<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/NCT01662063</url>
  </required_header>
  <id_info>
    <org_study_id>ML28338</org_study_id>
    <nct_id>NCT01662063</nct_id>
  </id_info>
  <brief_title>A Long-Term Extension Study of WA22762 and NA25220 of Subcutaneous (SC) Tocilizumab (TCZ) in Moderate to Severe Rheumatoid Arthritis (RA)</brief_title>
  <official_title>A Multicenter Open-Label, Long-Term Extension Study of WA22762 and NA25220 to Evaluate Safety and Efficacy of Subcutaneous Tocilizumab in Patients With Moderate to Severe Rheumatoid Arthritis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Genentech, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Genentech, Inc.</source>
  <brief_summary>
    <textblock>
      This open-label extension study will evaluate the long-term safety and efficacy of SC TCZ in&#xD;
      participants with moderate to severe RA who have completed the 97-week WA22762 (NCT01194414)&#xD;
      or 96-week NA25220 (NCT01232569) core studies on SC or intravenous (IV) TCZ. Participants&#xD;
      will receive TCZ 162 milligrams (mg) SC every week (QW) or every 2 weeks (Q2W) for up to 96&#xD;
      weeks.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">June 2014</completion_date>
  <primary_completion_date type="Actual">April 2014</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants With at Least One Serious Adverse Event (SAE)</measure>
    <time_frame>From Baseline to 8 weeks after last dose; assessed continuously during treatment (up to 96 weeks) and up to 8 weeks after last dose (up to 2 years overall)</time_frame>
    <description>Adverse events (AEs) were monitored throughout treatment. AEs were defined as any untoward medical occurrence in a participant who received study drug regardless of causality. SAEs were defined as AEs that were fatal or life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, manifested as a congenital anomaly/birth defect, were medically significant, or required intervention to prevent any of the aforementioned outcomes. The number of participants with at least one SAE regardless of treatment relationship was reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants With at Least One SAE</measure>
    <time_frame>From Baseline to 8 weeks after last dose; assessed continuously during treatment (up to 96 weeks) and up to 8 weeks after last dose (up to 2 years overall)</time_frame>
    <description>AEs were monitored throughout treatment. AEs were defined as any untoward medical occurrence in a participant who received study drug regardless of causality. SAEs were defined as AEs that were fatal or life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, manifested as a congenital anomaly/birth defect, were medically significant, or required intervention to prevent any of the aforementioned outcomes. The percentage of participants with at least one SAE regardless of treatment relationship was calculated.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants With a Positive Anti-TCZ Antibody Assay at Any Timepoint</measure>
    <time_frame>From Baseline to 8 weeks after last dose; assessed at Baseline; Weeks 12, 24, 36, 48, 60, 72, 84, 96; and up to 8 weeks after last dose (up to 2 years overall)</time_frame>
    <description>Blood samples were collected to test for the presence of antibodies to TCZ. The percentage of participants with a positive anti-TCZ antibody assay was calculated.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants With a Positive Anti-TCZ Antibody Assay at Baseline</measure>
    <time_frame>Baseline</time_frame>
    <description>Blood samples were collected to test for the presence of antibodies to TCZ. The percentage of participants with a positive anti-TCZ antibody assay was calculated.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants With a Positive Anti-TCZ Antibody Assay Post-Baseline</measure>
    <time_frame>From Week 12 up to 8 weeks after last dose; assessed at Weeks 12, 24, 36, 48, 60, 72, 84, 96; and up to 8 weeks after last dose (up to 2 years overall)</time_frame>
    <description>Blood samples were collected to test for the presence of antibodies to TCZ. The percentage of participants with a positive anti-TCZ antibody assay was calculated. Positive assay results obtained post-Baseline were further investigated via confirmation assay and a neutralization assay.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Who Correctly Administered All SC TCZ Doses</measure>
    <time_frame>From Baseline to last dose; assessed every 4 weeks during treatment (up to 96 weeks overall)</time_frame>
    <description>Compliance was assessed using drug dispensing logs, diary cards kept by the participant, and return records, as reviewed by the Investigator at regular visits. Total compliance up to the end of treatment was defined as the percentage of participants who correctly administered all scheduled doses of SC TCZ. Correct administration was defined as proper injection technique, injection of the correct amount (162 mg), device not left at room temperature for greater than (&gt;) 8 hours, and absence of other medication errors.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease Activity Score Based on 28 Joints (DAS28) Score</measure>
    <time_frame>Baseline and Weeks 12, 24, 36, 48, 60, 72, 84</time_frame>
    <description>The DAS28 was calculated using the Swollen Joint Count (SJC), Tender Joint Count (TJC), erythrocyte sedimentation rate (ESR), and Global Assessment of Disease Activity by the participant according to Visual Analog Scale (VAS) score. For the DAS28 formula, the SJC and TJC values were based upon 28 joints, and VAS was transformed from a 100-millimeter (mm) scale to a 10-point score. The DAS28 was calculated as (0.56 multiplied by [×] square root of TJC) + (0.28 × square root of SJC) + (0.7 × log natural [ln] ESR) + (0.014 × VAS). Scores may range from 0 to 10, where higher scores indicate increased disease activity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in DAS28 Score</measure>
    <time_frame>Baseline to Weeks 12, 24, 36, 48, 60, 72, 84</time_frame>
    <description>The DAS28 was calculated using the SJC, TJC, ESR, and Global Assessment of Disease Activity by the participant according to VAS score. For the DAS28 formula, the SJC and TJC values were based upon 28 joints, and VAS was transformed from a 100-mm scale to a 10-point score. The DAS28 was calculated as (0.56 × square root of TJC) + (0.28 × square root of SJC) + (0.7 × ln ESR) + (0.014 × VAS). Scores may range from 0 to 10, where higher scores indicate increased disease activity. The change from Baseline to each visit was calculated, where positive changes represent an increase or worsening in disease activity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical Disease Activity Index (CDAI) Score</measure>
    <time_frame>Baseline and Weeks 12, 24, 36, 48, 60, 72, 84</time_frame>
    <description>The CDAI was calculated using the SJC, TJC, and Global Assessment of Disease Activity by the patient and by the physician according to separate VAS scores. For the CDAI formula, the SJC and TJC values were based upon 28 joints, and VAS was transformed from a 100-mm scale to a 10-point score. The CDAI was calculated as the sum of the component scores, that is, SJC + TJC + VAS (participant) + VAS (physician). Scores may range from 0 to 76, where higher scores indicate increased disease activity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in CDAI Score</measure>
    <time_frame>Baseline to Weeks 12, 24, 36, 48, 60, 72, 84</time_frame>
    <description>The CDAI was calculated using the SJC, TJC, and Global Assessment of Disease Activity by the patient and by the physician according to separate VAS scores. For the CDAI formula, the SJC and TJC values were based upon 28 joints, and VAS was transformed from a 100-mm scale to a 10-point score. The CDAI was calculated as the sum of the component scores, that is, SJC + TJC + VAS (participant) + VAS (physician). Scores may range from 0 to 76, where higher scores indicate increased disease activity. The change from Baseline to each visit was calculated, where positive changes represent an increase or worsening in disease activity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Simplified Disease Activity Index (SDAI) Score</measure>
    <time_frame>Baseline and Weeks 12, 24, 36, 48, 60, 72, 84</time_frame>
    <description>The SDAI was calculated using the SJC, TJC, Global Assessment of Disease Activity by the patient and by the physician according to separate VAS scores, and high-sensitivity C-reactive protein (hsCRP) level. For the SDAI formula, the SJC and TJC values were based upon 28 joints, and VAS was transformed from a 100-mm scale to a 10-point score. The SDAI was calculated as the sum of the component scores, that is, SJC + TJC + VAS (participant) + VAS (physician) + hsCRP. Because the formula includes hsCRP, scores may theoretically range from 0 to infinity, where higher scores indicate increased disease activity. However, based upon normal hsCRP level within 1 milligram per deciliter (mg/dL), scores would be expected to fall within less than or equal to (≤) 77 points.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in SDAI Score</measure>
    <time_frame>Baseline to Weeks 12, 24, 36, 48, 60, 72, 84</time_frame>
    <description>The SDAI was calculated using the SJC, TJC, Global Assessment of Disease Activity by the patient and by the physician according to separate VAS scores, and hsCRP level. For the SDAI formula, the SJC and TJC values were based upon 28 joints, and VAS was transformed from a 100-mm scale to a 10-point score. The SDAI was calculated as the sum of the component scores, that is, SJC + TJC + VAS (participant) + VAS (physician) + hsCRP. Because the formula includes hsCRP, scores may theoretically range from 0 to infinity, where higher scores indicate increased disease activity. However, based upon normal hsCRP level within 1 mg/dL, scores would be expected to fall within ≤77 points. The change from Baseline to each visit was calculated, where positive changes represent an increase or worsening in disease activity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tender Joint Count (TJC) Score</measure>
    <time_frame>Baseline and Weeks 12, 24, 36, 48, 60, 72, 84</time_frame>
    <description>Sixty-eight joints were assessed and classified as tender/not tender by pressure and joint manipulation on physical examination. The number of tender joints was taken as the TJC score, where values may range from 0 to 68.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in TJC Score</measure>
    <time_frame>Baseline to Weeks 12, 24, 36, 48, 60, 72, 84</time_frame>
    <description>Sixty-eight joints were assessed and classified as tender/not tender by pressure and joint manipulation on physical examination. The number of tender joints was taken as the TJC score, where values may range from 0 to 68. The change from Baseline to each visit was calculated, where positive changes represent an increase in number of tender joints.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Swollen Joint Count (SJC) Score</measure>
    <time_frame>Baseline and Weeks 12, 24, 36, 48, 60, 72, 84</time_frame>
    <description>Sixty-six joints were assessed and classified as swollen/not swollen by pressure and joint manipulation on physical examination. The number of swollen joints was taken as the SJC score, where values may range from 0 to 66.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in SJC Score</measure>
    <time_frame>Baseline to Weeks 12, 24, 36, 48, 60, 72, 84</time_frame>
    <description>Sixty-six joints were assessed and classified as swollen/not swollen by pressure and joint manipulation on physical examination. The number of swollen joints was taken as the SJC score, where values may range from 0 to 66. The change from Baseline to each visit was calculated, where positive changes represent an increase in number of swollen joints.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With a Disease-Modifying Anti-Rheumatic Drug (DMARD) Dose Reduction, Interruption, or Discontinuation</measure>
    <time_frame>From Baseline to last dose; assessed every 4 weeks during treatment (up to 96 weeks overall)</time_frame>
    <description>Use of concomitant medications, including non-biologic DMARDs, was recorded throughout the study. Any change in DMARD therapy was documented and reported among those participants receiving at least one DMARD at Baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With a DMARD Dose Reduction, Interruption, or Discontinuation</measure>
    <time_frame>From Baseline to last dose; assessed every 4 weeks during treatment (up to 96 weeks overall)</time_frame>
    <description>Use of concomitant medications, including non-biologic DMARDs, was recorded throughout the study. Any change in DMARD therapy was documented and reported among those participants receiving at least one DMARD at Baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Reasons Given for DMARD Dose Reduction or Interruption</measure>
    <time_frame>From Baseline to last dose; assessed every 4 weeks during treatment (up to 96 weeks overall)</time_frame>
    <description>Use of concomitant medications, including non-biologic DMARDs, was recorded throughout the study. Any change in DMARD therapy was documented and reported among those participants receiving at least one DMARD at Baseline. The reasons for any DMARD dose reduction/interruption ≤60 days were reported. More than one reason could be given for a single change in DMARD therapy, and each participant could also change DMARD therapy more than once. Therefore, the number of reasons could exceed the number of participants analyzed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Reasons Given for DMARD Discontinuation</measure>
    <time_frame>From Baseline to last dose; assessed every 4 weeks during treatment (up to 96 weeks overall)</time_frame>
    <description>Use of concomitant medications, including non-biologic DMARDs, was recorded throughout the study. Any change in DMARD therapy was documented and reported among those participants receiving at least one DMARD at Baseline. The reasons for any DMARD discontinuation were reported. More than one reason could be given for a single change in DMARD therapy, and each participant could also change DMARD therapy more than once. Therefore, the number of reasons could exceed the number of participants analyzed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With a Corticosteroid (CCS) Dose Reduction, Interruption, or Discontinuation</measure>
    <time_frame>From Baseline to last dose; assessed every 4 weeks during treatment (up to 96 weeks overall)</time_frame>
    <description>Use of concomitant medications, including CCS treatment, was recorded throughout the study. Any change in CCS therapy was documented and reported among those participants who received at least one CCS before the last dose of SC TCZ.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With a CCS Dose Reduction, Interruption, or Discontinuation</measure>
    <time_frame>From Baseline to last dose; assessed every 4 weeks during treatment (up to 96 weeks overall)</time_frame>
    <description>Use of concomitant medications, including CCS treatment, was recorded throughout the study. Any change in CCS therapy was documented and reported among those participants who received at least one CCS before the last dose of SC TCZ.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Reasons Given for CCS Dose Reduction</measure>
    <time_frame>From Baseline to last dose; assessed every 4 weeks during treatment (up to 96 weeks overall)</time_frame>
    <description>Use of concomitant medications, including CCS treatment, was recorded throughout the study. Any change in CCS therapy was documented and reported among those participants who received at least one CCS before the last dose of SC TCZ. The reasons for any CCS dose reduction were reported. More than one reason could be given for a single change in CCS therapy, and each participant could also change CCS therapy more than once. Therefore, the number of reasons could exceed the number of participants analyzed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Reasons Given for CCS Dose Interruption</measure>
    <time_frame>From Baseline to last dose; assessed every 4 weeks during treatment (up to 96 weeks overall)</time_frame>
    <description>Use of concomitant medications, including CCS treatment, was recorded throughout the study. Any change in CCS therapy was documented and reported among those participants who received at least one CCS before the last dose of SC TCZ. The reasons for any CCS dose interruption ≤14 days were reported. More than one reason could be given for a single change in CCS therapy, and each participant could also change CCS therapy more than once. Therefore, the number of reasons could exceed the number of participants analyzed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Reasons Given for CCS Discontinuation</measure>
    <time_frame>From Baseline to last dose; assessed every 4 weeks during treatment (up to 96 weeks overall)</time_frame>
    <description>Use of concomitant medications, including CCS treatment, was recorded throughout the study. Any change in CCS therapy was documented and reported among those participants who received at least one CCS before the last dose of SC TCZ. The reasons for any CCS discontinuation &gt;14 days were reported. More than one reason could be given for a single change in CCS therapy, and each participant could also change CCS therapy more than once. Therefore, the number of reasons could exceed the number of participants analyzed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Who Switched From the QW Regimen and Remained on the Q2W Regimen</measure>
    <time_frame>From Baseline to last dose; assessed every 4 weeks during treatment (up to 96 weeks overall)</time_frame>
    <description>Participants could switch between regimens at the Investigator's judgment based upon safety, efficacy, and pharmacokinetic/pharmacodynamic data. The number of participants who switched from the QW to the Q2W regimen and did not return to the QW regimen was reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Who Switched From the QW Regimen and Remained on the Q2W Regimen</measure>
    <time_frame>From Baseline to last dose; assessed every 4 weeks during treatment (up to 96 weeks overall)</time_frame>
    <description>Participants could switch between regimens at the Investigator's judgment based upon safety, efficacy, and pharmacokinetic/pharmacodynamic data. The percentage of participants who switched from the QW to the Q2W regimen and did not return to the QW regimen was calculated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Who Returned to the QW Regimen After Switching to the Q2W Regimen</measure>
    <time_frame>From Baseline to last dose; assessed every 4 weeks during treatment (up to 96 weeks overall)</time_frame>
    <description>Participants could switch between regimens at the Investigator's judgment based upon safety, efficacy, and pharmacokinetic/pharmacodynamic data. The number of participants who switched from the QW to the Q2W regimen and thereafter returned to the QW regimen was reported with the reason for returning to the QW regimen.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Return to the QW Regimen After Switching to the Q2W Regimen</measure>
    <time_frame>From Baseline to last dose; assessed every 4 weeks during treatment (up to 96 weeks overall)</time_frame>
    <description>Participants could switch between regimens at the Investigator's judgment based upon safety, efficacy, and pharmacokinetic/pharmacodynamic data. Time to return was defined as the time between switching to the Q2W regimen and returning to the previous QW regimen.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Global Assessment of Disease Activity by the Participant According to Visual Analog Scale (VAS) Score</measure>
    <time_frame>Baseline and Weeks 12, 24, 36, 48, 60, 72, 84</time_frame>
    <description>The Global Assessment of Disease Activity was performed using a 100-mm horizontal VAS. Scores may range from 0 mm (&quot;no disease activity&quot;) to 100 mm (&quot;maximum disease activity&quot;), with higher scores representing an increase in perceived symptoms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Global Assessment of Disease Activity by the Participant According to VAS Score</measure>
    <time_frame>Baseline to Weeks 12, 24, 36, 48, 60, 72, 84</time_frame>
    <description>The Global Assessment of Disease Activity was performed using a 100-mm horizontal VAS. Scores may range from 0 mm (&quot;no disease activity&quot;) to 100 mm (&quot;maximum disease activity&quot;), with higher scores representing an increase in perceived symptoms. The change from Baseline to each visit was calculated, where positive changes represent an increase or worsening in perceived disease activity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Global Assessment of Pain by the Participant According to VAS Score</measure>
    <time_frame>Baseline and Weeks 12, 24, 36, 48, 60, 72, 84</time_frame>
    <description>The Global Assessment of Pain was performed using a 100-mm horizontal VAS. Scores may range from 0 mm (&quot;no pain&quot;) to 100 mm (&quot;unbearable pain&quot;), with higher scores representing an increase in pain.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Global Assessment of Pain by the Participant According to VAS Score</measure>
    <time_frame>Baseline to Weeks 12, 24, 36, 48, 60, 72, 84</time_frame>
    <description>The Global Assessment of Pain was performed using a 100-mm horizontal VAS. Scores may range from 0 mm (&quot;no pain&quot;) to 100 mm (&quot;unbearable pain&quot;), with higher scores representing an increase in pain. The change from Baseline to each visit was calculated, where positive changes represent an increase or worsening in pain.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Heath Assessment Questionnaire-Disability Index (HAQ-DI) Score</measure>
    <time_frame>Baseline and Weeks 12, 24, 36, 48, 60, 72, 84</time_frame>
    <description>The Stanford HAQ-DI was calculated as the average of 20 questions, each scored from 0 (no difficulty) to 3 (unable to do). The questionnaire included 8 component sets: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and common activities. Overall scores may range from 0 to 3, with higher scores representing increased disability.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in HAQ-DI Score</measure>
    <time_frame>Baseline to Weeks 12, 24, 36, 48, 60, 72, 84</time_frame>
    <description>The Stanford HAQ-DI was calculated as the average of 20 questions, each scored from 0 (no difficulty) to 3 (unable to do). The questionnaire included 8 component sets: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and common activities. Overall scores may range from 0 to 3, with higher scores representing increased disability. The change from Baseline to each visit was calculated, where positive changes represent an increased need for assistance with daily activities.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With HAQ-DI Score &lt;0.5</measure>
    <time_frame>Baseline and Weeks 12, 24, 36, 48, 60, 72, 84</time_frame>
    <description>The Stanford HAQ-DI was calculated as the average of 20 questions, each scored from 0 (no difficulty) to 3 (unable to do). The questionnaire included 8 component sets: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and common activities. Overall scores may range from 0 to 3, with higher scores representing increased disability. The percentage of participants achieving a score &lt;0.5 was calculated at each visit.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Low Disease Activity According to DAS28, SDAI, and CDAI Criteria</measure>
    <time_frame>Baseline and Weeks 12, 24, 36, 48, 60, 72, 84</time_frame>
    <description>Low disease activity was defined as DAS28 ≤3.2, SDAI ≤11, or CDAI ≤10. For each formula, the SJC and TJC values were based upon 28 joints, and VAS was transformed from a 100-mm scale to a 10-point score. The DAS28 was calculated as (0.56 × square root of TJC) + (0.28 × square root of SJC) + (0.7 × ln ESR) + (0.014 × VAS), with potential scores from 0 to 10. The SDAI was calculated as SJC + TJC + VAS (participant) + VAS (physician) + hsCRP, with potential scores from 0 to infinity. However, based upon normal hsCRP level within 1 mg/dL, scores would be expected to fall within ≤77 points. The CDAI was calculated as SJC + TJC + VAS (participant) + VAS (physician), with potential scores from 0 to 76. For all instruments, higher scores indicate increased disease activity. The number of participants who met criteria for low disease activity was reported at each visit.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Low Disease Activity According to DAS28, SDAI, and CDAI Criteria</measure>
    <time_frame>Baseline and Weeks 12, 24, 36, 48, 60, 72, 84</time_frame>
    <description>Low disease activity was defined as DAS28 ≤3.2, SDAI ≤11, or CDAI ≤10. For each formula, the SJC and TJC values were based upon 28 joints, and VAS was transformed from a 100-mm scale to a 10-point score. The DAS28 was calculated as (0.56 × square root of TJC) + (0.28 × square root of SJC) + (0.7 × ln ESR) + (0.014 × VAS), with potential scores from 0 to 10. The SDAI was calculated as SJC + TJC + VAS (participant) + VAS (physician) + hsCRP, with potential scores from 0 to infinity. However, based upon normal hsCRP level within 1 mg/dL, scores would be expected to fall within ≤77 points. The CDAI was calculated as SJC + TJC + VAS (participant) + VAS (physician), with potential scores from 0 to 76. For all instruments, higher scores indicate increased disease activity. The percentage of participants who met criteria for low disease activity was calculated at each visit.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Remission According to DAS28, SDAI, and Boolean Criteria</measure>
    <time_frame>Baseline and Weeks 12, 24, 36, 48, 60, 72, 84</time_frame>
    <description>Remission was defined as DAS28 &lt;2.6, SDAI ≤3.3, or meeting all Boolean criteria (28-count SJC and TJC ≤1, VAS ≤10 mm, and hsCRP ≤1 mg/dL). For DAS28 and SDAI formulas, the SJC and TJC values were based upon 28 joints, and VAS was transformed from a 100-mm scale to a 10-point score. The DAS28 was calculated as (0.56 × square root of TJC) + (0.28 × square root of SJC) + (0.7 × ln ESR) + (0.014 × VAS), with potential scores from 0 to 10. The SDAI was calculated as SJC + TJC + VAS (participant) + VAS (physician) + hsCRP, with potential scores from 0 to infinity. However, based upon normal hsCRP level within 1 mg/dL, scores would be expected to fall within ≤77 points. For these instruments, higher scores indicate increased disease activity. The number of participants who met criteria for remission was reported at each visit.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Remission According to DAS28, SDAI, and Boolean Criteria</measure>
    <time_frame>Baseline and Weeks 12, 24, 36, 48, 60, 72, 84</time_frame>
    <description>Remission was defined as DAS28 &lt;2.6, SDAI ≤3.3, or meeting all Boolean criteria (28-count SJC and TJC ≤1, VAS ≤10 mm, and hsCRP ≤1 mg/dL). For DAS28 and SDAI formulas, the SJC and TJC values were based upon 28 joints, and VAS was transformed from a 100-mm scale to a 10-point score. The DAS28 was calculated as (0.56 × square root of TJC) + (0.28 × square root of SJC) + (0.7 × ln ESR) + (0.014 × VAS), with potential scores from 0 to 10. The SDAI was calculated as SJC + TJC + VAS (participant) + VAS (physician) + hsCRP, with potential scores from 0 to infinity. However, based upon normal hsCRP level within 1 mg/dL, scores would be expected to fall within ≤77 points. For these instruments, higher scores indicate increased disease activity. The percentage of participants who met criteria for remission was calculated at each visit.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">218</enrollment>
  <condition>Rheumatoid Arthritis</condition>
  <arm_group>
    <arm_group_label>SC TCZ QW</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants who received IV TCZ in the previous trial will be switched to SC TCZ 162 mg QW, and those who received SC TCZ will continue at their same dosage of SC TCZ 162 mg QW. Tocilizumab will be given for an additional 96 weeks in this open-label extension study.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SC TCZ Q2W</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants who received SC TCZ will continue at their same dosage of SC TCZ 162 mg Q2W. Tocilizumab will be given for an additional 96 weeks in this open-label extension study.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tocilizumab</intervention_name>
    <description>TCZ will be given as 162 mg SC QW or Q2W for up to 96 weeks.</description>
    <arm_group_label>SC TCZ Q2W</arm_group_label>
    <arm_group_label>SC TCZ QW</arm_group_label>
    <other_name>RoActemra/Actemra</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Completed the 97-week WA22762 (NCT01194414) or 96-week NA25220 (NCT01232569) core&#xD;
             study on SC or IV TCZ and, based on the Investigator's judgment, may continue to&#xD;
             benefit from TCZ treatment in this study investigating the SC formulation&#xD;
&#xD;
          -  Receiving treatment on an outpatient basis&#xD;
&#xD;
          -  Females of childbearing potential and males with female partners of childbearing&#xD;
             potential must agree to use reliable means of contraception as defined by protocol&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Premature withdrawal from WA22762 (NCT01194414) or NA25220 (NCT01232569) core studies&#xD;
             for any reason&#xD;
&#xD;
          -  History of severe allergic or anaphylactic reactions to human, humanized, or murine&#xD;
             monoclonal antibodies&#xD;
&#xD;
          -  Evidence of serious uncontrolled concomitant disease or disorder&#xD;
&#xD;
          -  Known active current or history of recurrent bacterial, viral, fungal, mycobacterial,&#xD;
             or other infections&#xD;
&#xD;
          -  Any major episode of infection requiring hospitalization or treatment with IV&#xD;
             antibiotics within 4 weeks of Screening or oral antibiotics within 2 weeks of&#xD;
             Screening&#xD;
&#xD;
          -  History of or currently active primary or secondary immunodeficiency&#xD;
&#xD;
          -  Oral corticosteroids at greater than (&gt;) 10 mg per day prednisone or equivalent, or&#xD;
             non-steroidal anti-inflammatory drugs (NSAIDs) above the maximum recommended dose&#xD;
&#xD;
          -  Intra-articular or parenteral corticosteroids within 4 weeks prior to Baseline&#xD;
&#xD;
          -  Treatment with any investigational or commercially available biologic&#xD;
             disease-modifying anti-rheumatic drug (DMARD) other than TCZ at any time between&#xD;
             completion of the core study WA22762 (NCT01194414) or NA25220 (NCT01232569) and&#xD;
             enrollment in the long-term extension study&#xD;
&#xD;
          -  Pregnant or breastfeeding women&#xD;
&#xD;
          -  History of alcohol, drug, or chemical abuse within 1 year prior to Screening&#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>Clinical Trials</last_name>
    <role>Study Director</role>
    <affiliation>Genentech, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <address>
        <city>Tuscaloosa</city>
        <state>Alabama</state>
        <zip>35406</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Peoria</city>
        <state>Arizona</state>
        <zip>85381</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Scottsdale</city>
        <state>Arizona</state>
        <zip>85258</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85704</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85715</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85723</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85724</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Fullerton</city>
        <state>California</state>
        <zip>92835</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Long Beach</city>
        <state>California</state>
        <zip>90806</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90048</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92108</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>San Leandro</city>
        <state>California</state>
        <zip>94578</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Upland</city>
        <state>California</state>
        <zip>91786</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Van Nuys</city>
        <state>California</state>
        <zip>91405</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>West Hills</city>
        <state>California</state>
        <zip>91307</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Whittier</city>
        <state>California</state>
        <zip>90606</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <zip>80230-7127</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Bridgeport</city>
        <state>Connecticut</state>
        <zip>06606</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Trumbull</city>
        <state>Connecticut</state>
        <zip>06611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Jupiter</city>
        <state>Florida</state>
        <zip>33458</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32806</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Palm Harbor</city>
        <state>Florida</state>
        <zip>34684</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>South Miami</city>
        <state>Florida</state>
        <zip>33143</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33614</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Venice</city>
        <state>Florida</state>
        <zip>34233</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Gainesville</city>
        <state>Georgia</state>
        <zip>30501</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Coeur D'alene</city>
        <state>Idaho</state>
        <zip>83814</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Idaho Falls</city>
        <state>Idaho</state>
        <zip>83404</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Meridian</city>
        <state>Idaho</state>
        <zip>83642</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Morton Grove</city>
        <state>Illinois</state>
        <zip>60053</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Springfield</city>
        <state>Illinois</state>
        <zip>62703</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Vernon Hills</city>
        <state>Illinois</state>
        <zip>60061</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Wichita</city>
        <state>Kansas</state>
        <zip>67208</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Monroe</city>
        <state>Louisiana</state>
        <zip>71203</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Hagerstown</city>
        <state>Maryland</state>
        <zip>21740</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Wheaton</city>
        <state>Maryland</state>
        <zip>20902</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Worcester</city>
        <state>Massachusetts</state>
        <zip>01605</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>St. Claire Shores</city>
        <state>Michigan</state>
        <zip>48081</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Eagan</city>
        <state>Minnesota</state>
        <zip>55121</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Flowood</city>
        <state>Mississippi</state>
        <zip>39232</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Jackson</city>
        <state>Mississippi</state>
        <zip>39202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Florissant</city>
        <state>Missouri</state>
        <zip>63031</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63117</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63141</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Lincoln</city>
        <state>Nebraska</state>
        <zip>68516</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Lebanon</city>
        <state>New Hampshire</state>
        <zip>03756</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Clifton</city>
        <state>New Jersey</state>
        <zip>07012</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Freehold</city>
        <state>New Jersey</state>
        <zip>07728</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Manalapan</city>
        <state>New Jersey</state>
        <zip>07726</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Voorhees</city>
        <state>New Jersey</state>
        <zip>08043</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Albuquerque</city>
        <state>New Mexico</state>
        <zip>87102</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Albany</city>
        <state>New York</state>
        <zip>12206</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Brooklyn</city>
        <state>New York</state>
        <zip>11201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Orchard Park</city>
        <state>New York</state>
        <zip>14127</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Asheville</city>
        <state>North Carolina</state>
        <zip>28803</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Charlotte</city>
        <state>North Carolina</state>
        <zip>28210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Raleigh</city>
        <state>North Carolina</state>
        <zip>27615</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Wilmington</city>
        <state>North Carolina</state>
        <zip>28401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45219</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Perrysburg</city>
        <state>Ohio</state>
        <zip>43551</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Toledo</city>
        <state>Ohio</state>
        <zip>43606</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Oklahoma City</city>
        <state>Oklahoma</state>
        <zip>73103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Oklahoma City</city>
        <state>Oklahoma</state>
        <zip>73104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Tulsa</city>
        <state>Oklahoma</state>
        <zip>74135</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Bethlehem</city>
        <state>Pennsylvania</state>
        <zip>18015</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Duncansville</city>
        <state>Pennsylvania</state>
        <zip>16635</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Wyomissing</city>
        <state>Pennsylvania</state>
        <zip>19610</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>29407</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Knoxville</city>
        <state>Tennessee</state>
        <zip>37909</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Memphis</city>
        <state>Tennessee</state>
        <zip>38104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Memphis</city>
        <state>Tennessee</state>
        <zip>38119</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77004</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77074</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Nassau Bay</city>
        <state>Texas</state>
        <zip>77058</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Olympia</city>
        <state>Washington</state>
        <zip>98502</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Spokane</city>
        <state>Washington</state>
        <zip>99204</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Wenatchee</city>
        <state>Washington</state>
        <zip>98801</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Ponce</city>
        <zip>00716</zip>
        <country>Puerto Rico</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Puerto Rico</country>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2016</verification_date>
  <study_first_submitted>July 30, 2012</study_first_submitted>
  <study_first_submitted_qc>August 7, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 10, 2012</study_first_posted>
  <results_first_submitted>May 23, 2016</results_first_submitted>
  <results_first_submitted_qc>August 17, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">October 12, 2016</results_first_posted>
  <last_update_submitted>August 17, 2016</last_update_submitted>
  <last_update_submitted_qc>August 17, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 12, 2016</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>Arthritis</mesh_term>
    <mesh_term>Arthritis, Rheumatoid</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Subcutaneous (SC) Tocilizumab (TCZ) Every 2 Weeks (Q2W)</title>
          <description>Participants with moderate to severe rheumatoid arthritis (RA) who completed treatment with SC or intravenous (IV) TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this long-term extension (LTE) study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 milligrams (mg) Q2W.</description>
        </group>
        <group group_id="P2">
          <title>SC TCZ Every Week (QW)</title>
          <description>Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW.</description>
        </group>
        <group group_id="P3">
          <title>Not Treated</title>
          <description>Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) were enrolled in this LTE study for an additional 96 weeks. Participants who met Screening criteria but did not receive treatment were excluded from analysis and reported in a separate arm.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="44"/>
                <participants group_id="P2" count="173"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="39"/>
                <participants group_id="P2" count="144"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="29"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event or Intercurrent Illness</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="12"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lack of Efficacy</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="6"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="4"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="4"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Safety Population: All participants who received at least one dose of study medication and had at least one post-dose safety assessment.</population>
      <group_list>
        <group group_id="B1">
          <title>SC TCZ Q2W</title>
          <description>Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W.</description>
        </group>
        <group group_id="B2">
          <title>SC TCZ QW</title>
          <description>Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW.</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="44"/>
            <count group_id="B2" value="173"/>
            <count group_id="B3" value="217"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="59.7" spread="10.18"/>
                    <measurement group_id="B2" value="58.1" spread="10.38"/>
                    <measurement group_id="B3" value="58.4" spread="10.33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="33"/>
                    <measurement group_id="B2" value="133"/>
                    <measurement group_id="B3" value="166"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="40"/>
                    <measurement group_id="B3" value="51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With at Least One Serious Adverse Event (SAE)</title>
        <description>Adverse events (AEs) were monitored throughout treatment. AEs were defined as any untoward medical occurrence in a participant who received study drug regardless of causality. SAEs were defined as AEs that were fatal or life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, manifested as a congenital anomaly/birth defect, were medically significant, or required intervention to prevent any of the aforementioned outcomes. The number of participants with at least one SAE regardless of treatment relationship was reported.</description>
        <time_frame>From Baseline to 8 weeks after last dose; assessed continuously during treatment (up to 96 weeks) and up to 8 weeks after last dose (up to 2 years overall)</time_frame>
        <population>Safety Population.</population>
        <group_list>
          <group group_id="O1">
            <title>SC TCZ Q2W</title>
            <description>Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W.</description>
          </group>
          <group group_id="O2">
            <title>SC TCZ QW</title>
            <description>Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With at Least One Serious Adverse Event (SAE)</title>
          <description>Adverse events (AEs) were monitored throughout treatment. AEs were defined as any untoward medical occurrence in a participant who received study drug regardless of causality. SAEs were defined as AEs that were fatal or life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, manifested as a congenital anomaly/birth defect, were medically significant, or required intervention to prevent any of the aforementioned outcomes. The number of participants with at least one SAE regardless of treatment relationship was reported.</description>
          <population>Safety Population.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="44"/>
                <count group_id="O2" value="173"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants With at Least One SAE</title>
        <description>AEs were monitored throughout treatment. AEs were defined as any untoward medical occurrence in a participant who received study drug regardless of causality. SAEs were defined as AEs that were fatal or life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, manifested as a congenital anomaly/birth defect, were medically significant, or required intervention to prevent any of the aforementioned outcomes. The percentage of participants with at least one SAE regardless of treatment relationship was calculated.</description>
        <time_frame>From Baseline to 8 weeks after last dose; assessed continuously during treatment (up to 96 weeks) and up to 8 weeks after last dose (up to 2 years overall)</time_frame>
        <population>Safety Population.</population>
        <group_list>
          <group group_id="O1">
            <title>SC TCZ Q2W</title>
            <description>Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W.</description>
          </group>
          <group group_id="O2">
            <title>SC TCZ QW</title>
            <description>Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With at Least One SAE</title>
          <description>AEs were monitored throughout treatment. AEs were defined as any untoward medical occurrence in a participant who received study drug regardless of causality. SAEs were defined as AEs that were fatal or life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, manifested as a congenital anomaly/birth defect, were medically significant, or required intervention to prevent any of the aforementioned outcomes. The percentage of participants with at least one SAE regardless of treatment relationship was calculated.</description>
          <population>Safety Population.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="44"/>
                <count group_id="O2" value="173"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.1"/>
                    <measurement group_id="O2" value="11.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants With a Positive Anti-TCZ Antibody Assay at Any Timepoint</title>
        <description>Blood samples were collected to test for the presence of antibodies to TCZ. The percentage of participants with a positive anti-TCZ antibody assay was calculated.</description>
        <time_frame>From Baseline to 8 weeks after last dose; assessed at Baseline; Weeks 12, 24, 36, 48, 60, 72, 84, 96; and up to 8 weeks after last dose (up to 2 years overall)</time_frame>
        <population>Safety Population; only participants with a valid assay at Screening were included.</population>
        <group_list>
          <group group_id="O1">
            <title>SC TCZ Q2W</title>
            <description>Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W.</description>
          </group>
          <group group_id="O2">
            <title>SC TCZ QW</title>
            <description>Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With a Positive Anti-TCZ Antibody Assay at Any Timepoint</title>
          <description>Blood samples were collected to test for the presence of antibodies to TCZ. The percentage of participants with a positive anti-TCZ antibody assay was calculated.</description>
          <population>Safety Population; only participants with a valid assay at Screening were included.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="44"/>
                <count group_id="O2" value="166"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.5"/>
                    <measurement group_id="O2" value="7.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants With a Positive Anti-TCZ Antibody Assay at Baseline</title>
        <description>Blood samples were collected to test for the presence of antibodies to TCZ. The percentage of participants with a positive anti-TCZ antibody assay was calculated.</description>
        <time_frame>Baseline</time_frame>
        <population>Safety Population; only participants with a valid assay at Screening were included.</population>
        <group_list>
          <group group_id="O1">
            <title>SC TCZ Q2W</title>
            <description>Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W.</description>
          </group>
          <group group_id="O2">
            <title>SC TCZ QW</title>
            <description>Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With a Positive Anti-TCZ Antibody Assay at Baseline</title>
          <description>Blood samples were collected to test for the presence of antibodies to TCZ. The percentage of participants with a positive anti-TCZ antibody assay was calculated.</description>
          <population>Safety Population; only participants with a valid assay at Screening were included.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="44"/>
                <count group_id="O2" value="166"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.3"/>
                    <measurement group_id="O2" value="4.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants With a Positive Anti-TCZ Antibody Assay Post-Baseline</title>
        <description>Blood samples were collected to test for the presence of antibodies to TCZ. The percentage of participants with a positive anti-TCZ antibody assay was calculated. Positive assay results obtained post-Baseline were further investigated via confirmation assay and a neutralization assay.</description>
        <time_frame>From Week 12 up to 8 weeks after last dose; assessed at Weeks 12, 24, 36, 48, 60, 72, 84, 96; and up to 8 weeks after last dose (up to 2 years overall)</time_frame>
        <population>Safety Population; only participants with a valid assay at Screening were included.</population>
        <group_list>
          <group group_id="O1">
            <title>SC TCZ Q2W</title>
            <description>Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W.</description>
          </group>
          <group group_id="O2">
            <title>SC TCZ QW</title>
            <description>Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With a Positive Anti-TCZ Antibody Assay Post-Baseline</title>
          <description>Blood samples were collected to test for the presence of antibodies to TCZ. The percentage of participants with a positive anti-TCZ antibody assay was calculated. Positive assay results obtained post-Baseline were further investigated via confirmation assay and a neutralization assay.</description>
          <population>Safety Population; only participants with a valid assay at Screening were included.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="44"/>
                <count group_id="O2" value="166"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Positive Anti-TCZ Assay</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.3"/>
                    <measurement group_id="O2" value="3.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Positive Confirmation Assay</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Positive Neutralizing Assay</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Who Correctly Administered All SC TCZ Doses</title>
        <description>Compliance was assessed using drug dispensing logs, diary cards kept by the participant, and return records, as reviewed by the Investigator at regular visits. Total compliance up to the end of treatment was defined as the percentage of participants who correctly administered all scheduled doses of SC TCZ. Correct administration was defined as proper injection technique, injection of the correct amount (162 mg), device not left at room temperature for greater than (&gt;) 8 hours, and absence of other medication errors.</description>
        <time_frame>From Baseline to last dose; assessed every 4 weeks during treatment (up to 96 weeks overall)</time_frame>
        <population>Intent-to-Treat (ITT) Population: All participants who received at least one dose of study medication and had at least one post-dose efficacy assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>SC TCZ Q2W</title>
            <description>Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W.</description>
          </group>
          <group group_id="O2">
            <title>SC TCZ QW</title>
            <description>Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Correctly Administered All SC TCZ Doses</title>
          <description>Compliance was assessed using drug dispensing logs, diary cards kept by the participant, and return records, as reviewed by the Investigator at regular visits. Total compliance up to the end of treatment was defined as the percentage of participants who correctly administered all scheduled doses of SC TCZ. Correct administration was defined as proper injection technique, injection of the correct amount (162 mg), device not left at room temperature for greater than (&gt;) 8 hours, and absence of other medication errors.</description>
          <population>Intent-to-Treat (ITT) Population: All participants who received at least one dose of study medication and had at least one post-dose efficacy assessment.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="44"/>
                <count group_id="O2" value="173"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="97.7"/>
                    <measurement group_id="O2" value="97.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Disease Activity Score Based on 28 Joints (DAS28) Score</title>
        <description>The DAS28 was calculated using the Swollen Joint Count (SJC), Tender Joint Count (TJC), erythrocyte sedimentation rate (ESR), and Global Assessment of Disease Activity by the participant according to Visual Analog Scale (VAS) score. For the DAS28 formula, the SJC and TJC values were based upon 28 joints, and VAS was transformed from a 100-millimeter (mm) scale to a 10-point score. The DAS28 was calculated as (0.56 multiplied by [×] square root of TJC) + (0.28 × square root of SJC) + (0.7 × log natural [ln] ESR) + (0.014 × VAS). Scores may range from 0 to 10, where higher scores indicate increased disease activity.</description>
        <time_frame>Baseline and Weeks 12, 24, 36, 48, 60, 72, 84</time_frame>
        <population>ITT Population. The &quot;Number of Participants Analyzed&quot; reflects the total number of participants who provided data for the outcome measure. The number of participants who provided data for each analysis (n) is shown in the table.</population>
        <group_list>
          <group group_id="O1">
            <title>SC TCZ Q2W</title>
            <description>Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W.</description>
          </group>
          <group group_id="O2">
            <title>SC TCZ QW</title>
            <description>Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW.</description>
          </group>
        </group_list>
        <measure>
          <title>Disease Activity Score Based on 28 Joints (DAS28) Score</title>
          <description>The DAS28 was calculated using the Swollen Joint Count (SJC), Tender Joint Count (TJC), erythrocyte sedimentation rate (ESR), and Global Assessment of Disease Activity by the participant according to Visual Analog Scale (VAS) score. For the DAS28 formula, the SJC and TJC values were based upon 28 joints, and VAS was transformed from a 100-millimeter (mm) scale to a 10-point score. The DAS28 was calculated as (0.56 multiplied by [×] square root of TJC) + (0.28 × square root of SJC) + (0.7 × log natural [ln] ESR) + (0.014 × VAS). Scores may range from 0 to 10, where higher scores indicate increased disease activity.</description>
          <population>ITT Population. The &quot;Number of Participants Analyzed&quot; reflects the total number of participants who provided data for the outcome measure. The number of participants who provided data for each analysis (n) is shown in the table.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="44"/>
                <count group_id="O2" value="173"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (n=44,172)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.55" spread="1.732"/>
                    <measurement group_id="O2" value="4.60" spread="1.869"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12 (n=44,172)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.17" spread="1.443"/>
                    <measurement group_id="O2" value="3.42" spread="1.728"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24 (n=43,168)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.08" spread="1.351"/>
                    <measurement group_id="O2" value="3.35" spread="1.786"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 36 (n=39,159)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.07" spread="1.425"/>
                    <measurement group_id="O2" value="3.29" spread="1.624"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 48 (n=18,141)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.15" spread="1.392"/>
                    <measurement group_id="O2" value="3.25" spread="1.639"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 60 (n=2,92)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.10" spread="0.515"/>
                    <measurement group_id="O2" value="3.12" spread="1.626"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 72 (n=1,52)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.76" spread="NA">Standard deviation could not be calculated because the analysis only included 1 participant.</measurement>
                    <measurement group_id="O2" value="3.05" spread="1.970"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 84 (n=0,11)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" spread="NA">No participants provided evaluable data for the analysis.</measurement>
                    <measurement group_id="O2" value="2.78" spread="1.434"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in DAS28 Score</title>
        <description>The DAS28 was calculated using the SJC, TJC, ESR, and Global Assessment of Disease Activity by the participant according to VAS score. For the DAS28 formula, the SJC and TJC values were based upon 28 joints, and VAS was transformed from a 100-mm scale to a 10-point score. The DAS28 was calculated as (0.56 × square root of TJC) + (0.28 × square root of SJC) + (0.7 × ln ESR) + (0.014 × VAS). Scores may range from 0 to 10, where higher scores indicate increased disease activity. The change from Baseline to each visit was calculated, where positive changes represent an increase or worsening in disease activity.</description>
        <time_frame>Baseline to Weeks 12, 24, 36, 48, 60, 72, 84</time_frame>
        <population>ITT Population. The &quot;Number of Participants Analyzed&quot; reflects the total number of participants who provided data for the outcome measure. The number of participants who provided data for each analysis (n) is shown in the table.</population>
        <group_list>
          <group group_id="O1">
            <title>SC TCZ Q2W</title>
            <description>Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W.</description>
          </group>
          <group group_id="O2">
            <title>SC TCZ QW</title>
            <description>Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in DAS28 Score</title>
          <description>The DAS28 was calculated using the SJC, TJC, ESR, and Global Assessment of Disease Activity by the participant according to VAS score. For the DAS28 formula, the SJC and TJC values were based upon 28 joints, and VAS was transformed from a 100-mm scale to a 10-point score. The DAS28 was calculated as (0.56 × square root of TJC) + (0.28 × square root of SJC) + (0.7 × ln ESR) + (0.014 × VAS). Scores may range from 0 to 10, where higher scores indicate increased disease activity. The change from Baseline to each visit was calculated, where positive changes represent an increase or worsening in disease activity.</description>
          <population>ITT Population. The &quot;Number of Participants Analyzed&quot; reflects the total number of participants who provided data for the outcome measure. The number of participants who provided data for each analysis (n) is shown in the table.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="44"/>
                <count group_id="O2" value="172"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 12 (n=44,171)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.38" spread="1.522"/>
                    <measurement group_id="O2" value="-1.19" spread="1.415"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24 (n=43,167)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.42" spread="1.383"/>
                    <measurement group_id="O2" value="-1.23" spread="1.692"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 36 (n=39,158)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.51" spread="1.312"/>
                    <measurement group_id="O2" value="-1.29" spread="1.429"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 48 (n=18,140)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.66" spread="1.340"/>
                    <measurement group_id="O2" value="-1.32" spread="1.538"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 60 (n=2,91)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.65" spread="1.410"/>
                    <measurement group_id="O2" value="-1.29" spread="1.286"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 72 (n=1,52)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.35" spread="NA">Standard deviation could not be calculated because the analysis only included 1 participant.</measurement>
                    <measurement group_id="O2" value="-1.53" spread="1.435"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 84 (n=0,10)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" spread="NA">No participants provided evaluable data for the analysis.</measurement>
                    <measurement group_id="O2" value="-1.57" spread="1.312"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Clinical Disease Activity Index (CDAI) Score</title>
        <description>The CDAI was calculated using the SJC, TJC, and Global Assessment of Disease Activity by the patient and by the physician according to separate VAS scores. For the CDAI formula, the SJC and TJC values were based upon 28 joints, and VAS was transformed from a 100-mm scale to a 10-point score. The CDAI was calculated as the sum of the component scores, that is, SJC + TJC + VAS (participant) + VAS (physician). Scores may range from 0 to 76, where higher scores indicate increased disease activity.</description>
        <time_frame>Baseline and Weeks 12, 24, 36, 48, 60, 72, 84</time_frame>
        <population>ITT Population; only those participants who provided evaluable data (n) were included in the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>SC TCZ Q2W</title>
            <description>Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W.</description>
          </group>
          <group group_id="O2">
            <title>SC TCZ QW</title>
            <description>Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW.</description>
          </group>
        </group_list>
        <measure>
          <title>Clinical Disease Activity Index (CDAI) Score</title>
          <description>The CDAI was calculated using the SJC, TJC, and Global Assessment of Disease Activity by the patient and by the physician according to separate VAS scores. For the CDAI formula, the SJC and TJC values were based upon 28 joints, and VAS was transformed from a 100-mm scale to a 10-point score. The CDAI was calculated as the sum of the component scores, that is, SJC + TJC + VAS (participant) + VAS (physician). Scores may range from 0 to 76, where higher scores indicate increased disease activity.</description>
          <population>ITT Population; only those participants who provided evaluable data (n) were included in the analysis.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="44"/>
                <count group_id="O2" value="173"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (n=44,173)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.10" spread="15.467"/>
                    <measurement group_id="O2" value="23.91" spread="16.346"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12 (n=44,172)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.99" spread="13.058"/>
                    <measurement group_id="O2" value="18.19" spread="14.145"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24 (n=42,166)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.86" spread="13.232"/>
                    <measurement group_id="O2" value="18.03" spread="13.665"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 36 (n=39,159)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.26" spread="11.839"/>
                    <measurement group_id="O2" value="16.92" spread="12.598"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 48 (n=18,140)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.81" spread="16.479"/>
                    <measurement group_id="O2" value="16.55" spread="13.559"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 60 (n=2,92)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.60" spread="2.828"/>
                    <measurement group_id="O2" value="14.71" spread="11.954"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 72 (n=1,52)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27.80" spread="NA">Standard deviation could not be calculated because the analysis only included 1 participant.</measurement>
                    <measurement group_id="O2" value="16.04" spread="15.476"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 84 (n=0,11)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" spread="NA">No participants provided evaluable data for the analysis</measurement>
                    <measurement group_id="O2" value="12.82" spread="9.154"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in CDAI Score</title>
        <description>The CDAI was calculated using the SJC, TJC, and Global Assessment of Disease Activity by the patient and by the physician according to separate VAS scores. For the CDAI formula, the SJC and TJC values were based upon 28 joints, and VAS was transformed from a 100-mm scale to a 10-point score. The CDAI was calculated as the sum of the component scores, that is, SJC + TJC + VAS (participant) + VAS (physician). Scores may range from 0 to 76, where higher scores indicate increased disease activity. The change from Baseline to each visit was calculated, where positive changes represent an increase or worsening in disease activity.</description>
        <time_frame>Baseline to Weeks 12, 24, 36, 48, 60, 72, 84</time_frame>
        <population>ITT Population. The &quot;Number of Participants Analyzed&quot; reflects the total number of participants who provided data for the outcome measure. The number of participants who provided data for each analysis (n) is shown in the table.</population>
        <group_list>
          <group group_id="O1">
            <title>SC TCZ Q2W</title>
            <description>Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W.</description>
          </group>
          <group group_id="O2">
            <title>SC TCZ QW</title>
            <description>Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in CDAI Score</title>
          <description>The CDAI was calculated using the SJC, TJC, and Global Assessment of Disease Activity by the patient and by the physician according to separate VAS scores. For the CDAI formula, the SJC and TJC values were based upon 28 joints, and VAS was transformed from a 100-mm scale to a 10-point score. The CDAI was calculated as the sum of the component scores, that is, SJC + TJC + VAS (participant) + VAS (physician). Scores may range from 0 to 76, where higher scores indicate increased disease activity. The change from Baseline to each visit was calculated, where positive changes represent an increase or worsening in disease activity.</description>
          <population>ITT Population. The &quot;Number of Participants Analyzed&quot; reflects the total number of participants who provided data for the outcome measure. The number of participants who provided data for each analysis (n) is shown in the table.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="44"/>
                <count group_id="O2" value="173"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 12 (n=44,172)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-6.11" spread="13.219"/>
                    <measurement group_id="O2" value="-5.81" spread="12.010"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24 (n=42,166)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-5.23" spread="14.134"/>
                    <measurement group_id="O2" value="-5.47" spread="13.754"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 36 (n=39,159)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-7.00" spread="12.266"/>
                    <measurement group_id="O2" value="-6.63" spread="10.676"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 48 (n=18,140)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-6.63" spread="13.479"/>
                    <measurement group_id="O2" value="-6.70" spread="12.328"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 60 (n=2,92)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-14.05" spread="20.294"/>
                    <measurement group_id="O2" value="-7.05" spread="11.065"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 72 (n=1,52)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-16.20" spread="NA">Standard deviation could not be calculated because the analysis only included 1 participant.</measurement>
                    <measurement group_id="O2" value="-6.31" spread="12.999"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 84 (n=0,11)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" spread="NA">No participants provided evaluable data for the analysis</measurement>
                    <measurement group_id="O2" value="-10.01" spread="18.580"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Simplified Disease Activity Index (SDAI) Score</title>
        <description>The SDAI was calculated using the SJC, TJC, Global Assessment of Disease Activity by the patient and by the physician according to separate VAS scores, and high-sensitivity C-reactive protein (hsCRP) level. For the SDAI formula, the SJC and TJC values were based upon 28 joints, and VAS was transformed from a 100-mm scale to a 10-point score. The SDAI was calculated as the sum of the component scores, that is, SJC + TJC + VAS (participant) + VAS (physician) + hsCRP. Because the formula includes hsCRP, scores may theoretically range from 0 to infinity, where higher scores indicate increased disease activity. However, based upon normal hsCRP level within 1 milligram per deciliter (mg/dL), scores would be expected to fall within less than or equal to (≤) 77 points.</description>
        <time_frame>Baseline and Weeks 12, 24, 36, 48, 60, 72, 84</time_frame>
        <population>ITT Population. The &quot;Number of Participants Analyzed&quot; reflects the total number of participants who provided data for the outcome measure. The number of participants who provided data for each analysis (n) is shown in the table.</population>
        <group_list>
          <group group_id="O1">
            <title>SC TCZ Q2W</title>
            <description>Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W.</description>
          </group>
          <group group_id="O2">
            <title>SC TCZ QW</title>
            <description>Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW.</description>
          </group>
        </group_list>
        <measure>
          <title>Simplified Disease Activity Index (SDAI) Score</title>
          <description>The SDAI was calculated using the SJC, TJC, Global Assessment of Disease Activity by the patient and by the physician according to separate VAS scores, and high-sensitivity C-reactive protein (hsCRP) level. For the SDAI formula, the SJC and TJC values were based upon 28 joints, and VAS was transformed from a 100-mm scale to a 10-point score. The SDAI was calculated as the sum of the component scores, that is, SJC + TJC + VAS (participant) + VAS (physician) + hsCRP. Because the formula includes hsCRP, scores may theoretically range from 0 to infinity, where higher scores indicate increased disease activity. However, based upon normal hsCRP level within 1 milligram per deciliter (mg/dL), scores would be expected to fall within less than or equal to (≤) 77 points.</description>
          <population>ITT Population. The &quot;Number of Participants Analyzed&quot; reflects the total number of participants who provided data for the outcome measure. The number of participants who provided data for each analysis (n) is shown in the table.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="44"/>
                <count group_id="O2" value="173"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (n=44,170)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.54" spread="15.717"/>
                    <measurement group_id="O2" value="25.10" spread="16.972"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12 (n=44,172)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.48" spread="13.058"/>
                    <measurement group_id="O2" value="18.32" spread="14.199"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24 (n=41,166)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.42" spread="13.266"/>
                    <measurement group_id="O2" value="18.18" spread="13.779"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 36 (n=39,159)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.75" spread="11.841"/>
                    <measurement group_id="O2" value="17.06" spread="12.621"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 48 (n=18,140)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.85" spread="16.490"/>
                    <measurement group_id="O2" value="16.76" spread="13.603"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 60 (n=2,92)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.63" spread="2.841"/>
                    <measurement group_id="O2" value="14.90" spread="12.045"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 72 (n=1,52)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27.82" spread="NA">Standard deviation could not be calculated because the analysis only included 1 participant.</measurement>
                    <measurement group_id="O2" value="16.23" spread="15.730"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 84 (n=0,11)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" spread="NA">No participants provided evaluable data for the analysis</measurement>
                    <measurement group_id="O2" value="12.90" spread="9.163"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in SDAI Score</title>
        <description>The SDAI was calculated using the SJC, TJC, Global Assessment of Disease Activity by the patient and by the physician according to separate VAS scores, and hsCRP level. For the SDAI formula, the SJC and TJC values were based upon 28 joints, and VAS was transformed from a 100-mm scale to a 10-point score. The SDAI was calculated as the sum of the component scores, that is, SJC + TJC + VAS (participant) + VAS (physician) + hsCRP. Because the formula includes hsCRP, scores may theoretically range from 0 to infinity, where higher scores indicate increased disease activity. However, based upon normal hsCRP level within 1 mg/dL, scores would be expected to fall within ≤77 points. The change from Baseline to each visit was calculated, where positive changes represent an increase or worsening in disease activity.</description>
        <time_frame>Baseline to Weeks 12, 24, 36, 48, 60, 72, 84</time_frame>
        <population>ITT Population. The &quot;Number of Participants Analyzed&quot; reflects the total number of participants who provided data for the outcome measure. The number of participants who provided data for each analysis (n) is shown in the table.</population>
        <group_list>
          <group group_id="O1">
            <title>SC TCZ Q2W</title>
            <description>Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W.</description>
          </group>
          <group group_id="O2">
            <title>SC TCZ QW</title>
            <description>Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in SDAI Score</title>
          <description>The SDAI was calculated using the SJC, TJC, Global Assessment of Disease Activity by the patient and by the physician according to separate VAS scores, and hsCRP level. For the SDAI formula, the SJC and TJC values were based upon 28 joints, and VAS was transformed from a 100-mm scale to a 10-point score. The SDAI was calculated as the sum of the component scores, that is, SJC + TJC + VAS (participant) + VAS (physician) + hsCRP. Because the formula includes hsCRP, scores may theoretically range from 0 to infinity, where higher scores indicate increased disease activity. However, based upon normal hsCRP level within 1 mg/dL, scores would be expected to fall within ≤77 points. The change from Baseline to each visit was calculated, where positive changes represent an increase or worsening in disease activity.</description>
          <population>ITT Population. The &quot;Number of Participants Analyzed&quot; reflects the total number of participants who provided data for the outcome measure. The number of participants who provided data for each analysis (n) is shown in the table.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="44"/>
                <count group_id="O2" value="170"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 12 (n=44,169)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-7.07" spread="13.671"/>
                    <measurement group_id="O2" value="-7.00" spread="12.056"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24 (n=41,163)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-5.71" spread="14.217"/>
                    <measurement group_id="O2" value="-6.79" spread="13.069"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 36 (n=39,157)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-7.99" spread="12.858"/>
                    <measurement group_id="O2" value="-7.38" spread="10.953"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 48 (n=18,139)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-8.17" spread="14.640"/>
                    <measurement group_id="O2" value="-7.29" spread="12.454"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 60 (n=2,91)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-14.46" spread="20.873"/>
                    <measurement group_id="O2" value="-7.52" spread="10.846"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 72 (n=1,52)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-17.04" spread="NA">Standard deviation could not be calculated because the analysis only included 1 participant.</measurement>
                    <measurement group_id="O2" value="-7.10" spread="13.379"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 84 (n=0,10)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" spread="NA">No participants provided evaluable data for the analysis</measurement>
                    <measurement group_id="O2" value="-9.48" spread="19.290"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Tender Joint Count (TJC) Score</title>
        <description>Sixty-eight joints were assessed and classified as tender/not tender by pressure and joint manipulation on physical examination. The number of tender joints was taken as the TJC score, where values may range from 0 to 68.</description>
        <time_frame>Baseline and Weeks 12, 24, 36, 48, 60, 72, 84</time_frame>
        <population>ITT Population; only those participants who provided evaluable data (n) were included in the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>SC TCZ Q2W</title>
            <description>Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W.</description>
          </group>
          <group group_id="O2">
            <title>SC TCZ QW</title>
            <description>Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW.</description>
          </group>
        </group_list>
        <measure>
          <title>Tender Joint Count (TJC) Score</title>
          <description>Sixty-eight joints were assessed and classified as tender/not tender by pressure and joint manipulation on physical examination. The number of tender joints was taken as the TJC score, where values may range from 0 to 68.</description>
          <population>ITT Population; only those participants who provided evaluable data (n) were included in the analysis.</population>
          <units>tender joints</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="44"/>
                <count group_id="O2" value="173"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (n=44,173)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.84" spread="13.883"/>
                    <measurement group_id="O2" value="19.14" spread="18.469"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12 (n=44,172)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.86" spread="11.727"/>
                    <measurement group_id="O2" value="14.06" spread="14.874"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24 (n=42,167)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.95" spread="14.221"/>
                    <measurement group_id="O2" value="13.86" spread="15.176"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 36 (n=39,159)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.10" spread="11.392"/>
                    <measurement group_id="O2" value="13.45" spread="14.398"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 48 (n=18,141)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.61" spread="14.825"/>
                    <measurement group_id="O2" value="12.85" spread="16.192"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 60 (n=2,92)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.50" spread="0.707"/>
                    <measurement group_id="O2" value="10.47" spread="12.589"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 72 (n=1,52)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.00" spread="NA">Standard deviation could not be calculated because the analysis only included 1 participant.</measurement>
                    <measurement group_id="O2" value="11.38" spread="15.444"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 84 (n=0,11)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" spread="NA">No participants provided evaluable data for the analysis</measurement>
                    <measurement group_id="O2" value="9.36" spread="10.984"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in TJC Score</title>
        <description>Sixty-eight joints were assessed and classified as tender/not tender by pressure and joint manipulation on physical examination. The number of tender joints was taken as the TJC score, where values may range from 0 to 68. The change from Baseline to each visit was calculated, where positive changes represent an increase in number of tender joints.</description>
        <time_frame>Baseline to Weeks 12, 24, 36, 48, 60, 72, 84</time_frame>
        <population>ITT Population. The &quot;Number of Participants Analyzed&quot; reflects the total number of participants who provided data for the outcome measure. The number of participants who provided data for each analysis (n) is shown in the table.</population>
        <group_list>
          <group group_id="O1">
            <title>SC TCZ Q2W</title>
            <description>Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W.</description>
          </group>
          <group group_id="O2">
            <title>SC TCZ QW</title>
            <description>Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in TJC Score</title>
          <description>Sixty-eight joints were assessed and classified as tender/not tender by pressure and joint manipulation on physical examination. The number of tender joints was taken as the TJC score, where values may range from 0 to 68. The change from Baseline to each visit was calculated, where positive changes represent an increase in number of tender joints.</description>
          <population>ITT Population. The &quot;Number of Participants Analyzed&quot; reflects the total number of participants who provided data for the outcome measure. The number of participants who provided data for each analysis (n) is shown in the table.</population>
          <units>tender joints</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="44"/>
                <count group_id="O2" value="173"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 12 (n=44,172)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.98" spread="12.082"/>
                    <measurement group_id="O2" value="-5.17" spread="12.175"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24 (n=42,167)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.69" spread="12.546"/>
                    <measurement group_id="O2" value="-5.12" spread="14.817"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 36 (n=39,159)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.03" spread="10.559"/>
                    <measurement group_id="O2" value="-5.60" spread="12.402"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 48 (n=18,141)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.00" spread="12.902"/>
                    <measurement group_id="O2" value="-5.95" spread="13.899"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 60 (n=2,92)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-9.00" spread="12.728"/>
                    <measurement group_id="O2" value="-6.23" spread="10.672"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 72 (n=1,52)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.00" spread="NA">Standard deviation could not be calculated because the analysis only included 1 participant.</measurement>
                    <measurement group_id="O2" value="-4.98" spread="11.514"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 84 (n=0,11)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" spread="NA">No participants provided evaluable data for the analysis</measurement>
                    <measurement group_id="O2" value="-6.27" spread="13.835"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Swollen Joint Count (SJC) Score</title>
        <description>Sixty-six joints were assessed and classified as swollen/not swollen by pressure and joint manipulation on physical examination. The number of swollen joints was taken as the SJC score, where values may range from 0 to 66.</description>
        <time_frame>Baseline and Weeks 12, 24, 36, 48, 60, 72, 84</time_frame>
        <population>ITT Population; only those participants who provided evaluable data (n) were included in the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>SC TCZ Q2W</title>
            <description>Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W.</description>
          </group>
          <group group_id="O2">
            <title>SC TCZ QW</title>
            <description>Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW.</description>
          </group>
        </group_list>
        <measure>
          <title>Swollen Joint Count (SJC) Score</title>
          <description>Sixty-six joints were assessed and classified as swollen/not swollen by pressure and joint manipulation on physical examination. The number of swollen joints was taken as the SJC score, where values may range from 0 to 66.</description>
          <population>ITT Population; only those participants who provided evaluable data (n) were included in the analysis.</population>
          <units>swollen joints</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="44"/>
                <count group_id="O2" value="173"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (n=44,173)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.07" spread="8.877"/>
                    <measurement group_id="O2" value="10.83" spread="10.855"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12 (n=44,172)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.61" spread="7.144"/>
                    <measurement group_id="O2" value="7.87" spread="8.839"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24 (n=42,167)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.98" spread="8.587"/>
                    <measurement group_id="O2" value="8.57" spread="8.783"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 36 (n=39,159)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.51" spread="8.398"/>
                    <measurement group_id="O2" value="6.92" spread="7.055"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 48 (n=18,141)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.78" spread="9.078"/>
                    <measurement group_id="O2" value="7.23" spread="7.870"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 60 (n=2,92)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.00" spread="2.828"/>
                    <measurement group_id="O2" value="6.52" spread="7.184"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 72 (n=1,52)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.00" spread="NA">Standard deviation could not be calculated because the analysis only included 1 participant.</measurement>
                    <measurement group_id="O2" value="7.98" spread="8.873"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 84 (n=0,11)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" spread="NA">No participants provided evaluable data for the analysis</measurement>
                    <measurement group_id="O2" value="8.64" spread="8.857"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in SJC Score</title>
        <description>Sixty-six joints were assessed and classified as swollen/not swollen by pressure and joint manipulation on physical examination. The number of swollen joints was taken as the SJC score, where values may range from 0 to 66. The change from Baseline to each visit was calculated, where positive changes represent an increase in number of swollen joints.</description>
        <time_frame>Baseline to Weeks 12, 24, 36, 48, 60, 72, 84</time_frame>
        <population>ITT Population. The &quot;Number of Participants Analyzed&quot; reflects the total number of participants who provided data for the outcome measure. The number of participants who provided data for each analysis (n) is shown in the table.</population>
        <group_list>
          <group group_id="O1">
            <title>SC TCZ Q2W</title>
            <description>Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W.</description>
          </group>
          <group group_id="O2">
            <title>SC TCZ QW</title>
            <description>Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in SJC Score</title>
          <description>Sixty-six joints were assessed and classified as swollen/not swollen by pressure and joint manipulation on physical examination. The number of swollen joints was taken as the SJC score, where values may range from 0 to 66. The change from Baseline to each visit was calculated, where positive changes represent an increase in number of swollen joints.</description>
          <population>ITT Population. The &quot;Number of Participants Analyzed&quot; reflects the total number of participants who provided data for the outcome measure. The number of participants who provided data for each analysis (n) is shown in the table.</population>
          <units>swollen joints</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="44"/>
                <count group_id="O2" value="173"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 12 (n=44,172)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.45" spread="7.026"/>
                    <measurement group_id="O2" value="-3.00" spread="8.543"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24 (n=42,167)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.45" spread="8.434"/>
                    <measurement group_id="O2" value="-2.31" spread="9.162"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 36 (n=39,159)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.33" spread="6.868"/>
                    <measurement group_id="O2" value="-3.89" spread="8.134"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 48 (n=18,141)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-6.56" spread="9.332"/>
                    <measurement group_id="O2" value="-3.25" spread="9.543"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 60 (n=2,92)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-8.50" spread="12.021"/>
                    <measurement group_id="O2" value="-3.20" spread="8.702"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 72 (n=1,52)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-15.00" spread="NA">Standard deviation could not be calculated because the analysis only included 1 participant.</measurement>
                    <measurement group_id="O2" value="-1.15" spread="10.114"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 84 (n=0,11)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" spread="NA">No participants provided evaluable data for the analysis</measurement>
                    <measurement group_id="O2" value="-2.64" spread="13.493"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With a Disease-Modifying Anti-Rheumatic Drug (DMARD) Dose Reduction, Interruption, or Discontinuation</title>
        <description>Use of concomitant medications, including non-biologic DMARDs, was recorded throughout the study. Any change in DMARD therapy was documented and reported among those participants receiving at least one DMARD at Baseline.</description>
        <time_frame>From Baseline to last dose; assessed every 4 weeks during treatment (up to 96 weeks overall)</time_frame>
        <population>ITT Population; only participants receiving at least one DMARD at Baseline were included.</population>
        <group_list>
          <group group_id="O1">
            <title>SC TCZ Q2W</title>
            <description>Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W.</description>
          </group>
          <group group_id="O2">
            <title>SC TCZ QW</title>
            <description>Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With a Disease-Modifying Anti-Rheumatic Drug (DMARD) Dose Reduction, Interruption, or Discontinuation</title>
          <description>Use of concomitant medications, including non-biologic DMARDs, was recorded throughout the study. Any change in DMARD therapy was documented and reported among those participants receiving at least one DMARD at Baseline.</description>
          <population>ITT Population; only participants receiving at least one DMARD at Baseline were included.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="41"/>
                <count group_id="O2" value="161"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Any Dose Reduction/Interruption/Discontinuation</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Dose Reduction</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Dose Interruption ≤60 Days</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Dose Reduction/Interruption ≤60 Days</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Discontinuation &gt;60 Days</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With a DMARD Dose Reduction, Interruption, or Discontinuation</title>
        <description>Use of concomitant medications, including non-biologic DMARDs, was recorded throughout the study. Any change in DMARD therapy was documented and reported among those participants receiving at least one DMARD at Baseline.</description>
        <time_frame>From Baseline to last dose; assessed every 4 weeks during treatment (up to 96 weeks overall)</time_frame>
        <population>ITT Population; only participants receiving at least one DMARD at Baseline were included.</population>
        <group_list>
          <group group_id="O1">
            <title>SC TCZ Q2W</title>
            <description>Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W.</description>
          </group>
          <group group_id="O2">
            <title>SC TCZ QW</title>
            <description>Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With a DMARD Dose Reduction, Interruption, or Discontinuation</title>
          <description>Use of concomitant medications, including non-biologic DMARDs, was recorded throughout the study. Any change in DMARD therapy was documented and reported among those participants receiving at least one DMARD at Baseline.</description>
          <population>ITT Population; only participants receiving at least one DMARD at Baseline were included.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="41"/>
                <count group_id="O2" value="161"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Any Dose Reduction/Interruption/Discontinuation</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.3"/>
                    <measurement group_id="O2" value="23.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Dose Reduction</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.4"/>
                    <measurement group_id="O2" value="8.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Dose Interruption ≤60 Days</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.4"/>
                    <measurement group_id="O2" value="9.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Dose Reduction/Interruption ≤60 Days</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.4"/>
                    <measurement group_id="O2" value="16.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Discontinuation &gt;60 Days</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.9"/>
                    <measurement group_id="O2" value="9.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Reasons Given for DMARD Dose Reduction or Interruption</title>
        <description>Use of concomitant medications, including non-biologic DMARDs, was recorded throughout the study. Any change in DMARD therapy was documented and reported among those participants receiving at least one DMARD at Baseline. The reasons for any DMARD dose reduction/interruption ≤60 days were reported. More than one reason could be given for a single change in DMARD therapy, and each participant could also change DMARD therapy more than once. Therefore, the number of reasons could exceed the number of participants analyzed.</description>
        <time_frame>From Baseline to last dose; assessed every 4 weeks during treatment (up to 96 weeks overall)</time_frame>
        <population>ITT Population; only participants with a DMARD dose reduction/interruption ≤60 days were included.</population>
        <group_list>
          <group group_id="O1">
            <title>SC TCZ Q2W</title>
            <description>Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W.</description>
          </group>
          <group group_id="O2">
            <title>SC TCZ QW</title>
            <description>Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Reasons Given for DMARD Dose Reduction or Interruption</title>
          <description>Use of concomitant medications, including non-biologic DMARDs, was recorded throughout the study. Any change in DMARD therapy was documented and reported among those participants receiving at least one DMARD at Baseline. The reasons for any DMARD dose reduction/interruption ≤60 days were reported. More than one reason could be given for a single change in DMARD therapy, and each participant could also change DMARD therapy more than once. Therefore, the number of reasons could exceed the number of participants analyzed.</description>
          <population>ITT Population; only participants with a DMARD dose reduction/interruption ≤60 days were included.</population>
          <units>percentage of reasons</units>
          <param>Number</param>
          <units_analyzed>Participants</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
                <count group_id="O2" value="27"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Reasons</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
                <count group_id="O2" value="41"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>AEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="70.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Efficacy</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="2.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Joint Surgery</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="2.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Medical History</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100.0"/>
                    <measurement group_id="O2" value="2.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>RA Improvement</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="7.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>RA Treatment</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="2.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Replace Previous Drug</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="2.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Participant Request</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="2.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Not Specified</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="7.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Reasons Given for DMARD Discontinuation</title>
        <description>Use of concomitant medications, including non-biologic DMARDs, was recorded throughout the study. Any change in DMARD therapy was documented and reported among those participants receiving at least one DMARD at Baseline. The reasons for any DMARD discontinuation were reported. More than one reason could be given for a single change in DMARD therapy, and each participant could also change DMARD therapy more than once. Therefore, the number of reasons could exceed the number of participants analyzed.</description>
        <time_frame>From Baseline to last dose; assessed every 4 weeks during treatment (up to 96 weeks overall)</time_frame>
        <population>ITT Population; only participants with a DMARD discontinuation &gt;60 days were included.</population>
        <group_list>
          <group group_id="O1">
            <title>SC TCZ Q2W</title>
            <description>Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W.</description>
          </group>
          <group group_id="O2">
            <title>SC TCZ QW</title>
            <description>Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Reasons Given for DMARD Discontinuation</title>
          <description>Use of concomitant medications, including non-biologic DMARDs, was recorded throughout the study. Any change in DMARD therapy was documented and reported among those participants receiving at least one DMARD at Baseline. The reasons for any DMARD discontinuation were reported. More than one reason could be given for a single change in DMARD therapy, and each participant could also change DMARD therapy more than once. Therefore, the number of reasons could exceed the number of participants analyzed.</description>
          <population>ITT Population; only participants with a DMARD discontinuation &gt;60 days were included.</population>
          <units>percentage of reasons</units>
          <param>Number</param>
          <units_analyzed>Participants</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
                <count group_id="O2" value="15"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Reasons</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
                <count group_id="O2" value="16"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>AEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="66.7"/>
                    <measurement group_id="O2" value="43.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Efficacy</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="33.3"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Investigator Recommendation</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="6.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>RA Improvement</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="31.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Participant Request</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="6.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Too Expensive</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="6.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Not Specified</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="6.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With a Corticosteroid (CCS) Dose Reduction, Interruption, or Discontinuation</title>
        <description>Use of concomitant medications, including CCS treatment, was recorded throughout the study. Any change in CCS therapy was documented and reported among those participants who received at least one CCS before the last dose of SC TCZ.</description>
        <time_frame>From Baseline to last dose; assessed every 4 weeks during treatment (up to 96 weeks overall)</time_frame>
        <population>ITT Population; only participants who received at least one CCS before the last dose of TCZ were included.</population>
        <group_list>
          <group group_id="O1">
            <title>SC TCZ Q2W</title>
            <description>Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W.</description>
          </group>
          <group group_id="O2">
            <title>SC TCZ QW</title>
            <description>Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With a Corticosteroid (CCS) Dose Reduction, Interruption, or Discontinuation</title>
          <description>Use of concomitant medications, including CCS treatment, was recorded throughout the study. Any change in CCS therapy was documented and reported among those participants who received at least one CCS before the last dose of SC TCZ.</description>
          <population>ITT Population; only participants who received at least one CCS before the last dose of TCZ were included.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="89"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Any Dose Reduction/Interruption/Discontinuation</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Dose Reduction</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Dose Interruption ≤14 Days</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Discontinuation &gt;14 Days</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With a CCS Dose Reduction, Interruption, or Discontinuation</title>
        <description>Use of concomitant medications, including CCS treatment, was recorded throughout the study. Any change in CCS therapy was documented and reported among those participants who received at least one CCS before the last dose of SC TCZ.</description>
        <time_frame>From Baseline to last dose; assessed every 4 weeks during treatment (up to 96 weeks overall)</time_frame>
        <population>ITT Population; only participants who received at least one CCS before the last dose of TCZ were included.</population>
        <group_list>
          <group group_id="O1">
            <title>SC TCZ Q2W</title>
            <description>Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W.</description>
          </group>
          <group group_id="O2">
            <title>SC TCZ QW</title>
            <description>Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With a CCS Dose Reduction, Interruption, or Discontinuation</title>
          <description>Use of concomitant medications, including CCS treatment, was recorded throughout the study. Any change in CCS therapy was documented and reported among those participants who received at least one CCS before the last dose of SC TCZ.</description>
          <population>ITT Population; only participants who received at least one CCS before the last dose of TCZ were included.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="89"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Any Dose Reduction/Interruption/Discontinuation</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40.0"/>
                    <measurement group_id="O2" value="37.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Dose Reduction</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="33.3"/>
                    <measurement group_id="O2" value="27.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Dose Interruption ≤14 Days</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="2.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Discontinuation &gt;14 Days</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.3"/>
                    <measurement group_id="O2" value="21.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Reasons Given for CCS Dose Reduction</title>
        <description>Use of concomitant medications, including CCS treatment, was recorded throughout the study. Any change in CCS therapy was documented and reported among those participants who received at least one CCS before the last dose of SC TCZ. The reasons for any CCS dose reduction were reported. More than one reason could be given for a single change in CCS therapy, and each participant could also change CCS therapy more than once. Therefore, the number of reasons could exceed the number of participants analyzed.</description>
        <time_frame>From Baseline to last dose; assessed every 4 weeks during treatment (up to 96 weeks overall)</time_frame>
        <population>ITT Population; only participants with a CCS dose reduction were included.</population>
        <group_list>
          <group group_id="O1">
            <title>SC TCZ Q2W</title>
            <description>Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W.</description>
          </group>
          <group group_id="O2">
            <title>SC TCZ QW</title>
            <description>Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Reasons Given for CCS Dose Reduction</title>
          <description>Use of concomitant medications, including CCS treatment, was recorded throughout the study. Any change in CCS therapy was documented and reported among those participants who received at least one CCS before the last dose of SC TCZ. The reasons for any CCS dose reduction were reported. More than one reason could be given for a single change in CCS therapy, and each participant could also change CCS therapy more than once. Therefore, the number of reasons could exceed the number of participants analyzed.</description>
          <population>ITT Population; only participants with a CCS dose reduction were included.</population>
          <units>percentage of reasons</units>
          <param>Number</param>
          <units_analyzed>Participants</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5"/>
                <count group_id="O2" value="24"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Reasons</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
                <count group_id="O2" value="84"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>AEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="3.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Medical History</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42.9"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>RA Treatment</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="2.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Steroid Tapering</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="50.0"/>
                    <measurement group_id="O2" value="91.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Participant Request</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Not Specified</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.1"/>
                    <measurement group_id="O2" value="1.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Reasons Given for CCS Dose Interruption</title>
        <description>Use of concomitant medications, including CCS treatment, was recorded throughout the study. Any change in CCS therapy was documented and reported among those participants who received at least one CCS before the last dose of SC TCZ. The reasons for any CCS dose interruption ≤14 days were reported. More than one reason could be given for a single change in CCS therapy, and each participant could also change CCS therapy more than once. Therefore, the number of reasons could exceed the number of participants analyzed.</description>
        <time_frame>From Baseline to last dose; assessed every 4 weeks during treatment (up to 96 weeks overall)</time_frame>
        <population>ITT Population; only participants with a CCS dose interruption ≤14 days were included. Results were only reported for the QW arm because no participants in the Q2W arm had a CCS dose interruption.</population>
        <group_list>
          <group group_id="O1">
            <title>SC TCZ QW</title>
            <description>Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Reasons Given for CCS Dose Interruption</title>
          <description>Use of concomitant medications, including CCS treatment, was recorded throughout the study. Any change in CCS therapy was documented and reported among those participants who received at least one CCS before the last dose of SC TCZ. The reasons for any CCS dose interruption ≤14 days were reported. More than one reason could be given for a single change in CCS therapy, and each participant could also change CCS therapy more than once. Therefore, the number of reasons could exceed the number of participants analyzed.</description>
          <population>ITT Population; only participants with a CCS dose interruption ≤14 days were included. Results were only reported for the QW arm because no participants in the Q2W arm had a CCS dose interruption.</population>
          <units>percentage of reasons</units>
          <param>Number</param>
          <units_analyzed>Participants</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Reasons</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Hospitalization</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="33.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Steroid Tapering</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="66.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Reasons Given for CCS Discontinuation</title>
        <description>Use of concomitant medications, including CCS treatment, was recorded throughout the study. Any change in CCS therapy was documented and reported among those participants who received at least one CCS before the last dose of SC TCZ. The reasons for any CCS discontinuation &gt;14 days were reported. More than one reason could be given for a single change in CCS therapy, and each participant could also change CCS therapy more than once. Therefore, the number of reasons could exceed the number of participants analyzed.</description>
        <time_frame>From Baseline to last dose; assessed every 4 weeks during treatment (up to 96 weeks overall)</time_frame>
        <population>ITT Population; only participants with a CCS discontinuation &gt;14 days were included.</population>
        <group_list>
          <group group_id="O1">
            <title>SC TCZ Q2W</title>
            <description>Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W.</description>
          </group>
          <group group_id="O2">
            <title>SC TCZ QW</title>
            <description>Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Reasons Given for CCS Discontinuation</title>
          <description>Use of concomitant medications, including CCS treatment, was recorded throughout the study. Any change in CCS therapy was documented and reported among those participants who received at least one CCS before the last dose of SC TCZ. The reasons for any CCS discontinuation &gt;14 days were reported. More than one reason could be given for a single change in CCS therapy, and each participant could also change CCS therapy more than once. Therefore, the number of reasons could exceed the number of participants analyzed.</description>
          <population>ITT Population; only participants with a CCS discontinuation &gt;14 days were included.</population>
          <units>percentage of reasons</units>
          <param>Number</param>
          <units_analyzed>Participants</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Reasons</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
                <count group_id="O2" value="27"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>AE Resolution</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="18.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="50.0"/>
                    <measurement group_id="O2" value="11.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Prescription End</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="14.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>RA Improvement</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="14.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Steroid Tapering</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="50.0"/>
                    <measurement group_id="O2" value="18.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Participant Request</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="7.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Not Specified</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="14.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Who Switched From the QW Regimen and Remained on the Q2W Regimen</title>
        <description>Participants could switch between regimens at the Investigator's judgment based upon safety, efficacy, and pharmacokinetic/pharmacodynamic data. The number of participants who switched from the QW to the Q2W regimen and did not return to the QW regimen was reported.</description>
        <time_frame>From Baseline to last dose; assessed every 4 weeks during treatment (up to 96 weeks overall)</time_frame>
        <population>ITT Population. The results were presented for all participants to account for multiple switches between arms (i.e., participants who started in the Q2W arm could have switched to QW and then switched back to Q2W, making them analyzable for the outcome measure).</population>
        <group_list>
          <group group_id="O1">
            <title>SC TCZ/All Participants</title>
            <description>Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW or SC TCZ 162 mg Q2W.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Switched From the QW Regimen and Remained on the Q2W Regimen</title>
          <description>Participants could switch between regimens at the Investigator's judgment based upon safety, efficacy, and pharmacokinetic/pharmacodynamic data. The number of participants who switched from the QW to the Q2W regimen and did not return to the QW regimen was reported.</description>
          <population>ITT Population. The results were presented for all participants to account for multiple switches between arms (i.e., participants who started in the Q2W arm could have switched to QW and then switched back to Q2W, making them analyzable for the outcome measure).</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="217"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Who Switched From the QW Regimen and Remained on the Q2W Regimen</title>
        <description>Participants could switch between regimens at the Investigator's judgment based upon safety, efficacy, and pharmacokinetic/pharmacodynamic data. The percentage of participants who switched from the QW to the Q2W regimen and did not return to the QW regimen was calculated.</description>
        <time_frame>From Baseline to last dose; assessed every 4 weeks during treatment (up to 96 weeks overall)</time_frame>
        <population>ITT Population. The results were presented for all participants to account for multiple switches between arms (i.e., participants who started in the Q2W arm could have switched to QW and then switched back to Q2W, making them analyzable for the outcome measure).</population>
        <group_list>
          <group group_id="O1">
            <title>SC TCZ/All Participants</title>
            <description>Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW or SC TCZ 162 mg Q2W.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Switched From the QW Regimen and Remained on the Q2W Regimen</title>
          <description>Participants could switch between regimens at the Investigator's judgment based upon safety, efficacy, and pharmacokinetic/pharmacodynamic data. The percentage of participants who switched from the QW to the Q2W regimen and did not return to the QW regimen was calculated.</description>
          <population>ITT Population. The results were presented for all participants to account for multiple switches between arms (i.e., participants who started in the Q2W arm could have switched to QW and then switched back to Q2W, making them analyzable for the outcome measure).</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="217"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Who Returned to the QW Regimen After Switching to the Q2W Regimen</title>
        <description>Participants could switch between regimens at the Investigator's judgment based upon safety, efficacy, and pharmacokinetic/pharmacodynamic data. The number of participants who switched from the QW to the Q2W regimen and thereafter returned to the QW regimen was reported with the reason for returning to the QW regimen.</description>
        <time_frame>From Baseline to last dose; assessed every 4 weeks during treatment (up to 96 weeks overall)</time_frame>
        <population>ITT Population; only participants who switched from the QW to Q2W regimen were included.</population>
        <group_list>
          <group group_id="O1">
            <title>SC TCZ/All Participants</title>
            <description>Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW or SC TCZ 162 mg Q2W.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Returned to the QW Regimen After Switching to the Q2W Regimen</title>
          <description>Participants could switch between regimens at the Investigator's judgment based upon safety, efficacy, and pharmacokinetic/pharmacodynamic data. The number of participants who switched from the QW to the Q2W regimen and thereafter returned to the QW regimen was reported with the reason for returning to the QW regimen.</description>
          <population>ITT Population; only participants who switched from the QW to Q2W regimen were included.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Any Reason</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Investigator Recommendation</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Return to the QW Regimen After Switching to the Q2W Regimen</title>
        <description>Participants could switch between regimens at the Investigator's judgment based upon safety, efficacy, and pharmacokinetic/pharmacodynamic data. Time to return was defined as the time between switching to the Q2W regimen and returning to the previous QW regimen.</description>
        <time_frame>From Baseline to last dose; assessed every 4 weeks during treatment (up to 96 weeks overall)</time_frame>
        <population>ITT Population; only participants who switched from the QW to Q2W regimen and returned to the QW regimen were included.</population>
        <group_list>
          <group group_id="O1">
            <title>SC TCZ/All Participants</title>
            <description>Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW or SC TCZ 162 mg Q2W.</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Return to the QW Regimen After Switching to the Q2W Regimen</title>
          <description>Participants could switch between regimens at the Investigator's judgment based upon safety, efficacy, and pharmacokinetic/pharmacodynamic data. Time to return was defined as the time between switching to the Q2W regimen and returning to the previous QW regimen.</description>
          <population>ITT Population; only participants who switched from the QW to Q2W regimen and returned to the QW regimen were included.</population>
          <units>weeks</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Global Assessment of Disease Activity by the Participant According to Visual Analog Scale (VAS) Score</title>
        <description>The Global Assessment of Disease Activity was performed using a 100-mm horizontal VAS. Scores may range from 0 mm (&quot;no disease activity&quot;) to 100 mm (&quot;maximum disease activity&quot;), with higher scores representing an increase in perceived symptoms.</description>
        <time_frame>Baseline and Weeks 12, 24, 36, 48, 60, 72, 84</time_frame>
        <population>ITT Population; only those participants who provided evaluable data (n) were included in the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>SC TCZ Q2W</title>
            <description>Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W.</description>
          </group>
          <group group_id="O2">
            <title>SC TCZ QW</title>
            <description>Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW.</description>
          </group>
        </group_list>
        <measure>
          <title>Global Assessment of Disease Activity by the Participant According to Visual Analog Scale (VAS) Score</title>
          <description>The Global Assessment of Disease Activity was performed using a 100-mm horizontal VAS. Scores may range from 0 mm (&quot;no disease activity&quot;) to 100 mm (&quot;maximum disease activity&quot;), with higher scores representing an increase in perceived symptoms.</description>
          <population>ITT Population; only those participants who provided evaluable data (n) were included in the analysis.</population>
          <units>mm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="44"/>
                <count group_id="O2" value="173"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (n=44,173)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="39.39" spread="24.483"/>
                    <measurement group_id="O2" value="47.25" spread="29.868"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12 (n=44,172)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31.80" spread="23.878"/>
                    <measurement group_id="O2" value="37.84" spread="28.130"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24 (n=43,168)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31.86" spread="25.639"/>
                    <measurement group_id="O2" value="37.51" spread="27.536"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 36 (n=39,159)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30.13" spread="23.345"/>
                    <measurement group_id="O2" value="37.44" spread="27.519"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 48 (n=18,141)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="37.95" spread="24.878"/>
                    <measurement group_id="O2" value="34.63" spread="27.136"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 60 (n=2,92)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="54.00" spread="24.042"/>
                    <measurement group_id="O2" value="32.86" spread="27.932"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 72 (n=1,52)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="57.00" spread="NA">Standard deviation could not be calculated because the analysis only included 1 participant.</measurement>
                    <measurement group_id="O2" value="30.83" spread="28.425"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 84 (n=0,11)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" spread="NA">No participants provided evaluable data for the analysis</measurement>
                    <measurement group_id="O2" value="30.00" spread="26.348"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Global Assessment of Disease Activity by the Participant According to VAS Score</title>
        <description>The Global Assessment of Disease Activity was performed using a 100-mm horizontal VAS. Scores may range from 0 mm (&quot;no disease activity&quot;) to 100 mm (&quot;maximum disease activity&quot;), with higher scores representing an increase in perceived symptoms. The change from Baseline to each visit was calculated, where positive changes represent an increase or worsening in perceived disease activity.</description>
        <time_frame>Baseline to Weeks 12, 24, 36, 48, 60, 72, 84</time_frame>
        <population>ITT Population. The &quot;Number of Participants Analyzed&quot; reflects the total number of participants who provided data for the outcome measure. The number of participants who provided data for each analysis (n) is shown in the table.</population>
        <group_list>
          <group group_id="O1">
            <title>SC TCZ Q2W</title>
            <description>Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W.</description>
          </group>
          <group group_id="O2">
            <title>SC TCZ QW</title>
            <description>Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Global Assessment of Disease Activity by the Participant According to VAS Score</title>
          <description>The Global Assessment of Disease Activity was performed using a 100-mm horizontal VAS. Scores may range from 0 mm (&quot;no disease activity&quot;) to 100 mm (&quot;maximum disease activity&quot;), with higher scores representing an increase in perceived symptoms. The change from Baseline to each visit was calculated, where positive changes represent an increase or worsening in perceived disease activity.</description>
          <population>ITT Population. The &quot;Number of Participants Analyzed&quot; reflects the total number of participants who provided data for the outcome measure. The number of participants who provided data for each analysis (n) is shown in the table.</population>
          <units>mm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="44"/>
                <count group_id="O2" value="173"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 12 (n=44,172)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-7.59" spread="22.689"/>
                    <measurement group_id="O2" value="-9.59" spread="22.348"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24 (n=43,168)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-6.67" spread="18.977"/>
                    <measurement group_id="O2" value="-9.67" spread="26.260"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 36 (n=39,159)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-11.59" spread="23.736"/>
                    <measurement group_id="O2" value="-10.14" spread="25.338"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 48 (n=18,141)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-5.61" spread="21.892"/>
                    <measurement group_id="O2" value="-11.47" spread="25.839"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 60 (n=2,92)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.50" spread="30.406"/>
                    <measurement group_id="O2" value="-9.93" spread="22.992"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 72 (n=1,52)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19.00" spread="NA">Standard deviation could not be calculated because the analysis only included 1 participant.</measurement>
                    <measurement group_id="O2" value="-13.82" spread="25.779"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 84 (n=0,11)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" spread="NA">No participants provided evaluable data for the analysis</measurement>
                    <measurement group_id="O2" value="-10.82" spread="19.778"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Global Assessment of Pain by the Participant According to VAS Score</title>
        <description>The Global Assessment of Pain was performed using a 100-mm horizontal VAS. Scores may range from 0 mm (&quot;no pain&quot;) to 100 mm (&quot;unbearable pain&quot;), with higher scores representing an increase in pain.</description>
        <time_frame>Baseline and Weeks 12, 24, 36, 48, 60, 72, 84</time_frame>
        <population>ITT Population; only those participants who provided evaluable data (n) were included in the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>SC TCZ Q2W</title>
            <description>Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W.</description>
          </group>
          <group group_id="O2">
            <title>SC TCZ QW</title>
            <description>Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW.</description>
          </group>
        </group_list>
        <measure>
          <title>Global Assessment of Pain by the Participant According to VAS Score</title>
          <description>The Global Assessment of Pain was performed using a 100-mm horizontal VAS. Scores may range from 0 mm (&quot;no pain&quot;) to 100 mm (&quot;unbearable pain&quot;), with higher scores representing an increase in pain.</description>
          <population>ITT Population; only those participants who provided evaluable data (n) were included in the analysis.</population>
          <units>mm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="44"/>
                <count group_id="O2" value="173"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (n=44,173)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="36.89" spread="23.044"/>
                    <measurement group_id="O2" value="45.42" spread="29.448"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12 (n=44,172)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29.30" spread="22.782"/>
                    <measurement group_id="O2" value="33.27" spread="25.984"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24 (n=43,168)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29.42" spread="24.509"/>
                    <measurement group_id="O2" value="34.48" spread="24.841"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 36 (n=39,159)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28.38" spread="20.607"/>
                    <measurement group_id="O2" value="34.40" spread="25.149"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 48 (n=18,141)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="33.44" spread="21.742"/>
                    <measurement group_id="O2" value="31.52" spread="25.892"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 60 (n=2,92)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="50.00" spread="14.142"/>
                    <measurement group_id="O2" value="30.94" spread="27.635"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 72 (n=1,52)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42.00" spread="NA">Standard deviation could not be calculated because the analysis only included 1 participant.</measurement>
                    <measurement group_id="O2" value="29.20" spread="26.733"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 84 (n=0,11)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" spread="NA">No participants provided evaluable data for the analysis</measurement>
                    <measurement group_id="O2" value="25.36" spread="25.598"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Global Assessment of Pain by the Participant According to VAS Score</title>
        <description>The Global Assessment of Pain was performed using a 100-mm horizontal VAS. Scores may range from 0 mm (&quot;no pain&quot;) to 100 mm (&quot;unbearable pain&quot;), with higher scores representing an increase in pain. The change from Baseline to each visit was calculated, where positive changes represent an increase or worsening in pain.</description>
        <time_frame>Baseline to Weeks 12, 24, 36, 48, 60, 72, 84</time_frame>
        <population>ITT Population. The &quot;Number of Participants Analyzed&quot; reflects the total number of participants who provided data for the outcome measure. The number of participants who provided data for each analysis (n) is shown in the table.</population>
        <group_list>
          <group group_id="O1">
            <title>SC TCZ Q2W</title>
            <description>Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W.</description>
          </group>
          <group group_id="O2">
            <title>SC TCZ QW</title>
            <description>Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Global Assessment of Pain by the Participant According to VAS Score</title>
          <description>The Global Assessment of Pain was performed using a 100-mm horizontal VAS. Scores may range from 0 mm (&quot;no pain&quot;) to 100 mm (&quot;unbearable pain&quot;), with higher scores representing an increase in pain. The change from Baseline to each visit was calculated, where positive changes represent an increase or worsening in pain.</description>
          <population>ITT Population. The &quot;Number of Participants Analyzed&quot; reflects the total number of participants who provided data for the outcome measure. The number of participants who provided data for each analysis (n) is shown in the table.</population>
          <units>mm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="44"/>
                <count group_id="O2" value="173"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 12 (n=44,172)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-7.59" spread="22.145"/>
                    <measurement group_id="O2" value="-12.27" spread="21.582"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24 (n=43,168)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-6.63" spread="20.641"/>
                    <measurement group_id="O2" value="-10.76" spread="24.154"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 36 (n=39,159)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-10.62" spread="22.783"/>
                    <measurement group_id="O2" value="-10.91" spread="22.747"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 48 (n=18,141)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-8.00" spread="18.166"/>
                    <measurement group_id="O2" value="-12.91" spread="24.950"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 60 (n=2,92)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.00" spread="25.456"/>
                    <measurement group_id="O2" value="-10.07" spread="22.001"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 72 (n=1,52)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.00" spread="NA">Standard deviation could not be calculated because the analysis only included 1 participant.</measurement>
                    <measurement group_id="O2" value="-12.47" spread="23.522"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 84 (n=0,11)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" spread="NA">No participants provided evaluable data for the analysis</measurement>
                    <measurement group_id="O2" value="-14.64" spread="20.911"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Heath Assessment Questionnaire-Disability Index (HAQ-DI) Score</title>
        <description>The Stanford HAQ-DI was calculated as the average of 20 questions, each scored from 0 (no difficulty) to 3 (unable to do). The questionnaire included 8 component sets: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and common activities. Overall scores may range from 0 to 3, with higher scores representing increased disability.</description>
        <time_frame>Baseline and Weeks 12, 24, 36, 48, 60, 72, 84</time_frame>
        <population>ITT Population; only those participants who provided evaluable data (n) were included in the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>SC TCZ Q2W</title>
            <description>Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W.</description>
          </group>
          <group group_id="O2">
            <title>SC TCZ QW</title>
            <description>Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW.</description>
          </group>
        </group_list>
        <measure>
          <title>Heath Assessment Questionnaire-Disability Index (HAQ-DI) Score</title>
          <description>The Stanford HAQ-DI was calculated as the average of 20 questions, each scored from 0 (no difficulty) to 3 (unable to do). The questionnaire included 8 component sets: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and common activities. Overall scores may range from 0 to 3, with higher scores representing increased disability.</description>
          <population>ITT Population; only those participants who provided evaluable data (n) were included in the analysis.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="44"/>
                <count group_id="O2" value="173"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (n=44,173)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.98" spread="0.682"/>
                    <measurement group_id="O2" value="1.20" spread="0.729"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12 (n=44,172)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.95" spread="0.688"/>
                    <measurement group_id="O2" value="1.11" spread="0.750"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24 (n=43,167)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.94" spread="0.717"/>
                    <measurement group_id="O2" value="1.09" spread="0.725"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 36 (n=39,159)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.95" spread="0.682"/>
                    <measurement group_id="O2" value="1.10" spread="0.741"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 48 (n=18,141)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.97" spread="0.596"/>
                    <measurement group_id="O2" value="1.04" spread="0.745"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 60 (n=2,92)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.13" spread="0.530"/>
                    <measurement group_id="O2" value="1.01" spread="0.779"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 72 (n=1,52)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.25" spread="NA">Standard deviation could not be calculated because the analysis only included 1 participant.</measurement>
                    <measurement group_id="O2" value="0.97" spread="0.844"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 84 (n=0,11)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" spread="NA">No participants provided evaluable data for the analysis.</measurement>
                    <measurement group_id="O2" value="1.14" spread="0.730"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in HAQ-DI Score</title>
        <description>The Stanford HAQ-DI was calculated as the average of 20 questions, each scored from 0 (no difficulty) to 3 (unable to do). The questionnaire included 8 component sets: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and common activities. Overall scores may range from 0 to 3, with higher scores representing increased disability. The change from Baseline to each visit was calculated, where positive changes represent an increased need for assistance with daily activities.</description>
        <time_frame>Baseline to Weeks 12, 24, 36, 48, 60, 72, 84</time_frame>
        <population>ITT Population. The &quot;Number of Participants Analyzed&quot; reflects the total number of participants who provided data for the outcome measure. The number of participants who provided data for each analysis (n) is shown in the table.</population>
        <group_list>
          <group group_id="O1">
            <title>SC TCZ Q2W</title>
            <description>Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W.</description>
          </group>
          <group group_id="O2">
            <title>SC TCZ QW</title>
            <description>Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in HAQ-DI Score</title>
          <description>The Stanford HAQ-DI was calculated as the average of 20 questions, each scored from 0 (no difficulty) to 3 (unable to do). The questionnaire included 8 component sets: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and common activities. Overall scores may range from 0 to 3, with higher scores representing increased disability. The change from Baseline to each visit was calculated, where positive changes represent an increased need for assistance with daily activities.</description>
          <population>ITT Population. The &quot;Number of Participants Analyzed&quot; reflects the total number of participants who provided data for the outcome measure. The number of participants who provided data for each analysis (n) is shown in the table.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="44"/>
                <count group_id="O2" value="173"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 12 (n=44,172)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.02" spread="0.254"/>
                    <measurement group_id="O2" value="-0.10" spread="0.339"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24 (n=43,167)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.01" spread="0.272"/>
                    <measurement group_id="O2" value="-0.11" spread="0.372"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 36 (n=39,159)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.08" spread="0.276"/>
                    <measurement group_id="O2" value="-0.09" spread="0.394"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 48 (n=18,141)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.01" spread="0.237"/>
                    <measurement group_id="O2" value="-0.14" spread="0.390"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 60 (n=2,92)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.56" spread="0.795"/>
                    <measurement group_id="O2" value="-0.08" spread="0.394"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 72 (n=1,52)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.88" spread="NA">Standard deviation could not be calculated because the analysis only included 1 participant.</measurement>
                    <measurement group_id="O2" value="-0.06" spread="0.420"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 84 (n=0,11)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" spread="NA">No participants provided evaluable data for the analysis</measurement>
                    <measurement group_id="O2" value="-0.07" spread="0.397"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With HAQ-DI Score &lt;0.5</title>
        <description>The Stanford HAQ-DI was calculated as the average of 20 questions, each scored from 0 (no difficulty) to 3 (unable to do). The questionnaire included 8 component sets: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and common activities. Overall scores may range from 0 to 3, with higher scores representing increased disability. The percentage of participants achieving a score &lt;0.5 was calculated at each visit.</description>
        <time_frame>Baseline and Weeks 12, 24, 36, 48, 60, 72, 84</time_frame>
        <population>ITT Population; only those participants who provided evaluable data (n) were included in the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>SC TCZ Q2W</title>
            <description>Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W.</description>
          </group>
          <group group_id="O2">
            <title>SC TCZ QW</title>
            <description>Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With HAQ-DI Score &lt;0.5</title>
          <description>The Stanford HAQ-DI was calculated as the average of 20 questions, each scored from 0 (no difficulty) to 3 (unable to do). The questionnaire included 8 component sets: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and common activities. Overall scores may range from 0 to 3, with higher scores representing increased disability. The percentage of participants achieving a score &lt;0.5 was calculated at each visit.</description>
          <population>ITT Population; only those participants who provided evaluable data (n) were included in the analysis.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="44"/>
                <count group_id="O2" value="173"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (n=44,173)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31.8"/>
                    <measurement group_id="O2" value="17.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12 (n=44,172)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27.3"/>
                    <measurement group_id="O2" value="20.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24 (n=43,167)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32.6"/>
                    <measurement group_id="O2" value="23.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 36 (n=39,159)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="38.5"/>
                    <measurement group_id="O2" value="24.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 48 (n=18,141)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27.8"/>
                    <measurement group_id="O2" value="24.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 60 (n=2,92)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0"/>
                    <measurement group_id="O2" value="29.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 72 (n=1,52)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0"/>
                    <measurement group_id="O2" value="34.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 84 (n=0,11)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA">No participants provided evaluable data for the analysis</measurement>
                    <measurement group_id="O2" value="9.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Low Disease Activity According to DAS28, SDAI, and CDAI Criteria</title>
        <description>Low disease activity was defined as DAS28 ≤3.2, SDAI ≤11, or CDAI ≤10. For each formula, the SJC and TJC values were based upon 28 joints, and VAS was transformed from a 100-mm scale to a 10-point score. The DAS28 was calculated as (0.56 × square root of TJC) + (0.28 × square root of SJC) + (0.7 × ln ESR) + (0.014 × VAS), with potential scores from 0 to 10. The SDAI was calculated as SJC + TJC + VAS (participant) + VAS (physician) + hsCRP, with potential scores from 0 to infinity. However, based upon normal hsCRP level within 1 mg/dL, scores would be expected to fall within ≤77 points. The CDAI was calculated as SJC + TJC + VAS (participant) + VAS (physician), with potential scores from 0 to 76. For all instruments, higher scores indicate increased disease activity. The number of participants who met criteria for low disease activity was reported at each visit.</description>
        <time_frame>Baseline and Weeks 12, 24, 36, 48, 60, 72, 84</time_frame>
        <population>ITT Population; only those participants who provided evaluable data (n) were included in the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>SC TCZ Q2W</title>
            <description>Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W.</description>
          </group>
          <group group_id="O2">
            <title>SC TCZ QW</title>
            <description>Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Low Disease Activity According to DAS28, SDAI, and CDAI Criteria</title>
          <description>Low disease activity was defined as DAS28 ≤3.2, SDAI ≤11, or CDAI ≤10. For each formula, the SJC and TJC values were based upon 28 joints, and VAS was transformed from a 100-mm scale to a 10-point score. The DAS28 was calculated as (0.56 × square root of TJC) + (0.28 × square root of SJC) + (0.7 × ln ESR) + (0.014 × VAS), with potential scores from 0 to 10. The SDAI was calculated as SJC + TJC + VAS (participant) + VAS (physician) + hsCRP, with potential scores from 0 to infinity. However, based upon normal hsCRP level within 1 mg/dL, scores would be expected to fall within ≤77 points. The CDAI was calculated as SJC + TJC + VAS (participant) + VAS (physician), with potential scores from 0 to 76. For all instruments, higher scores indicate increased disease activity. The number of participants who met criteria for low disease activity was reported at each visit.</description>
          <population>ITT Population; only those participants who provided evaluable data (n) were included in the analysis.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="44"/>
                <count group_id="O2" value="173"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline, DAS28 (n=44,172)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O2" value="46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline, SDAI (n=44,170)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                    <measurement group_id="O2" value="43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline, CDAI (n=44,173)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                    <measurement group_id="O2" value="41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12, DAS28 (n=44,172)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21"/>
                    <measurement group_id="O2" value="81"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12, SDAI (n=44,172)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22"/>
                    <measurement group_id="O2" value="65"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12, CDAI (n=44,172)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20"/>
                    <measurement group_id="O2" value="63"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24, DAS28 (n=43,168)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23"/>
                    <measurement group_id="O2" value="82"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24, SDAI (n=41,166)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19"/>
                    <measurement group_id="O2" value="67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24, CDAI (n=42,166)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20"/>
                    <measurement group_id="O2" value="60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 36, DAS28 (n=39,159)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21"/>
                    <measurement group_id="O2" value="75"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 36, SDAI (n=39,159)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20"/>
                    <measurement group_id="O2" value="61"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 36, CDAI (n=39,159)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21"/>
                    <measurement group_id="O2" value="60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 48, DAS28 (n=18,141)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="69"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 48, SDAI (n=18,140)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="63"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 48, CDAI (n=18,140)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="59"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 60, DAS28 (n=2,92)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="52"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 60, SDAI (n=2,92)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 60, CDAI (n=2,92)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 72, DAS28 (n=1,52)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 72, SDAI (n=1,52)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 72, CDAI (n=1,52)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 84, DAS28 (n=0,11)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA">No participants provided evaluable data for the analysis</measurement>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 84, SDAI (n=0,11)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA">No participants provided evaluable data for the analysis</measurement>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 84, CDAI (n=0,11)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA">No participants provided evaluable data for the analysis</measurement>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Low Disease Activity According to DAS28, SDAI, and CDAI Criteria</title>
        <description>Low disease activity was defined as DAS28 ≤3.2, SDAI ≤11, or CDAI ≤10. For each formula, the SJC and TJC values were based upon 28 joints, and VAS was transformed from a 100-mm scale to a 10-point score. The DAS28 was calculated as (0.56 × square root of TJC) + (0.28 × square root of SJC) + (0.7 × ln ESR) + (0.014 × VAS), with potential scores from 0 to 10. The SDAI was calculated as SJC + TJC + VAS (participant) + VAS (physician) + hsCRP, with potential scores from 0 to infinity. However, based upon normal hsCRP level within 1 mg/dL, scores would be expected to fall within ≤77 points. The CDAI was calculated as SJC + TJC + VAS (participant) + VAS (physician), with potential scores from 0 to 76. For all instruments, higher scores indicate increased disease activity. The percentage of participants who met criteria for low disease activity was calculated at each visit.</description>
        <time_frame>Baseline and Weeks 12, 24, 36, 48, 60, 72, 84</time_frame>
        <population>ITT Population; only those participants who provided evaluable data (n) were included in the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>SC TCZ Q2W</title>
            <description>Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W.</description>
          </group>
          <group group_id="O2">
            <title>SC TCZ QW</title>
            <description>Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Low Disease Activity According to DAS28, SDAI, and CDAI Criteria</title>
          <description>Low disease activity was defined as DAS28 ≤3.2, SDAI ≤11, or CDAI ≤10. For each formula, the SJC and TJC values were based upon 28 joints, and VAS was transformed from a 100-mm scale to a 10-point score. The DAS28 was calculated as (0.56 × square root of TJC) + (0.28 × square root of SJC) + (0.7 × ln ESR) + (0.014 × VAS), with potential scores from 0 to 10. The SDAI was calculated as SJC + TJC + VAS (participant) + VAS (physician) + hsCRP, with potential scores from 0 to infinity. However, based upon normal hsCRP level within 1 mg/dL, scores would be expected to fall within ≤77 points. The CDAI was calculated as SJC + TJC + VAS (participant) + VAS (physician), with potential scores from 0 to 76. For all instruments, higher scores indicate increased disease activity. The percentage of participants who met criteria for low disease activity was calculated at each visit.</description>
          <population>ITT Population; only those participants who provided evaluable data (n) were included in the analysis.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="44"/>
                <count group_id="O2" value="173"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline, DAS28 (n=44,172)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25.0"/>
                    <measurement group_id="O2" value="26.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline, SDAI (n=44,170)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31.8"/>
                    <measurement group_id="O2" value="25.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline, CDAI (n=44,173)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29.5"/>
                    <measurement group_id="O2" value="23.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12, DAS28 (n=44,172)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="47.7"/>
                    <measurement group_id="O2" value="47.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12, SDAI (n=44,172)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="50.0"/>
                    <measurement group_id="O2" value="37.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12, CDAI (n=44,172)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="45.5"/>
                    <measurement group_id="O2" value="36.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24, DAS28 (n=43,168)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="53.5"/>
                    <measurement group_id="O2" value="48.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24, SDAI (n=41,166)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="46.3"/>
                    <measurement group_id="O2" value="40.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24, CDAI (n=42,166)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="47.6"/>
                    <measurement group_id="O2" value="36.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 36, DAS28 (n=39,159)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="53.8"/>
                    <measurement group_id="O2" value="47.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 36, SDAI (n=39,159)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="51.3"/>
                    <measurement group_id="O2" value="38.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 36, CDAI (n=39,159)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="53.8"/>
                    <measurement group_id="O2" value="37.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 48, DAS28 (n=18,141)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="55.6"/>
                    <measurement group_id="O2" value="48.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 48, SDAI (n=18,140)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="44.4"/>
                    <measurement group_id="O2" value="45.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 48, CDAI (n=18,140)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="38.9"/>
                    <measurement group_id="O2" value="42.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 60, DAS28 (n=2,92)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0"/>
                    <measurement group_id="O2" value="56.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 60, SDAI (n=2,92)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0"/>
                    <measurement group_id="O2" value="43.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 60, CDAI (n=2,92)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0"/>
                    <measurement group_id="O2" value="40.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 72, DAS28 (n=1,52)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0"/>
                    <measurement group_id="O2" value="53.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 72, SDAI (n=1,52)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0"/>
                    <measurement group_id="O2" value="50.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 72, CDAI (n=1,52)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0"/>
                    <measurement group_id="O2" value="48.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 84, DAS28 (n=0,11)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA">No participants provided evaluable data for the analysis</measurement>
                    <measurement group_id="O2" value="54.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 84, SDAI (n=0,11)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA">No participants provided evaluable data for the analysis</measurement>
                    <measurement group_id="O2" value="36.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 84, CDAI (n=0,11)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA">No participants provided evaluable data for the analysis</measurement>
                    <measurement group_id="O2" value="36.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Remission According to DAS28, SDAI, and Boolean Criteria</title>
        <description>Remission was defined as DAS28 &lt;2.6, SDAI ≤3.3, or meeting all Boolean criteria (28-count SJC and TJC ≤1, VAS ≤10 mm, and hsCRP ≤1 mg/dL). For DAS28 and SDAI formulas, the SJC and TJC values were based upon 28 joints, and VAS was transformed from a 100-mm scale to a 10-point score. The DAS28 was calculated as (0.56 × square root of TJC) + (0.28 × square root of SJC) + (0.7 × ln ESR) + (0.014 × VAS), with potential scores from 0 to 10. The SDAI was calculated as SJC + TJC + VAS (participant) + VAS (physician) + hsCRP, with potential scores from 0 to infinity. However, based upon normal hsCRP level within 1 mg/dL, scores would be expected to fall within ≤77 points. For these instruments, higher scores indicate increased disease activity. The number of participants who met criteria for remission was reported at each visit.</description>
        <time_frame>Baseline and Weeks 12, 24, 36, 48, 60, 72, 84</time_frame>
        <population>ITT Population. The &quot;Number of Participants Analyzed&quot; reflects the total number of participants who provided data for the outcome measure. The number of participants who provided data for each analysis (n) is shown in the table.</population>
        <group_list>
          <group group_id="O1">
            <title>SC TCZ Q2W</title>
            <description>Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W.</description>
          </group>
          <group group_id="O2">
            <title>SC TCZ QW</title>
            <description>Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Remission According to DAS28, SDAI, and Boolean Criteria</title>
          <description>Remission was defined as DAS28 &lt;2.6, SDAI ≤3.3, or meeting all Boolean criteria (28-count SJC and TJC ≤1, VAS ≤10 mm, and hsCRP ≤1 mg/dL). For DAS28 and SDAI formulas, the SJC and TJC values were based upon 28 joints, and VAS was transformed from a 100-mm scale to a 10-point score. The DAS28 was calculated as (0.56 × square root of TJC) + (0.28 × square root of SJC) + (0.7 × ln ESR) + (0.014 × VAS), with potential scores from 0 to 10. The SDAI was calculated as SJC + TJC + VAS (participant) + VAS (physician) + hsCRP, with potential scores from 0 to infinity. However, based upon normal hsCRP level within 1 mg/dL, scores would be expected to fall within ≤77 points. For these instruments, higher scores indicate increased disease activity. The number of participants who met criteria for remission was reported at each visit.</description>
          <population>ITT Population. The &quot;Number of Participants Analyzed&quot; reflects the total number of participants who provided data for the outcome measure. The number of participants who provided data for each analysis (n) is shown in the table.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="44"/>
                <count group_id="O2" value="173"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline, DAS28 (n=44,172)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline, SDAI (n=44,170)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline, Boolean (n=44,172)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12, DAS28 (n=44,172)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                    <measurement group_id="O2" value="61"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12, SDAI (n=44,172)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12, Boolean (n=44,172)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24, DAS28 (n=43,168)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18"/>
                    <measurement group_id="O2" value="61"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24, SDAI (n=41,166)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24, Boolean (n=43,170)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 36, DAS28 (n=39,159)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                    <measurement group_id="O2" value="57"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 36, SDAI (n=39,159)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 36, Boolean (n=39,161)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 48, DAS28 (n=18,141)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 48, SDAI (n=18,140)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 48, Boolean (n=18,143)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 60, DAS28 (n=2,92)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 60, SDAI (n=2,92)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 60, Boolean (n=2,93)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 72, DAS28 (n=1,52)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 72, SDAI (n=1,52)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 72, Boolean (n=1,54)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 84, DAS28 (n=0,11)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA">No participants provided evaluable data for the analysis</measurement>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 84, SDAI (n=0,11)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA">No participants provided evaluable data for the analysis</measurement>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 84, Boolean (n=0,11)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA">No participants provided evaluable data for the analysis</measurement>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Remission According to DAS28, SDAI, and Boolean Criteria</title>
        <description>Remission was defined as DAS28 &lt;2.6, SDAI ≤3.3, or meeting all Boolean criteria (28-count SJC and TJC ≤1, VAS ≤10 mm, and hsCRP ≤1 mg/dL). For DAS28 and SDAI formulas, the SJC and TJC values were based upon 28 joints, and VAS was transformed from a 100-mm scale to a 10-point score. The DAS28 was calculated as (0.56 × square root of TJC) + (0.28 × square root of SJC) + (0.7 × ln ESR) + (0.014 × VAS), with potential scores from 0 to 10. The SDAI was calculated as SJC + TJC + VAS (participant) + VAS (physician) + hsCRP, with potential scores from 0 to infinity. However, based upon normal hsCRP level within 1 mg/dL, scores would be expected to fall within ≤77 points. For these instruments, higher scores indicate increased disease activity. The percentage of participants who met criteria for remission was calculated at each visit.</description>
        <time_frame>Baseline and Weeks 12, 24, 36, 48, 60, 72, 84</time_frame>
        <population>ITT Population. The &quot;Number of Participants Analyzed&quot; reflects the total number of participants who provided data for the outcome measure. The number of participants who provided data for each analysis (n) is shown in the table.</population>
        <group_list>
          <group group_id="O1">
            <title>SC TCZ Q2W</title>
            <description>Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W.</description>
          </group>
          <group group_id="O2">
            <title>SC TCZ QW</title>
            <description>Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Remission According to DAS28, SDAI, and Boolean Criteria</title>
          <description>Remission was defined as DAS28 &lt;2.6, SDAI ≤3.3, or meeting all Boolean criteria (28-count SJC and TJC ≤1, VAS ≤10 mm, and hsCRP ≤1 mg/dL). For DAS28 and SDAI formulas, the SJC and TJC values were based upon 28 joints, and VAS was transformed from a 100-mm scale to a 10-point score. The DAS28 was calculated as (0.56 × square root of TJC) + (0.28 × square root of SJC) + (0.7 × ln ESR) + (0.014 × VAS), with potential scores from 0 to 10. The SDAI was calculated as SJC + TJC + VAS (participant) + VAS (physician) + hsCRP, with potential scores from 0 to infinity. However, based upon normal hsCRP level within 1 mg/dL, scores would be expected to fall within ≤77 points. For these instruments, higher scores indicate increased disease activity. The percentage of participants who met criteria for remission was calculated at each visit.</description>
          <population>ITT Population. The &quot;Number of Participants Analyzed&quot; reflects the total number of participants who provided data for the outcome measure. The number of participants who provided data for each analysis (n) is shown in the table.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="44"/>
                <count group_id="O2" value="173"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline, DAS28 (n=44,172)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.6"/>
                    <measurement group_id="O2" value="19.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline, SDAI (n=44,170)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.5"/>
                    <measurement group_id="O2" value="8.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline, Boolean (n=44,172)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.3"/>
                    <measurement group_id="O2" value="8.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12, DAS28 (n=44,172)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31.8"/>
                    <measurement group_id="O2" value="35.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12, SDAI (n=44,172)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.9"/>
                    <measurement group_id="O2" value="11.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12, Boolean (n=44,172)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.1"/>
                    <measurement group_id="O2" value="8.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24, DAS28 (n=43,168)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="41.9"/>
                    <measurement group_id="O2" value="36.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24, SDAI (n=41,166)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19.5"/>
                    <measurement group_id="O2" value="13.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24, Boolean (n=43,170)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.6"/>
                    <measurement group_id="O2" value="9.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 36, DAS28 (n=39,159)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="38.5"/>
                    <measurement group_id="O2" value="35.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 36, SDAI (n=39,159)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.9"/>
                    <measurement group_id="O2" value="13.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 36, Boolean (n=39,161)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.7"/>
                    <measurement group_id="O2" value="10.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 48, DAS28 (n=18,141)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="50.0"/>
                    <measurement group_id="O2" value="36.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 48, SDAI (n=18,140)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.6"/>
                    <measurement group_id="O2" value="10.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 48, Boolean (n=18,143)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.6"/>
                    <measurement group_id="O2" value="9.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 60, DAS28 (n=2,92)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0"/>
                    <measurement group_id="O2" value="42.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 60, SDAI (n=2,92)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0"/>
                    <measurement group_id="O2" value="18.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 60, Boolean (n=2,93)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0"/>
                    <measurement group_id="O2" value="15.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 72, DAS28 (n=1,52)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0"/>
                    <measurement group_id="O2" value="42.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 72, SDAI (n=1,52)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0"/>
                    <measurement group_id="O2" value="21.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 72, Boolean (n=1,54)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0"/>
                    <measurement group_id="O2" value="18.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 84, DAS28 (n=0,11)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA">No participants provided evaluable data for the analysis</measurement>
                    <measurement group_id="O2" value="54.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 84, SDAI (n=0,11)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA">No participants provided evaluable data for the analysis</measurement>
                    <measurement group_id="O2" value="18.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 84, Boolean (n=0,11)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA">No participants provided evaluable data for the analysis</measurement>
                    <measurement group_id="O2" value="18.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From Baseline to 8 weeks after last dose; assessed continuously during treatment (up to 96 weeks) and up to 8 weeks after last dose (up to 2 years overall)</time_frame>
      <desc>Safety Population.</desc>
      <group_list>
        <group group_id="E1">
          <title>SC TCZ Q2W</title>
          <description>Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W.</description>
        </group>
        <group group_id="E2">
          <title>SC TCZ QW</title>
          <description>Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA (17.0)</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="19" subjects_at_risk="173"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Thrombocytopenia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="173"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal compartment syndrome</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="173"/>
              </event>
              <event>
                <sub_title>Diverticular perforation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="173"/>
              </event>
              <event>
                <sub_title>Gastric ulcer perforation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="173"/>
              </event>
              <event>
                <sub_title>Pancreatitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="173"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Chest pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="173"/>
              </event>
              <event>
                <sub_title>Device malfunction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="173"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="173"/>
              </event>
              <event>
                <sub_title>Staphylococcal bacteraemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="173"/>
              </event>
              <event>
                <sub_title>Arthritis bacterial</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="173"/>
              </event>
              <event>
                <sub_title>Bronchopneumonia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="173"/>
              </event>
              <event>
                <sub_title>Endocarditis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="173"/>
              </event>
              <event>
                <sub_title>Endophthalmitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="173"/>
              </event>
              <event>
                <sub_title>Pyelonephritis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="173"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Joint dislocation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="173"/>
              </event>
              <event>
                <sub_title>Post procedural complication</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="173"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Hyperglycaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="173"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="173"/>
              </event>
              <event>
                <sub_title>Lumbar spinal stenosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="173"/>
              </event>
              <event>
                <sub_title>Muscular weakness</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="173"/>
              </event>
              <event>
                <sub_title>Osteoarthritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="173"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Endometrial stromal sarcoma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="173"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="173"/>
              </event>
              <event>
                <sub_title>Transient ischaemic attack</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="173"/>
              </event>
              <event>
                <sub_title>Cerebrovascular accident</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="173"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Mental status change</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="173"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Haematuria</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="173"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Pulmonary embolism</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="173"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Drug eruption</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="173"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Deep vein thrombosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="173"/>
              </event>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="173"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA (17.0)</default_vocab>
        <default_assessment>Non-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="44"/>
                <counts group_id="E2" subjects_affected="102" subjects_at_risk="173"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="173"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="35" subjects_at_risk="173"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="22" subjects_at_risk="173"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="20" subjects_at_risk="173"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="15" subjects_at_risk="173"/>
              </event>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="173"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="173"/>
              </event>
              <event>
                <sub_title>Contusion</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="173"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="12" subjects_at_risk="173"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="12" subjects_at_risk="173"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="173"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="173"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="173"/>
              </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>The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Medical Communications</name_or_title>
      <organization>Hoffmann-La Roche</organization>
      <phone>800-821-8590</phone>
      <email>genentech@druginfo.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01662063
org study id: ML28338
nct id: NCT01662063
lead sponsor: 
This open-label extension study will evaluate the long-term safety and efficacy of SC TCZ in
      participants with moderate to severe RA who have completed the 97-week WA22762 (NCT01194414)
      or 96-week NA25220 (NCT01232569) core studies on SC or intravenous (IV) TCZ. Participants
      will receive TCZ 162 milligrams (mg) SC every week (QW) or every 2 weeks (Q2W) for up to 96
      weeks.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of Participants With at Least One Serious Adverse Event (SAE)
time frame: From Baseline to 8 weeks after last dose; assessed continuously during treatment (up to 96 weeks) and up to 8 weeks after last dose (up to 2 years overall)
description: Adverse events (AEs) were monitored throughout treatment. AEs were defined as any untoward medical occurrence in a participant who received study drug regardless of causality. SAEs were defined as AEs that were fatal or life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, manifested as a congenital anomaly/birth defect, were medically significant, or required intervention to prevent any of the aforementioned outcomes. The number of participants with at least one SAE regardless of treatment relationship was reported.
measure: Percentage of Participants With at Least One SAE
time frame: From Baseline to 8 weeks after last dose; assessed continuously during treatment (up to 96 weeks) and up to 8 weeks after last dose (up to 2 years overall)
description: AEs were monitored throughout treatment. AEs were defined as any untoward medical occurrence in a participant who received study drug regardless of causality. SAEs were defined as AEs that were fatal or life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, manifested as a congenital anomaly/birth defect, were medically significant, or required intervention to prevent any of the aforementioned outcomes. The percentage of participants with at least one SAE regardless of treatment relationship was calculated.
measure: Percentage of Participants With a Positive Anti-TCZ Antibody Assay at Any Timepoint
time frame: From Baseline to 8 weeks after last dose; assessed at Baseline; Weeks 12, 24, 36, 48, 60, 72, 84, 96; and up to 8 weeks after last dose (up to 2 years overall)
description: Blood samples were collected to test for the presence of antibodies to TCZ. The percentage of participants with a positive anti-TCZ antibody assay was calculated.
measure: Percentage of Participants With a Positive Anti-TCZ Antibody Assay at Baseline
time frame: Baseline
description: Blood samples were collected to test for the presence of antibodies to TCZ. The percentage of participants with a positive anti-TCZ antibody assay was calculated.
measure: Percentage of Participants With a Positive Anti-TCZ Antibody Assay Post-Baseline
time frame: From Week 12 up to 8 weeks after last dose; assessed at Weeks 12, 24, 36, 48, 60, 72, 84, 96; and up to 8 weeks after last dose (up to 2 years overall)
description: Blood samples were collected to test for the presence of antibodies to TCZ. The percentage of participants with a positive anti-TCZ antibody assay was calculated. Positive assay results obtained post-Baseline were further investigated via confirmation assay and a neutralization assay.
measure: Percentage of Participants Who Correctly Administered All SC TCZ Doses
time frame: From Baseline to last dose; assessed every 4 weeks during treatment (up to 96 weeks overall)
description: Compliance was assessed using drug dispensing logs, diary cards kept by the participant, and return records, as reviewed by the Investigator at regular visits. Total compliance up to the end of treatment was defined as the percentage of participants who correctly administered all scheduled doses of SC TCZ. Correct administration was defined as proper injection technique, injection of the correct amount (162 mg), device not left at room temperature for greater than (>) 8 hours, and absence of other medication errors.
measure: Disease Activity Score Based on 28 Joints (DAS28) Score
time frame: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84
description: The DAS28 was calculated using the Swollen Joint Count (SJC), Tender Joint Count (TJC), erythrocyte sedimentation rate (ESR), and Global Assessment of Disease Activity by the participant according to Visual Analog Scale (VAS) score. For the DAS28 formula, the SJC and TJC values were based upon 28 joints, and VAS was transformed from a 100-millimeter (mm) scale to a 10-point score. The DAS28 was calculated as (0.56 multiplied by [×] square root of TJC) + (0.28 × square root of SJC) + (0.7 × log natural [ln] ESR) + (0.014 × VAS). Scores may range from 0 to 10, where higher scores indicate increased disease activity.
measure: Change From Baseline in DAS28 Score
time frame: Baseline to Weeks 12, 24, 36, 48, 60, 72, 84
description: The DAS28 was calculated using the SJC, TJC, ESR, and Global Assessment of Disease Activity by the participant according to VAS score. For the DAS28 formula, the SJC and TJC values were based upon 28 joints, and VAS was transformed from a 100-mm scale to a 10-point score. The DAS28 was calculated as (0.56 × square root of TJC) + (0.28 × square root of SJC) + (0.7 × ln ESR) + (0.014 × VAS). Scores may range from 0 to 10, where higher scores indicate increased disease activity. The change from Baseline to each visit was calculated, where positive changes represent an increase or worsening in disease activity.
measure: Clinical Disease Activity Index (CDAI) Score
time frame: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84
description: The CDAI was calculated using the SJC, TJC, and Global Assessment of Disease Activity by the patient and by the physician according to separate VAS scores. For the CDAI formula, the SJC and TJC values were based upon 28 joints, and VAS was transformed from a 100-mm scale to a 10-point score. The CDAI was calculated as the sum of the component scores, that is, SJC + TJC + VAS (participant) + VAS (physician). Scores may range from 0 to 76, where higher scores indicate increased disease activity.
measure: Change From Baseline in CDAI Score
time frame: Baseline to Weeks 12, 24, 36, 48, 60, 72, 84
description: The CDAI was calculated using the SJC, TJC, and Global Assessment of Disease Activity by the patient and by the physician according to separate VAS scores. For the CDAI formula, the SJC and TJC values were based upon 28 joints, and VAS was transformed from a 100-mm scale to a 10-point score. The CDAI was calculated as the sum of the component scores, that is, SJC + TJC + VAS (participant) + VAS (physician). Scores may range from 0 to 76, where higher scores indicate increased disease activity. The change from Baseline to each visit was calculated, where positive changes represent an increase or worsening in disease activity.
measure: Simplified Disease Activity Index (SDAI) Score
time frame: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84
description: The SDAI was calculated using the SJC, TJC, Global Assessment of Disease Activity by the patient and by the physician according to separate VAS scores, and high-sensitivity C-reactive protein (hsCRP) level. For the SDAI formula, the SJC and TJC values were based upon 28 joints, and VAS was transformed from a 100-mm scale to a 10-point score. The SDAI was calculated as the sum of the component scores, that is, SJC + TJC + VAS (participant) + VAS (physician) + hsCRP. Because the formula includes hsCRP, scores may theoretically range from 0 to infinity, where higher scores indicate increased disease activity. However, based upon normal hsCRP level within 1 milligram per deciliter (mg/dL), scores would be expected to fall within less than or equal to (≤) 77 points.
measure: Change From Baseline in SDAI Score
time frame: Baseline to Weeks 12, 24, 36, 48, 60, 72, 84
description: The SDAI was calculated using the SJC, TJC, Global Assessment of Disease Activity by the patient and by the physician according to separate VAS scores, and hsCRP level. For the SDAI formula, the SJC and TJC values were based upon 28 joints, and VAS was transformed from a 100-mm scale to a 10-point score. The SDAI was calculated as the sum of the component scores, that is, SJC + TJC + VAS (participant) + VAS (physician) + hsCRP. Because the formula includes hsCRP, scores may theoretically range from 0 to infinity, where higher scores indicate increased disease activity. However, based upon normal hsCRP level within 1 mg/dL, scores would be expected to fall within ≤77 points. The change from Baseline to each visit was calculated, where positive changes represent an increase or worsening in disease activity.
measure: Tender Joint Count (TJC) Score
time frame: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84
description: Sixty-eight joints were assessed and classified as tender/not tender by pressure and joint manipulation on physical examination. The number of tender joints was taken as the TJC score, where values may range from 0 to 68.
measure: Change From Baseline in TJC Score
time frame: Baseline to Weeks 12, 24, 36, 48, 60, 72, 84
description: Sixty-eight joints were assessed and classified as tender/not tender by pressure and joint manipulation on physical examination. The number of tender joints was taken as the TJC score, where values may range from 0 to 68. The change from Baseline to each visit was calculated, where positive changes represent an increase in number of tender joints.
measure: Swollen Joint Count (SJC) Score
time frame: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84
description: Sixty-six joints were assessed and classified as swollen/not swollen by pressure and joint manipulation on physical examination. The number of swollen joints was taken as the SJC score, where values may range from 0 to 66.
measure: Change From Baseline in SJC Score
time frame: Baseline to Weeks 12, 24, 36, 48, 60, 72, 84
description: Sixty-six joints were assessed and classified as swollen/not swollen by pressure and joint manipulation on physical examination. The number of swollen joints was taken as the SJC score, where values may range from 0 to 66. The change from Baseline to each visit was calculated, where positive changes represent an increase in number of swollen joints.
measure: Number of Participants With a Disease-Modifying Anti-Rheumatic Drug (DMARD) Dose Reduction, Interruption, or Discontinuation
time frame: From Baseline to last dose; assessed every 4 weeks during treatment (up to 96 weeks overall)
description: Use of concomitant medications, including non-biologic DMARDs, was recorded throughout the study. Any change in DMARD therapy was documented and reported among those participants receiving at least one DMARD at Baseline.
measure: Percentage of Participants With a DMARD Dose Reduction, Interruption, or Discontinuation
time frame: From Baseline to last dose; assessed every 4 weeks during treatment (up to 96 weeks overall)
description: Use of concomitant medications, including non-biologic DMARDs, was recorded throughout the study. Any change in DMARD therapy was documented and reported among those participants receiving at least one DMARD at Baseline.
measure: Percentage of Reasons Given for DMARD Dose Reduction or Interruption
time frame: From Baseline to last dose; assessed every 4 weeks during treatment (up to 96 weeks overall)
description: Use of concomitant medications, including non-biologic DMARDs, was recorded throughout the study. Any change in DMARD therapy was documented and reported among those participants receiving at least one DMARD at Baseline. The reasons for any DMARD dose reduction/interruption ≤60 days were reported. More than one reason could be given for a single change in DMARD therapy, and each participant could also change DMARD therapy more than once. Therefore, the number of reasons could exceed the number of participants analyzed.
measure: Percentage of Reasons Given for DMARD Discontinuation
time frame: From Baseline to last dose; assessed every 4 weeks during treatment (up to 96 weeks overall)
description: Use of concomitant medications, including non-biologic DMARDs, was recorded throughout the study. Any change in DMARD therapy was documented and reported among those participants receiving at least one DMARD at Baseline. The reasons for any DMARD discontinuation were reported. More than one reason could be given for a single change in DMARD therapy, and each participant could also change DMARD therapy more than once. Therefore, the number of reasons could exceed the number of participants analyzed.
measure: Number of Participants With a Corticosteroid (CCS) Dose Reduction, Interruption, or Discontinuation
time frame: From Baseline to last dose; assessed every 4 weeks during treatment (up to 96 weeks overall)
description: Use of concomitant medications, including CCS treatment, was recorded throughout the study. Any change in CCS therapy was documented and reported among those participants who received at least one CCS before the last dose of SC TCZ.
measure: Percentage of Participants With a CCS Dose Reduction, Interruption, or Discontinuation
time frame: From Baseline to last dose; assessed every 4 weeks during treatment (up to 96 weeks overall)
description: Use of concomitant medications, including CCS treatment, was recorded throughout the study. Any change in CCS therapy was documented and reported among those participants who received at least one CCS before the last dose of SC TCZ.
measure: Percentage of Reasons Given for CCS Dose Reduction
time frame: From Baseline to last dose; assessed every 4 weeks during treatment (up to 96 weeks overall)
description: Use of concomitant medications, including CCS treatment, was recorded throughout the study. Any change in CCS therapy was documented and reported among those participants who received at least one CCS before the last dose of SC TCZ. The reasons for any CCS dose reduction were reported. More than one reason could be given for a single change in CCS therapy, and each participant could also change CCS therapy more than once. Therefore, the number of reasons could exceed the number of participants analyzed.
measure: Percentage of Reasons Given for CCS Dose Interruption
time frame: From Baseline to last dose; assessed every 4 weeks during treatment (up to 96 weeks overall)
description: Use of concomitant medications, including CCS treatment, was recorded throughout the study. Any change in CCS therapy was documented and reported among those participants who received at least one CCS before the last dose of SC TCZ. The reasons for any CCS dose interruption ≤14 days were reported. More than one reason could be given for a single change in CCS therapy, and each participant could also change CCS therapy more than once. Therefore, the number of reasons could exceed the number of participants analyzed.
measure: Percentage of Reasons Given for CCS Discontinuation
time frame: From Baseline to last dose; assessed every 4 weeks during treatment (up to 96 weeks overall)
description: Use of concomitant medications, including CCS treatment, was recorded throughout the study. Any change in CCS therapy was documented and reported among those participants who received at least one CCS before the last dose of SC TCZ. The reasons for any CCS discontinuation >14 days were reported. More than one reason could be given for a single change in CCS therapy, and each participant could also change CCS therapy more than once. Therefore, the number of reasons could exceed the number of participants analyzed.
measure: Number of Participants Who Switched From the QW Regimen and Remained on the Q2W Regimen
time frame: From Baseline to last dose; assessed every 4 weeks during treatment (up to 96 weeks overall)
description: Participants could switch between regimens at the Investigator's judgment based upon safety, efficacy, and pharmacokinetic/pharmacodynamic data. The number of participants who switched from the QW to the Q2W regimen and did not return to the QW regimen was reported.
measure: Percentage of Participants Who Switched From the QW Regimen and Remained on the Q2W Regimen
time frame: From Baseline to last dose; assessed every 4 weeks during treatment (up to 96 weeks overall)
description: Participants could switch between regimens at the Investigator's judgment based upon safety, efficacy, and pharmacokinetic/pharmacodynamic data. The percentage of participants who switched from the QW to the Q2W regimen and did not return to the QW regimen was calculated.
measure: Number of Participants Who Returned to the QW Regimen After Switching to the Q2W Regimen
time frame: From Baseline to last dose; assessed every 4 weeks during treatment (up to 96 weeks overall)
description: Participants could switch between regimens at the Investigator's judgment based upon safety, efficacy, and pharmacokinetic/pharmacodynamic data. The number of participants who switched from the QW to the Q2W regimen and thereafter returned to the QW regimen was reported with the reason for returning to the QW regimen.
measure: Time to Return to the QW Regimen After Switching to the Q2W Regimen
time frame: From Baseline to last dose; assessed every 4 weeks during treatment (up to 96 weeks overall)
description: Participants could switch between regimens at the Investigator's judgment based upon safety, efficacy, and pharmacokinetic/pharmacodynamic data. Time to return was defined as the time between switching to the Q2W regimen and returning to the previous QW regimen.
measure: Global Assessment of Disease Activity by the Participant According to Visual Analog Scale (VAS) Score
time frame: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84
description: The Global Assessment of Disease Activity was performed using a 100-mm horizontal VAS. Scores may range from 0 mm ("no disease activity") to 100 mm ("maximum disease activity"), with higher scores representing an increase in perceived symptoms.
measure: Change From Baseline in Global Assessment of Disease Activity by the Participant According to VAS Score
time frame: Baseline to Weeks 12, 24, 36, 48, 60, 72, 84
description: The Global Assessment of Disease Activity was performed using a 100-mm horizontal VAS. Scores may range from 0 mm ("no disease activity") to 100 mm ("maximum disease activity"), with higher scores representing an increase in perceived symptoms. The change from Baseline to each visit was calculated, where positive changes represent an increase or worsening in perceived disease activity.
measure: Global Assessment of Pain by the Participant According to VAS Score
time frame: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84
description: The Global Assessment of Pain was performed using a 100-mm horizontal VAS. Scores may range from 0 mm ("no pain") to 100 mm ("unbearable pain"), with higher scores representing an increase in pain.
measure: Change From Baseline in Global Assessment of Pain by the Participant According to VAS Score
time frame: Baseline to Weeks 12, 24, 36, 48, 60, 72, 84
description: The Global Assessment of Pain was performed using a 100-mm horizontal VAS. Scores may range from 0 mm ("no pain") to 100 mm ("unbearable pain"), with higher scores representing an increase in pain. The change from Baseline to each visit was calculated, where positive changes represent an increase or worsening in pain.
measure: Heath Assessment Questionnaire-Disability Index (HAQ-DI) Score
time frame: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84
description: The Stanford HAQ-DI was calculated as the average of 20 questions, each scored from 0 (no difficulty) to 3 (unable to do). The questionnaire included 8 component sets: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and common activities. Overall scores may range from 0 to 3, with higher scores representing increased disability.
measure: Change From Baseline in HAQ-DI Score
time frame: Baseline to Weeks 12, 24, 36, 48, 60, 72, 84
description: The Stanford HAQ-DI was calculated as the average of 20 questions, each scored from 0 (no difficulty) to 3 (unable to do). The questionnaire included 8 component sets: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and common activities. Overall scores may range from 0 to 3, with higher scores representing increased disability. The change from Baseline to each visit was calculated, where positive changes represent an increased need for assistance with daily activities.
measure: Percentage of Participants With HAQ-DI Score <0.5
time frame: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84
description: The Stanford HAQ-DI was calculated as the average of 20 questions, each scored from 0 (no difficulty) to 3 (unable to do). The questionnaire included 8 component sets: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and common activities. Overall scores may range from 0 to 3, with higher scores representing increased disability. The percentage of participants achieving a score <0.5 was calculated at each visit.
measure: Number of Participants With Low Disease Activity According to DAS28, SDAI, and CDAI Criteria
time frame: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84
description: Low disease activity was defined as DAS28 ≤3.2, SDAI ≤11, or CDAI ≤10. For each formula, the SJC and TJC values were based upon 28 joints, and VAS was transformed from a 100-mm scale to a 10-point score. The DAS28 was calculated as (0.56 × square root of TJC) + (0.28 × square root of SJC) + (0.7 × ln ESR) + (0.014 × VAS), with potential scores from 0 to 10. The SDAI was calculated as SJC + TJC + VAS (participant) + VAS (physician) + hsCRP, with potential scores from 0 to infinity. However, based upon normal hsCRP level within 1 mg/dL, scores would be expected to fall within ≤77 points. The CDAI was calculated as SJC + TJC + VAS (participant) + VAS (physician), with potential scores from 0 to 76. For all instruments, higher scores indicate increased disease activity. The number of participants who met criteria for low disease activity was reported at each visit.
measure: Percentage of Participants With Low Disease Activity According to DAS28, SDAI, and CDAI Criteria
time frame: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84
description: Low disease activity was defined as DAS28 ≤3.2, SDAI ≤11, or CDAI ≤10. For each formula, the SJC and TJC values were based upon 28 joints, and VAS was transformed from a 100-mm scale to a 10-point score. The DAS28 was calculated as (0.56 × square root of TJC) + (0.28 × square root of SJC) + (0.7 × ln ESR) + (0.014 × VAS), with potential scores from 0 to 10. The SDAI was calculated as SJC + TJC + VAS (participant) + VAS (physician) + hsCRP, with potential scores from 0 to infinity. However, based upon normal hsCRP level within 1 mg/dL, scores would be expected to fall within ≤77 points. The CDAI was calculated as SJC + TJC + VAS (participant) + VAS (physician), with potential scores from 0 to 76. For all instruments, higher scores indicate increased disease activity. The percentage of participants who met criteria for low disease activity was calculated at each visit.
measure: Number of Participants With Remission According to DAS28, SDAI, and Boolean Criteria
time frame: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84
description: Remission was defined as DAS28 <2.6, SDAI ≤3.3, or meeting all Boolean criteria (28-count SJC and TJC ≤1, VAS ≤10 mm, and hsCRP ≤1 mg/dL). For DAS28 and SDAI formulas, the SJC and TJC values were based upon 28 joints, and VAS was transformed from a 100-mm scale to a 10-point score. The DAS28 was calculated as (0.56 × square root of TJC) + (0.28 × square root of SJC) + (0.7 × ln ESR) + (0.014 × VAS), with potential scores from 0 to 10. The SDAI was calculated as SJC + TJC + VAS (participant) + VAS (physician) + hsCRP, with potential scores from 0 to infinity. However, based upon normal hsCRP level within 1 mg/dL, scores would be expected to fall within ≤77 points. For these instruments, higher scores indicate increased disease activity. The number of participants who met criteria for remission was reported at each visit.
measure: Percentage of Participants With Remission According to DAS28, SDAI, and Boolean Criteria
time frame: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84
description: Remission was defined as DAS28 <2.6, SDAI ≤3.3, or meeting all Boolean criteria (28-count SJC and TJC ≤1, VAS ≤10 mm, and hsCRP ≤1 mg/dL). For DAS28 and SDAI formulas, the SJC and TJC values were based upon 28 joints, and VAS was transformed from a 100-mm scale to a 10-point score. The DAS28 was calculated as (0.56 × square root of TJC) + (0.28 × square root of SJC) + (0.7 × ln ESR) + (0.014 × VAS), with potential scores from 0 to 10. The SDAI was calculated as SJC + TJC + VAS (participant) + VAS (physician) + hsCRP, with potential scores from 0 to infinity. However, based upon normal hsCRP level within 1 mg/dL, scores would be expected to fall within ≤77 points. For these instruments, higher scores indicate increased disease activity. The percentage of participants who met criteria for remission was calculated at each visit.
arm group label: SC TCZ QW
arm group type: Experimental
description: Participants who received IV TCZ in the previous trial will be switched to SC TCZ 162 mg QW, and those who received SC TCZ will continue at their same dosage of SC TCZ 162 mg QW. Tocilizumab will be given for an additional 96 weeks in this open-label extension study.
arm group label: SC TCZ Q2W
arm group type: Experimental
description: Participants who received SC TCZ will continue at their same dosage of SC TCZ 162 mg Q2W. Tocilizumab will be given for an additional 96 weeks in this open-label extension study.
intervention type: Drug
intervention name: Tocilizumab
description: TCZ will be given as 162 mg SC QW or Q2W for up to 96 weeks.
arm group label: SC TCZ Q2W
arm group label: SC TCZ QW
other name: RoActemra/Actemra
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Clinical Trials
role: Study Director
affiliation: Genentech, Inc.
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country: Puerto Rico
country: United States
responsible party type: Sponsor
mesh term: Arthritis
mesh term: Arthritis, Rheumatoid
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 