change from Baseline in UPCR at Day 365 of the double-blind period in nephrotic participants
measure: Adjusted Mean Change From Baseline in UPCR at Day 365 of the Double-blind Period in Overall Population
time frame: Day 1 and Day 365
description: Adjusted Mean Change from Baseline in Urine protein/creatinine ratio (UPCR) at Day 365 of the double-blind period in the overall population
measure: Adjusted Mean Change From Baseline in Disease Activity as Measured by BILAG 2004 Over Time During Year 1 of the Double-blind Period
time frame: Day 1 to Day 365
description: Adjusted mean change from baseline in British Isles Lupus Assessment Group (BILAG) score over time during Year 1 of the double-blind period based on a repeated measure mixed model and presented at each visit in the first 12-month of the double-blind period. BILAG index measures disease activity in different organs/systems separately. BILAG score is calculated for each of 9 systems depending on the clinical features present and whether they are new (4 points), worse (3 points), the same (2 points), improving (1 point) or not present (0 points) in the last 4 weeks compared with previously. BILAG "A" represents the presence of serious features of lupus. BILAG "B" represents more moderate features of the disease. BILAG "C" includes only mild symptomatic features. BILAG "D" represents prior activity with no current symptoms due to active lupus. BILAG "E" represents an organ that has never been involved. Overall BILAG score ranges from 0-108, with higher scores reflecting a worse outcome.
measure: Number of Participants With Any Adverse Events (AEs) During Year 1 of the Double-blind Period
time frame: From Day 1 up to 56 days post last dose in Year 1 of the double-blind period
description: All AEs were coded and grouped into preferred terms (PT) by system organ class (SOC), using the Medical Dictionary for Regulatory Activities (MedDRA, version 21.0). Investigators determined the intensity of each AE as mild, moderate, severe, or very severe and assessed the relationship to study drug.
measure: Percentage of Participants With Ranked Outcome of Complete Renal Response, Partial Renal Response (PR), and No Renal Response (NR) During the Double-blind Period
time frame: Day 365, Day 729
description: Complete Renal Response or Complete Response (CR): defined as meeting ALL of the following criteria: eGFR normal OR no less than 85% of the baseline value; UPCR < 0.5; Urine sediment: No cellular casts; Daily corticosteroid dose must be no greater than 10 mg prednisone or equivalent for at least 28 days prior to assessment. Partial Renal Response or Partial Response (PR): defined as meeting ALL of the following criteria: Participant does not meet criteria for CR; eGFR no less than 85% of the lesser of the values at screening or randomization (Day 1); UPCR < 0.5 OR 50% reduced from baseline and < 1 if baseline value was < 3, OR 50% reduced from baseline and < 3 if baseline value was greater than or equal to 3; Urine sediment: no cellular casts; daily corticosteroid dose no greater than 10 mg/day prednisone or prednisone equivalent for at least 28 days prior to assessment. No Renal Response or No Response (NR): defined as not meeting criteria for CR or PR or withdrawn
measure: Median Time to Complete Renal Response During the Double-blind Period in All Participants
time frame: Day 365, Day 729
description: The estimate of median time to Complete Renal Response is based on Kaplan-Meier analysis. Complete renal response (CR): defined as meeting ALL of the following criteria: eGFR normal OR no less than 85% of the baseline value; Urine protein/creatinine ratio (UPCR) < 0.5; Urine sediment: No cellular casts; Daily corticosteroid dose must be no greater than 10 mg prednisone or equivalent for at least 28 days prior to assessment.
measure: Median Time to Complete Renal Response During the Double-blind Period in Nephrotic Participants
time frame: Day 365, Day 729
description: The estimate of median time to Complete Renal Response in nephrotic participants is based on Kaplan-Meier analysis. Complete renal response (CR): defined as meeting ALL of the following criteria: eGFR normal OR no less than 85% of the baseline value; Urine protein/creatinine ratio (UPCR) < 0.5; Urine sediment: No cellular casts; Daily corticosteroid dose must be no greater than 10 mg prednisone or equivalent for at least 28 days prior to assessment.
measure: Median Time to Partial Renal Response During the Double-blind Period in All Participants
time frame: Day 365, Day 729
description: The estimate of median time to Partial Response (PR) is based on Kaplan-Meier analysis. Partial renal response (PR): defined as meeting ALL of the following criteria: Participant does not meet criteria for CR; eGFR no less than 85% of the lesser of the values at screening or randomization (Day 1); UPCR < 0.5 OR 50% reduced from baseline and < 1 if baseline value was < 3, OR 50% reduced from baseline and < 3 if baseline value was 3; Urine sediment: no cellular casts; daily corticosteroid dose no greater than 10 mg/day prednisone or prednisone equivalent for at least 28 days prior to assessment
measure: Median Time to Partial Renal Response During the Double-blind Period in Nephrotic Participants
time frame: Day 365, Day 729
description: The estimate of median time to Partial Response (PR) in nephrotic participants is based on Kaplan-Meier analysis. Partial renal response (PR): defined as meeting ALL of the following criteria: Participant does not meet criteria for CR; eGFR no less than 85% of the lesser of the values at screening or randomization (Day 1); UPCR < 0.5 OR 50% reduced from baseline and < 1 if baseline value was < 3, OR 50% reduced from baseline and < 3 if baseline value was 3; Urine sediment: no cellular casts; daily corticosteroid dose no greater than 10 mg/day prednisone or prednisone equivalent for at least 28 days prior to assessment
measure: Adjusted Mean Change From Baseline in UPCR Over Time
time frame: Day 365; Day 729, includes data up to July 1st 2017 when double-blind therapy ended
description: A repeated measure mixed model that included the baseline UPCR value, randomization stratification factors, time, and time by treatment interaction as fixed effects and subject as a random effect was used.
measure: Median Percent Change From Baseline in UPCR Over Time
time frame: Day 365, Day 729
description: A repeated measure mixed model that included the baseline UPCR value, randomization stratification factors, time, and time by treatment interaction as fixed effects and subject as a random effect was used.
% Change from Baseline = (post baseline - baseline value) / baseline value x 100
measure: Adjusted Mean Change From Baseline in eGFR Over Time
time frame: Day 365, Day 729
description: Estimated glomerular filtration rate(eGFR), will be calculated by the CKD-EPI formula shown below.50 eGFR is expressed as mL/min per 1.73m2. For the purpose of this study lower limit of normal eGFR is defined as 90mL/min per 1.73m2 eGFR = 141 X min (Scr/k, 1)α X max (Scr/k, 1)-1.209 X 0.993Age X (1.018 [if female]) X (1.159 [if black]) Where Scr is serum creatinine (mg/dL), k is 0.7 for females and 0.9 for males, α is -0.329 for females and -0.411 for males, min indicates the minimum of Scr/k or 1, and max indicates the maximum of Scr/k or 1, age in years.
measure: Median Time to First Sustained Change to No Response During the Double-blind Period
time frame: Day 365, Day 729
description: Sustained response defined as response present at 2 consecutive visits approximately 4 weeks apart. No renal response (NR): defined as not meeting criteria for CR or PR or withdrawn
The estimate of median time is based on Kaplan-Meier analysis
measure: Number of Participants With Sustained Change From Higher Level of Response to no Response During the Double-blind Period
time frame: Day 365, Day 729
description: Sustained change to no response is defined as going from CR (or PR) to NR and remaining in NR for at least 2 consecutive visits; visits should be approximately 4 weeks apart. This analysis will be based on time from response CR (or PR) to the first visit in which the no response (NR) was achieved and sustained to the next visit.
measure: Adjusted Mean Change From Baseline in Disease Activity as Measured by BILAG 2004 Over Time During the Double-blind Period
time frame: Day 1 to Day 729; Day 365 to Day 729
description: BILAG index measures and reports disease activity in different organs/systems separately. The BILAG score is calculated for each of nine systems depending on the clinical features present and whether they are new (4 points), worse (3 points), the same (2 points), improving (1 point) or not present (0 points) in the last 4 weeks compared with previously. A BILAG "A" represents the presence of one or more serious features of lupus. A BILAG "B" represents more moderate features of the disease. A BILAG "C" includes only mild symptomatic features. A BILAG "D" represents only prior activity with no current symptoms due to active lupus. A BILAG "E" represents an organ that has never been involved. Overall BILAG score ranges from 0-108, with higher scores reflecting a worse outcome.
measure: Cmin (ug/mL): Trough Level Serum Concentration of Abatacept Prior to the Administration of the IV Infusion
time frame: Days 1 to 365
description: Trough level serum concentration of abatacept prior to the administration of the IV infusion on Days 1 to 365
measure: Cmax: Maximum Observed Serum Concentration Following Participants Receiving Active Abatacept IV
time frame: at 1 hour post Day 1 dose and 30 minutes post Day 337 dose
description: Cmax: Maximum observed serum concentration following participants receiving active abatacept IV
measure: AUC (TAU): Area Under the Serum Concentration Time Curve Over a Dosing Interval
time frame: Days 337 to 365
description: AUC (TAU): Area under the serum concentration time curve over a dosing interval between Days 337 to 365.
measure: Summary Statistics for Systolic Blood Pressure
time frame: Day 1 to Day 729
description: Summary statistics for systolic blood pressure
measure: Summary Statistics for Diastolic Blood Pressure
time frame: Day 1 to Day 729
description: Summary statistics for diastolic blood pressure
measure: Summary Statistics for Heart Rate
time frame: Day 1 to Day 729
description: Summary statistics for Heart Rate
measure: Mean Change From Baseline in Laboratory Analytes During the Double-blind Period (U/L)
time frame: Day 729
description: Laboratory assessments were analyzed centrally, with the exception of pregnancy testing. Blood draws and urine collections were performed at visits specified in the protocol.
Change from Baseline = Post-baseline - Baseline value.
measure: Mean Change From Baseline in Laboratory Analytes During the Double-blind Period (g/L)
time frame: Day 729
description: Laboratory assessments were analyzed centrally, with the exception of pregnancy testing. Blood draws and urine collections were performed at visits specified in the protocol.
Change from Baseline = Post-baseline - Baseline value.
measure: Mean Change From Baseline in Laboratory Analytes During the Double-blind Period (Percentage of Blood)
time frame: Day 729
description: Laboratory assessments were analyzed centrally, with the exception of pregnancy testing. Blood draws and urine collections were performed at visits specified in the protocol.
Change from Baseline = Post-baseline - Baseline value.
measure: Mean Change From Baseline in Laboratory Analytes During the Double-blind Period (Umol/L)
time frame: Day 729
description: Laboratory assessments were analyzed centrally, with the exception of pregnancy testing. Blood draws and urine collections were performed at visits specified in the protocol.
Change from Baseline = Post-baseline - Baseline value.
measure: Mean Change From Baseline in Laboratory Analytes During the Double-blind Period (mmol/L)
time frame: Day 729
description: Laboratory assessments were analyzed centrally, with the exception of pregnancy testing. Blood draws and urine collections were performed at visits specified in the protocol.
Change from Baseline = Post-baseline - Baseline value.
measure: Mean Change From Baseline in Laboratory Analytes During the Double-blind Period (x10^9 Cells/L)
time frame: Day 729
description: Laboratory assessments were analyzed centrally, with the exception of pregnancy testing. Blood draws and urine collections were performed at visits specified in the protocol.
Change from Baseline = Post-baseline - Baseline value.
measure: Number of Participants With Marked Hematology Laboratory Abnormalities During Year 1 of the Double Blind Period
time frame: Day 1 to Day 365; includes data up to 56 days post last dose in year 1 of double-blind period or first dose date in the year 2 of double-blind period, whichever is earlier
description: LLN= Lower limit of normals ULN= Upper limit of normals Pre RX = Baseline value HEMOGLOBIN g/L 4.0 HB >3 G/DL DECREASE FROM PRE RX HEMATOCRIT vol 6.3 HCT <0.75X PRE RX ERYTHROCYTES x10*12 c/L 5.2 RBC <0.75X PRE RX PLATELET COUNT x10*9 c/L 5.0 PLAT <0.67X LLN OR >1.5X ULN, OR IF PRE RX<LLN THEN USE 0.5X PRE RX AND <100,000/MM3 LEUKOCYTES x10*9 c/L 6.2 WBC <0.75X LLN OR >1.25X ULN, OR IF PRE RX<LLN THEN USE <0.8X PRE RX OR >ULN, OR IF PRE RX>ULN THEN USE >1.2X PRE RX OR <LLN EOSINOPHILS (ABSOLUTE) x10*9 c/L 8.3 EOSA IF VALUE > .750 X10*3 c/uL BASOPHILS (ABSOLUTE) x10*9 c/L 8.3 BASOA IF VALUE > 400/MM3 MONOCYTES (ABSOLUTE) x10*9 c/L 8.3 MONOA IF VALUE > 2000/MM3 LYMPHOCYTES (ABSOLUTE) x10*9 c/L 8.3 LYMPA IF VALUE < .750 X10*3 c/uL OR IF VALUE > 7.50 X10*3 c/uL
N = the number of participants with at least 1 on treatment lab result for each analyte
measure: Number of Participants With Marked Liver and Kidney Function Laboratory Abnormalities During Year 1 of the Double Blind Period
time frame: Day 1 to Day 365; includes data up to 56 days post last dose in year 1 of double-blind period or first dose date in the year 2 of double-blind period, whichever is earlier
description: LLN= Lower limit of normals ULN= Upper limit of normals Pre RX = Baseline value ALKALINE PHOSPHATASE (ALP) U/L 5.0 ALP >2X ULN, OR IF PRE RX>ULN THEN USE >3X PRE RX ASPARTATE AMINOTRANSFERASE (AST) U/L 5.0 AST >3X ULN, OR IF PRE RX>ULN THEN USE >4X PRE RX ALANINE AMINOTRANSFERASE (ALT) U/L 5.0 ALT >3X ULN, OR IF PRE RX>ULN THEN USE >4X PRE RX G-GLUTAMYL TRANSFERASE (GGT) U/L 5.0 GGT >2X ULN, OR IF PRE RX>ULN THEN USE >3X PRE RX BILIRUBIN, TOTAL umol/L 5.1 TBILI >2X ULN, OR IF PRE RX>ULN THEN USE >4X PRE RX BILIRUBIN, DIRECT umol/L 5.1 DBILI >1.5X ULN, OR IF PRE RX>ULN THEN USE >2X PRE RX BLOOD UREA NITROGEN mmol/L 5.1 BUN >2X PRE RX CREATININE umol/L 5.0 CREAT >1.5X PRE RX
N = the number of participants with at least 1 on treatment lab result for each analyte
measure: Number of Participants With Marked Electrolyte Laboratory Abnormalities During Year 1 of the Double Blind Period
time frame: Day 1 to Day 365; includes data up to 56 days post last dose in year 1 of double-blind period or first dose date in the year 2 of double-blind period, whichever is earlier
description: LLN= Lower limit of normals ULN= Upper limit of normals Pre RX = Baseline value SODIUM, SERUM mmol/L 4.0 NA <0.95X LLN OR >1.05X ULN, OR IF PRE RX<LLN THEN USE <0.95X PRE RX OR >ULN, OR IF PRE RX>ULN THEN USE >1.05X PRE RX OR <LLN POTASSIUM, SERUM mmol/L 4.1 K <0.9X LLN OR >1.1X ULN, OR IF PRE RX<LLN THEN USE <0.9X PRE RX OR >ULN, OR IF PRE RX>ULN THEN USE >1.1X PRE RX OR <LLN CHLORIDE, SERUM mmol/L 5.0 CL <0.9X LLN OR >1.1X ULN, OR IF PRE RX<LLN THEN USE <0.9X PRE RX OR >ULN, OR IF PRE RX>ULN THEN USE >1.1X PRE RX OR <LLN
N = the number of participants with at least 1 on treatment lab result for each analyte
measure: Number of Participants With Marked Urinalysis Laboratory Abnormalities During Year 1 of the Double Blind Period
time frame: Day 1 to Day 365; includes data up to 56 days post last dose in year 1 of double-blind period or first dose date in the year 2 of double-blind period, whichever is earlier
description: LLN= Lower limit of normals ULN= Upper limit of normals Pre RX = Baseline value PROTEIN, URINE Unknown UPRO IF MISSING PRE THEN USE >=2, OR IF VALUE >=4, OR IF PRE RX =0 OR 0.5 THEN USE >=2, OR IF PRE RX =1 THEN USE >=3, OR IF PRE RX =2 OR 3 THEN USE >=4 GLUCOSE, URINE N/A UGLU IF MISSING PRE THEN USE >=2, OR IF VALUE >=4, OR IF PRE RX =0 OR 0.5 THEN USE >=2, OR IF PRE RX =1 THEN USE >=3, OR IF PRE RX =2 OR 3 THEN USE >=4 BLOOD, URINE N/A UBLD IF MISSING PRE THEN USE >=2, OR IF VALUE >=4, OR IF PRE RX =0 OR 0.5 THEN USE >=2, OR IF PRE RX =1 THEN USE >=3, OR IF PRE RX =2 OR 3 THEN USE >=4 RBC, URINE hpf 5.0 URBC IF MISSING PRE THEN USE >=2, OR IF VALUE >=4, OR IF PRE RX =0 OR 0.5 THEN USE >=2, OR IF PRE RX =1 THEN USE >=3, OR IF PRE RX =2 OR 3 THEN USE >=4 WBC, URINE hpf 5.0 UWBC IF MISSING PRE THEN USE >=2, OR IF VALUE >=4, OR IF PRE RX =0 OR 0.5 THEN USE >=2, OR IF PRE RX =1 THEN USE >=3, OR IF PRE RX =2 OR 3 THEN USE >=4
measure: Number of Participants With Other Marked Chemistry Laboratory Abnormalities During Year 1 of the Double Blind Period
time frame: Day 1 to Day 365; includes data up to 56 days post last dose in year 1 of double-blind period or first dose date in the year 2 of double-blind period, whichever is earlier
description: LLN= Lower limit of normals ULN= Upper limit of normals Pre RX = Baseline value CALCIUM, TOTAL mmol/L 5.2 CA <0.8X LLN OR >1.2X ULN, OR IF PRE RX<LLN THEN USE <0.75X PRE RX OR >ULN, OR IF PRE RX>ULN THEN USE >1.25X PRE RX OR <LLN PHOSPHORUS, INORGANIC mmol/L 5.2 PHOS <0.75X LLN OR >1.25X ULN, OR IF PRE RX<LLN THEN USE <0.67X PRE RX OR >ULN GLUCOSE, SERUM mmol/L 4.1 GLUC <65 mg/dL, OR >220 mg/dL PROTEIN, TOTAL g/L 5.0 TPRO <0.9X LLN OR >1.1X ULN, OR IF PRE RX<LLN THEN USE 0.9X PRE RX OR >ULN, OR IF PRE RX>ULN THEN USE 1.1X PRE RX OR <LLN ALBUMIN g/L 3.0 ALB <0.9X LLN, OR IF PRE RX<LLN THEN USE <0.75X PRE RX CHOLESTEROL, TOTAL (TC) mmol/L 5.2 CHOL >2X PRE R
N = the number of participants with at least 1 on treatment lab result for each analyte
measure: Number of Participants With Any Adverse Events (AEs) During Year 2 of the Double-blind Period and Long-term Extension
time frame: From the first dose in Year 2 of the double-blind period up to 56 days post last dose
description: All AEs were coded and grouped into preferred terms (PT) by system organ class (SOC), using the Medical Dictionary for Regulatory Activities (MedDRA, version 21.0). Investigators determined the intensity of each AE as mild, moderate, severe, or very severe and assessed the relationship to study drug.
measure: Percentage of Participants in Treatment Failure Over Time During the Double-blind Period
time frame: Day 365, Day 729
description: Lupus treatment failure is defined as any of the following: Death, unless due to physical trauma or violence; Renal Flare; sustained doubling of creatinine from baseline (greater of Screening or Study Day 1 value); initiation of rescue therapy for treatment of active lupus nephritis after Study Week 20.
Overall treatment failure is defined as lupus treatment failure plus discontinuation of study drug for any reason except death due to physical trauma or violence, pregnancy or administrative decision by Sponsor.
measure: Median Time to First Treatment Failure and Overall Treatment Failure During the Double-blind Period
time frame: Day 365, Day 729
description: First treatment failure (or Lupus treatment failure) is defined as any of the following: Death, unless due to physical trauma or violence; Renal Flare; sustained doubling of creatinine from baseline (greater of Screening or Study Day 1 value); initiation of rescue therapy for treatment of active lupus nephritis after Study Week 20.
Overall treatment failure is defined as lupus treatment failure plus discontinuation of study drug for any reason except death due to physical trauma or violence, pregnancy or administrative decision by Sponsor.
The hazard ratio is estimated using the Cox proportional hazards model which includes treatment group, stratification variables (baseline ACEis/ARBs use, RACE) and baseline UPCR.
The estimate of median time is based on Kaplan-Meier analysis
measure: Percentage of Nephrotic Participants in Complete Renal Response of Lupus Glomerulonephritis at Day 729 of the Double-blind Period
time frame: Day 729
description: Number of participants achieving CR was divided by total participants in that arm, expressed as a percentage. CR is defined the following criteria: eGFR is normal or no <85% of the baseline value; eGFR is based on mean creatinine value from day 358 and 365. Proteinuria: UPCR<0.5 mg/mg. Urine sediment: No cellular casts. Corticosteroid dose: Daily dose must be no >10 mg prednisone or equivalent for at least 28 days prior. Subjects with >10mg/day prednisone or equivalent for non-renal disease within 28 days prior to day 365 will be imputed as CR if the following are true: Met all criteria for CR at day 337 and all criteria for CR except corticosteroid dose at day 365; Investigator confirms increase in steroid dose is not related to renal disease. Adjusted odds ratio is estimated from logistic regression model which includes treatment group, baseline ACEi/ARBs use, race and baseline UPCR as a continuous variable.
measure: Percentage of Participants in Overall Population in Complete Renal Response of Lupus Glomerulonephritis at Day 729 of the Double-blind Period
time frame: Day 729
description: Number of participants achieving CR was divided by total participants in that arm, expressed as a percentage. CR is defined the following criteria: eGFR is normal or no <85% of the baseline value; eGFR is based on mean creatinine value from day 358 and 365. Proteinuria: UPCR<0.5 mg/mg. Urine sediment: No cellular casts. Corticosteroid dose: Daily dose must be no >10 mg prednisone or equivalent for at least 28 days prior. Subjects with >10mg/day prednisone or equivalent for non-renal disease within 28 days prior to day 365 will be imputed as CR if the following are true: Met all criteria for CR at day 337 and all criteria for CR except corticosteroid dose at day 365; Investigator confirms increase in steroid dose is not related to renal disease. Adjusted odds ratio is estimated from logistic regression model which includes treatment group, baseline ACEi/ARBs use, race and baseline UPCR as a continuous variable.
measure: Number of Participants With Marked Hematology Laboratory Abnormalities in the Double Blind Period
time frame: Day 1 to Day 729
description: LLN= Lower limit of normals ULN= Upper limit of normals Pre RX = Baseline value HEMOGLOBIN g/L 4.0 HB >3 G/DL DECREASE FROM PRE RX HEMATOCRIT vol 6.3 HCT <0.75X PRE RX ERYTHROCYTES x10*12 c/L 5.2 RBC <0.75X PRE RX PLATELET COUNT x10*9 c/L 5.0 PLAT <0.67X LLN OR >1.5X ULN, OR IF PRE RX<LLN THEN USE 0.5X PRE RX AND <100,000/MM3 LEUKOCYTES x10*9 c/L 6.2 WBC <0.75X LLN OR >1.25X ULN, OR IF PRE RX<LLN THEN USE <0.8X PRE RX OR >ULN, OR IF PRE RX>ULN THEN USE >1.2X PRE RX OR <LLN EOSINOPHILS (ABSOLUTE) x10*9 c/L 8.3 EOSA IF VALUE > .750 X10*3 c/uL BASOPHILS (ABSOLUTE) x10*9 c/L 8.3 BASOA IF VALUE > 400/MM3 MONOCYTES (ABSOLUTE) x10*9 c/L 8.3 MONOA IF VALUE > 2000/MM3 LYMPHOCYTES (ABSOLUTE) x10*9 c/L 8.3 LYMPA IF VALUE < .750 X10*3 c/uL OR IF VALUE > 7.50 X10*3 c/uL
N = the number of participants with at least 1 on treatment lab result for each analyte
measure: Number of Participants With Marked Liver and Kidney Function Laboratory Abnormalities in the Double Blind Period
time frame: Day 1 to Day 729
description: LLN= Lower limit of normals ULN= Upper limit of normals Pre RX = Baseline value ALKALINE PHOSPHATASE (ALP) U/L 5.0 ALP >2X ULN, OR IF PRE RX>ULN THEN USE >3X PRE RX ASPARTATE AMINOTRANSFERASE (AST) U/L 5.0 AST >3X ULN, OR IF PRE RX>ULN THEN USE >4X PRE RX ALANINE AMINOTRANSFERASE (ALT) U/L 5.0 ALT >3X ULN, OR IF PRE RX>ULN THEN USE >4X PRE RX G-GLUTAMYL TRANSFERASE (GGT) U/L 5.0 GGT >2X ULN, OR IF PRE RX>ULN THEN USE >3X PRE RX BILIRUBIN, TOTAL umol/L 5.1 TBILI >2X ULN, OR IF PRE RX>ULN THEN USE >4X PRE RX BILIRUBIN, DIRECT umol/L 5.1 DBILI >1.5X ULN, OR IF PRE RX>ULN THEN USE >2X PRE RX BLOOD UREA NITROGEN mmol/L 5.1 BUN >2X PRE RX CREATININE umol/L 5.0 CREAT >1.5X PRE RX
N = the number of participants with at least 1 on treatment lab result for each analyte
measure: Number of Participants With Marked Electrolyte Laboratory Abnormalities in the Double Blind Period
time frame: Day 1 to Day 729
description: LLN= Lower limit of normals ULN= Upper limit of normals Pre RX = Baseline value SODIUM, SERUM mmol/L 4.0 NA <0.95X LLN OR >1.05X ULN, OR IF PRE RX<LLN THEN USE <0.95X PRE RX OR >ULN, OR IF PRE RX>ULN THEN USE >1.05X PRE RX OR <LLN POTASSIUM, SERUM mmol/L 4.1 K <0.9X LLN OR >1.1X ULN, OR IF PRE RX<LLN THEN USE <0.9X PRE RX OR >ULN, OR IF PRE RX>ULN THEN USE >1.1X PRE RX OR <LLN CHLORIDE, SERUM mmol/L 5.0 CL <0.9X LLN OR >1.1X ULN, OR IF PRE RX<LLN THEN USE <0.9X PRE RX OR >ULN, OR IF PRE RX>ULN THEN USE >1.1X PRE RX OR <LLN
N = the number of participants with at least 1 on treatment lab result for each analyte
measure: Number of Participants With Marked Urinalysis Laboratory Abnormalities in the Double Blind Period
time frame: Day 1 to Day 729
description: LLN= Lower limit of normals ULN= Upper limit of normals Pre RX = Baseline value PROTEIN, URINE Unknown UPRO IF MISSING PRE THEN USE >=2, OR IF VALUE >=4, OR IF PRE RX =0 OR 0.5 THEN USE >=2, OR IF PRE RX =1 THEN USE >=3, OR IF PRE RX =2 OR 3 THEN USE >=4 GLUCOSE, URINE N/A UGLU IF MISSING PRE THEN USE >=2, OR IF VALUE >=4, OR IF PRE RX =0 OR 0.5 THEN USE >=2, OR IF PRE RX =1 THEN USE >=3, OR IF PRE RX =2 OR 3 THEN USE >=4 BLOOD, URINE N/A UBLD IF MISSING PRE THEN USE >=2, OR IF VALUE >=4, OR IF PRE RX =0 OR 0.5 THEN USE >=2, OR IF PRE RX =1 THEN USE >=3, OR IF PRE RX =2 OR 3 THEN USE >=4 RBC, URINE hpf 5.0 URBC IF MISSING PRE THEN USE >=2, OR IF VALUE >=4, OR IF PRE RX =0 OR 0.5 THEN USE >=2, OR IF PRE RX =1 THEN USE >=3, OR IF PRE RX =2 OR 3 THEN USE >=4 WBC, URINE hpf 5.0 UWBC IF MISSING PRE THEN USE >=2, OR IF VALUE >=4, OR IF PRE RX =0 OR 0.5 THEN USE >=2, OR IF PRE RX =1 THEN USE >=3, OR IF PRE RX =2 OR 3 THEN USE >=4
measure: Number of Participants With Other Marked Chemistry Laboratory Abnormalities in the Double Blind Period
time frame: Day 1 to Day 729
description: LLN= Lower limit of normals ULN= Upper limit of normals Pre RX = Baseline value CALCIUM, TOTAL mmol/L 5.2 CA <0.8X LLN OR >1.2X ULN, OR IF PRE RX<LLN THEN USE <0.75X PRE RX OR >ULN, OR IF PRE RX>ULN THEN USE >1.25X PRE RX OR <LLN PHOSPHORUS, INORGANIC mmol/L 5.2 PHOS <0.75X LLN OR >1.25X ULN, OR IF PRE RX<LLN THEN USE <0.67X PRE RX OR >ULN GLUCOSE, SERUM mmol/L 4.1 GLUC <65 mg/dL, OR >220 mg/dL PROTEIN, TOTAL g/L 5.0 TPRO <0.9X LLN OR >1.1X ULN, OR IF PRE RX<LLN THEN USE 0.9X PRE RX OR >ULN, OR IF PRE RX>ULN THEN USE 1.1X PRE RX OR <LLN ALBUMIN g/L 3.0 ALB <0.9X LLN, OR IF PRE RX<LLN THEN USE <0.75X PRE RX CHOLESTEROL, TOTAL (TC) mmol/L 5.2 CHOL >2X PRE R
N = the number of participants with at least 1 on treatment lab result for each analyte
measure: Number of Participants With Abatacept Induced Antibody Response Over Time in the Double-blind Period
time frame: Day 365, Day 729
description: Participants who experienced a positive antibody response relative to baseline (ECL Assay)
arm group label: BMS-188667 + Mycophenolate mofetil + Prednisone
arm group type: Experimental
description: BMS-188667 30 mg/kg injection by intravenous on Days 1,15, 29, and 57, followed by a weight-tiered dose approximating 10mg/kg injection by intravenous every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 weeks
arm group label: Placebo + Mycophenolate mofetil + Prednisone
arm group type: Placebo Comparator
description: Placebo matching with BMS-188667 injection by intravenous on Days 1,15, 29, and 57, followed by every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 Weeks
intervention type: Biological
intervention name: BMS-188667
arm group label: BMS-188667 + Mycophenolate mofetil + Prednisone
other name: Abatacept
intervention type: Drug
intervention name: Mycophenolate mofetil
arm group label: BMS-188667 + Mycophenolate mofetil + Prednisone
arm group label: Placebo + Mycophenolate mofetil + Prednisone
other name: Cellcept
intervention type: Drug
intervention name: Prednisone
arm group label: BMS-188667 + Mycophenolate mofetil + Prednisone
arm group label: Placebo + Mycophenolate mofetil + Prednisone
intervention type: Biological
intervention name: Placebo matching with BMS-188667
arm group label: Placebo + Mycophenolate mofetil + Prednisone
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Bristol-Myers Squibb
role: Study Director
affiliation: Bristol-Myers Squibb
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country: Argentina
country: Australia
country: Brazil
country: Canada
country: Chile
country: China
country: Colombia
country: Czechia
country: Hong Kong
country: India
country: Israel
country: Italy
country: Japan
country: Korea, Republic of
country: Mexico
country: Peru
country: Puerto Rico
country: Romania
country: Russian Federation
country: Spain
country: Taiwan
country: Turkey
country: United States
country: Czech Republic
url: https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
description: BMS Clinical Trial Information
url: https://www.bmsstudyconnect.com/s/US/English/USenHome
description: BMS Clinical Trial Patient Recruiting
url: https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
description: FDA Safety Alerts and Recalls
responsible party type: Sponsor
mesh term: Nephritis
mesh term: Lupus Nephritis
mesh term: Mycophenolic Acid
mesh term: Prednisone
mesh term: Abatacept
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Study terminated early after review of Year 1 data. Only Year 2/LTE data captured within blind was analyzed. Outcomes related to renal responses were not calculated due to lack of data caused by the early termination.
point of contact: 