<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/NCT02260934</url>
  </required_header>
  <id_info>
    <org_study_id>DAIT ITN055AI</org_study_id>
    <secondary_id>CALIBRATE</secondary_id>
    <nct_id>NCT02260934</nct_id>
  </id_info>
  <brief_title>Rituximab and Belimumab for Lupus Nephritis</brief_title>
  <acronym>CALIBRATE</acronym>
  <official_title>Rituximab Plus Cyclophosphamide Followed by Belimumab for the Treatment of Lupus Nephritis (ITN055AI)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Institute of Allergy and Infectious Diseases (NIAID)</agency>
      <agency_class>NIH</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Immune Tolerance Network (ITN)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>National Institute of Allergy and Infectious Diseases (NIAID)</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      In this experimental study, researchers will try to find out if treatment of lupus nephritis&#xD;
      with a combination of rituximab and cyclophosphamide (CTX), or a combination of rituximab and&#xD;
      CTX followed by treatment with belimumab is safe and if this drug combination can block the&#xD;
      immune system attacks.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Lupus nephritis is a severe form of systemic lupus erythematosus (SLE) with active disease in&#xD;
      the kidneys. SLE is a complex disease in which the body's own immune system attacks some of&#xD;
      the body parts: the skin, the joints, the kidneys, the nervous system, the heart, the lungs&#xD;
      and the blood. The cause of SLE is not known. Treatment for SLE usually involves drugs that&#xD;
      are designed to block the immune system attacks. When SLE affects the kidneys (nephritis),&#xD;
      stronger immune suppressing treatment is usually needed.&#xD;
&#xD;
      The drugs used in treatment of lupus nephritis often do not cure the disease and can cause&#xD;
      serious side effects, including lowering the immune system too much. When the immune system&#xD;
      is too low, a person is at a higher risk of getting infections. Therefore, research into new&#xD;
      treatments with fewer serious side effects is needed for lupus nephritis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 9, 2015</start_date>
  <completion_date type="Actual">February 8, 2019</completion_date>
  <primary_completion_date type="Actual">March 12, 2018</primary_completion_date>
  <phase>Phase 2</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Participants With At Least One Grade 3 or Higher Infectious Adverse Event By Week 24, Week 48 and Week 96</measure>
    <time_frame>Week 0 to Week 96</time_frame>
    <description>The percentage of participants who experienced at least one Grade 3 or higher treatment-emergent infectious adverse event. The severity of adverse events (AEs) was classified into grades using the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE, v4.03:June 14, 2010). Treatment-emergent AEs are those:&#xD;
with an onset date on or after the first dose of study medication,&#xD;
with onset before first dose but that worsened in severity after first dose, and&#xD;
for which the start of the AE in relation to the start of study medication could not be established.&#xD;
AEs were classified by system organ class and preferred term according to the Medical Dictionary for Regulatory Activities (MedDRA) version 17.0. Grade 3 or higher AEs were classified infectious based on the study team's review of the MedDRA body systems and preferred terms of the AEs.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With B Cell Reconstitution at Week 24, Week 48 and Week 96</measure>
    <time_frame>Week 24, Week 48 and Week 96</time_frame>
    <description>The percentage of participants who achieved B cell reconstitution, defined as a peripheral blood total B cell count ≥ to the baseline count or the lower limit of normal, whichever was lower. Note: B cell depletion was expected to occur in this study between Weeks 0 and 4, after initiation of rituximab and cyclophosphamide.&#xD;
Normal peripheral blood B Cell count: 107 to 698 cells/µL.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Grade 4 Hypogammaglobulinemia by Week 24, Week 48, and Week 96</measure>
    <time_frame>Week 24, Week 48 and Week 96</time_frame>
    <description>The percentage of participants who experienced Grade 4 hypogammaglobulinemia, defined as having a serum Immunoglobulin G (IgG) level &lt; 300 mg/dL. Severity of adverse events (AEs) was classified using the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE, v4.03:June 14, 2010).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With a Complete Response at Week 24, Week 48, and Week 96</measure>
    <time_frame>Week 24, Week 48 and Week 96</time_frame>
    <description>The percentage of participants who achieved a complete response, defined as meeting all of the following criteria:&#xD;
Urine protein-to-creatinine ratio (UPCR) &lt; 0.5, based on a 24-hour collection;&#xD;
Estimated glomerular filtration rate (eGFR) ≥ 120 ml/min/1.73 m^2 calculated by the CKD-EPI formula or, if &lt; 120 ml/min/1.73 m^2, then &gt; 80% of eGFR at entry; and&#xD;
Prednisone dose tapered to 10 mg/day and adherence to prednisone dosing provisions.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With an Overall Response at Week 24, Week 48, and Week 96</measure>
    <time_frame>Week 24, Week 48 and Week 96</time_frame>
    <description>The percentage of participants who achieved an overall response, defined as meeting all of the following criteria:&#xD;
&gt;50% improvement in the urine protein-to-creatinine ratio (UPCR) from study entry, based on a 24-hour collection;&#xD;
Estimated glomerular filtration rate (eGFR) ≥120 ml/min/1.73 m^2 calculated by the CKD-EPI formula or, if &lt; 120 ml/min/1.73 m^2, then &gt; 80% of eGFR at entry; and&#xD;
Prednisone dose tapered to 10 mg/day and adherence to prednisone dosing provisions.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With a Sustained Complete Response</measure>
    <time_frame>Week 48, Week 96</time_frame>
    <description>The percentage of participants who achieved a sustained complete response, defined as a complete response achieved at Week 48 and Week 96.&#xD;
Complete response was defined as meeting all of the following criteria:&#xD;
Urine protein-to-creatinine ratio (UPCR) &lt; 0.5, based on a 24-hour collection;&#xD;
Estimated glomerular filtration rate (eGFR) ≥120 ml/min/1.73 m^2 calculated by the CKD-EPI formula or, if &lt; 120 ml/min/1.73 m^2, then &gt; 80% of eGFR at entry; and&#xD;
Prednisone dose tapered to 10 mg/day and adherence to prednisone dosing provisions.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Treatment Failure by Week 24, Week 48, and Week 96</measure>
    <time_frame>Week 24, Week 48 and Week 96</time_frame>
    <description>The percentage of participants who met the criteria for treatment failure, defined by withdrawal from the protocol treatment regimen due to worsening nephritis, infection, or study medication toxicity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Count of Participants: Frequency of Non-renal Flares by Week 24</measure>
    <time_frame>Week 24</time_frame>
    <description>Count of participants who experienced non-renal flares, defined as any new &quot;A&quot; finding in a non-renal organ system in the British Isles Lupus Assessment Group (BILAG) assessment. A BILAG &quot;A&quot; finding represents a significant increase in, or a new manifestation of, disease activity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Count of Participants: Frequency of Non-renal Flares by Week 48</measure>
    <time_frame>Week 48</time_frame>
    <description>Count of participants who experienced non-renal flares, defined as any new &quot;A&quot; finding in a non-renal organ system in the British Isles Lupus Assessment Group (BILAG) assessment. A BILAG &quot;A&quot; finding represents a significant increase in, or a new manifestation of, disease activity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Count of Participants: Frequency of Non-renal Flares by Week 96</measure>
    <time_frame>Week 96</time_frame>
    <description>Count of participants who experienced non-renal flares, defined as any new &quot;A&quot; finding in a non-renal organ system in the British Isles Lupus Assessment Group (BILAG) assessment. A BILAG &quot;A&quot; finding represents a significant increase in, or a new manifestation of, disease activity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With an Negative Anti-dsDNA Result at Week 24, Week 48, and Week 96</measure>
    <time_frame>Week 24, Week 48 and Week 96</time_frame>
    <description>The percentage of participants who were anti-double stranded DNA (anti-dsDNA) negative, defined as having anti-dsDNA levels &lt;30 IU/mL.&#xD;
Anti-dsDNA levels are associated with systemic lupus erythematosus disease activity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Hypocomplementemic for Complement Component C3 at Week 24, Week 48, and Week 96</measure>
    <time_frame>Week 24, Week 48 and Week 96</time_frame>
    <description>The percentage of participants who were hypocomplementemic for complement component, C3, defined as a C3 level &lt;90 mg/dL.&#xD;
Serum C3 complement is a protein which can be measured in the blood. Low blood levels of C3 are common in those with active lupus.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Hypocomplementemic for Complement Component C4 at Week 24, Week 48, and Week 96</measure>
    <time_frame>Week 24, Week 48 and Week 96</time_frame>
    <description>The percentage of participants who were hypocomplementemic for complemen component C4, defined as a C4 level &lt;10 mg/dL.&#xD;
Serum C4 complement is a protein which can be measured in the blood. Low blood levels of C4 are common in those with active lupus.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of Specific Adverse Events of Interest By Event by Week 96</measure>
    <time_frame>Week 96</time_frame>
    <description>Number of ≥ Grade 2 specific treatment-emergent adverse events (AEs) of interest. Grade 2 or higher AEs were classified according to the listed categories of interest based on the study team's review of the AEs.&#xD;
Treatment-emergent AEs are those:&#xD;
with an onset date on or after the first dose of study medication,&#xD;
with onset before first dose but that worsened in severity after first dose, and&#xD;
for which the start of the AE in relation to the start of study medication could not be established.&#xD;
The severity of AEs was classified using the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE, v4.03: June 14, 2010). AEs were classified by system organ class and preferred term according to the Medical Dictionary for Regulatory Activities (MedDRA) version 17.0.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of Specific Adverse Events of Interest By Participant, By Week 96</measure>
    <time_frame>Week 96</time_frame>
    <description>Number of participants who experienced ≥Grade 2 specific treatment-emergent adverse events (AEs) of interest. Grade 2 or higher AEs were classified according to the listed categories of interest based on the study team's review of the AEs.&#xD;
Treatment-emergent AEs are those:&#xD;
with an onset date on or after the first dose of study medication,&#xD;
with onset before first dose but that worsened in severity after first dose, and&#xD;
for which the start of the AE in relation to the start of study medication could not be established.&#xD;
The severity of AEs was classified using the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE, v4.03: June 14, 2010). AEs were classified by system organ class and preferred term according to the Medical Dictionary for Regulatory Activities (MedDRA) version 17.0.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">43</enrollment>
  <condition>Lupus Nephritis</condition>
  <arm_group>
    <arm_group_label>Rituximab/Cyclophosphamide (RC)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Prednisone taper to 10 mg/day by week 12 and continue prednisone 10 mg/day to week 96.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Rituximab/Cyclophosphamide/Belimumab (RCB)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Belimumab (10 mg/kg IV) at weeks 4, 6, 8, and every 4 weeks to week 48.&#xD;
Prednisone taper to 10 mg/day by week 12, and continue prednisone 10 mg/day to week 96.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Rituximab</intervention_name>
    <description>Rituximab 1000mg intravenously (IV) at week 0 and week 2</description>
    <arm_group_label>Rituximab/Cyclophosphamide (RC)</arm_group_label>
    <other_name>Rituxan</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cyclophosphamide</intervention_name>
    <description>Cyclophosphamide (750 mg) intravenously (IV) at week 0 and week 2.</description>
    <arm_group_label>Rituximab/Cyclophosphamide (RC)</arm_group_label>
    <other_name>Cytoxan</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Prednisone</intervention_name>
    <description>Week 0 and Week 2: Prednisone (40 mg/day; taper to 10 mg/day by week 12)&#xD;
Continue prednisone 10 mg/day to week 96</description>
    <arm_group_label>Rituximab/Cyclophosphamide (RC)</arm_group_label>
    <other_name>Deltasone</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Methylprednisolone</intervention_name>
    <description>Week 0 and Week 2:&#xD;
Solumedrol (100 mg) IV</description>
    <arm_group_label>Rituximab/Cyclophosphamide (RC)</arm_group_label>
    <other_name>Solu-Medrol</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Diphenhydramine</intervention_name>
    <description>Diphenhydramine (50 mg, or equivalent dose of similar antihistamine) will be given orally 1 hour (plus or minus 15 minutes) before each infusion of rituximab.</description>
    <arm_group_label>Rituximab/Cyclophosphamide (RC)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Acetaminophen</intervention_name>
    <description>Acetaminophen (650 mg) will be given orally 1 hour (plus or minus 15 minutes) before each infusion of rituximab.</description>
    <arm_group_label>Rituximab/Cyclophosphamide (RC)</arm_group_label>
    <other_name>Tylenol</other_name>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Rituximab</intervention_name>
    <description>Rituximab 1000mg intravenously (IV) at week 0 and week 2.</description>
    <arm_group_label>Rituximab/Cyclophosphamide/Belimumab (RCB)</arm_group_label>
    <other_name>Rituxan</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cyclophosphamide</intervention_name>
    <description>Cyclophosphamide (750 mg) intravenously (IV) at week 0 and week 2.</description>
    <arm_group_label>Rituximab/Cyclophosphamide/Belimumab (RCB)</arm_group_label>
    <other_name>Cytoxan</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Prednisone</intervention_name>
    <description>Week 0 and Week 2: Prednisone (40 mg/day; taper to 10 mg/day by week 12)&#xD;
Continue prednisone 10 mg/day to week 96</description>
    <arm_group_label>Rituximab/Cyclophosphamide/Belimumab (RCB)</arm_group_label>
    <other_name>Deltasone</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Methylprednisolone</intervention_name>
    <description>Week 0 and Week 2: Solumedrol (100 mg) IV</description>
    <arm_group_label>Rituximab/Cyclophosphamide/Belimumab (RCB)</arm_group_label>
    <other_name>Solu-Medrol</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Diphenhydramine</intervention_name>
    <description>Diphenhydramine (50 mg, or equivalent dose of similar antihistamine) will be given orally 1 hour (plus or minus 15 minutes) before each infusion of rituximab.</description>
    <arm_group_label>Rituximab/Cyclophosphamide/Belimumab (RCB)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Acetaminophen</intervention_name>
    <description>Acetaminophen (650 mg) will be given orally 1 hour (plus or minus 15 minutes) before each infusion of rituximab.</description>
    <arm_group_label>Rituximab/Cyclophosphamide/Belimumab (RCB)</arm_group_label>
    <other_name>Tylenol</other_name>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Belimumab</intervention_name>
    <description>The RCB Group will receive IV belimumab 10mg/kg at weeks 4, 6, 8, and then every 4 weeks through week 48</description>
    <arm_group_label>Rituximab/Cyclophosphamide/Belimumab (RCB)</arm_group_label>
    <other_name>Benlysta</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Diagnosis of Systemic Lupus Erythematosus (SLE) by American College of Rheumatology&#xD;
             (ACR) criteria.&#xD;
&#xD;
          2. Positive antinuclear antibody (ANA) or positive anti-ds DNA test results at visit -1&#xD;
             or any time within 14 days before visit -1.&#xD;
&#xD;
          3. Active proliferative lupus nephritis, as defined by either of the following:&#xD;
&#xD;
               -  Kidney biopsy documentation within the last 3 months of International Society of&#xD;
                  Nephrology/Renal Pathology Society (ISN/RPS) proliferative nephritis: Class III,&#xD;
                  Class IV, or Class V in combination with Class III or IV.&#xD;
&#xD;
               -  Active urinary sediment and kidney biopsy documentation within the last 12 months&#xD;
                  of ISN/RPS proliferative nephritis: Class III, Class IV, or Class V in&#xD;
                  combination with Class III or IV. Active urinary sediment is defined as any one&#xD;
                  of the following:&#xD;
&#xD;
               -  &gt;5 RBC/hpf in the absence of menses and infection;&#xD;
&#xD;
               -  &gt;5 White blood cell per high powered field (WBC/hpf) in the absence of infection;&#xD;
                  or&#xD;
&#xD;
               -  Cellular casts limited to RBC or WBC casts.&#xD;
&#xD;
          4. Urine protein-to-creatinine ratio (UPCR) &gt;1 at study entry based on a 24-hour&#xD;
             collection.&#xD;
&#xD;
          5. Ability to provide informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. New onset lupus nephritis, defined as lupus nephritis for which the participant has&#xD;
             not yet been treated with either mycophenolate mofetil or cyclophosphamide.&#xD;
&#xD;
          2. Neutropenia (absolute neutrophil count &lt;1500/mm^3).&#xD;
&#xD;
          3. Thrombocytopenia (platelets &lt;50,000/mm^3).&#xD;
&#xD;
          4. Moderately severe anemia (Hgb &lt; mg/dL).&#xD;
&#xD;
          5. Moderately severe hypogammaglobulinemia (IgG &lt;450 mg/dL) or Immunoglobulin A (IgA)&#xD;
             &lt;10mg/dL.&#xD;
&#xD;
          6. Positive QuantiFERON -Tuberculosis (TB) Gold test results.&#xD;
&#xD;
          7. Pulmonary fibrotic changes on chest radiograph consistent with prior healed&#xD;
             tuberculosis.&#xD;
&#xD;
          8. Active bacterial, viral, fungal, or opportunistic infections.&#xD;
&#xD;
          9. Evidence of infection with human immunodeficiency virus (HIV), hepatitis B (as&#xD;
             assessed by HBsAg and anti-HBc) or hepatitis C.&#xD;
&#xD;
         10. Hospitalization for treatment of infections, or parenteral (IV or IM) antibacterials,&#xD;
             antivirals, anti-fungals, or anti-parasitic agents within the past 60 days.&#xD;
&#xD;
         11. Chronic infection that is currently being treated with suppressive antibiotic therapy,&#xD;
             including but not limited to tuberculosis, pneumocystis, cytomegalovirus, herpes&#xD;
             simplex virus, herpes zoster, and atypical mycobacteria.&#xD;
&#xD;
         12. History of significant infection or recurrent infection that, in the investigator's&#xD;
             opinion, places the participant at risk by participating in this study.&#xD;
&#xD;
         13. Receipt of a live-attenuated vaccine within 3 months of study enrollment.&#xD;
&#xD;
         14. End-stage renal disease (eGFR &lt;20 mL/min/1.73m^2).&#xD;
&#xD;
         15. Concomitant malignancies or a history of malignancy, with the exception of adequately&#xD;
             treated basal and squamous cell carcinoma of the skin, or carcinoma in situ of the&#xD;
             cervix.&#xD;
&#xD;
         16. History of transplantation.&#xD;
&#xD;
         17. History of primary immunodeficiency.&#xD;
&#xD;
         18. Pregnancy.&#xD;
&#xD;
         19. Breastfeeding.&#xD;
&#xD;
         20. Unwillingness to use an FDA-approved form of birth control (including but not limited&#xD;
             to a diaphragm, an intrauterine device, progesterone implants or injections, oral&#xD;
             contraceptives, the double-barrier method, or a condom).&#xD;
&#xD;
         21. Use of cyclophosphamide within the past 6 months.&#xD;
&#xD;
         22. Use of anti-Tumor Necrosis Factor (TNF) medication, other biologic medications, or&#xD;
             experimental non- biologic therapeutic agents within the past 90 days, or 5 half-lives&#xD;
             prior to screening, whichever is greater.&#xD;
&#xD;
         23. Intravenous immunoglobulin (IVIG), plasmapheresis, or leukopheresis within the past 90&#xD;
             days.&#xD;
&#xD;
         24. Use of investigational biologic agent within the past 12 months.&#xD;
&#xD;
         25. Prior treatment with rituximab, belimumab, atacicept, or other biologic B cell&#xD;
             therapy.&#xD;
&#xD;
         26. Liver function test [aspartate aminotransferase (AST), alanine aminotransferase (ALT),&#xD;
             or alkaline phosphatase] results that are &gt;=2 times the upper limit of normal.&#xD;
&#xD;
         27. Severe, progressive, or uncontrolled renal, hepatic, hematological,gastrointestinal,&#xD;
             pulmonary, cardiac, or neurological disease, either related or unrelated to SLE, with&#xD;
             the exception of active lupus nephritis (or, in the investigator's opinion, any other&#xD;
             concomitant medical condition that places the participant at risk by participating in&#xD;
             this study).&#xD;
&#xD;
         28. Comorbidities requiring corticosteroid therapy, including those which have required&#xD;
             three or more courses of systemic corticosteroids within the previous 12 months.&#xD;
&#xD;
         29. Current substance abuse or history of substance abuse within the past year.&#xD;
&#xD;
         30. History of severe allergic or anaphylactic reactions to chimeric or fully human&#xD;
             monoclonal antibodies.&#xD;
&#xD;
         31. History of anaphylactic reaction to parenteral administration of contrast agents.&#xD;
&#xD;
         32. Lack of peripheral venous access.&#xD;
&#xD;
         33. History of severe depression or severe psychiatric condition.&#xD;
&#xD;
         34. History of suicidal thoughts within the past 2 months or suicidal behavior within the&#xD;
             past 6 months, or a significant suicide risk in the investigator's opinion.&#xD;
&#xD;
         35. Inability to comply with study and follow-up procedures.&#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>Betty Diamond, M.D.</last_name>
    <role>Study Chair</role>
    <affiliation>Feinstein Institute for Medical Research</affiliation>
  </overall_official>
  <overall_official>
    <last_name>David Wofsy, M.D.</last_name>
    <role>Study Chair</role>
    <affiliation>University of California San Francisco, Department of Medicine</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Maria Dall'Era, M.D.</last_name>
    <role>Study Chair</role>
    <affiliation>University of California San Francisco, Department of Medicine</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Cynthia Aranow, M.D.</last_name>
    <role>Study Chair</role>
    <affiliation>Feinstein Institute for Medical Research</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Alabama, Birmingham</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35294</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UCLA Medical Center: Division of Rheumatology</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90095</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of California, San Francisco</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94143</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Colorado Denver: School of Medicine: Division of Rheumatology</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Colorado Kidney Care</name>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <zip>80218</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Emory University School of Medicine</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30303</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Washington University in St. Louis</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>36110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Feinstein Institute, North Shore Hospital</name>
      <address>
        <city>Manhasset</city>
        <state>New York</state>
        <zip>10030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>New York University, Langone Medical Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Weill Cornell Medical College: Hospital for Special Surgery -</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10021</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Columbia University Medical Center</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 School of Medicine:</name>
      <address>
        <city>Chapel Hill</city>
        <state>North Carolina</state>
        <zip>27599</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ohio State University Wexner Medical Center:</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43213</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical University of South Carolina</name>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>29425</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Texas Southwestern</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75390</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://www.niaid.nih.gov/</url>
    <description>National Institute of Allergy and Infectious Diseases website</description>
  </link>
  <link>
    <url>https://www.niaid.nih.gov/about/dait</url>
    <description>Division of Allergy, Immunology, and Transplantation (DAIT)</description>
  </link>
  <link>
    <url>http://www.immunetolerance.org/</url>
    <description>Immune Tolerance Network (ITN) website</description>
  </link>
  <link>
    <url>http://calibratestudy.org/about-calibrate</url>
    <description>ITN CALIBRATE study website</description>
  </link>
  <results_reference>
    <citation>Atisha-Fregoso Y, Malkiel S, Harris KM, Byron M, Ding L, Kanaparthi S, Barry WT, Gao W, Ryker K, Tosta P, Askanase AD, Boackle SA, Chatham WW, Kamen DL, Karp DR, Kirou KA, Sam Lim S, Marder B, McMahon M, Parikh SV, Pendergraft WF 3rd, Podoll AS, Saxena A, Wofsy D, Diamond B, Smilek DE, Aranow C, Dall'Era M. Phase II Randomized Trial of Rituximab Plus Cyclophosphamide Followed by Belimumab for the Treatment of Lupus Nephritis. Arthritis Rheumatol. 2021 Jan;73(1):121-131. doi: 10.1002/art.41466. Epub 2020 Dec 1. Erratum In: Arthritis Rheumatol. 2021 Dec;73(12):2356.</citation>
    <PMID>32755035</PMID>
  </results_reference>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>October 6, 2014</study_first_submitted>
  <study_first_submitted_qc>October 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 9, 2014</study_first_posted>
  <results_first_submitted>March 13, 2019</results_first_submitted>
  <results_first_submitted_qc>April 5, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">April 8, 2019</results_first_posted>
  <last_update_submitted>November 13, 2020</last_update_submitted>
  <last_update_submitted_qc>November 13, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">December 1, 2020</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>Acetaminophen</mesh_term>
    <mesh_term>Diphenhydramine</mesh_term>
    <mesh_term>Promethazine</mesh_term>
    <mesh_term>Prednisone</mesh_term>
    <mesh_term>Methylprednisolone</mesh_term>
    <mesh_term>Methylprednisolone Acetate</mesh_term>
    <mesh_term>Methylprednisolone Hemisuccinate</mesh_term>
    <mesh_term>Prednisolone</mesh_term>
    <mesh_term>Prednisolone acetate</mesh_term>
    <mesh_term>Cyclophosphamide</mesh_term>
    <mesh_term>Rituximab</mesh_term>
    <mesh_term>Belimumab</mesh_term>
    <mesh_term>Prednisolone hemisuccinate</mesh_term>
    <mesh_term>Prednisolone phosphate</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Participant level data access will be made available to the public at some point in the future via the mechanisms of : 1.) the Immunology Database and Analysis Portal (ImmPort), a long-term archive of clinical and mechanistic data from DAIT-funded grants and contracts; and 2.) TrialShare, the Immune Tolerance Network (ITN) Clinical Trials Research Portal.</ipd_description>
    <ipd_time_frame>The aim is to share IPD within 24 months upon study completion.</ipd_time_frame>
    <ipd_access_criteria>ImmPort public data access.</ipd_access_criteria>
    <ipd_url>http://www.immport.org/immport-open/public/home/home</ipd_url>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>October 9, 2015</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/34/NCT02260934/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>May 7, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/34/NCT02260934/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Of the 59 participants screened, 43 were enrolled at 14 sites in the US from July 9, 2015 to May 22, 2017.</recruitment_details>
      <pre_assignment_details>Prior to randomization, enrolled participants received infusions of Solumedrol 100mg, rituximab 1000mg, and cyclophosphamide 750mg intravenously (IV) at Week 0 and Week 2. Prednisone was administered at 40 mg/day for the first 2 weeks, followed by a guided steroid taper. Participants were randomized at Week 4.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Rituximab/Cyclophosphamide (RC)</title>
          <description>Participants received infusions of Solumedrol 100mg, rituximab 1000mg, and cyclophosphamide 750mg intravenously (IV) at Week 0 and Week 2. Prednisone was administered at 40 mg/day for the first 2 weeks, followed by a guided steroid taper to 10 mg/day by Week 12. Prednisone was continued through to Week 96 at 10 mg/day, with the potential of a taper to a minimum of 5 mg/day.</description>
        </group>
        <group group_id="P2">
          <title>Rituximab/Cyclophosphamide/Belimumab (RCB)</title>
          <description>Participants received infusions of Solumedrol 100mg, rituximab 1000mg, and cyclophosphamide 750mg intravenously (IV) at Week 0 and Week 2. Prednisone was administered at 40 mg/day for the first 2 weeks, followed by a guided steroid taper to 10 mg/day by Week 12. Prednisone was continued through to Week 96 at 10 mg/day, with the potential of a taper to a minimum of 5 mg/day. In addition, participants received IV belimumab 10mg/kg at Weeks 4, 6, 8, and then every 4 weeks through Week 48 in addition to prednisone.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="22"/>
                <participants group_id="P2" count="21"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="19">At primary outcome timepoint: Ten participants engaged in ongoing scheduled study visits.</participants>
                <participants group_id="P2" count="17">At primary outcome timepoint: Eleven participants engaged in ongoing scheduled study visits.</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Participant Relocated</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Site error</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>Participants who signed informed consent and were enrolled in the study. Reported baseline measurements are the most recent measurements for a participant taken between the Screening Visit (occurring within 21 days of Week 0/Study Enrollment) and Week 0 (Study Enrollment).</population>
      <group_list>
        <group group_id="B1">
          <title>Rituximab/Cyclophosphamide (RC)</title>
          <description>Participants received infusions of Solumedrol 100mg, rituximab 1000mg, and cyclophosphamide 750mg intravenously (IV) at Week 0 and Week 2. Prednisone was administered at 40 mg/day for the first 2 weeks, followed by a guided steroid taper to 10 mg/day by Week 12. Prednisone was continued through to Week 96 at 10 mg/day, with the potential of a taper to a minimum of 5 mg/day.</description>
        </group>
        <group group_id="B2">
          <title>Rituximab/Cyclophosphamide/Belimumab (RCB)</title>
          <description>Participants received infusions of Solumedrol 100mg, rituximab 1000mg, and cyclophosphamide 750mg intravenously (IV) at Week 0 and Week 2. Prednisone was administered at 40 mg/day for the first 2 weeks, followed by a guided steroid taper to 10 mg/day by Week 12. Prednisone was continued through to Week 96 at 10 mg/day, with the potential of a taper to a minimum of 5 mg/day. In addition, participants received IV belimumab 10mg/kg at Weeks 4, 6, 8, and then every 4 weeks through Week 48 in addition to prednisone.</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="22"/>
            <count group_id="B2" value="21"/>
            <count group_id="B3" value="43"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="22"/>
                    <count group_id="B2" value="21"/>
                    <count group_id="B3" value="43"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="32.3" spread="11.4"/>
                    <measurement group_id="B2" value="34.5" spread="9.1"/>
                    <measurement group_id="B3" value="33.4" spread="10.3"/>
                  </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="22"/>
                    <count group_id="B2" value="21"/>
                    <count group_id="B3" value="43"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                    <measurement group_id="B2" value="19"/>
                    <measurement group_id="B3" value="37"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="22"/>
                    <count group_id="B2" value="21"/>
                    <count group_id="B3" value="43"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="15"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="28"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="22"/>
                    <count group_id="B2" value="21"/>
                    <count group_id="B3" value="43"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="17"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="16"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="22"/>
                    <count group_id="B2" value="21"/>
                    <count group_id="B3" value="43"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="22"/>
                    <measurement group_id="B2" value="21"/>
                    <measurement group_id="B3" value="43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Urine Protein-to-Creatinine Ratio (UPCR) from 24 Hour Collection</title>
          <description>Urine protein-to-creatinine ratio (UPCR) from a 24-hour collection is a measure of lupus nephritis disease activity. Higher ratios indicate poorer kidney function. Elevated ratio: &gt;3.</description>
          <units>Ratio</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="22"/>
                    <count group_id="B2" value="21"/>
                    <count group_id="B3" value="43"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3.4" spread="1.5"/>
                    <measurement group_id="B2" value="3.3" spread="2.5"/>
                    <measurement group_id="B3" value="3.4" spread="2.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Elevated Urine Protein-to-Creatinine Ratio (UPCR)</title>
          <description>Count of participants with a urine protein-to-creatinine ratio (UPCR) from a 24-hour collection that was &gt;3.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="22"/>
                    <count group_id="B2" value="21"/>
                    <count group_id="B3" value="43"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Serum Creatinine</title>
          <description>Serum creatinine is a measure of renal function. Normal values: 0.67 to 1.18mg/dL for men and 0.51 to 0.95mg/dL for women. Higher results indicate poorer kidney function.</description>
          <units>mg/dL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="22"/>
                    <count group_id="B2" value="21"/>
                    <count group_id="B3" value="43"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1.0" spread="0.4"/>
                    <measurement group_id="B2" value="1.0" spread="0.5"/>
                    <measurement group_id="B3" value="1.0" spread="0.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Estimated glomerular filtration rate (eGFR)</title>
          <description>Estimated glomerular filtration rate (eGFR) is a measure of renal function. Methodology: Calculated by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula based on serum creatinine, age, sex and race. Normal GFR: ≥90 mL/min/1.73m^2. Lower GFRs reflect poorer kidney function.</description>
          <units>mL/min/1.73m^2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="22"/>
                    <count group_id="B2" value="21"/>
                    <count group_id="B3" value="43"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="92.7" spread="36.0"/>
                    <measurement group_id="B2" value="89.1" spread="33.9"/>
                    <measurement group_id="B3" value="90.9" spread="34.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Serum Albumin</title>
          <description>Normal values: 3.7 to 4.9 g/dL.</description>
          <units>g/dL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="22"/>
                    <count group_id="B2" value="21"/>
                    <count group_id="B3" value="43"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3.0" spread="0.5"/>
                    <measurement group_id="B2" value="2.9" spread="0.6"/>
                    <measurement group_id="B3" value="2.9" spread="0.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>B Cell Count</title>
          <description>Total B cell number in the peripheral blood. B cell depletion was expected to occur in this study between Weeks 0 and 4, after initiation of rituximab and cyclophosphamide. Normal B Cell Count in the peripheral blood: 107 to 698 cells/µL.</description>
          <population>Participants who signed informed consent and were enrolled in the study. Reported baseline measurements are the most recent measurements for a participant taken between the screening visit and Week 0.</population>
          <units>cells/µL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="18"/>
                    <count group_id="B2" value="18"/>
                    <count group_id="B3" value="36"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="160.5" spread="157.4"/>
                    <measurement group_id="B2" value="216.0" spread="207.3"/>
                    <measurement group_id="B3" value="188.3" spread="183.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Immunoglobulin G (IgG) Level</title>
          <description>Immunoglobulin G (IgG) is a measure of immune function. Normal values: 700 to 1600 mg/dL.</description>
          <units>mg/dL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="22"/>
                    <count group_id="B2" value="21"/>
                    <count group_id="B3" value="43"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1044.9" spread="408.9"/>
                    <measurement group_id="B2" value="1057.1" spread="589.5"/>
                    <measurement group_id="B3" value="1050.8" spread="499.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Hypogammaglobulinemia</title>
          <description>Count of participants with hypogammaglobulinemia at baseline, defined as having a serum Immunoglobulin G (IgG) level &lt;450 mg/dL.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="22"/>
                    <count group_id="B2" value="21"/>
                    <count group_id="B3" value="43"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Anti-Double Stranded DNA (Anti-dsDNA) Positive</title>
          <description>Count of participants who were anti-double stranded DNA (anti-dsDNA) positive at baseline, defined as anti-dsDNA levels &gt;30 IU/mL. Anti-dsDNA levels are associated with systemic lupus erythematosus disease activity.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="22"/>
                    <count group_id="B2" value="21"/>
                    <count group_id="B3" value="43"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="19"/>
                    <measurement group_id="B3" value="39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Hypocomplementemic for C3</title>
          <description>Count of participants who were hypocomplementemic for C3, defined as a C3 level &lt;90 mg/dL. Serum C3 complement is a protein which can be measured in the blood. Low blood levels of C3 are common in those with active lupus.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="22"/>
                    <count group_id="B2" value="21"/>
                    <count group_id="B3" value="43"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Hypocomplementemic for C4</title>
          <description>Count of participants who were hypocomplementemic for C4, defined as C4 level &lt;10 mg/dL. Serum C4 complement is a protein which can be measured in the blood. Low blood levels of C4 are common in those with active lupus.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="22"/>
                    <count group_id="B2" value="21"/>
                    <count group_id="B3" value="43"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Weight</title>
          <description>Body weight measurement taken before infusion of study drug.</description>
          <units>kg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="22"/>
                    <count group_id="B2" value="21"/>
                    <count group_id="B3" value="43"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="69.7" spread="18.0"/>
                    <measurement group_id="B2" value="75.4" spread="26.0"/>
                    <measurement group_id="B3" value="72.5" spread="22.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Duration of Lupus Nephritis</title>
          <description>Duration of lupus nephritis (LN) is the number of years at the screening visit since the onset of LN.</description>
          <units>Years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="22"/>
                    <count group_id="B2" value="21"/>
                    <count group_id="B3" value="43"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4.8" spread="4.5"/>
                    <measurement group_id="B2" value="6.8" spread="6.6"/>
                    <measurement group_id="B3" value="5.8" spread="5.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Duration of Lupus Nephritis More Than One Year</title>
          <description>Count of participants with a duration of lupus nephritis of greater than one year. Duration of lupus nephritis is defined by the number of years from onset of lupus nephritis to the screening visit.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="22"/>
                    <count group_id="B2" value="21"/>
                    <count group_id="B3" value="43"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>&gt; 1 year</title>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                    <measurement group_id="B2" value="18"/>
                    <measurement group_id="B3" value="36"/>
                  </measurement_list>
                </category>
                <category>
                  <title>≤ 1 year</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants With At Least One Grade 3 or Higher Infectious Adverse Event By Week 24, Week 48 and Week 96</title>
        <description>The percentage of participants who experienced at least one Grade 3 or higher treatment-emergent infectious adverse event. The severity of adverse events (AEs) was classified into grades using the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE, v4.03:June 14, 2010). Treatment-emergent AEs are those:&#xD;
with an onset date on or after the first dose of study medication,&#xD;
with onset before first dose but that worsened in severity after first dose, and&#xD;
for which the start of the AE in relation to the start of study medication could not be established.&#xD;
AEs were classified by system organ class and preferred term according to the Medical Dictionary for Regulatory Activities (MedDRA) version 17.0. Grade 3 or higher AEs were classified infectious based on the study team's review of the MedDRA body systems and preferred terms of the AEs.</description>
        <time_frame>Week 0 to Week 96</time_frame>
        <population>The modified intent-to-treat population includes all randomized participants who received 1 dose of Solumedrol, 1 dose of rituximab, 1 dose of cyclophosphamide, and, if in the Rituximab/Cyclophosphamide/Belimumab (RCB) arm, 1 dose of belimumab.&#xD;
Confidence intervals were calculated using Clopper-Pearson method.</population>
        <group_list>
          <group group_id="O1">
            <title>Rituximab/Cyclophosphamide (RC)</title>
            <description>Participants received infusions of Solumedrol 100mg, rituximab 1000mg, and cyclophosphamide 750mg intravenously (IV) at Week 0 and Week 2. Prednisone was administered at 40 mg/day for the first 2 weeks, followed by a guided steroid taper to 10 mg/day by Week 12. Prednisone was continued through to Week 96 at 10 mg/day, with the potential of a taper to a minimum of 5 mg/day.</description>
          </group>
          <group group_id="O2">
            <title>Rituximab/Cyclophosphamide/Belimumab (RCB)</title>
            <description>Participants received infusions of Solumedrol 100mg, rituximab 1000mg, and cyclophosphamide 750mg intravenously (IV) at Week 0 and Week 2. Prednisone was administered at 40 mg/day for the first 2 weeks, followed by a guided steroid taper to 10 mg/day by Week 12. Prednisone was continued through to Week 96 at 10 mg/day, with the potential of a taper to a minimum of 5 mg/day. In addition, participants received IV belimumab 10mg/kg at Weeks 4, 6, 8, and then every 4 weeks through Week 48 in addition to prednisone.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With At Least One Grade 3 or Higher Infectious Adverse Event By Week 24, Week 48 and Week 96</title>
          <description>The percentage of participants who experienced at least one Grade 3 or higher treatment-emergent infectious adverse event. The severity of adverse events (AEs) was classified into grades using the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE, v4.03:June 14, 2010). Treatment-emergent AEs are those:&#xD;
with an onset date on or after the first dose of study medication,&#xD;
with onset before first dose but that worsened in severity after first dose, and&#xD;
for which the start of the AE in relation to the start of study medication could not be established.&#xD;
AEs were classified by system organ class and preferred term according to the Medical Dictionary for Regulatory Activities (MedDRA) version 17.0. Grade 3 or higher AEs were classified infectious based on the study team's review of the MedDRA body systems and preferred terms of the AEs.</description>
          <population>The modified intent-to-treat population includes all randomized participants who received 1 dose of Solumedrol, 1 dose of rituximab, 1 dose of cyclophosphamide, and, if in the Rituximab/Cyclophosphamide/Belimumab (RCB) arm, 1 dose of belimumab.&#xD;
Confidence intervals were calculated using Clopper-Pearson method.</population>
          <units>percentage of participants</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="22"/>
                <count group_id="O2" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 0 to Week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.1" lower_limit="1.1" upper_limit="29.2"/>
                    <measurement group_id="O2" value="4.8" lower_limit="0.1" upper_limit="23.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 0 to Week 48</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22.7" lower_limit="7.8" upper_limit="45.4"/>
                    <measurement group_id="O2" value="9.5" lower_limit="1.2" upper_limit="30.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 0 to Week 96</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27.3" lower_limit="10.7" upper_limit="50.2"/>
                    <measurement group_id="O2" value="9.5" lower_limit="1.2" upper_limit="30.4"/>
                  </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>Week 0 to Week 24</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.58</p_value>
            <p_value_desc>Two-sided test</p_value_desc>
            <method>Regression, Logistic</method>
            <method_desc>Treatment group was the independent variable in the logistic regression.</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Week 0 to Week 48</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.25</p_value>
            <p_value_desc>Two-sided test.</p_value_desc>
            <method>Regression, Logistic</method>
            <method_desc>Treatment group was the independent variable in the logistic regression.</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Week 0 to Week 96.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.15</p_value>
            <p_value_desc>Two-sided test.</p_value_desc>
            <method>Regression, Logistic</method>
            <method_desc>Treatment group was the independent variable in the logistic regression.</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With B Cell Reconstitution at Week 24, Week 48 and Week 96</title>
        <description>The percentage of participants who achieved B cell reconstitution, defined as a peripheral blood total B cell count ≥ to the baseline count or the lower limit of normal, whichever was lower. Note: B cell depletion was expected to occur in this study between Weeks 0 and 4, after initiation of rituximab and cyclophosphamide.&#xD;
Normal peripheral blood B Cell count: 107 to 698 cells/µL.</description>
        <time_frame>Week 24, Week 48 and Week 96</time_frame>
        <population>The modified intent-to-treat population includes all randomized participants who received 1 dose of Solumedrol, 1 dose of rituximab, 1 dose of cyclophosphamide, and, if in the Rituximab/Cyclophosphamide/Belimumab (RCB) arm, 1 dose of belimumab.&#xD;
Confidence intervals were calculated using Clopper-Pearson method.</population>
        <group_list>
          <group group_id="O1">
            <title>Rituximab/Cyclophosphamide (RC)</title>
            <description>Participants received infusions of Solumedrol 100mg, rituximab 1000mg, and cyclophosphamide 750mg intravenously (IV) at Week 0 and Week 2. Prednisone was administered at 40 mg/day for the first 2 weeks, followed by a guided steroid taper to 10 mg/day by Week 12. Prednisone was continued through to Week 96 at 10 mg/day, with the potential of a taper to a minimum of 5 mg/day.</description>
          </group>
          <group group_id="O2">
            <title>Rituximab/Cyclophosphamide/Belimumab (RCB)</title>
            <description>Participants received infusions of Solumedrol 100mg, rituximab 1000mg, and cyclophosphamide 750mg intravenously (IV) at Week 0 and Week 2. Prednisone was administered at 40 mg/day for the first 2 weeks, followed by a guided steroid taper to 10 mg/day by Week 12. Prednisone was continued through to Week 96 at 10 mg/day, with the potential of a taper to a minimum of 5 mg/day. In addition, participants received IV belimumab 10mg/kg at Weeks 4, 6, 8, and then every 4 weeks through Week 48 in addition to prednisone.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With B Cell Reconstitution at Week 24, Week 48 and Week 96</title>
          <description>The percentage of participants who achieved B cell reconstitution, defined as a peripheral blood total B cell count ≥ to the baseline count or the lower limit of normal, whichever was lower. Note: B cell depletion was expected to occur in this study between Weeks 0 and 4, after initiation of rituximab and cyclophosphamide.&#xD;
Normal peripheral blood B Cell count: 107 to 698 cells/µL.</description>
          <population>The modified intent-to-treat population includes all randomized participants who received 1 dose of Solumedrol, 1 dose of rituximab, 1 dose of cyclophosphamide, and, if in the Rituximab/Cyclophosphamide/Belimumab (RCB) arm, 1 dose of belimumab.&#xD;
Confidence intervals were calculated using Clopper-Pearson method.</population>
          <units>Percentage of Participants</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="22"/>
                <count group_id="O2" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="16"/>
                    <count group_id="O2" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31.3" lower_limit="11.0" upper_limit="58.7"/>
                    <measurement group_id="O2" value="6.3" lower_limit="0.2" upper_limit="30.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 48</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35.7" lower_limit="12.8" upper_limit="64.9"/>
                    <measurement group_id="O2" value="11.8" lower_limit="1.5" upper_limit="36.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 96</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40.0" lower_limit="16.3" upper_limit="67.7"/>
                    <measurement group_id="O2" value="30.8" lower_limit="9.1" upper_limit="61.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Grade 4 Hypogammaglobulinemia by Week 24, Week 48, and Week 96</title>
        <description>The percentage of participants who experienced Grade 4 hypogammaglobulinemia, defined as having a serum Immunoglobulin G (IgG) level &lt; 300 mg/dL. Severity of adverse events (AEs) was classified using the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE, v4.03:June 14, 2010).</description>
        <time_frame>Week 24, Week 48 and Week 96</time_frame>
        <population>The modified intent-to-treat population includes all randomized participants who received 1 dose of Solumedrol, 1 dose of rituximab, 1 dose of cyclophosphamide, and, if in the Rituximab/Cyclophosphamide/Belimumab (RCB) arm, 1 dose of belimumab.&#xD;
Confidence intervals were calculated using Clopper-Pearson method.</population>
        <group_list>
          <group group_id="O1">
            <title>Rituximab/Cyclophosphamide (RC)</title>
            <description>Participants received infusions of Solumedrol 100mg, rituximab 1000mg, and cyclophosphamide 750mg intravenously (IV) at Week 0 and Week 2. Prednisone was administered at 40 mg/day for the first 2 weeks, followed by a guided steroid taper to 10 mg/day by Week 12. Prednisone was continued through to Week 96 at 10 mg/day, with the potential of a taper to a minimum of 5 mg/day.</description>
          </group>
          <group group_id="O2">
            <title>Rituximab/Cyclophosphamide/Belimumab (RCB)</title>
            <description>Participants received infusions of Solumedrol 100mg, rituximab 1000mg, and cyclophosphamide 750mg intravenously (IV) at Week 0 and Week 2. Prednisone was administered at 40 mg/day for the first 2 weeks, followed by a guided steroid taper to 10 mg/day by Week 12. Prednisone was continued through to Week 96 at 10 mg/day, with the potential of a taper to a minimum of 5 mg/day.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Grade 4 Hypogammaglobulinemia by Week 24, Week 48, and Week 96</title>
          <description>The percentage of participants who experienced Grade 4 hypogammaglobulinemia, defined as having a serum Immunoglobulin G (IgG) level &lt; 300 mg/dL. Severity of adverse events (AEs) was classified using the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE, v4.03:June 14, 2010).</description>
          <population>The modified intent-to-treat population includes all randomized participants who received 1 dose of Solumedrol, 1 dose of rituximab, 1 dose of cyclophosphamide, and, if in the Rituximab/Cyclophosphamide/Belimumab (RCB) arm, 1 dose of belimumab.&#xD;
Confidence intervals were calculated using Clopper-Pearson method.</population>
          <units>percentage of participants</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="22"/>
                <count group_id="O2" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 0 to Week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="0.0" upper_limit="15.4"/>
                    <measurement group_id="O2" value="0" lower_limit="0.0" upper_limit="16.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 0 to Week 48</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="0.0" upper_limit="15.4"/>
                    <measurement group_id="O2" value="0" lower_limit="0.0" upper_limit="16.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 0 to Week 96</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="0.0" upper_limit="15.4"/>
                    <measurement group_id="O2" value="0" lower_limit="0.0" upper_limit="16.1"/>
                  </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>Week 0 to Week 24</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>P-value could not be produced because of zero count in at least one of the treatment arms.</non_inferiority_desc>
            <other_analysis_desc>Treatment group was the independent variable in the logistic regression.</other_analysis_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Week 0 to Week 48</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <other_analysis_desc>P-value could not be produced because of zero count in at least one of the treatment arms.</other_analysis_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Week 0 to Week 96 The modified intent to treat population includes all randomized participants who received 1 dose of Solumedrol, 1 dose of rituximab, 1 dose of cyclophosphamide, and, if in the Rituximab/Cyclophosphamide/Belimumab (RCB) arm, 1 dose of belimumab.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>P-value could not be produced because of zero count in at least one of the treatment arms</non_inferiority_desc>
            <other_analysis_desc>P-value could not be produced because of zero count in at least one of the treatment arms</other_analysis_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With a Complete Response at Week 24, Week 48, and Week 96</title>
        <description>The percentage of participants who achieved a complete response, defined as meeting all of the following criteria:&#xD;
Urine protein-to-creatinine ratio (UPCR) &lt; 0.5, based on a 24-hour collection;&#xD;
Estimated glomerular filtration rate (eGFR) ≥ 120 ml/min/1.73 m^2 calculated by the CKD-EPI formula or, if &lt; 120 ml/min/1.73 m^2, then &gt; 80% of eGFR at entry; and&#xD;
Prednisone dose tapered to 10 mg/day and adherence to prednisone dosing provisions.</description>
        <time_frame>Week 24, Week 48 and Week 96</time_frame>
        <population>The modified intent-to-treat population includes all randomized participants who received 1 dose of Solumedrol, 1 dose of rituximab, 1 dose of cyclophosphamide, and, if in the Rituximab/Cyclophosphamide/Belimumab (RCB) arm, 1 dose of belimumab.&#xD;
Confidence intervals were calculated using Clopper-Pearson method.</population>
        <group_list>
          <group group_id="O1">
            <title>Rituximab/Cyclophosphamide (RC)</title>
            <description>The modified intent to treat population includes all randomized participants who received 1 dose of Solumedrol, 1 dose of rituximab, 1 dose of cyclophosphamide, and, if in the Rituximab/Cyclophosphamide/Belimumab (RCB) arm, 1 dose of belimumab.</description>
          </group>
          <group group_id="O2">
            <title>Rituximab/Cyclophosphamide/Belimumab (RCB)</title>
            <description>The modified intent to treat population includes all randomized participants who received 1 dose of Solumedrol, 1 dose of rituximab, 1 dose of cyclophosphamide, and, if in the Rituximab/Cyclophosphamide/Belimumab (RCB) arm, 1 dose of belimumab.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With a Complete Response at Week 24, Week 48, and Week 96</title>
          <description>The percentage of participants who achieved a complete response, defined as meeting all of the following criteria:&#xD;
Urine protein-to-creatinine ratio (UPCR) &lt; 0.5, based on a 24-hour collection;&#xD;
Estimated glomerular filtration rate (eGFR) ≥ 120 ml/min/1.73 m^2 calculated by the CKD-EPI formula or, if &lt; 120 ml/min/1.73 m^2, then &gt; 80% of eGFR at entry; and&#xD;
Prednisone dose tapered to 10 mg/day and adherence to prednisone dosing provisions.</description>
          <population>The modified intent-to-treat population includes all randomized participants who received 1 dose of Solumedrol, 1 dose of rituximab, 1 dose of cyclophosphamide, and, if in the Rituximab/Cyclophosphamide/Belimumab (RCB) arm, 1 dose of belimumab.&#xD;
Confidence intervals were calculated using Clopper-Pearson method.</population>
          <units>percentage of participants</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="22"/>
                <count group_id="O2" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="21"/>
                    <count group_id="O2" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23.8" lower_limit="8.2" upper_limit="47.2"/>
                    <measurement group_id="O2" value="30.0" lower_limit="11.9" upper_limit="54.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 48</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35.0" lower_limit="15.4" upper_limit="59.2"/>
                    <measurement group_id="O2" value="42.1" lower_limit="20.3" upper_limit="66.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 96</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                    <count group_id="O2" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="33.3" lower_limit="11.8" upper_limit="61.6"/>
                    <measurement group_id="O2" value="42.9" lower_limit="17.7" upper_limit="71.1"/>
                  </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>Week 24</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Treatment group was the independent variable in the logistic regression.</non_inferiority_desc>
            <p_value>0.66</p_value>
            <p_value_desc>Treatment group was the independent variable in the logistic regression.</p_value_desc>
            <method>Regression, Logistic</method>
            <method_desc>2 sided test</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Week 48</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Treatment group was the independent variable in the logistic regression.</non_inferiority_desc>
            <p_value>0.65</p_value>
            <p_value_desc>Treatment group was the independent variable in the logistic regression.</p_value_desc>
            <method>Regression, Logistic</method>
            <method_desc>2 sided test</method_desc>
            <other_analysis_desc>Treatment group was the independent variable in the logistic regression.</other_analysis_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With an Overall Response at Week 24, Week 48, and Week 96</title>
        <description>The percentage of participants who achieved an overall response, defined as meeting all of the following criteria:&#xD;
&gt;50% improvement in the urine protein-to-creatinine ratio (UPCR) from study entry, based on a 24-hour collection;&#xD;
Estimated glomerular filtration rate (eGFR) ≥120 ml/min/1.73 m^2 calculated by the CKD-EPI formula or, if &lt; 120 ml/min/1.73 m^2, then &gt; 80% of eGFR at entry; and&#xD;
Prednisone dose tapered to 10 mg/day and adherence to prednisone dosing provisions.</description>
        <time_frame>Week 24, Week 48 and Week 96</time_frame>
        <population>The modified intent-to-treat population includes all randomized participants who received 1 dose of Solumedrol, 1 dose of rituximab, 1 dose of cyclophosphamide, and, if in the Rituximab/Cyclophosphamide/Belimumab (RCB) arm, 1 dose of belimumab.&#xD;
Confidence intervals were calculated using Clopper-Pearson method.</population>
        <group_list>
          <group group_id="O1">
            <title>Rituximab/Cyclophosphamide (RC)</title>
            <description>The modified intent to treat population includes all randomized participants who received 1 dose of Solumedrol, 1 dose of rituximab, 1 dose of cyclophosphamide, and, if in the Rituximab/Cyclophosphamide/Belimumab (RCB) arm, 1 dose of belimumab.</description>
          </group>
          <group group_id="O2">
            <title>Rituximab/Cyclophosphamide/Belimumab (RCB)</title>
            <description>The modified intent to treat population includes all randomized participants who received 1 dose of Solumedrol, 1 dose of rituximab, 1 dose of cyclophosphamide, and, if in the Rituximab/Cyclophosphamide/Belimumab (RCB) arm, 1 dose of belimumab.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With an Overall Response at Week 24, Week 48, and Week 96</title>
          <description>The percentage of participants who achieved an overall response, defined as meeting all of the following criteria:&#xD;
&gt;50% improvement in the urine protein-to-creatinine ratio (UPCR) from study entry, based on a 24-hour collection;&#xD;
Estimated glomerular filtration rate (eGFR) ≥120 ml/min/1.73 m^2 calculated by the CKD-EPI formula or, if &lt; 120 ml/min/1.73 m^2, then &gt; 80% of eGFR at entry; and&#xD;
Prednisone dose tapered to 10 mg/day and adherence to prednisone dosing provisions.</description>
          <population>The modified intent-to-treat population includes all randomized participants who received 1 dose of Solumedrol, 1 dose of rituximab, 1 dose of cyclophosphamide, and, if in the Rituximab/Cyclophosphamide/Belimumab (RCB) arm, 1 dose of belimumab.&#xD;
Confidence intervals were calculated using Clopper-Pearson method.</population>
          <units>percentage of participants</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="22"/>
                <count group_id="O2" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="21"/>
                    <count group_id="O2" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="46.7" lower_limit="25.7" upper_limit="70.2"/>
                    <measurement group_id="O2" value="55.0" lower_limit="31.5" upper_limit="76.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 48</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="60.0" lower_limit="36.1" upper_limit="80.9"/>
                    <measurement group_id="O2" value="73.7" lower_limit="48.8" upper_limit="90.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 96</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                    <count group_id="O2" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="53.3" lower_limit="26.6" upper_limit="78.7"/>
                    <measurement group_id="O2" value="71.4" lower_limit="41.9" upper_limit="91.6"/>
                  </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>Week 24 Treatment group was the independent variable in the logistic regression.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Treatment group was the independent variable in the logistic regression.</non_inferiority_desc>
            <p_value>0.64</p_value>
            <p_value_desc>2 sided test</p_value_desc>
            <method>Regression, Logistic</method>
            <method_desc>Treatment group was the independent variable in the logistic regression.</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Week 48</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Treatment group was the independent variable in the logistic regression.</non_inferiority_desc>
            <p_value>0.37</p_value>
            <p_value_desc>2 sided test</p_value_desc>
            <method>Regression, Logistic</method>
            <method_desc>Treatment group was the independent variable in the logistic regression.</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Week 96</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Treatment group was the independent variable in the logistic regression.</non_inferiority_desc>
            <p_value>0.32</p_value>
            <method>Regression, Logistic</method>
            <method_desc>Treatment group was the independent variable in the logistic regression.</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With a Sustained Complete Response</title>
        <description>The percentage of participants who achieved a sustained complete response, defined as a complete response achieved at Week 48 and Week 96.&#xD;
Complete response was defined as meeting all of the following criteria:&#xD;
Urine protein-to-creatinine ratio (UPCR) &lt; 0.5, based on a 24-hour collection;&#xD;
Estimated glomerular filtration rate (eGFR) ≥120 ml/min/1.73 m^2 calculated by the CKD-EPI formula or, if &lt; 120 ml/min/1.73 m^2, then &gt; 80% of eGFR at entry; and&#xD;
Prednisone dose tapered to 10 mg/day and adherence to prednisone dosing provisions.</description>
        <time_frame>Week 48, Week 96</time_frame>
        <population>The modified intent-to-treat population includes all randomized participants who received 1 dose of Solumedrol, 1 dose of rituximab, 1 dose of cyclophosphamide, and, if in the Rituximab/Cyclophosphamide/Belimumab (RCB) arm, 1 dose of belimumab.&#xD;
Confidence intervals were calculated using Clopper-Pearson method.</population>
        <group_list>
          <group group_id="O1">
            <title>Rituximab/Cyclophosphamide (RC)</title>
            <description>The modified intent to treat population includes all randomized participants who received 1 dose of Solumedrol, 1 dose of rituximab, 1 dose of cyclophosphamide, and, if in the Rituximab/Cyclophosphamide/Belimumab (RCB) arm, 1 dose of belimumab.</description>
          </group>
          <group group_id="O2">
            <title>Rituximab/Cyclophosphamide/Belimumab (RCB)</title>
            <description>The modified intent to treat population includes all randomized participants who received 1 dose of Solumedrol, 1 dose of rituximab, 1 dose of cyclophosphamide, and, if in the Rituximab/Cyclophosphamide/Belimumab (RCB) arm, 1 dose of belimumab.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With a Sustained Complete Response</title>
          <description>The percentage of participants who achieved a sustained complete response, defined as a complete response achieved at Week 48 and Week 96.&#xD;
Complete response was defined as meeting all of the following criteria:&#xD;
Urine protein-to-creatinine ratio (UPCR) &lt; 0.5, based on a 24-hour collection;&#xD;
Estimated glomerular filtration rate (eGFR) ≥120 ml/min/1.73 m^2 calculated by the CKD-EPI formula or, if &lt; 120 ml/min/1.73 m^2, then &gt; 80% of eGFR at entry; and&#xD;
Prednisone dose tapered to 10 mg/day and adherence to prednisone dosing provisions.</description>
          <population>The modified intent-to-treat population includes all randomized participants who received 1 dose of Solumedrol, 1 dose of rituximab, 1 dose of cyclophosphamide, and, if in the Rituximab/Cyclophosphamide/Belimumab (RCB) arm, 1 dose of belimumab.&#xD;
Confidence intervals were calculated using Clopper-Pearson method.</population>
          <units>percentage of participants</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="22"/>
                <count group_id="O2" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26.7" lower_limit="7.8" upper_limit="55.1"/>
                    <measurement group_id="O2" value="28.6" lower_limit="8.4" upper_limit="58.1"/>
                  </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>Week 96</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Treatment group was the independent variable in the logistic regression.</non_inferiority_desc>
            <p_value>0.91</p_value>
            <p_value_desc>2 sided test</p_value_desc>
            <method>Regression, Logistic</method>
            <method_desc>2 sided test</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Treatment Failure by Week 24, Week 48, and Week 96</title>
        <description>The percentage of participants who met the criteria for treatment failure, defined by withdrawal from the protocol treatment regimen due to worsening nephritis, infection, or study medication toxicity.</description>
        <time_frame>Week 24, Week 48 and Week 96</time_frame>
        <population>The modified intent-to-treat population includes all randomized participants who received 1 dose of Solumedrol, 1 dose of rituximab, 1 dose of cyclophosphamide, and, if in the Rituximab/Cyclophosphamide/Belimumab (RCB) arm, 1 dose of belimumab.&#xD;
Confidence intervals were calculated using Clopper-Pearson method.</population>
        <group_list>
          <group group_id="O1">
            <title>Rituximab/Cyclophosphamide (RC)</title>
            <description>The modified intent to treat population includes all randomized participants who received 1 dose of Solumedrol, 1 dose of rituximab, 1 dose of cyclophosphamide, and, if in the Rituximab/Cyclophosphamide/Belimumab (RCB) arm, 1 dose of belimumab.</description>
          </group>
          <group group_id="O2">
            <title>Rituximab/Cyclophosphamide/Belimumab (RCB)</title>
            <description>The modified intent to treat population includes all randomized participants who received 1 dose of Solumedrol, 1 dose of rituximab, 1 dose of cyclophosphamide, and, if in the Rituximab/Cyclophosphamide/Belimumab (RCB) arm, 1 dose of belimumab.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Treatment Failure by Week 24, Week 48, and Week 96</title>
          <description>The percentage of participants who met the criteria for treatment failure, defined by withdrawal from the protocol treatment regimen due to worsening nephritis, infection, or study medication toxicity.</description>
          <population>The modified intent-to-treat population includes all randomized participants who received 1 dose of Solumedrol, 1 dose of rituximab, 1 dose of cyclophosphamide, and, if in the Rituximab/Cyclophosphamide/Belimumab (RCB) arm, 1 dose of belimumab.&#xD;
Confidence intervals were calculated using Clopper-Pearson method.</population>
          <units>percentage of participants</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="22"/>
                <count group_id="O2" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 0 to Week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.2" lower_limit="5.2" upper_limit="40.3"/>
                    <measurement group_id="O2" value="14.3" lower_limit="3.1" upper_limit="36.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 0 to Week 48</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="45.5" lower_limit="24.4" upper_limit="67.8"/>
                    <measurement group_id="O2" value="28.6" lower_limit="11.3" upper_limit="52.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 0 to Week 96</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="63.6" lower_limit="40.7" upper_limit="82.8"/>
                    <measurement group_id="O2" value="47.6" lower_limit="25.7" upper_limit="70.2"/>
                  </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>Week 0 to Week 24</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Treatment group was the independent variable in the logistic regression.</non_inferiority_desc>
            <p_value>.73</p_value>
            <p_value_desc>2 sided test</p_value_desc>
            <method>Regression, Logistic</method>
            <method_desc>2 sided test</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Week 0 to Week 48</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Treatment group was the independent variable in the logistic regression.</non_inferiority_desc>
            <p_value>0.26</p_value>
            <p_value_desc>2 sided test</p_value_desc>
            <method>Regression, Logistic</method>
            <method_desc>2 sided test</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Week 0 to Week 96</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Treatment group was the independent variable in the logistic regression.</non_inferiority_desc>
            <p_value>0.29</p_value>
            <p_value_desc>2 sided test</p_value_desc>
            <method>Regression, Logistic</method>
            <method_desc>2 sided test</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Count of Participants: Frequency of Non-renal Flares by Week 24</title>
        <description>Count of participants who experienced non-renal flares, defined as any new &quot;A&quot; finding in a non-renal organ system in the British Isles Lupus Assessment Group (BILAG) assessment. A BILAG &quot;A&quot; finding represents a significant increase in, or a new manifestation of, disease activity.</description>
        <time_frame>Week 24</time_frame>
        <population>The modified intent-to-treat population includes all randomized participants who received 1 dose of Solumedrol, 1 dose of rituximab, 1 dose of cyclophosphamide, and, if in the Rituximab/Cyclophosphamide/Belimumab (RCB) arm, 1 dose of belimumab.</population>
        <group_list>
          <group group_id="O1">
            <title>Rituximab/Cyclophosphamide (RC)</title>
            <description>The modified intent to treat population includes all randomized participants who received 1 dose of Solumedrol, 1 dose of rituximab, 1 dose of cyclophosphamide, and, if in the Rituximab/Cyclophosphamide/Belimumab (RCB) arm, 1 dose of belimumab.</description>
          </group>
          <group group_id="O2">
            <title>Rituximab/Cyclophosphamide/Belimumab (RCB)</title>
            <description>The modified intent to treat population includes all randomized participants who received 1 dose of Solumedrol, 1 dose of rituximab, 1 dose of cyclophosphamide, and, if in the Rituximab/Cyclophosphamide/Belimumab (RCB) arm, 1 dose of belimumab.</description>
          </group>
        </group_list>
        <measure>
          <title>Count of Participants: Frequency of Non-renal Flares by Week 24</title>
          <description>Count of participants who experienced non-renal flares, defined as any new &quot;A&quot; finding in a non-renal organ system in the British Isles Lupus Assessment Group (BILAG) assessment. A BILAG &quot;A&quot; finding represents a significant increase in, or a new manifestation of, disease activity.</description>
          <population>The modified intent-to-treat population includes all randomized participants who received 1 dose of Solumedrol, 1 dose of rituximab, 1 dose of cyclophosphamide, and, if in the Rituximab/Cyclophosphamide/Belimumab (RCB) arm, 1 dose of belimumab.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="22"/>
                <count group_id="O2" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>0 Non-renal flares</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21"/>
                    <measurement group_id="O2" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 Non-renal flare</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>2 Non-renal flares</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_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Week 0 to Week 24</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>2 sided test</non_inferiority_desc>
            <p_value>&gt;0.99</p_value>
            <p_value_desc>2 sided test</p_value_desc>
            <method>Fisher Exact</method>
            <method_desc>2 sided test</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Count of Participants: Frequency of Non-renal Flares by Week 48</title>
        <description>Count of participants who experienced non-renal flares, defined as any new &quot;A&quot; finding in a non-renal organ system in the British Isles Lupus Assessment Group (BILAG) assessment. A BILAG &quot;A&quot; finding represents a significant increase in, or a new manifestation of, disease activity.</description>
        <time_frame>Week 48</time_frame>
        <population>The modified intent-to-treat population includes all randomized participants who received 1 dose of Solumedrol, 1 dose of rituximab, 1 dose of cyclophosphamide, and, if in the Rituximab/Cyclophosphamide/Belimumab (RCB) arm, 1 dose of belimumab.</population>
        <group_list>
          <group group_id="O1">
            <title>Rituximab/Cyclophosphamide (RC)</title>
            <description>The modified intent to treat population includes all randomized participants who received 1 dose of Solumedrol, 1 dose of rituximab, 1 dose of cyclophosphamide, and, if in the Rituximab/Cyclophosphamide/Belimumab (RCB) arm, 1 dose of belimumab.</description>
          </group>
          <group group_id="O2">
            <title>Rituximab/Cyclophosphamide/Belimumab (RCB)</title>
            <description>The modified intent to treat population includes all randomized participants who received 1 dose of Solumedrol, 1 dose of rituximab, 1 dose of cyclophosphamide, and, if in the Rituximab/Cyclophosphamide/Belimumab (RCB) arm, 1 dose of belimumab.</description>
          </group>
        </group_list>
        <measure>
          <title>Count of Participants: Frequency of Non-renal Flares by Week 48</title>
          <description>Count of participants who experienced non-renal flares, defined as any new &quot;A&quot; finding in a non-renal organ system in the British Isles Lupus Assessment Group (BILAG) assessment. A BILAG &quot;A&quot; finding represents a significant increase in, or a new manifestation of, disease activity.</description>
          <population>The modified intent-to-treat population includes all randomized participants who received 1 dose of Solumedrol, 1 dose of rituximab, 1 dose of cyclophosphamide, and, if in the Rituximab/Cyclophosphamide/Belimumab (RCB) arm, 1 dose of belimumab.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="22"/>
                <count group_id="O2" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>0 Non-renal flares</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20"/>
                    <measurement group_id="O2" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 Non-renal flares</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>2 Non-renal flare</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_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Week 0 to Week 48</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>2 sided test</non_inferiority_desc>
            <p_value>0.49</p_value>
            <p_value_desc>2 sided test</p_value_desc>
            <method>Fisher Exact</method>
            <method_desc>2 sided test</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Count of Participants: Frequency of Non-renal Flares by Week 96</title>
        <description>Count of participants who experienced non-renal flares, defined as any new &quot;A&quot; finding in a non-renal organ system in the British Isles Lupus Assessment Group (BILAG) assessment. A BILAG &quot;A&quot; finding represents a significant increase in, or a new manifestation of, disease activity.</description>
        <time_frame>Week 96</time_frame>
        <population>The modified intent-to-treat population includes all randomized participants who received 1 dose of Solumedrol, 1 dose of rituximab, 1 dose of cyclophosphamide, and, if in the Rituximab/Cyclophosphamide/Belimumab (RCB) arm, 1 dose of belimumab.</population>
        <group_list>
          <group group_id="O1">
            <title>Rituximab/Cyclophosphamide (RC)</title>
            <description>The modified intent to treat population includes all randomized participants who received 1 dose of Solumedrol, 1 dose of rituximab, 1 dose of cyclophosphamide, and, if in the Rituximab/Cyclophosphamide/Belimumab (RCB) arm, 1 dose of belimumab.</description>
          </group>
          <group group_id="O2">
            <title>Rituximab/Cyclophosphamide/Belimumab (RCB)</title>
            <description>The modified intent to treat population includes all randomized participants who received 1 dose of Solumedrol, 1 dose of rituximab, 1 dose of cyclophosphamide, and, if in the Rituximab/Cyclophosphamide/Belimumab (RCB) arm, 1 dose of belimumab.</description>
          </group>
        </group_list>
        <measure>
          <title>Count of Participants: Frequency of Non-renal Flares by Week 96</title>
          <description>Count of participants who experienced non-renal flares, defined as any new &quot;A&quot; finding in a non-renal organ system in the British Isles Lupus Assessment Group (BILAG) assessment. A BILAG &quot;A&quot; finding represents a significant increase in, or a new manifestation of, disease activity.</description>
          <population>The modified intent-to-treat population includes all randomized participants who received 1 dose of Solumedrol, 1 dose of rituximab, 1 dose of cyclophosphamide, and, if in the Rituximab/Cyclophosphamide/Belimumab (RCB) arm, 1 dose of belimumab.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="22"/>
                <count group_id="O2" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>0 Non-renal flares</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18"/>
                    <measurement group_id="O2" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 Non-renal flare</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2 Non-renal flares</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_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With an Negative Anti-dsDNA Result at Week 24, Week 48, and Week 96</title>
        <description>The percentage of participants who were anti-double stranded DNA (anti-dsDNA) negative, defined as having anti-dsDNA levels &lt;30 IU/mL.&#xD;
Anti-dsDNA levels are associated with systemic lupus erythematosus disease activity.</description>
        <time_frame>Week 24, Week 48 and Week 96</time_frame>
        <population>The modified intent-to-treat population includes all randomized participants who received 1 dose of Solumedrol, 1 dose of rituximab, 1 dose of cyclophosphamide, and, if in the Rituximab/Cyclophosphamide/Belimumab (RCB) arm, 1 dose of belimumab.&#xD;
Confidence intervals were calculated using Clopper-Pearson method.</population>
        <group_list>
          <group group_id="O1">
            <title>Rituximab/Cyclophosphamide (RC)</title>
            <description>The modified intent to treat population includes all randomized participants who received 1 dose of Solumedrol, 1 dose of rituximab, 1 dose of cyclophosphamide, and, if in the Rituximab/Cyclophosphamide/Belimumab (RCB) arm, 1 dose of belimumab.</description>
          </group>
          <group group_id="O2">
            <title>Rituximab/Cyclophosphamide/Belimumab (RCB)</title>
            <description>The modified intent to treat population includes all randomized participants who received 1 dose of Solumedrol, 1 dose of rituximab, 1 dose of cyclophosphamide, and, if in the Rituximab/Cyclophosphamide/Belimumab (RCB) arm, 1 dose of belimumab.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With an Negative Anti-dsDNA Result at Week 24, Week 48, and Week 96</title>
          <description>The percentage of participants who were anti-double stranded DNA (anti-dsDNA) negative, defined as having anti-dsDNA levels &lt;30 IU/mL.&#xD;
Anti-dsDNA levels are associated with systemic lupus erythematosus disease activity.</description>
          <population>The modified intent-to-treat population includes all randomized participants who received 1 dose of Solumedrol, 1 dose of rituximab, 1 dose of cyclophosphamide, and, if in the Rituximab/Cyclophosphamide/Belimumab (RCB) arm, 1 dose of belimumab.&#xD;
Confidence intervals were calculated using Clopper-Pearson method.</population>
          <units>percentage of participants</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="22"/>
                <count group_id="O2" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="21"/>
                    <count group_id="O2" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.3" lower_limit="3.1" upper_limit="36.3"/>
                    <measurement group_id="O2" value="15.8" lower_limit="3.4" upper_limit="39.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 48</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.0" lower_limit="5.7" upper_limit="43.7"/>
                    <measurement group_id="O2" value="30.0" lower_limit="11.9" upper_limit="54.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 96</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                    <count group_id="O2" value="18"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" lower_limit="0.0" upper_limit="19.5"/>
                    <measurement group_id="O2" value="27.8" lower_limit="9.7" upper_limit="53.5"/>
                  </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>
            <groups_desc>Treatment group was the independent variable in the logistic regression.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>2 sided test</non_inferiority_desc>
            <p_value>0.89</p_value>
            <p_value_desc>2 sided test</p_value_desc>
            <method>Regression, Logistic</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Treatment group was the independent variable in the logistic regression.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Week 48</non_inferiority_desc>
            <p_value>0.47</p_value>
            <p_value_desc>2 sided test</p_value_desc>
            <method>Regression, Logistic</method>
            <method_desc>2 sided test</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Treatment group was the independent variable in the logistic regression.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Week 96</non_inferiority_desc>
            <p_value>0.94</p_value>
            <p_value_desc>2 sided test</p_value_desc>
            <method>Regression, Logistic</method>
            <method_desc>2 sided test</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Hypocomplementemic for Complement Component C3 at Week 24, Week 48, and Week 96</title>
        <description>The percentage of participants who were hypocomplementemic for complement component, C3, defined as a C3 level &lt;90 mg/dL.&#xD;
Serum C3 complement is a protein which can be measured in the blood. Low blood levels of C3 are common in those with active lupus.</description>
        <time_frame>Week 24, Week 48 and Week 96</time_frame>
        <population>The modified intent-to-treat population includes all randomized participants who received 1 dose of Solumedrol, 1 dose of rituximab, 1 dose of cyclophosphamide, and, if in the Rituximab/Cyclophosphamide/Belimumab (RCB) arm, 1 dose of belimumab.&#xD;
Confidence intervals were calculated using Clopper-Pearson method.</population>
        <group_list>
          <group group_id="O1">
            <title>Rituximab/Cyclophosphamide (RC)</title>
            <description>The modified intent to treat population includes all randomized participants who received 1 dose of Solumedrol, 1 dose of rituximab, 1 dose of cyclophosphamide, and, if in the Rituximab/Cyclophosphamide/Belimumab (RCB) arm, 1 dose of belimumab.</description>
          </group>
          <group group_id="O2">
            <title>Rituximab/Cyclophosphamide/Belimumab (RCB)</title>
            <description>The modified intent to treat population includes all randomized participants who received 1 dose of Solumedrol, 1 dose of rituximab, 1 dose of cyclophosphamide, and, if in the Rituximab/Cyclophosphamide/Belimumab (RCB) arm, 1 dose of belimumab.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Hypocomplementemic for Complement Component C3 at Week 24, Week 48, and Week 96</title>
          <description>The percentage of participants who were hypocomplementemic for complement component, C3, defined as a C3 level &lt;90 mg/dL.&#xD;
Serum C3 complement is a protein which can be measured in the blood. Low blood levels of C3 are common in those with active lupus.</description>
          <population>The modified intent-to-treat population includes all randomized participants who received 1 dose of Solumedrol, 1 dose of rituximab, 1 dose of cyclophosphamide, and, if in the Rituximab/Cyclophosphamide/Belimumab (RCB) arm, 1 dose of belimumab.&#xD;
Confidence intervals were calculated using Clopper-Pearson method.</population>
          <units>percentage of participants</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="22"/>
                <count group_id="O2" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="21"/>
                    <count group_id="O2" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="57.1" lower_limit="34.0" upper_limit="78.2"/>
                    <measurement group_id="O2" value="30.0" lower_limit="11.9" upper_limit="54.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 48</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="55.0" lower_limit="31.5" upper_limit="76.9"/>
                    <measurement group_id="O2" value="30.0" lower_limit="11.9" upper_limit="54.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 96</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="18"/>
                    <count group_id="O2" value="18"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="61.1" lower_limit="35.8" upper_limit="82.7"/>
                    <measurement group_id="O2" value="27.8" lower_limit="9.7" upper_limit="53.5"/>
                  </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>
            <groups_desc>Treatment group was the independent variable in the logistic regression.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Week 24</non_inferiority_desc>
            <p_value>0.08</p_value>
            <p_value_desc>2 sided test</p_value_desc>
            <method>Regression, Logistic</method>
            <method_desc>2 sided test</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Treatment group was the independent variable in the logistic regression.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Week 48</non_inferiority_desc>
            <p_value>0.11</p_value>
            <p_value_desc>2 sided test</p_value_desc>
            <method>Regression, Logistic</method>
            <method_desc>2 sided test</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Treatment group was the independent variable in the logistic regression.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Week 96</non_inferiority_desc>
            <p_value>0.05</p_value>
            <p_value_desc>2 sided test</p_value_desc>
            <method>Regression, Logistic</method>
            <method_desc>2 sided test</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Hypocomplementemic for Complement Component C4 at Week 24, Week 48, and Week 96</title>
        <description>The percentage of participants who were hypocomplementemic for complemen component C4, defined as a C4 level &lt;10 mg/dL.&#xD;
Serum C4 complement is a protein which can be measured in the blood. Low blood levels of C4 are common in those with active lupus.</description>
        <time_frame>Week 24, Week 48 and Week 96</time_frame>
        <population>The modified intent-to-treat population includes all randomized participants who received 1 dose of Solumedrol, 1 dose of rituximab, 1 dose of cyclophosphamide, and, if in the Rituximab/Cyclophosphamide/Belimumab (RCB) arm, 1 dose of belimumab.&#xD;
Confidence intervals were calculated using Clopper-Pearson method.</population>
        <group_list>
          <group group_id="O1">
            <title>Rituximab/Cyclophosphamide (RC)</title>
            <description>The modified intent to treat population includes all randomized participants who received 1 dose of Solumedrol, 1 dose of rituximab, 1 dose of cyclophosphamide, and, if in the Rituximab/Cyclophosphamide/Belimumab (RCB) arm, 1 dose of belimumab.</description>
          </group>
          <group group_id="O2">
            <title>Rituximab/Cyclophosphamide/Belimumab (RCB)</title>
            <description>The modified intent to treat population includes all randomized participants who received 1 dose of Solumedrol, 1 dose of rituximab, 1 dose of cyclophosphamide, and, if in the Rituximab/Cyclophosphamide/Belimumab (RCB) arm, 1 dose of belimumab.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Hypocomplementemic for Complement Component C4 at Week 24, Week 48, and Week 96</title>
          <description>The percentage of participants who were hypocomplementemic for complemen component C4, defined as a C4 level &lt;10 mg/dL.&#xD;
Serum C4 complement is a protein which can be measured in the blood. Low blood levels of C4 are common in those with active lupus.</description>
          <population>The modified intent-to-treat population includes all randomized participants who received 1 dose of Solumedrol, 1 dose of rituximab, 1 dose of cyclophosphamide, and, if in the Rituximab/Cyclophosphamide/Belimumab (RCB) arm, 1 dose of belimumab.&#xD;
Confidence intervals were calculated using Clopper-Pearson method.</population>
          <units>percentage of participants</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="22"/>
                <count group_id="O2" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="21"/>
                    <count group_id="O2" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19.0" lower_limit="5.5" upper_limit="41.9"/>
                    <measurement group_id="O2" value="5.0" lower_limit="0.1" upper_limit="24.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 48</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.0" lower_limit="3.2" upper_limit="37.9"/>
                    <measurement group_id="O2" value="15.0" lower_limit="3.2" upper_limit="37.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 96</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="18"/>
                    <count group_id="O2" value="18"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.7" lower_limit="3.6" upper_limit="41.4"/>
                    <measurement group_id="O2" value="11.1" lower_limit="1.4" upper_limit="34.7"/>
                  </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>Treatment group was the independent variable in the logistic regression.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Week 24</non_inferiority_desc>
            <p_value>.20</p_value>
            <p_value_desc>2 sided test</p_value_desc>
            <method>Regression, Logistic</method>
            <method_desc>2 sided test</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Treatment group was the independent variable in the logistic regression.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Week 48</non_inferiority_desc>
            <p_value>&gt;0.99</p_value>
            <p_value_desc>2 sided test</p_value_desc>
            <method>Regression, Logistic</method>
            <method_desc>2 sided test</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Treatment group was the independent variable in the logistic regression.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Week 96</non_inferiority_desc>
            <p_value>0.63</p_value>
            <p_value_desc>2 sided test</p_value_desc>
            <method>Regression, Logistic</method>
            <method_desc>2 sided test</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Frequency of Specific Adverse Events of Interest By Event by Week 96</title>
        <description>Number of ≥ Grade 2 specific treatment-emergent adverse events (AEs) of interest. Grade 2 or higher AEs were classified according to the listed categories of interest based on the study team's review of the AEs.&#xD;
Treatment-emergent AEs are those:&#xD;
with an onset date on or after the first dose of study medication,&#xD;
with onset before first dose but that worsened in severity after first dose, and&#xD;
for which the start of the AE in relation to the start of study medication could not be established.&#xD;
The severity of AEs was classified using the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE, v4.03: June 14, 2010). AEs were classified by system organ class and preferred term according to the Medical Dictionary for Regulatory Activities (MedDRA) version 17.0.</description>
        <time_frame>Week 96</time_frame>
        <population>The safety population includes all participants who received at least one dose of study treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>Rituximab/Cyclophosphamide (RC)</title>
            <description>The safety population includes all participants who received at least one dose of study treatment.</description>
          </group>
          <group group_id="O2">
            <title>Rituximab/Cyclophosphamide/Belimumab (RCB)</title>
            <description>The safety population includes all participants who received at least one dose of study treatment.</description>
          </group>
        </group_list>
        <measure>
          <title>Frequency of Specific Adverse Events of Interest By Event by Week 96</title>
          <description>Number of ≥ Grade 2 specific treatment-emergent adverse events (AEs) of interest. Grade 2 or higher AEs were classified according to the listed categories of interest based on the study team's review of the AEs.&#xD;
Treatment-emergent AEs are those:&#xD;
with an onset date on or after the first dose of study medication,&#xD;
with onset before first dose but that worsened in severity after first dose, and&#xD;
for which the start of the AE in relation to the start of study medication could not be established.&#xD;
The severity of AEs was classified using the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE, v4.03: June 14, 2010). AEs were classified by system organ class and preferred term according to the Medical Dictionary for Regulatory Activities (MedDRA) version 17.0.</description>
          <population>The safety population includes all participants who received at least one dose of study treatment.</population>
          <units>Events</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="22"/>
                <count group_id="O2" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Any event leading to death</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>≥Grade 2 leukopenia or thrombocytopenia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                    <measurement group_id="O2" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Premature ovarian failure</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>Malignancy</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>Venous thromboembolic event</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Frequency of Specific Adverse Events of Interest By Participant, By Week 96</title>
        <description>Number of participants who experienced ≥Grade 2 specific treatment-emergent adverse events (AEs) of interest. Grade 2 or higher AEs were classified according to the listed categories of interest based on the study team's review of the AEs.&#xD;
Treatment-emergent AEs are those:&#xD;
with an onset date on or after the first dose of study medication,&#xD;
with onset before first dose but that worsened in severity after first dose, and&#xD;
for which the start of the AE in relation to the start of study medication could not be established.&#xD;
The severity of AEs was classified using the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE, v4.03: June 14, 2010). AEs were classified by system organ class and preferred term according to the Medical Dictionary for Regulatory Activities (MedDRA) version 17.0.</description>
        <time_frame>Week 96</time_frame>
        <population>The safety population includes all participants who received at least one dose of study treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>Rituximab/Cyclophosphamide (RC)</title>
            <description>The safety population includes all participants who received at least one dose of study treatment.</description>
          </group>
          <group group_id="O2">
            <title>Rituximab/Cyclophosphamide/Belimumab (RCB)</title>
            <description>The safety population includes all participants who received at least one dose of study treatment.</description>
          </group>
        </group_list>
        <measure>
          <title>Frequency of Specific Adverse Events of Interest By Participant, By Week 96</title>
          <description>Number of participants who experienced ≥Grade 2 specific treatment-emergent adverse events (AEs) of interest. Grade 2 or higher AEs were classified according to the listed categories of interest based on the study team's review of the AEs.&#xD;
Treatment-emergent AEs are those:&#xD;
with an onset date on or after the first dose of study medication,&#xD;
with onset before first dose but that worsened in severity after first dose, and&#xD;
for which the start of the AE in relation to the start of study medication could not be established.&#xD;
The severity of AEs was classified using the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE, v4.03: June 14, 2010). AEs were classified by system organ class and preferred term according to the Medical Dictionary for Regulatory Activities (MedDRA) version 17.0.</description>
          <population>The safety population includes all participants who received at least one dose of study treatment.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="22"/>
                <count group_id="O2" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Any event leading to death</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>≥Grade 2 leukopenia or thrombocytopenia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Premature ovarian failure</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>Malignancy</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>Venous thromboembolic event</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_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>1 year, 8 months (96 Weeks)</time_frame>
      <group_list>
        <group group_id="E1">
          <title>RC Group on Treatment</title>
          <description>Participants received infusions of Solumedrol 100mg, rituximab 1000mg, and cyclophosphamide 750mg intravenously (IV) at Week 0 and Week 2. Prednisone 40 mg per day was administered for the first 2 weeks, with a guided steroid taper to 10mg per day by Week 12 and continued treatment until Week 96.</description>
        </group>
        <group group_id="E2">
          <title>RCB Group on Treatment</title>
          <description>Participants received infusions of Solumedrol 100mg, rituximab 1000mg, and cyclophosphamide 750mg intravenously (IV) at Week 0 and Week 2. Prednisone 40 mg per day was administered for the first 2 weeks, with a guided steroid taper to 10mg per day by Week 12 and continued treatment until Week 96. In addition, participants received IV belimumab 10mg/kg at Weeks 4, 6, 8, and then every 4 weeks through Week 48 in addition to prednisone.</description>
        </group>
        <group group_id="E3">
          <title>RC Group After Treatment Discontinuation</title>
          <description>Participants received infusions of Solumedrol 100mg, rituximab 1000mg, and cyclophosphamide 750mg intravenously (IV) at Week 0 and Week 2. Prednisone 40 mg per day was administered for the first 2 weeks, with a guided steroid taper to 10mg per day by Week 12 and continued treatment until Week 96.</description>
        </group>
        <group group_id="E4">
          <title>RCB Group After Treatment Discontinuation</title>
          <description>Participants received infusions of Solumedrol 100mg, rituximab 1000mg, and cyclophosphamide 750mg intravenously (IV) at Week 0 and Week 2. Prednisone 40 mg per day was administered for the first 2 weeks, with a guided steroid taper to 10mg per day by Week 12 and continued treatment until Week 96. In addition, participants received IV belimumab 10mg/kg at Weeks 4, 6, 8, and then every 4 weeks through Week 48 in addition to prednisone.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>17.0</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="0" subjects_at_risk="22"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="22"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="8" subjects_at_risk="22"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="2" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Pancytopenia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Aortic valve incompetence</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Myocardial ischaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Blindness transient</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Serum sickness</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Abscess soft tissue</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E4" events="2" subjects_affected="1" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Infective myositis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Mediastinitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Pneumonia respiratory syncytial viral</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Pseudomonal bacteraemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Staphylococcal bacteraemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Tendon rupture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Blood creatinine increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Hypocalcaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Intervertebral disc protrusion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Osteonecrosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Systemic lupus erythematosus</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="3" subjects_affected="2" subjects_at_risk="22"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Grand mal convulsion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Posterior reversible encephalopathy syndrome</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="2" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Lupus nephritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Renal failure</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="22"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Renal failure acute</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="2" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Pulmonary alveolar haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Axillary vein thrombosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Hypertensive emergency</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="2" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Subclavian vein thrombosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>17.0</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="22" subjects_at_risk="22"/>
                <counts group_id="E2" subjects_affected="21" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="11" subjects_at_risk="22"/>
                <counts group_id="E4" subjects_affected="6" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" events="17" subjects_affected="10" subjects_at_risk="22"/>
                <counts group_id="E2" events="20" subjects_affected="13" subjects_at_risk="21"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="22"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Leukopenia</sub_title>
                <counts group_id="E1" events="10" subjects_affected="5" subjects_at_risk="22"/>
                <counts group_id="E2" events="15" subjects_affected="6" subjects_at_risk="21"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="22"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Lymphopenia</sub_title>
                <counts group_id="E1" events="33" subjects_affected="17" subjects_at_risk="22"/>
                <counts group_id="E2" events="19" subjects_affected="11" subjects_at_risk="21"/>
                <counts group_id="E3" events="11" subjects_affected="9" subjects_at_risk="22"/>
                <counts group_id="E4" events="4" subjects_affected="3" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Neutropenia</sub_title>
                <counts group_id="E1" events="5" subjects_affected="3" subjects_at_risk="22"/>
                <counts group_id="E2" events="8" subjects_affected="5" subjects_at_risk="21"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="22"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Cushingoid</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="22"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="21"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="22"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="6" subjects_affected="5" subjects_at_risk="22"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="21"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="4" subjects_affected="2" subjects_at_risk="22"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Local swelling</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="21"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Oedema peripheral</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="22"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Hypogammaglobulinaemia</sub_title>
                <counts group_id="E1" events="12" subjects_affected="9" subjects_at_risk="22"/>
                <counts group_id="E2" events="18" subjects_affected="11" subjects_at_risk="21"/>
                <counts group_id="E3" events="5" subjects_affected="4" subjects_at_risk="22"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Herpes zoster</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="21"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="21"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Oral candidiasis</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="22"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="21"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="6" subjects_affected="3" subjects_at_risk="22"/>
                <counts group_id="E2" events="4" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="7" subjects_affected="3" subjects_at_risk="22"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Viral upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Infusion related reaction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="21"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Maternal exposure during pregnancy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="4" subjects_affected="3" subjects_at_risk="21"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Blood creatinine increased</sub_title>
                <counts group_id="E1" events="9" subjects_affected="6" subjects_at_risk="22"/>
                <counts group_id="E2" events="11" subjects_affected="8" subjects_at_risk="21"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Hypoalbuminaemia</sub_title>
                <counts group_id="E1" events="15" subjects_affected="10" subjects_at_risk="22"/>
                <counts group_id="E2" events="10" subjects_affected="8" subjects_at_risk="21"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="22"/>
                <counts group_id="E4" events="2" subjects_affected="1" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="22"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="22"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="21"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Lupus nephritis</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="22"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="21"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Proteinuria</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="22"/>
                <counts group_id="E2" events="8" subjects_affected="6" subjects_at_risk="21"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="22"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="22"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="21"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="22"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Alopecia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="22"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E3" events="2" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="21"/>
              </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>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Director, Clinical Research Operations Program</name_or_title>
      <organization>DAIT/NIAID</organization>
      <phone>301-594-7669</phone>
      <email>DAITClinicalTrialsGov@niaid.nih.gov</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/NCT02260934
org study id: DAIT ITN055AI
secondary id: CALIBRATE
nct id: NCT02260934
lead sponsor: 
collaborator: 
has dmc: Yes
In this experimental study, researchers will try to find out if treatment of lupus nephritis
      with a combination of rituximab and cyclophosphamide (CTX), or a combination of rituximab and
      CTX followed by treatment with belimumab is safe and if this drug combination can block the
      immune system attacks.
Lupus nephritis is a severe form of systemic lupus erythematosus (SLE) with active disease in
      the kidneys. SLE is a complex disease in which the body's own immune system attacks some of
      the body parts: the skin, the joints, the kidneys, the nervous system, the heart, the lungs
      and the blood. The cause of SLE is not known. Treatment for SLE usually involves drugs that
      are designed to block the immune system attacks. When SLE affects the kidneys (nephritis),
      stronger immune suppressing treatment is usually needed.

      The drugs used in treatment of lupus nephritis often do not cure the disease and can cause
      serious side effects, including lowering the immune system too much. When the immune system
      is too low, a person is at a higher risk of getting infections. Therefore, research into new
      treatments with fewer serious side effects is needed for lupus nephritis.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Percentage of Participants With At Least One Grade 3 or Higher Infectious Adverse Event By Week 24, Week 48 and Week 96
time frame: Week 0 to Week 96
description: The percentage of participants who experienced at least one Grade 3 or higher treatment-emergent infectious adverse event. The severity of adverse events (AEs) was classified into grades using the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE, v4.03:June 14, 2010). Treatment-emergent AEs are those:
with an onset date on or after the first dose of study medication,
with onset before first dose but that worsened in severity after first dose, and
for which the start of the AE in relation to the start of study medication could not be established.
AEs were classified by system organ class and preferred term according to the Medical Dictionary for Regulatory Activities (MedDRA) version 17.0. Grade 3 or higher AEs were classified infectious based on the study team's review of the MedDRA body systems and preferred terms of the AEs.
measure: Percentage of Participants With B Cell Reconstitution at Week 24, Week 48 and Week 96
time frame: Week 24, Week 48 and Week 96
description: The percentage of participants who achieved B cell reconstitution, defined as a peripheral blood total B cell count ≥ to the baseline count or the lower limit of normal, whichever was lower. Note: B cell depletion was expected to occur in this study between Weeks 0 and 4, after initiation of rituximab and cyclophosphamide.
Normal peripheral blood B Cell count: 107 to 698 cells/µL.
measure: Percentage of Participants With Grade 4 Hypogammaglobulinemia by Week 24, Week 48, and Week 96
time frame: Week 24, Week 48 and Week 96
description: The percentage of participants who experienced Grade 4 hypogammaglobulinemia, defined as having a serum Immunoglobulin G (IgG) level < 300 mg/dL. Severity of adverse events (AEs) was classified using the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE, v4.03:June 14, 2010).
measure: Percentage of Participants With a Complete Response at Week 24, Week 48, and Week 96
time frame: Week 24, Week 48 and Week 96
description: The percentage of participants who achieved a complete response, defined as meeting all of the following criteria:
Urine protein-to-creatinine ratio (UPCR) < 0.5, based on a 24-hour collection;
Estimated glomerular filtration rate (eGFR) ≥ 120 ml/min/1.73 m^2 calculated by the CKD-EPI formula or, if < 120 ml/min/1.73 m^2, then > 80% of eGFR at entry; and
Prednisone dose tapered to 10 mg/day and adherence to prednisone dosing provisions.
measure: Percentage of Participants With an Overall Response at Week 24, Week 48, and Week 96
time frame: Week 24, Week 48 and Week 96
description: The percentage of participants who achieved an overall response, defined as meeting all of the following criteria:
>50% improvement in the urine protein-to-creatinine ratio (UPCR) from study entry, based on a 24-hour collection;
Estimated glomerular filtration rate (eGFR) ≥120 ml/min/1.73 m^2 calculated by the CKD-EPI formula or, if < 120 ml/min/1.73 m^2, then > 80% of eGFR at entry; and
Prednisone dose tapered to 10 mg/day and adherence to prednisone dosing provisions.
measure: Percentage of Participants With a Sustained Complete Response
time frame: Week 48, Week 96
description: The percentage of participants who achieved a sustained complete response, defined as a complete response achieved at Week 48 and Week 96.
Complete response was defined as meeting all of the following criteria:
Urine protein-to-creatinine ratio (UPCR) < 0.5, based on a 24-hour collection;
Estimated glomerular filtration rate (eGFR) ≥120 ml/min/1.73 m^2 calculated by the CKD-EPI formula or, if < 120 ml/min/1.73 m^2, then > 80% of eGFR at entry; and
Prednisone dose tapered to 10 mg/day and adherence to prednisone dosing provisions.
measure: Percentage of Participants With Treatment Failure by Week 24, Week 48, and Week 96
time frame: Week 24, Week 48 and Week 96
description: The percentage of participants who met the criteria for treatment failure, defined by withdrawal from the protocol treatment regimen due to worsening nephritis, infection, or study medication toxicity.
measure: Count of Participants: Frequency of Non-renal Flares by Week 24
time frame: Week 24
description: Count of participants who experienced non-renal flares, defined as any new "A" finding in a non-renal organ system in the British Isles Lupus Assessment Group (BILAG) assessment. A BILAG "A" finding represents a significant increase in, or a new manifestation of, disease activity.
measure: Count of Participants: Frequency of Non-renal Flares by Week 48
time frame: Week 48
description: Count of participants who experienced non-renal flares, defined as any new "A" finding in a non-renal organ system in the British Isles Lupus Assessment Group (BILAG) assessment. A BILAG "A" finding represents a significant increase in, or a new manifestation of, disease activity.
measure: Count of Participants: Frequency of Non-renal Flares by Week 96
time frame: Week 96
description: Count of participants who experienced non-renal flares, defined as any new "A" finding in a non-renal organ system in the British Isles Lupus Assessment Group (BILAG) assessment. A BILAG "A" finding represents a significant increase in, or a new manifestation of, disease activity.
measure: Percentage of Participants With an Negative Anti-dsDNA Result at Week 24, Week 48, and Week 96
time frame: Week 24, Week 48 and Week 96
description: The percentage of participants who were anti-double stranded DNA (anti-dsDNA) negative, defined as having anti-dsDNA levels <30 IU/mL.
Anti-dsDNA levels are associated with systemic lupus erythematosus disease activity.
measure: Percentage of Participants Hypocomplementemic for Complement Component C3 at Week 24, Week 48, and Week 96
time frame: Week 24, Week 48 and Week 96
description: The percentage of participants who were hypocomplementemic for complement component, C3, defined as a C3 level <90 mg/dL.
Serum C3 complement is a protein which can be measured in the blood. Low blood levels of C3 are common in those with active lupus.
measure: Percentage of Participants Hypocomplementemic for Complement Component C4 at Week 24, Week 48, and Week 96
time frame: Week 24, Week 48 and Week 96
description: The percentage of participants who were hypocomplementemic for complemen component C4, defined as a C4 level <10 mg/dL.
Serum C4 complement is a protein which can be measured in the blood. Low blood levels of C4 are common in those with active lupus.
measure: Frequency of Specific Adverse Events of Interest By Event by Week 96
time frame: Week 96
description: Number of ≥ Grade 2 specific treatment-emergent adverse events (AEs) of interest. Grade 2 or higher AEs were classified according to the listed categories of interest based on the study team's review of the AEs.
Treatment-emergent AEs are those:
with an onset date on or after the first dose of study medication,
with onset before first dose but that worsened in severity after first dose, and
for which the start of the AE in relation to the start of study medication could not be established.
The severity of AEs was classified using the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE, v4.03: June 14, 2010). AEs were classified by system organ class and preferred term according to the Medical Dictionary for Regulatory Activities (MedDRA) version 17.0.
measure: Frequency of Specific Adverse Events of Interest By Participant, By Week 96
time frame: Week 96
description: Number of participants who experienced ≥Grade 2 specific treatment-emergent adverse events (AEs) of interest. Grade 2 or higher AEs were classified according to the listed categories of interest based on the study team's review of the AEs.
Treatment-emergent AEs are those:
with an onset date on or after the first dose of study medication,
with onset before first dose but that worsened in severity after first dose, and
for which the start of the AE in relation to the start of study medication could not be established.
The severity of AEs was classified using the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE, v4.03: June 14, 2010). AEs were classified by system organ class and preferred term according to the Medical Dictionary for Regulatory Activities (MedDRA) version 17.0.
arm group label: Rituximab/Cyclophosphamide (RC)
arm group type: Active Comparator
description: Prednisone taper to 10 mg/day by week 12 and continue prednisone 10 mg/day to week 96.
arm group label: Rituximab/Cyclophosphamide/Belimumab (RCB)
arm group type: Experimental
description: Belimumab (10 mg/kg IV) at weeks 4, 6, 8, and every 4 weeks to week 48.
Prednisone taper to 10 mg/day by week 12, and continue prednisone 10 mg/day to week 96.
intervention type: Biological
intervention name: Rituximab
description: Rituximab 1000mg intravenously (IV) at week 0 and week 2
arm group label: Rituximab/Cyclophosphamide (RC)
other name: Rituxan
intervention type: Drug
intervention name: Cyclophosphamide
description: Cyclophosphamide (750 mg) intravenously (IV) at week 0 and week 2.
arm group label: Rituximab/Cyclophosphamide (RC)
other name: Cytoxan
intervention type: Drug
intervention name: Prednisone
description: Week 0 and Week 2: Prednisone (40 mg/day; taper to 10 mg/day by week 12)
Continue prednisone 10 mg/day to week 96
arm group label: Rituximab/Cyclophosphamide (RC)
other name: Deltasone
intervention type: Drug
intervention name: Methylprednisolone
description: Week 0 and Week 2:
Solumedrol (100 mg) IV
arm group label: Rituximab/Cyclophosphamide (RC)
other name: Solu-Medrol
intervention type: Drug
intervention name: Diphenhydramine
description: Diphenhydramine (50 mg, or equivalent dose of similar antihistamine) will be given orally 1 hour (plus or minus 15 minutes) before each infusion of rituximab.
arm group label: Rituximab/Cyclophosphamide (RC)
intervention type: Drug
intervention name: Acetaminophen
description: Acetaminophen (650 mg) will be given orally 1 hour (plus or minus 15 minutes) before each infusion of rituximab.
arm group label: Rituximab/Cyclophosphamide (RC)
other name: Tylenol
intervention type: Biological
intervention name: Rituximab
description: Rituximab 1000mg intravenously (IV) at week 0 and week 2.
arm group label: Rituximab/Cyclophosphamide/Belimumab (RCB)
other name: Rituxan
intervention type: Drug
intervention name: Cyclophosphamide
description: Cyclophosphamide (750 mg) intravenously (IV) at week 0 and week 2.
arm group label: Rituximab/Cyclophosphamide/Belimumab (RCB)
other name: Cytoxan
intervention type: Drug
intervention name: Prednisone
description: Week 0 and Week 2: Prednisone (40 mg/day; taper to 10 mg/day by week 12)
Continue prednisone 10 mg/day to week 96
arm group label: Rituximab/Cyclophosphamide/Belimumab (RCB)
other name: Deltasone
intervention type: Drug
intervention name: Methylprednisolone
description: Week 0 and Week 2: Solumedrol (100 mg) IV
arm group label: Rituximab/Cyclophosphamide/Belimumab (RCB)
other name: Solu-Medrol
intervention type: Drug
intervention name: Diphenhydramine
description: Diphenhydramine (50 mg, or equivalent dose of similar antihistamine) will be given orally 1 hour (plus or minus 15 minutes) before each infusion of rituximab.
arm group label: Rituximab/Cyclophosphamide/Belimumab (RCB)
intervention type: Drug
intervention name: Acetaminophen
description: Acetaminophen (650 mg) will be given orally 1 hour (plus or minus 15 minutes) before each infusion of rituximab.
arm group label: Rituximab/Cyclophosphamide/Belimumab (RCB)
other name: Tylenol
intervention type: Biological
intervention name: Belimumab
description: The RCB Group will receive IV belimumab 10mg/kg at weeks 4, 6, 8, and then every 4 weeks through week 48
arm group label: Rituximab/Cyclophosphamide/Belimumab (RCB)
other name: Benlysta
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Betty Diamond, M.D.
role: Study Chair
affiliation: Feinstein Institute for Medical Research
last name: David Wofsy, M.D.
role: Study Chair
affiliation: University of California San Francisco, Department of Medicine
last name: Maria Dall'Era, M.D.
role: Study Chair
affiliation: University of California San Francisco, Department of Medicine
last name: Cynthia Aranow, M.D.
role: Study Chair
affiliation: Feinstein Institute for Medical Research
facility: 
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country: United States
url: https://www.niaid.nih.gov/
description: National Institute of Allergy and Infectious Diseases website
url: https://www.niaid.nih.gov/about/dait
description: Division of Allergy, Immunology, and Transplantation (DAIT)
url: http://www.immunetolerance.org/
description: Immune Tolerance Network (ITN) website
url: http://calibratestudy.org/about-calibrate
description: ITN CALIBRATE study website
citation: Atisha-Fregoso Y, Malkiel S, Harris KM, Byron M, Ding L, Kanaparthi S, Barry WT, Gao W, Ryker K, Tosta P, Askanase AD, Boackle SA, Chatham WW, Kamen DL, Karp DR, Kirou KA, Sam Lim S, Marder B, McMahon M, Parikh SV, Pendergraft WF 3rd, Podoll AS, Saxena A, Wofsy D, Diamond B, Smilek DE, Aranow C, Dall'Era M. Phase II Randomized Trial of Rituximab Plus Cyclophosphamide Followed by Belimumab for the Treatment of Lupus Nephritis. Arthritis Rheumatol. 2021 Jan;73(1):121-131. doi: 10.1002/art.41466. Epub 2020 Dec 1. Erratum In: Arthritis Rheumatol. 2021 Dec;73(12):2356.
PMID: 32755035
responsible party type: Sponsor
mesh term: Nephritis
mesh term: Lupus Nephritis
mesh term: Acetaminophen
mesh term: Diphenhydramine
mesh term: Promethazine
mesh term: Prednisone
mesh term: Methylprednisolone
mesh term: Methylprednisolone Acetate
mesh term: Methylprednisolone Hemisuccinate
mesh term: Prednisolone
mesh term: Prednisolone acetate
mesh term: Cyclophosphamide
mesh term: Rituximab
mesh term: Belimumab
mesh term: Prednisolone hemisuccinate
mesh term: Prednisolone phosphate
sharing ipd: Yes
ipd description: Participant level data access will be made available to the public at some point in the future via the mechanisms of : 1.) the Immunology Database and Analysis Portal (ImmPort), a long-term archive of clinical and mechanistic data from DAIT-funded grants and contracts; and 2.) TrialShare, the Immune Tolerance Network (ITN) Clinical Trials Research Portal.
ipd time frame: The aim is to share IPD within 24 months upon study completion.
ipd access criteria: ImmPort public data access.
ipd url: http://www.immport.org/immport-open/public/home/home
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 