<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/NCT01663506</url>
  </required_header>
  <id_info>
    <org_study_id>ML28311</org_study_id>
    <nct_id>NCT01663506</nct_id>
  </id_info>
  <brief_title>A Non-Interventional Study in Patients With Moderate to Severe Rheumatoid Arthritis Treated With RoActemra/Actemra (Tocilizumab)</brief_title>
  <official_title>A Multi-national, Multi-center Non-interventional Study in Rheumatoid Arthritis (RA) Patients Treated With Tocilizumab</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hoffmann-La Roche</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hoffmann-La Roche</source>
  <brief_summary>
    <textblock>
      This non-interventional study will evaluate the use and efficacy of RoActemra/Actemra&#xD;
      (tocilizumab) in patients with moderate to severe rheumatoid arthritis. Eligible patients&#xD;
      initiated on RoActemra/Actemra treatment according to the local label will be followed for 12&#xD;
      months.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>April 2012</start_date>
  <completion_date type="Actual">September 2014</completion_date>
  <primary_completion_date type="Actual">September 2014</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Participants With Tocilizumab Treatment at 6 Months After Treatment Initiation</measure>
    <time_frame>6 Months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Tocilizumab Treatment at 12 Months After Treatment Initiation</measure>
    <time_frame>Month 12</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Tocilizumab Dose Modification, Interruption, and Irregularity</measure>
    <time_frame>Up to Month 12</time_frame>
    <description>Dose modification was defined as an increase or decrease in the dose of study drug compared to the previous dose received. Interruption was defined as temporary or permanent discontinuation of study drug due to any reason, for example adverse event. Irregularity was defined as a time interval of greater than and equal to (&gt;=) 75 days between two consecutive doses of study drug.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Comorbidities at Baseline</measure>
    <time_frame>Baseline</time_frame>
    <description>Participants were assessed for any comorbidity at study entry including anemia, fatigue, conventional risk factors for cardiovascular disease, C-reactive protein (CRP) level above upper limit of normal, rheumatoid nodules, rheumatoid vasculitis, interstitial lung disease, and so on. Number of participants with each comorbidity was reported. One participant could have presented with more than 1 comorbidity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Prior Exposure to Disease Modifying Anti-rheumatic Drugs (DMARDs)</measure>
    <time_frame>Baseline</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Prior Exposure of Biologics</measure>
    <time_frame>Baseline</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease Activity Score Based on 28-joints Count (DAS28)</measure>
    <time_frame>Baseline, Month 3, 6, and 12</time_frame>
    <description>DAS28 calculated from the number of swollen joints (SJC) and tender joints (TJC) using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hr]) and patient's global assessment (PtGA) of disease activity. DAS28 total score range = 0 to 10, where higher scores indicates higher disease activity. DAS28 less than and equal to (&lt;=) 2.6 meant clinical remission; DAS28 &lt;=3.2 meant low disease activity; DAS28 greater than (&gt;) 3.2 to 5.1 implied moderate disease activity; and DAS28 &gt;5.1 implied high disease activity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With European League Against Rheumatism (EULAR) Response Based on DAS28</measure>
    <time_frame>Month 3, 6, and 12</time_frame>
    <description>The DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Description of DAS28 calculation is provided in Outcome Measure 7. Good responders: decrease from baseline &gt;1.2 with DAS28 &lt;= 3.2; moderate responders: decrease from baseline &gt;1.2 with DAS28 &gt;3.2 or decrease from baseline &gt;0.6 to &lt;=1.2 with DAS28 &lt;=5.1; non-responders: decrease from baseline &lt;= 0.6 or decrease from baseline &gt;0.6 and &lt;=1.2 with DAS28 &gt;5.1.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physician Global Assessment (PGA) of Disease Activity</measure>
    <time_frame>Baseline, Month 6, and 12</time_frame>
    <description>PGA of disease activity was measured on a 0 to 100 millimeter (mm) visual analog scale (VAS), with 0 mm = no disease activity and 100 mm = highest possible disease activity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Global Assessment (PtGA) of Disease Activity Score</measure>
    <time_frame>Baseline, Month 6, and 12</time_frame>
    <description>PtGA of Disease Activity was measured on a 0 to 100 mm VAS, with 0 mm = no disease activity and 100 mm = highest possible disease activity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health Assessment Questionnaire-Disability Index (HAQ-DI) Score</measure>
    <time_frame>Baseline, Month 6, and 12</time_frame>
    <description>HAQ-DI: participant reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item was scored on a 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores divided by the number of domains answered. Total possible score range was 0-3 where 0 = least difficulty and 3 = extreme difficulty.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Visual Analog Scale (VAS)-Pain</measure>
    <time_frame>Baseline, Month 6, and 12</time_frame>
    <description>Intensity of pain was measured on a 100 mm line VAS marked by participant. It ranged (over the past week): 0 = no pain to 100 = worst possible pain.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Visual Analog Fatigue Scale (VAFS)</measure>
    <time_frame>Baseline, Month 6, and 12</time_frame>
    <description>Participants assessed their fatigue using a 0 - 100 mm VAS, where 0 mm = no fatigue and 100 mm = worst possible fatigue.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Visual Analog Scale-Morning Stiffness (VAS-MS)</measure>
    <time_frame>Baseline, Month 6, and 12</time_frame>
    <description>Participants assessed their morning stiffness using a 0 - 100 mm VAS, where 0 mm = no stiffness and 100 mm = worst possible stiffness.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Erythrocyte Sedimentation Rate (ESR)</measure>
    <time_frame>Baseline, Month 6, and 12</time_frame>
    <description>ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 mm/hr. A higher rate is consistent with inflammation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>C-Reactive Protein (CRP)</measure>
    <time_frame>Baseline, Month 6, and 12</time_frame>
    <description>The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. Normal range is up to 10 milligram per liter (mg/L). A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Swollen and Tender Joints Based on 66 and 68 Joints</measure>
    <time_frame>Baseline, Month 6, and 12</time_frame>
    <description>Number of swollen joints was determined by examination of 66 joints (SJC66) and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, 0 = no swelling, 1 = swelling. Number of tender joints was determined by examining 68 joints (TJC68) and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at each visit, 0 = no tenderness, 1 = tenderness.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Swollen and Tender Joints Based on 28 Joints</measure>
    <time_frame>Baseline, Month 6, and 12</time_frame>
    <description>Number of swollen joints was determined by examination of 28 (SJC28) joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, 0 = no swelling, 1 = swelling. Number of tender joints was determined by examining 28 joints (TJC28) and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at each visit, 0 = no tenderness, 1 = tenderness.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Simplified Disease Activity Index (SDAI) Score</measure>
    <time_frame>Baseline, Month 6, and 12</time_frame>
    <description>The SDAI is the numerical sum of five outcome parameters: TJC28, SJC28, PtGA, PGA, and CRP. Description of these outcome parameters is given in outcome measure 9, 10, 16, and 18. SDAI total score = 0-86. SDAI &lt;=3.3 indicates disease remission, &gt;3.4 to 11 = low disease activity, &gt;11 to 26 = moderate disease activity, and &gt;26 = high disease activity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical Disease Activity Index (CDAI) Score</measure>
    <time_frame>Baseline, Month 6, and 12</time_frame>
    <description>The CDAI is the numerical sum of 4 outcome parameters: TJC28, SJC28, PtGA, and PGA. Description of these outcome parameters is given come measure 9, 10, and 18. CDAI total score = 0-76. CDAI &lt;= 2.8 indicates disease remission, &gt;2.8 to 10 = low disease activity, &gt;10 to 22 = moderate disease activity, and &gt;22 = high disease activity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Who Received Tocilizumab as Monotherapy</measure>
    <time_frame>Baseline, Study end (at Month 12 or at time of study discontinuation)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Who Received Tocilizumab in Combination With Disease Modifying Anti-rheumatic Drugs (DMARDs)</measure>
    <time_frame>Baseline, Study end (at Month 12 or at time of study discontinuation)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Receiving Oral Corticosteroids</measure>
    <time_frame>Baseline, Month 3, 6, and 12</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Disease Activity Status Based on DAS28 Score</measure>
    <time_frame>Baseline, Month 3, 6, and 12</time_frame>
    <description>Participants were assigned the disease activity status on the basis of DAS28 score. Description of DAS28 calculation is provided in Outcome Measure 7. Remission: DAS28 score &lt;= 2.6; low disease activity: DAS28 &lt;=3.2; moderate disease activity: DAS28 &lt;=5.1; and high disease activity: DAS28 &gt;5.1.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Disease Activity Status Based on SDAI Score</measure>
    <time_frame>Baseline, Month 3, 6, and 12</time_frame>
    <description>Participants were assigned the disease activity status on the basis of SDAI score. Description of SDAI score calculation is provided in Outcome Measure 19. Remission: SDAI score &lt;= 3.3; low disease activity: SDAI &lt;=11.0; moderate disease activity: SDAI &lt;=26.0; and high disease activity: SDAI &gt;26.0.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Disease Activity Status Based on CDAI Score</measure>
    <time_frame>Baseline, Month 3, 6, and 12</time_frame>
    <description>Participants were assigned the disease activity status on the basis of CDAI score. Description of CDAI score calculation is provided in Outcome Measure 20. Remission: CDAI score &lt;= 2.8; low disease activity: CDAI &lt;=10.0; moderate disease activity: CDAI &lt;=22.0; and high disease activity: CDAI &gt;22.0.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">23</enrollment>
  <condition>Rheumatoid Arthritis</condition>
  <arm_group>
    <arm_group_label>Cohort</arm_group_label>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with rheumatoid arthritis initiated on treatment with RoActemra/Actemra&#xD;
        (tocilizumab)&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patients, &gt;/= 18 years of age&#xD;
&#xD;
          -  Moderate to severe rheumatoid arthritis according to the revised (1987) ACR criteria&#xD;
&#xD;
          -  Patients in whom the treating physician has made the decision to commence&#xD;
             RoActemra/Actemra treatment (in accordance with the local label); this can include&#xD;
             patients who have received RoActemra/Actemra treatment within 8 week prior to the&#xD;
             enrolment visit&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who have received RoActemra/Actemra more than 8 weeks prior to the enrolment&#xD;
             visit&#xD;
&#xD;
          -  Patients who have previously received RoActemra/Actemra in a clinical trial or for&#xD;
             compassionate use&#xD;
&#xD;
          -  Treatment with any investigational agent within 4 weeks (or 5 half-lives of the&#xD;
             investigational agent, whichever is longer) before starting treatment with&#xD;
             RoActemra/Actemra&#xD;
&#xD;
          -  History of autoimmune disease or any joint inflammatory disease other than rheumatoid&#xD;
             arthritis&#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>Hoffmann-La Roche</affiliation>
  </overall_official>
  <location>
    <facility>
      <address>
        <city>Tallinn</city>
        <zip>11312</zip>
        <country>Estonia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Tallinn</city>
        <zip>13419</zip>
        <country>Estonia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Tartu</city>
        <zip>51014</zip>
        <country>Estonia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Estonia</country>
  </location_countries>
  <verification_date>November 2019</verification_date>
  <study_first_submitted>August 8, 2012</study_first_submitted>
  <study_first_submitted_qc>August 10, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 13, 2012</study_first_posted>
  <results_first_submitted>November 3, 2015</results_first_submitted>
  <results_first_submitted_qc>November 3, 2015</results_first_submitted_qc>
  <results_first_posted type="Estimate">December 9, 2015</results_first_posted>
  <last_update_submitted>November 25, 2019</last_update_submitted>
  <last_update_submitted_qc>November 25, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">December 10, 2019</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>Tocilizumab</title>
          <description>Participants with moderate to severe rheumatoid arthritis, in whom treating physician had made a decision to commence tocilizumab (RoActemra/Actemra) treatment according to local labeling (including participants who had started tocilizumab treatment within 8 weeks before enrollment) were observed prospectively for 12 months.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="23"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="15"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lack of Efficacy</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Consent Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Switched to Subcutaneous Tocilizumab</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Full analysis set (FAS) included all participants who were enrolled in this study.</population>
      <group_list>
        <group group_id="B1">
          <title>Tocilizumab</title>
          <description>Participants with moderate to severe rheumatoid arthritis, in whom treating physician had made a decision to commence tocilizumab treatment according to local labeling (including participants who had started tocilizumab treatment within 8 weeks before enrollment) were observed prospectively for 12 months.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="23"/>
          </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="52.4" spread="12.2"/>
                  </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="20"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants With Tocilizumab Treatment at 6 Months After Treatment Initiation</title>
        <time_frame>6 Months</time_frame>
        <population>FAS.</population>
        <group_list>
          <group group_id="O1">
            <title>Tocilizumab</title>
            <description>Participants with moderate to severe rheumatoid arthritis, in whom treating physician had made a decision to commence tocilizumab treatment according to local labeling (including participants who had started tocilizumab treatment within 8 weeks before enrollment) were observed prospectively for 12 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Tocilizumab Treatment at 6 Months After Treatment Initiation</title>
          <population>FAS.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="23"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="73.9" lower_limit="51.6" upper_limit="89.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Tocilizumab Treatment at 12 Months After Treatment Initiation</title>
        <time_frame>Month 12</time_frame>
        <population>FAS.</population>
        <group_list>
          <group group_id="O1">
            <title>Tocilizumab</title>
            <description>Participants with moderate to severe rheumatoid arthritis, in whom treating physician had made a decision to commence tocilizumab treatment according to local labeling (including participants who had started tocilizumab treatment within 8 weeks before enrollment) were observed prospectively for 12 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Tocilizumab Treatment at 12 Months After Treatment Initiation</title>
          <population>FAS.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="23"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="69.6" lower_limit="47.1" upper_limit="86.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Tocilizumab Dose Modification, Interruption, and Irregularity</title>
        <description>Dose modification was defined as an increase or decrease in the dose of study drug compared to the previous dose received. Interruption was defined as temporary or permanent discontinuation of study drug due to any reason, for example adverse event. Irregularity was defined as a time interval of greater than and equal to (&gt;=) 75 days between two consecutive doses of study drug.</description>
        <time_frame>Up to Month 12</time_frame>
        <population>FAS.</population>
        <group_list>
          <group group_id="O1">
            <title>Tocilizumab</title>
            <description>Participants with moderate to severe rheumatoid arthritis, in whom treating physician had made a decision to commence tocilizumab treatment according to local labeling (including participants who had started tocilizumab treatment within 8 weeks before enrollment) were observed prospectively for 12 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Tocilizumab Dose Modification, Interruption, and Irregularity</title>
          <description>Dose modification was defined as an increase or decrease in the dose of study drug compared to the previous dose received. Interruption was defined as temporary or permanent discontinuation of study drug due to any reason, for example adverse event. Irregularity was defined as a time interval of greater than and equal to (&gt;=) 75 days between two consecutive doses of study drug.</description>
          <population>FAS.</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="23"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Dose Modification</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Dose Modification + Interruption</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="39.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Dose Modification + Interruption + Irregularity</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="39.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Comorbidities at Baseline</title>
        <description>Participants were assessed for any comorbidity at study entry including anemia, fatigue, conventional risk factors for cardiovascular disease, C-reactive protein (CRP) level above upper limit of normal, rheumatoid nodules, rheumatoid vasculitis, interstitial lung disease, and so on. Number of participants with each comorbidity was reported. One participant could have presented with more than 1 comorbidity.</description>
        <time_frame>Baseline</time_frame>
        <population>FAS.</population>
        <group_list>
          <group group_id="O1">
            <title>Tocilizumab</title>
            <description>Participants with moderate to severe rheumatoid arthritis, in whom treating physician had made a decision to commence tocilizumab treatment according to local labeling (including participants who had started tocilizumab treatment within 8 weeks before enrollment) were observed prospectively for 12 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Comorbidities at Baseline</title>
          <description>Participants were assessed for any comorbidity at study entry including anemia, fatigue, conventional risk factors for cardiovascular disease, C-reactive protein (CRP) level above upper limit of normal, rheumatoid nodules, rheumatoid vasculitis, interstitial lung disease, and so on. Number of participants with each comorbidity was reported. One participant could have presented with more than 1 comorbidity.</description>
          <population>FAS.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="23"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Anemia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Iron deficiency anemia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Atrial fibrillation</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hypothyroidism</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Chronic gastritis</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Duodenitis</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Duodenal ulcer perforation</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Dyspepsia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Gastric disorder</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Inguinal hernia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Large intestine polyp</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cholelithiasis</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hepatic steatosis</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Latent tuberculosis</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pulmonary tuberculosis</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hyperlipidaemia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Spinal osteoarthritis</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Osteoarthritis</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Osteopenia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Osteoporosis</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Rotator cuff syndrome</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Scoliosis</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Spondyloarthropathy</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Spondylolisthesis</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Spinal column stenosis</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Haemangioma of liver</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ovarian cancer</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Radiculopathy</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cervical radiculopathy</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Gynaecomastia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Chronic obstructive pulmonary disease</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hypertension</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Prior Exposure to Disease Modifying Anti-rheumatic Drugs (DMARDs)</title>
        <time_frame>Baseline</time_frame>
        <population>FAS.</population>
        <group_list>
          <group group_id="O1">
            <title>Tocilizumab</title>
            <description>Participants with moderate to severe rheumatoid arthritis, in whom treating physician had made a decision to commence tocilizumab treatment according to local labeling (including participants who had started tocilizumab treatment within 8 weeks before enrollment) were observed prospectively for 12 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Prior Exposure to Disease Modifying Anti-rheumatic Drugs (DMARDs)</title>
          <population>FAS.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="23"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>No Prior DMARDs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 Prior DMARD</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2 Prior DMARDs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3 Prior DMARDs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>4 Prior DMARDs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>5 Prior DMARDs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Prior Exposure of Biologics</title>
        <time_frame>Baseline</time_frame>
        <population>FAS.</population>
        <group_list>
          <group group_id="O1">
            <title>Tocilizumab</title>
            <description>Participants with moderate to severe rheumatoid arthritis, in whom treating physician had made a decision to commence tocilizumab treatment according to local labeling (including participants who had started tocilizumab treatment within 8 weeks before enrollment) were observed prospectively for 12 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Prior Exposure of Biologics</title>
          <population>FAS.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="23"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>No Prior Biologics</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 Prior Biologic</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2 Prior Biologics</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Disease Activity Score Based on 28-joints Count (DAS28)</title>
        <description>DAS28 calculated from the number of swollen joints (SJC) and tender joints (TJC) using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hr]) and patient's global assessment (PtGA) of disease activity. DAS28 total score range = 0 to 10, where higher scores indicates higher disease activity. DAS28 less than and equal to (&lt;=) 2.6 meant clinical remission; DAS28 &lt;=3.2 meant low disease activity; DAS28 greater than (&gt;) 3.2 to 5.1 implied moderate disease activity; and DAS28 &gt;5.1 implied high disease activity.</description>
        <time_frame>Baseline, Month 3, 6, and 12</time_frame>
        <population>FAS. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure and 'n' signifies the number of participants analyzed at specified time point.</population>
        <group_list>
          <group group_id="O1">
            <title>Tocilizumab</title>
            <description>Participants with moderate to severe rheumatoid arthritis, in whom treating physician had made a decision to commence tocilizumab treatment according to local labeling (including participants who had started tocilizumab treatment within 8 weeks before enrollment) were observed prospectively for 12 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Disease Activity Score Based on 28-joints Count (DAS28)</title>
          <description>DAS28 calculated from the number of swollen joints (SJC) and tender joints (TJC) using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hr]) and patient's global assessment (PtGA) of disease activity. DAS28 total score range = 0 to 10, where higher scores indicates higher disease activity. DAS28 less than and equal to (&lt;=) 2.6 meant clinical remission; DAS28 &lt;=3.2 meant low disease activity; DAS28 greater than (&gt;) 3.2 to 5.1 implied moderate disease activity; and DAS28 &gt;5.1 implied high disease activity.</description>
          <population>FAS. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure and 'n' signifies the number of participants analyzed at specified time point.</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="22"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (n=22)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.35" spread="1.21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 3 (n=19)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.54" spread="1.20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6 (n=17)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.91" spread="1.59"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 12 (n=11)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.29" spread="1.11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Change from Baseline at Month 3</groups_desc>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>&lt;0.01</p_value>
            <method>Wilcoxon's signed-rank test</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Change from Baseline at Month 6</groups_desc>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>&lt;0.01</p_value>
            <method>Wilcoxon's signed-rank test</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Change from Baseline at Month 12</groups_desc>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>&lt;0.01</p_value>
            <method>Wilcoxon's signed-rank test</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With European League Against Rheumatism (EULAR) Response Based on DAS28</title>
        <description>The DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Description of DAS28 calculation is provided in Outcome Measure 7. Good responders: decrease from baseline &gt;1.2 with DAS28 &lt;= 3.2; moderate responders: decrease from baseline &gt;1.2 with DAS28 &gt;3.2 or decrease from baseline &gt;0.6 to &lt;=1.2 with DAS28 &lt;=5.1; non-responders: decrease from baseline &lt;= 0.6 or decrease from baseline &gt;0.6 and &lt;=1.2 with DAS28 &gt;5.1.</description>
        <time_frame>Month 3, 6, and 12</time_frame>
        <population>FAS. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure and 'n' signifies the number of participants analyzed for specified category.</population>
        <group_list>
          <group group_id="O1">
            <title>Tocilizumab</title>
            <description>Participants with moderate to severe rheumatoid arthritis, in whom treating physician had made a decision to commence tocilizumab treatment according to local labeling (including participants who had started tocilizumab treatment within 8 weeks before enrollment) were observed prospectively for 12 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With European League Against Rheumatism (EULAR) Response Based on DAS28</title>
          <description>The DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Description of DAS28 calculation is provided in Outcome Measure 7. Good responders: decrease from baseline &gt;1.2 with DAS28 &lt;= 3.2; moderate responders: decrease from baseline &gt;1.2 with DAS28 &gt;3.2 or decrease from baseline &gt;0.6 to &lt;=1.2 with DAS28 &lt;=5.1; non-responders: decrease from baseline &lt;= 0.6 or decrease from baseline &gt;0.6 and &lt;=1.2 with DAS28 &gt;5.1.</description>
          <population>FAS. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure and 'n' signifies the number of participants analyzed for specified category.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="22"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Month 3: Good responders (n=18)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="18"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 3: Moderate responders (n=18)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="18"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 3: Non-responders (n=18)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="18"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6: Good responders (n=16)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6: Moderate responders (n = 16)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6: Non-responders (n=16)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 12: Good responders (n=11)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 12: Moderate responders (n=11)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 12: Non-responders (n=11)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <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>Physician Global Assessment (PGA) of Disease Activity</title>
        <description>PGA of disease activity was measured on a 0 to 100 millimeter (mm) visual analog scale (VAS), with 0 mm = no disease activity and 100 mm = highest possible disease activity.</description>
        <time_frame>Baseline, Month 6, and 12</time_frame>
        <population>FAS. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure and 'n' signifies the number of participants analyzed at specified time point.</population>
        <group_list>
          <group group_id="O1">
            <title>Tocilizumab</title>
            <description>Participants with moderate to severe rheumatoid arthritis, in whom treating physician had made a decision to commence tocilizumab treatment according to local labeling (including participants who had started tocilizumab treatment within 8 weeks before enrollment) were observed prospectively for 12 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Physician Global Assessment (PGA) of Disease Activity</title>
          <description>PGA of disease activity was measured on a 0 to 100 millimeter (mm) visual analog scale (VAS), with 0 mm = no disease activity and 100 mm = highest possible disease activity.</description>
          <population>FAS. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure and 'n' signifies the number of participants analyzed at specified time point.</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="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (n=20)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="58.40" spread="10.08"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6 (n=15)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27.00" spread="18.34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 12 (n=10)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.80" spread="13.83"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Change from Baseline at Month 6</groups_desc>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Wilcoxon's signed-rank test</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Change from Baseline at Month 12</groups_desc>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>Wilcoxon's signed-rank test</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Patient Global Assessment (PtGA) of Disease Activity Score</title>
        <description>PtGA of Disease Activity was measured on a 0 to 100 mm VAS, with 0 mm = no disease activity and 100 mm = highest possible disease activity.</description>
        <time_frame>Baseline, Month 6, and 12</time_frame>
        <population>FAS. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure and 'n' signifies the number of participants analyzed at specified time point.</population>
        <group_list>
          <group group_id="O1">
            <title>Tocilizumab</title>
            <description>Participants with moderate to severe rheumatoid arthritis, in whom treating physician had made a decision to commence tocilizumab treatment according to local labeling (including participants who had started tocilizumab treatment within 8 weeks before enrollment) were observed prospectively for 12 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Patient Global Assessment (PtGA) of Disease Activity Score</title>
          <description>PtGA of Disease Activity was measured on a 0 to 100 mm VAS, with 0 mm = no disease activity and 100 mm = highest possible disease activity.</description>
          <population>FAS. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure and 'n' signifies the number of participants analyzed at specified time point.</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="22"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (n=22)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="62.68" spread="17.67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6 (n=17)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="36.85" spread="24.22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 12 (n=11)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22.27" spread="21.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Change from Baseline at Month 6</groups_desc>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>&lt;0.05</p_value>
            <method>Wilcoxon's signed-rank test</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Change from Baseline at Month 12</groups_desc>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>Wilcoxon's signed-rank test</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Health Assessment Questionnaire-Disability Index (HAQ-DI) Score</title>
        <description>HAQ-DI: participant reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item was scored on a 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores divided by the number of domains answered. Total possible score range was 0-3 where 0 = least difficulty and 3 = extreme difficulty.</description>
        <time_frame>Baseline, Month 6, and 12</time_frame>
        <population>FAS. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure and 'n' signifies the number of participants analyzed at specified time point.</population>
        <group_list>
          <group group_id="O1">
            <title>Tocilizumab</title>
            <description>Participants with moderate to severe rheumatoid arthritis, in whom treating physician had made a decision to commence tocilizumab treatment according to local labeling (including participants who had started tocilizumab treatment within 8 weeks before enrollment) were observed prospectively for 12 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Health Assessment Questionnaire-Disability Index (HAQ-DI) Score</title>
          <description>HAQ-DI: participant reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item was scored on a 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores divided by the number of domains answered. Total possible score range was 0-3 where 0 = least difficulty and 3 = extreme difficulty.</description>
          <population>FAS. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure and 'n' signifies the number of participants analyzed at specified time point.</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="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (n=20)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.22" spread="0.80"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6 (n=10)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.98" spread="0.81"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 12 (n=6)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.65" spread="0.52"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Visual Analog Scale (VAS)-Pain</title>
        <description>Intensity of pain was measured on a 100 mm line VAS marked by participant. It ranged (over the past week): 0 = no pain to 100 = worst possible pain.</description>
        <time_frame>Baseline, Month 6, and 12</time_frame>
        <population>FAS. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure and 'n' signifies the number of participants analyzed at specified time point.</population>
        <group_list>
          <group group_id="O1">
            <title>Tocilizumab</title>
            <description>Participants with moderate to severe rheumatoid arthritis, in whom treating physician had made a decision to commence tocilizumab treatment according to local labeling (including participants who had started tocilizumab treatment within 8 weeks before enrollment) were observed prospectively for 12 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Visual Analog Scale (VAS)-Pain</title>
          <description>Intensity of pain was measured on a 100 mm line VAS marked by participant. It ranged (over the past week): 0 = no pain to 100 = worst possible pain.</description>
          <population>FAS. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure and 'n' signifies the number of participants analyzed at specified time point.</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="22"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (n=22)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="56.18" spread="21.64"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6 (n=17)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35.00" spread="23.25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 12 (n=11)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22.91" spread="22.87"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Change from Baseline at Month 6</groups_desc>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>&lt;0.05</p_value>
            <method>Wilcoxon's signed-rank test</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Change from Baseline at Month 12</groups_desc>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>&lt;0.01</p_value>
            <method>Wilcoxon's signed-rank test</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Visual Analog Fatigue Scale (VAFS)</title>
        <description>Participants assessed their fatigue using a 0 - 100 mm VAS, where 0 mm = no fatigue and 100 mm = worst possible fatigue.</description>
        <time_frame>Baseline, Month 6, and 12</time_frame>
        <population>FAS. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure and 'n' signifies the number of participants analyzed at specified time point.</population>
        <group_list>
          <group group_id="O1">
            <title>Tocilizumab</title>
            <description>Participants with moderate to severe rheumatoid arthritis, in whom treating physician had made a decision to commence tocilizumab treatment according to local labeling (including participants who had started tocilizumab treatment within 8 weeks before enrollment) were observed prospectively for 12 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Visual Analog Fatigue Scale (VAFS)</title>
          <description>Participants assessed their fatigue using a 0 - 100 mm VAS, where 0 mm = no fatigue and 100 mm = worst possible fatigue.</description>
          <population>FAS. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure and 'n' signifies the number of participants analyzed at specified time point.</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="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (n=6)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="67.00" spread="30.66"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6 (n=5)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="39.80" spread="30.38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 12 (n=3)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.67" spread="6.66"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Change from Baseline at Month 12</groups_desc>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>&lt;0.01</p_value>
            <method>Wilcoxon's signed-rank test</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Visual Analog Scale-Morning Stiffness (VAS-MS)</title>
        <description>Participants assessed their morning stiffness using a 0 - 100 mm VAS, where 0 mm = no stiffness and 100 mm = worst possible stiffness.</description>
        <time_frame>Baseline, Month 6, and 12</time_frame>
        <population>FAS. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure and 'n' signifies the number of participants analyzed at specified time point.</population>
        <group_list>
          <group group_id="O1">
            <title>Tocilizumab</title>
            <description>Participants with moderate to severe rheumatoid arthritis, in whom treating physician had made a decision to commence tocilizumab treatment according to local labeling (including participants who had started tocilizumab treatment within 8 weeks before enrollment) were observed prospectively for 12 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Visual Analog Scale-Morning Stiffness (VAS-MS)</title>
          <description>Participants assessed their morning stiffness using a 0 - 100 mm VAS, where 0 mm = no stiffness and 100 mm = worst possible stiffness.</description>
          <population>FAS. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure and 'n' signifies the number of participants analyzed at specified time point.</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="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (n=6)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="67.00" spread="12.54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6 (n=5)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23.60" spread="33.22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 12 (n=2)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.00" spread="19.80"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Erythrocyte Sedimentation Rate (ESR)</title>
        <description>ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 mm/hr. A higher rate is consistent with inflammation.</description>
        <time_frame>Baseline, Month 6, and 12</time_frame>
        <population>FAS. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure and 'n' signifies the number of participants analyzed at specified time point.</population>
        <group_list>
          <group group_id="O1">
            <title>Tocilizumab</title>
            <description>Participants with moderate to severe rheumatoid arthritis, in whom treating physician had made a decision to commence tocilizumab treatment according to local labeling (including participants who had started tocilizumab treatment within 8 weeks before enrollment) were observed prospectively for 12 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Erythrocyte Sedimentation Rate (ESR)</title>
          <description>ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 mm/hr. A higher rate is consistent with inflammation.</description>
          <population>FAS. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure and 'n' signifies the number of participants analyzed at specified time point.</population>
          <units>mm/hr</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="23"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (n=23)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="23"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="36.83" spread="27.53"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6 (n=16)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.81" spread="14.11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 12 (n=13)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.54" spread="6.77"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Change from Baseline at Month 6</groups_desc>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Wilcoxon's signed-rank test</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Change from Baseline at Month 12</groups_desc>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>&lt;0.01</p_value>
            <method>Wilcoxon's signed-rank test</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>C-Reactive Protein (CRP)</title>
        <description>The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. Normal range is up to 10 milligram per liter (mg/L). A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.</description>
        <time_frame>Baseline, Month 6, and 12</time_frame>
        <population>FAS. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure and 'n' signifies the number of participants analyzed at specified time point.</population>
        <group_list>
          <group group_id="O1">
            <title>Tocilizumab</title>
            <description>Participants with moderate to severe rheumatoid arthritis, in whom treating physician had made a decision to commence tocilizumab treatment according to local labeling (including participants who had started tocilizumab treatment within 8 weeks before enrollment) were observed prospectively for 12 months.</description>
          </group>
        </group_list>
        <measure>
          <title>C-Reactive Protein (CRP)</title>
          <description>The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. Normal range is up to 10 milligram per liter (mg/L). A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.</description>
          <population>FAS. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure and 'n' signifies the number of participants analyzed at specified time point.</population>
          <units>mg/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="23"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (n=23)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="23"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30.16" spread="41.14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6 (n=18)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="18"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.54" spread="17.54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 12 (n=14)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.07" spread="7.70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Change from Baseline at Month 6</groups_desc>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>&lt;0.05</p_value>
            <method>Wilcoxon's signed-rank test</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Change from Baseline at Month 12</groups_desc>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>&lt;0.01</p_value>
            <method>Wilcoxon's signed-rank test</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Swollen and Tender Joints Based on 66 and 68 Joints</title>
        <description>Number of swollen joints was determined by examination of 66 joints (SJC66) and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, 0 = no swelling, 1 = swelling. Number of tender joints was determined by examining 68 joints (TJC68) and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at each visit, 0 = no tenderness, 1 = tenderness.</description>
        <time_frame>Baseline, Month 6, and 12</time_frame>
        <population>FAS. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure and 'n' signifies the number of participants analyzed at specified time point for specified category.</population>
        <group_list>
          <group group_id="O1">
            <title>Tocilizumab</title>
            <description>Participants with moderate to severe rheumatoid arthritis, in whom treating physician had made a decision to commence tocilizumab treatment according to local labeling (including participants who had started tocilizumab treatment within 8 weeks before enrollment) were observed prospectively for 12 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Swollen and Tender Joints Based on 66 and 68 Joints</title>
          <description>Number of swollen joints was determined by examination of 66 joints (SJC66) and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, 0 = no swelling, 1 = swelling. Number of tender joints was determined by examining 68 joints (TJC68) and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at each visit, 0 = no tenderness, 1 = tenderness.</description>
          <population>FAS. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure and 'n' signifies the number of participants analyzed at specified time point for specified category.</population>
          <units>joints count</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>SJC66: Baseline (n=7)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.29" spread="2.21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TJC68: Baseline (n=7)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.86" spread="7.99"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SJC66: Month 6 (n=1)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" spread="NA">Standard deviation was not calculated due to insufficient number of participants analyzed at this time point.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TJC68: Month 6 (n=1)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" spread="NA">Standard deviation was not calculated due to insufficient number of participants analyzed at this time point.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SJC66: Month 12 (n=1)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.00" spread="NA">Standard deviation was not calculated due to insufficient number of participants analyzed at this time point.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TJC68: Month 12 (n=1)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.00" spread="NA">Standard deviation was not calculated due to insufficient number of participants analyzed at this time point.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Swollen and Tender Joints Based on 28 Joints</title>
        <description>Number of swollen joints was determined by examination of 28 (SJC28) joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, 0 = no swelling, 1 = swelling. Number of tender joints was determined by examining 28 joints (TJC28) and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at each visit, 0 = no tenderness, 1 = tenderness.</description>
        <time_frame>Baseline, Month 6, and 12</time_frame>
        <population>FAS. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure and 'n' signifies the number of participants analyzed at specified time point for specified category.</population>
        <group_list>
          <group group_id="O1">
            <title>Tocilizumab</title>
            <description>Participants with moderate to severe rheumatoid arthritis, in whom treating physician had made a decision to commence tocilizumab treatment according to local labeling (including participants who had started tocilizumab treatment within 8 weeks before enrollment) were observed prospectively for 12 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Swollen and Tender Joints Based on 28 Joints</title>
          <description>Number of swollen joints was determined by examination of 28 (SJC28) joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, 0 = no swelling, 1 = swelling. Number of tender joints was determined by examining 28 joints (TJC28) and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at each visit, 0 = no tenderness, 1 = tenderness.</description>
          <population>FAS. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure and 'n' signifies the number of participants analyzed at specified time point for specified category.</population>
          <units>joints count</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="23"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>SJC28: Baseline (n=23)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="23"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.78" spread="4.06"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TJC28: Baseline (n=23)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="23"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.13" spread="7.23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SJC28: Month 6 (n=18)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="18"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.56" spread="2.79"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TJC28: Month 6 (n=18)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="18"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.11" spread="6.03"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SJC28: Month 12 (n=13)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.54" spread="2.40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TJC28: Month 12 (n=13)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.92" spread="1.85"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>SJC28: Change from Baseline at Month 6</groups_desc>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>&lt;0.01</p_value>
            <method>Wilcoxon's signed-rank test</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>TJC28: Change from Baseline at Month 6</groups_desc>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>&lt;0.01</p_value>
            <method>Wilcoxon's signed-rank test</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>SJC28: Change from Baseline at Month 12</groups_desc>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Wilcoxon's signed-rank test</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>TJC28: Change from Baseline at Month 12</groups_desc>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>&lt;0.01</p_value>
            <method>Wilcoxon's signed-rank test</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Simplified Disease Activity Index (SDAI) Score</title>
        <description>The SDAI is the numerical sum of five outcome parameters: TJC28, SJC28, PtGA, PGA, and CRP. Description of these outcome parameters is given in outcome measure 9, 10, 16, and 18. SDAI total score = 0-86. SDAI &lt;=3.3 indicates disease remission, &gt;3.4 to 11 = low disease activity, &gt;11 to 26 = moderate disease activity, and &gt;26 = high disease activity.</description>
        <time_frame>Baseline, Month 6, and 12</time_frame>
        <population>FAS. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure and 'n' signifies the number of participants analyzed at specified time point.</population>
        <group_list>
          <group group_id="O1">
            <title>Tocilizumab</title>
            <description>Participants with moderate to severe rheumatoid arthritis, in whom treating physician had made a decision to commence tocilizumab treatment according to local labeling (including participants who had started tocilizumab treatment within 8 weeks before enrollment) were observed prospectively for 12 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Simplified Disease Activity Index (SDAI) Score</title>
          <description>The SDAI is the numerical sum of five outcome parameters: TJC28, SJC28, PtGA, PGA, and CRP. Description of these outcome parameters is given in outcome measure 9, 10, 16, and 18. SDAI total score = 0-86. SDAI &lt;=3.3 indicates disease remission, &gt;3.4 to 11 = low disease activity, &gt;11 to 26 = moderate disease activity, and &gt;26 = high disease activity.</description>
          <population>FAS. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure and 'n' signifies the number of participants analyzed at specified time point.</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="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (n=20)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31.99" spread="10.77"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6 (n=15)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.69" spread="11.60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 12 (n=10)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.17" spread="6.12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Change from Baseline at Month 6</groups_desc>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>&lt;0.01</p_value>
            <method>Wilcoxon's signed-rank test</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Change from Baseline at Month 12</groups_desc>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Wilcoxon's signed-rank test</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Clinical Disease Activity Index (CDAI) Score</title>
        <description>The CDAI is the numerical sum of 4 outcome parameters: TJC28, SJC28, PtGA, and PGA. Description of these outcome parameters is given come measure 9, 10, and 18. CDAI total score = 0-76. CDAI &lt;= 2.8 indicates disease remission, &gt;2.8 to 10 = low disease activity, &gt;10 to 22 = moderate disease activity, and &gt;22 = high disease activity.</description>
        <time_frame>Baseline, Month 6, and 12</time_frame>
        <population>FAS. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure and 'n' signifies the number of participants analyzed at specified time point.</population>
        <group_list>
          <group group_id="O1">
            <title>Tocilizumab</title>
            <description>Participants with moderate to severe rheumatoid arthritis, in whom treating physician had made a decision to commence tocilizumab treatment according to local labeling (including participants who had started tocilizumab treatment within 8 weeks before enrollment) were observed prospectively for 12 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Clinical Disease Activity Index (CDAI) Score</title>
          <description>The CDAI is the numerical sum of 4 outcome parameters: TJC28, SJC28, PtGA, and PGA. Description of these outcome parameters is given come measure 9, 10, and 18. CDAI total score = 0-76. CDAI &lt;= 2.8 indicates disease remission, &gt;2.8 to 10 = low disease activity, &gt;10 to 22 = moderate disease activity, and &gt;22 = high disease activity.</description>
          <population>FAS. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure and 'n' signifies the number of participants analyzed at specified time point.</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="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (n=20)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28.68" spread="10.21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6 (n=15)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.12" spread="11.55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 12 (n=10)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.77" spread="5.33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Change from Baseline at Month 6</groups_desc>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>&lt;0.01</p_value>
            <method>Wilcoxon's signed-rank test</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Change from Baseline at Month 12</groups_desc>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Wilcoxon's signed-rank test</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Who Received Tocilizumab as Monotherapy</title>
        <time_frame>Baseline, Study end (at Month 12 or at time of study discontinuation)</time_frame>
        <population>FAS.</population>
        <group_list>
          <group group_id="O1">
            <title>Tocilizumab</title>
            <description>Participants with moderate to severe rheumatoid arthritis, in whom treating physician had made a decision to commence tocilizumab treatment according to local labeling (including participants who had started tocilizumab treatment within 8 weeks before enrollment) were observed prospectively for 12 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Received Tocilizumab as Monotherapy</title>
          <population>FAS.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="23"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Study end</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Who Received Tocilizumab in Combination With Disease Modifying Anti-rheumatic Drugs (DMARDs)</title>
        <time_frame>Baseline, Study end (at Month 12 or at time of study discontinuation)</time_frame>
        <population>FAS.</population>
        <group_list>
          <group group_id="O1">
            <title>Tocilizumab</title>
            <description>Participants with moderate to severe rheumatoid arthritis, in whom treating physician had made a decision to commence tocilizumab treatment according to local labeling (including participants who had started tocilizumab treatment within 8 weeks before enrollment) were observed prospectively for 12 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Received Tocilizumab in Combination With Disease Modifying Anti-rheumatic Drugs (DMARDs)</title>
          <population>FAS.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="23"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Study end</title>
              <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>Number of Participants Receiving Oral Corticosteroids</title>
        <time_frame>Baseline, Month 3, 6, and 12</time_frame>
        <population>FAS. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure and 'n' signifies the number of participants analyzed at specified time point.</population>
        <group_list>
          <group group_id="O1">
            <title>Tocilizumab</title>
            <description>Participants with moderate to severe rheumatoid arthritis, in whom treating physician had made a decision to commence tocilizumab treatment according to local labeling (including participants who had started tocilizumab treatment within 8 weeks before enrollment) were observed prospectively for 12 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Receiving Oral Corticosteroids</title>
          <population>FAS. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure and 'n' signifies the number of participants analyzed at specified time point.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="23"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (n=23)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="23"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 3 (n=21)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="21"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6 (n=19)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 12 (n=15)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Disease Activity Status Based on DAS28 Score</title>
        <description>Participants were assigned the disease activity status on the basis of DAS28 score. Description of DAS28 calculation is provided in Outcome Measure 7. Remission: DAS28 score &lt;= 2.6; low disease activity: DAS28 &lt;=3.2; moderate disease activity: DAS28 &lt;=5.1; and high disease activity: DAS28 &gt;5.1.</description>
        <time_frame>Baseline, Month 3, 6, and 12</time_frame>
        <population>FAS. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure and 'n' signifies the number of participants analyzed for specified category.</population>
        <group_list>
          <group group_id="O1">
            <title>Tocilizumab</title>
            <description>Participants with moderate to severe rheumatoid arthritis, in whom treating physician had made a decision to commence tocilizumab treatment according to local labeling (including participants who had started tocilizumab treatment within 8 weeks before enrollment) were observed prospectively for 12 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Disease Activity Status Based on DAS28 Score</title>
          <description>Participants were assigned the disease activity status on the basis of DAS28 score. Description of DAS28 calculation is provided in Outcome Measure 7. Remission: DAS28 score &lt;= 2.6; low disease activity: DAS28 &lt;=3.2; moderate disease activity: DAS28 &lt;=5.1; and high disease activity: DAS28 &gt;5.1.</description>
          <population>FAS. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure and 'n' signifies the number of participants analyzed for specified category.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="22"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline: Remission (n=22)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline: low disease activity (n=22)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline: moderate disease activity (n=22)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline: high disease activity (n=22)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 3: Remission (n=19)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 3: low disease activity (n=19)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 3: moderate disease activity (n=19)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 3: high disease activity (n=19)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6: Remission (n=17)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6: low disease activity (n=17)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6: moderate disease activity (n=17)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6: high disease activity (n=17)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 12: Remission (n=11)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 12: moderate disease activity (n=11)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Disease Activity Status Based on SDAI Score</title>
        <description>Participants were assigned the disease activity status on the basis of SDAI score. Description of SDAI score calculation is provided in Outcome Measure 19. Remission: SDAI score &lt;= 3.3; low disease activity: SDAI &lt;=11.0; moderate disease activity: SDAI &lt;=26.0; and high disease activity: SDAI &gt;26.0.</description>
        <time_frame>Baseline, Month 3, 6, and 12</time_frame>
        <population>FAS. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure and 'n' signifies the number of participants analyzed for specified category.</population>
        <group_list>
          <group group_id="O1">
            <title>Tocilizumab</title>
            <description>Participants with moderate to severe rheumatoid arthritis, in whom treating physician had made a decision to commence tocilizumab treatment according to local labeling (including participants who had started tocilizumab treatment within 8 weeks before enrollment) were observed prospectively for 12 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Disease Activity Status Based on SDAI Score</title>
          <description>Participants were assigned the disease activity status on the basis of SDAI score. Description of SDAI score calculation is provided in Outcome Measure 19. Remission: SDAI score &lt;= 3.3; low disease activity: SDAI &lt;=11.0; moderate disease activity: SDAI &lt;=26.0; and high disease activity: SDAI &gt;26.0.</description>
          <population>FAS. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure and 'n' signifies the number of participants analyzed for specified category.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline: moderate disease activity (n=20)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline: high disease activity (n=20)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 3: low disease activity (n=16)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 3: moderate disease activity (n=16)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 3: high disease activity (n=16)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6: Remission (n=15)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6: low disease activity (n=15)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6: moderate disease activity (n=15)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6: high disease activity (n=15)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 12: Remission (n=10)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 12: low disease activity (n=10)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 12: moderate disease activity (n=10)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Disease Activity Status Based on CDAI Score</title>
        <description>Participants were assigned the disease activity status on the basis of CDAI score. Description of CDAI score calculation is provided in Outcome Measure 20. Remission: CDAI score &lt;= 2.8; low disease activity: CDAI &lt;=10.0; moderate disease activity: CDAI &lt;=22.0; and high disease activity: CDAI &gt;22.0.</description>
        <time_frame>Baseline, Month 3, 6, and 12</time_frame>
        <population>FAS. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure and 'n' signifies the number of participants analyzed for specified category.</population>
        <group_list>
          <group group_id="O1">
            <title>Tocilizumab</title>
            <description>Participants with moderate to severe rheumatoid arthritis, in whom treating physician had made a decision to commence tocilizumab treatment according to local labeling (including participants who had started tocilizumab treatment within 8 weeks before enrollment) were observed prospectively for 12 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Disease Activity Status Based on CDAI Score</title>
          <description>Participants were assigned the disease activity status on the basis of CDAI score. Description of CDAI score calculation is provided in Outcome Measure 20. Remission: CDAI score &lt;= 2.8; low disease activity: CDAI &lt;=10.0; moderate disease activity: CDAI &lt;=22.0; and high disease activity: CDAI &gt;22.0.</description>
          <population>FAS. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure and 'n' signifies the number of participants analyzed for specified category.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline: moderate disease activity (n=20)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline: high disease activity (n=20)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 3: low disease activity (n=17)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 3: moderate disease activity (n=17)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 3: high disease activity (n=17)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6: Remission (n=15)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6: low disease activity (n=15)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6: moderate disease activity (n=15)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6: high disease activity (n=15)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 12: Remission (n=10)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 12: low disease activity (n=10)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 12: moderate disease activity (n=10)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Up to Month 12</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Tocilizumab</title>
          <description>Participants with moderate to severe rheumatoid arthritis, in whom treating physician had made a decision to commence tocilizumab treatment according to local labeling (including participants who had started tocilizumab treatment within 8 weeks before enrollment) were observed prospectively for 12 months.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 17.1</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="23"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Chronic tonsillitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>Post procedural infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="23"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Femur fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="23"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Interstitial lung disease</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="23"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Knee arthroplasty</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="23"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 17.1</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="10" subjects_at_risk="23"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Leukopenia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>Neutropenia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="23"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="23"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Hepatic enzyme increased</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="23"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="23"/>
              </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-LaRoche</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/NCT01663506
org study id: ML28311
nct id: NCT01663506
lead sponsor: 
This non-interventional study will evaluate the use and efficacy of RoActemra/Actemra
      (tocilizumab) in patients with moderate to severe rheumatoid arthritis. Eligible patients
      initiated on RoActemra/Actemra treatment according to the local label will be followed for 12
      months.
observational model: Cohort
time perspective: Prospective
measure: Percentage of Participants With Tocilizumab Treatment at 6 Months After Treatment Initiation
time frame: 6 Months
measure: Percentage of Participants With Tocilizumab Treatment at 12 Months After Treatment Initiation
time frame: Month 12
measure: Percentage of Participants With Tocilizumab Dose Modification, Interruption, and Irregularity
time frame: Up to Month 12
description: Dose modification was defined as an increase or decrease in the dose of study drug compared to the previous dose received. Interruption was defined as temporary or permanent discontinuation of study drug due to any reason, for example adverse event. Irregularity was defined as a time interval of greater than and equal to (>=) 75 days between two consecutive doses of study drug.
measure: Number of Participants With Comorbidities at Baseline
time frame: Baseline
description: Participants were assessed for any comorbidity at study entry including anemia, fatigue, conventional risk factors for cardiovascular disease, C-reactive protein (CRP) level above upper limit of normal, rheumatoid nodules, rheumatoid vasculitis, interstitial lung disease, and so on. Number of participants with each comorbidity was reported. One participant could have presented with more than 1 comorbidity.
measure: Number of Participants With Prior Exposure to Disease Modifying Anti-rheumatic Drugs (DMARDs)
time frame: Baseline
measure: Number of Participants With Prior Exposure of Biologics
time frame: Baseline
measure: Disease Activity Score Based on 28-joints Count (DAS28)
time frame: Baseline, Month 3, 6, and 12
description: DAS28 calculated from the number of swollen joints (SJC) and tender joints (TJC) using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hr]) and patient's global assessment (PtGA) of disease activity. DAS28 total score range = 0 to 10, where higher scores indicates higher disease activity. DAS28 less than and equal to (<=) 2.6 meant clinical remission; DAS28 <=3.2 meant low disease activity; DAS28 greater than (>) 3.2 to 5.1 implied moderate disease activity; and DAS28 >5.1 implied high disease activity.
measure: Number of Participants With European League Against Rheumatism (EULAR) Response Based on DAS28
time frame: Month 3, 6, and 12
description: The DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Description of DAS28 calculation is provided in Outcome Measure 7. Good responders: decrease from baseline >1.2 with DAS28 <= 3.2; moderate responders: decrease from baseline >1.2 with DAS28 >3.2 or decrease from baseline >0.6 to <=1.2 with DAS28 <=5.1; non-responders: decrease from baseline <= 0.6 or decrease from baseline >0.6 and <=1.2 with DAS28 >5.1.
measure: Physician Global Assessment (PGA) of Disease Activity
time frame: Baseline, Month 6, and 12
description: PGA of disease activity was measured on a 0 to 100 millimeter (mm) visual analog scale (VAS), with 0 mm = no disease activity and 100 mm = highest possible disease activity.
measure: Patient Global Assessment (PtGA) of Disease Activity Score
time frame: Baseline, Month 6, and 12
description: PtGA of Disease Activity was measured on a 0 to 100 mm VAS, with 0 mm = no disease activity and 100 mm = highest possible disease activity.
measure: Health Assessment Questionnaire-Disability Index (HAQ-DI) Score
time frame: Baseline, Month 6, and 12
description: HAQ-DI: participant reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item was scored on a 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores divided by the number of domains answered. Total possible score range was 0-3 where 0 = least difficulty and 3 = extreme difficulty.
measure: Visual Analog Scale (VAS)-Pain
time frame: Baseline, Month 6, and 12
description: Intensity of pain was measured on a 100 mm line VAS marked by participant. It ranged (over the past week): 0 = no pain to 100 = worst possible pain.
measure: Visual Analog Fatigue Scale (VAFS)
time frame: Baseline, Month 6, and 12
description: Participants assessed their fatigue using a 0 - 100 mm VAS, where 0 mm = no fatigue and 100 mm = worst possible fatigue.
measure: Visual Analog Scale-Morning Stiffness (VAS-MS)
time frame: Baseline, Month 6, and 12
description: Participants assessed their morning stiffness using a 0 - 100 mm VAS, where 0 mm = no stiffness and 100 mm = worst possible stiffness.
measure: Erythrocyte Sedimentation Rate (ESR)
time frame: Baseline, Month 6, and 12
description: ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 mm/hr. A higher rate is consistent with inflammation.
measure: C-Reactive Protein (CRP)
time frame: Baseline, Month 6, and 12
description: The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. Normal range is up to 10 milligram per liter (mg/L). A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.
measure: Number of Swollen and Tender Joints Based on 66 and 68 Joints
time frame: Baseline, Month 6, and 12
description: Number of swollen joints was determined by examination of 66 joints (SJC66) and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, 0 = no swelling, 1 = swelling. Number of tender joints was determined by examining 68 joints (TJC68) and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at each visit, 0 = no tenderness, 1 = tenderness.
measure: Number of Swollen and Tender Joints Based on 28 Joints
time frame: Baseline, Month 6, and 12
description: Number of swollen joints was determined by examination of 28 (SJC28) joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, 0 = no swelling, 1 = swelling. Number of tender joints was determined by examining 28 joints (TJC28) and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at each visit, 0 = no tenderness, 1 = tenderness.
measure: Simplified Disease Activity Index (SDAI) Score
time frame: Baseline, Month 6, and 12
description: The SDAI is the numerical sum of five outcome parameters: TJC28, SJC28, PtGA, PGA, and CRP. Description of these outcome parameters is given in outcome measure 9, 10, 16, and 18. SDAI total score = 0-86. SDAI <=3.3 indicates disease remission, >3.4 to 11 = low disease activity, >11 to 26 = moderate disease activity, and >26 = high disease activity.
measure: Clinical Disease Activity Index (CDAI) Score
time frame: Baseline, Month 6, and 12
description: The CDAI is the numerical sum of 4 outcome parameters: TJC28, SJC28, PtGA, and PGA. Description of these outcome parameters is given come measure 9, 10, and 18. CDAI total score = 0-76. CDAI <= 2.8 indicates disease remission, >2.8 to 10 = low disease activity, >10 to 22 = moderate disease activity, and >22 = high disease activity.
measure: Number of Participants Who Received Tocilizumab as Monotherapy
time frame: Baseline, Study end (at Month 12 or at time of study discontinuation)
measure: Number of Participants Who Received Tocilizumab in Combination With Disease Modifying Anti-rheumatic Drugs (DMARDs)
time frame: Baseline, Study end (at Month 12 or at time of study discontinuation)
measure: Number of Participants Receiving Oral Corticosteroids
time frame: Baseline, Month 3, 6, and 12
measure: Number of Participants With Disease Activity Status Based on DAS28 Score
time frame: Baseline, Month 3, 6, and 12
description: Participants were assigned the disease activity status on the basis of DAS28 score. Description of DAS28 calculation is provided in Outcome Measure 7. Remission: DAS28 score <= 2.6; low disease activity: DAS28 <=3.2; moderate disease activity: DAS28 <=5.1; and high disease activity: DAS28 >5.1.
measure: Number of Participants With Disease Activity Status Based on SDAI Score
time frame: Baseline, Month 3, 6, and 12
description: Participants were assigned the disease activity status on the basis of SDAI score. Description of SDAI score calculation is provided in Outcome Measure 19. Remission: SDAI score <= 3.3; low disease activity: SDAI <=11.0; moderate disease activity: SDAI <=26.0; and high disease activity: SDAI >26.0.
measure: Number of Participants With Disease Activity Status Based on CDAI Score
time frame: Baseline, Month 3, 6, and 12
description: Participants were assigned the disease activity status on the basis of CDAI score. Description of CDAI score calculation is provided in Outcome Measure 20. Remission: CDAI score <= 2.8; low disease activity: CDAI <=10.0; moderate disease activity: CDAI <=22.0; and high disease activity: CDAI >22.0.
arm group label: Cohort
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Clinical Trials
role: Study Director
affiliation: Hoffmann-La Roche
facility: 
facility: 
facility: 
country: Estonia
responsible party type: Sponsor
mesh term: Arthritis
mesh term: Arthritis, Rheumatoid
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 