<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/NCT01683604</url>
  </required_header>
  <id_info>
    <org_study_id>ML28144</org_study_id>
    <nct_id>NCT01683604</nct_id>
  </id_info>
  <brief_title>Observational Study of Tocilizumab in Participants With Rheumatoid Arthritis in Australia</brief_title>
  <official_title>A Multi-National, Multi-Center Non-Interventional Study in Rheumatoid Arthritis (RA) Patients Treated With Tocilizumab (ACT-UP)</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 multi-center, observational study will evaluate the treatment patterns in clinical&#xD;
      practice, efficacy and safety of tocilizumab in participants with rheumatoid arthritis (RA)&#xD;
      who have had an inadequate response (or were intolerant to) treatment with non-biological&#xD;
      disease-modifying anti-rheumatic drugs (DMARDs) or with one biological agent. Data will be&#xD;
      collected from each eligible participant initiated on tocilizumab treatment by their treating&#xD;
      physician according to approved label for 6 months from start of treatment.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 2012</start_date>
  <completion_date type="Actual">June 2014</completion_date>
  <primary_completion_date type="Actual">June 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 on Tocilizumab Treatment at Month 6 After Treatment Initiation</measure>
    <time_frame>Month 6</time_frame>
    <description>Percentage of participants on tocilizumab treatment at Month 6 was calculated as: [(participants on tocilizumab treatment at Month 6) divided by (participants evaluable for primary objective)] multiplied by 100.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Patient Assessment of Pain Using Visual Analog Scale (VAS) at Baseline</measure>
    <time_frame>Baseline</time_frame>
    <description>Participants measured the pain intensity due to RA on a 100 millimeter (mm) VAS, where the responses were on a continuous range from 0 = no pain to 100 = unbearable pain.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Patient Global Assessment of Disease Activity Using VAS at Baseline</measure>
    <time_frame>Baseline</time_frame>
    <description>The patient's global assessment of disease activity was measured using a 100 mm VAS, where the responses were on a continuous range from 0 = managing very well to 100 = managing very poorly.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Physician Global Assessment of Disease Activity Using VAS at Baseline</measure>
    <time_frame>Baseline</time_frame>
    <description>Physician global assessment of disease activity was assessed on a 100 mm VAS, where 0 = no arthritis activity to 100 = extremely active arthritis.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Health Assessment Questionnaire Disability Index (HAQ-DI) Scores at Baseline</measure>
    <time_frame>Baseline</time_frame>
    <description>The HAQ-DI is a questionnaire that measures functional status (disability) and health-related quality of life. It measures the participant's ability to perform everyday tasks. The index consists of 20 questions regarding the function of the upper and lower extremities. These questions are summarized in 8 categories: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and common activities over past week. Each question is evaluated according to the degree of severity on a 4-point scale. Total score for HAQ-DI is the average of all questions and ranges from 0 = without any difficulty to 3 = unable to do.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Tender Joint Count (TJC) and Swollen Joint Count (SJC) at Baseline</measure>
    <time_frame>Baseline</time_frame>
    <description>TJC was determined by examining 28 and 68 joints and identifying the joints that were painful under pressure or to passive motion. Tenderness was recorded on the joint assessment form at baseline, no tenderness = 0, tenderness = 1. SJC was determined by examining 28 and 66 joints and identifying when swelling was present. Swelling was recorded on the joint assessment form at baseline, no swelling = 0, swelling =1.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Erythrocyte Sedimentation Rate (ESR) at Baseline</measure>
    <time_frame>Baseline</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 millimeters per hour (mm/hr). A decrease in the level indicates reduction in inflammation and therefore improvement.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>C-Reactive Protein (CRP) at Baseline</measure>
    <time_frame>Baseline</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. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Starting Tocilizumab After Stopping a Biologic Treatment or After Failing DMARDs</measure>
    <time_frame>Baseline</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Median Dose at Month 6</measure>
    <time_frame>Month 6</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Tocilizumab Dose Changed According to the Reason for Change</measure>
    <time_frame>Baseline up to Month 6</time_frame>
    <description>Percentage of participants with increase or decrease in tocilizumab administration according to the reason for dose modification was reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Dosing Interval at Month 6</measure>
    <time_frame>Month 6</time_frame>
    <description>The time interval between two successive doses in days was reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Reasons Who Discontinued Tocilizumab</measure>
    <time_frame>Baseline up to Month 6</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Restoration of Initial Dosing Regimen</measure>
    <time_frame>Baseline up to Month 6</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants by Reason for Choice of Monotherapy at Baseline</measure>
    <time_frame>Baseline up to Month 6</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants on Tocilizumab Monotherapy (8 mg/Kg) at Baseline and at Month 6</measure>
    <time_frame>Baseline, Month 6</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of Tocilizumab Treatment</measure>
    <time_frame>Baseline up to Month 6</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants by Duration of Morning Stiffness</measure>
    <time_frame>Baseline, Month 3, Month 6</time_frame>
    <description>Duration of morning stiffness was defined as the time elapsed between the time of usual awakening (even if not in the morning) and the time the participant was able to resume normal activities without stiffness. The participant assessment of morning stiffness was measured using a ruler on a 100 mm VAS by 1 of the six categories: less than (&lt;) 30 minutes, between 30 and 240 minutes, greater than (&gt;) 240 minutes and whole day.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With and Without Morning Stiffness</measure>
    <time_frame>Baseline, Month 3, Month 6</time_frame>
    <description>Morning stiffness was defined by the time elapsed between the time of usual awakening (even if not in the morning) and the time the participant was able to resume normal activities without stiffness. The participant assessed morning stiffness based on the following criteria:&#xD;
Presence of participant's joints stiff when woke up that day, measured as yes or no&#xD;
Duration of morning stiffness, measured using a ruler on a 100 mm VAS by 1 of the six categories: &lt; 30 minutes, between 30 and 240 minutes, &gt; 240 minutes, and the whole day.&#xD;
Severity of morning stiffness measured using a ruler on a 100 mm VAS where the responses were on a continuous range from 0 = no stiffness to 100 = maximum stiffness.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Adhering to Local Label for Adverse Events</measure>
    <time_frame>Baseline up to Month 6</time_frame>
    <description>Percentage of participants who adhered to local label/protocol for the management of adverse events is reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease Activity Score Based on 28 Joint Count (DAS28) Score by Visit</measure>
    <time_frame>Baseline, Month 3, Month 6</time_frame>
    <description>The DAS28 score is a measurement of RA activity on a 0 to 10 scale, with higher scores representing higher disease activity, and calculated as DAS28 = 0.56 x √TJC28 + 0.28 x √SJC28 + 0.70 x natural logarithm (ln) (CRP + 1) + 0.014 x PGH + 0.96, where TJC28 = tender joint count on 28 units, SJC28 = swollen joint count on 28 units, CRP = serum concentration of c-reactive protein (after converting units to mg/dL), PGH = patient global assessment of disease activity, which was measured on a 100 mm VAS, where 0 = managing very well and 100 = managing very poorly. A score of less than 2.6 represents clinical remission, a score of greater than or equal to 2.6 and less than or equal to 3.2 represents low disease activity, a score of greater than 3.2 and less than or equal to 5.1 represents moderate disease activity, and a score of greater than 5.1 represents high (or severe) disease.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Achieving Good European League Against Rheumatism (EULAR) Response at Month 3 and Month 6</measure>
    <time_frame>Month 3 and Month 6</time_frame>
    <description>Clinical response was assessed according to EULAR criteria that classified the participant according to individual changes in DAS28 score as good, moderate, or no response. The DAS28 score is a measurement of RA activity on a 0 to 10 scale, with higher scores represent higher disease activity, and calculated as DAS28 = 0.56 x √TJC28 + 0.28 x √SJC28 + 0.36 x ln(CRP + 1) + 0.014 x PGH + 0.96, where TJC28 = tender joint count on 28 units, SJC28 = swollen joint count on 28 units, CRP = serum concentration of c-reactive protein (after converting units to mg/dL), PGH = patient's global assessment of disease activity, which was measured on a 100 mm VAS, where 0 = managing very well and 100 = managing very poorly. Good responders experienced a change from baseline of greater than 1.2 with a DAS28 score less than or equal to 3.2.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical Disease Activity Index (CDAI) Score by Visit</measure>
    <time_frame>Baseline, Month 3, Month 6</time_frame>
    <description>The CDAI is a combined index for measuring disease activity in RA and calculated as CDAI = TJC28 + SJC28 + PGH (in centimeters) + PhGH (in centimeters), where TJC28 = tender joint count on 28 units, SJC28 = swollen joint count on 28 units, PGH = patient's global assessment of disease activity, assessed on a 100 mm VAS, where 0 = managing very well and 100 = managing very poorly, and PhGH = physician global assessment of disease activity, assessed on a 100 mm VAS, where 0 = no arthritis activity and 100 = extremely active arthritis; with a total score ranged from 0-76. Higher scores indicate greater disease activity. CDAI score of less than or equal to 2.8 represents clinical remission, score of less than or equal to 10.0 represents low disease activity, score of less than or equal to 22.0 represents moderate disease activity, and score of greater than 22.0 represents high (or severe) disease.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in TJC and SJC at Month 3 and Month 6</measure>
    <time_frame>Baseline, Month 3, Month 6</time_frame>
    <description>TJC was determined by examining 28 and 68 joints 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 baseline, no tenderness = 0, tenderness = 1. SJC was determined by examination of 28 and 66 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at baseline, no swelling = 0, swelling =1.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Simplified Disease Activity Index (SDAI) Score by Visit</measure>
    <time_frame>Baseline, Month 3, Month 6</time_frame>
    <description>The SDAI is a combined index for measuring disease activity in RA and calculated as SDAI = TJC28 + SJC28 + PGH (in centimeters) + PhGH (in centimeters) + CRP (in mg/dL), where TJC28 = tender joint count on 28 units, SJC28 = swollen joint count on 28 units, PGH = patient's global assessment of disease activity, assessed on a 100 mm VAS, where 0 = managing very well and 100 = managing very poorly, PhGH = physician global assessment of disease activity, assessed on a 100 mm VAS, where 0 = no arthritis activity and 100 = extremely active arthritis, CRP = serum concentration of c-reactive protein; with a total SDAI score ranged from 0-86. Higher scores indicate greater disease activity. SDAI scores of less than or equal to 3.3 represents clinical remission, less than or equal to 11.0 represents low disease activity, less than or equal to 26.0 represents moderate disease activity, and greater than 26.0 represents high (or severe) disease.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With an American College of Rheumatology (ACR) 20%, 50%, or 70% (ACR20/50/70) Response at Month 3 and Month 6 From the Start of Tocilizumab Treatment</measure>
    <time_frame>Month 3 and Month 6</time_frame>
    <description>ACR 20,50 or 70 response=an improvement of ≥ 20%, ≥ 50% or ≥ 70% respectively, as compared to baseline in TJC28 and SJC28, and 20%, 50% or 70% improvement in at least 3 of the 5 following measures: Patient's Assessment of Pain over the previous 24 hours, PGA, PhGA, HAQ, and acute phase reactant (either CRP or ESR). TJC and SJC, based on 28-joint assessments. Number of tender joints and swollen joints were recorded on the joint assessment form at baseline, no tenderness = 0 and tenderness = 1, no swelling = 0 and swelling =1, respectively. HAQ measures functional status (disability) and health-related quality of life with 20 questions, summarized in 8 categories: dressing and grooming, arising, eating, walking, hygiene, reach, grip and common activities over past week, 0=without difficulty to 3=unable to do. Patient's assessment of pain assessed using a VAS; 0=no pain, 100=unbearable pain; PGA and PhGA, assessed using VAS ; 0= no disease activity, 100=maximum disease activity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Physician Global Assessment of Disease Activity at Months 3 and 6</measure>
    <time_frame>Baseline, Month 3, Month 6</time_frame>
    <description>The physician global assessment of disease activity was evaluated using a 100 mm VAS where 0 = no arthritis activity and 100 = extremely active arthritis. Higher scores indicated increased level of disease.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Patient Global Assessment of Disease Activity at Months 3 and 6</measure>
    <time_frame>Baseline, Month 3, Month 6</time_frame>
    <description>The patient's global assessment of disease activity was measured using a 100 mm VAS, where the responses were on a continuous range from 0= managing very well and 100 = managing very poorly.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in HAQ-DI Score at Months 3 and 6</measure>
    <time_frame>Baseline, Month 3, Month 6</time_frame>
    <description>The HAQ-DI is a questionnaire that measures functional status (disability) and health-related quality of life. It measures the participant's ability to perform everyday tasks. The index consists of 20 questions regarding the function of the upper and lower extremities. These questions are summarized in 8 categories: dressing and grooming, arising, eating, walking, hygiene, reach, grip and common activities over past week. Each question was evaluated according to the degree of severity on a 4-point scale ranging from 0 = without any difficulty to 3 = unable to do. Total score is the sum of each question, which ranges from 0 to 60, where higher scores represent higher disease activity. The change from baseline in HAQ-DI score at Month 3 and Month 6 was calculated as the difference between HAQ-D1 score reported at baseline and the HAQ-D1 score reported at Month 3 and Month 6.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in VAS-Fatigue at Months 3 and 6</measure>
    <time_frame>Baseline, Month 3, Month 6</time_frame>
    <description>Participants measured the level of fatigue due to RA using a 100 mm VAS, where the responses were on a continuous range from 0 = no fatigue to 100 = extreme fatigue.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Patient's Assessment of Pain at Months 3 and 6</measure>
    <time_frame>Baseline, Month 3, Month 6</time_frame>
    <description>Participants measured the pain intensity due to RA using a 100 mm VAS, where the responses were on a continuous range from 0 = no pain to 100 = unbearable pain.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Participant Assessment of Morning Stiffness Using VAS at Months 3 and 6</measure>
    <time_frame>Baseline, Month 3, Month 6</time_frame>
    <description>The participant assessment of morning stiffness was measured using a ruler on a 100 mm VAS, where the responses were on a continuous range from 0 = no stiffness and 100 = maximum stiffness.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">37</enrollment>
  <condition>Rheumatoid Arthritis</condition>
  <arm_group>
    <arm_group_label>Rheumatoid Arthritis (RA) Participants (All Groups)</arm_group_label>
    <description>Participants with severe RA were prescribed with tocilizumab in accordance with routine clinic practice, and were observed for 6 months.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Observational study</intervention_name>
    <arm_group_label>Rheumatoid Arthritis (RA) Participants (All Groups)</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        RA participants treated with tocilizumab&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Severe RA.&#xD;
&#xD;
          -  Inadequate response (or intolerant) to non-biological DMARDs or one biologic agent&#xD;
&#xD;
          -  Participants initiating treatment with tocilizumab on their physician's decision (in&#xD;
             accordance with the local label), including participants who started treatment with&#xD;
             tocilizumab within the 8 weeks prior to the enrolment visit.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Tocilizumab treatment more than 8 weeks prior to the enrolment visit.&#xD;
&#xD;
          -  Previous tocilizumab treatment in a clinical trial or for compassionate use.&#xD;
&#xD;
          -  Enrolled in an ongoing clinical trial and/or treatment with any investigational agent&#xD;
             within 4 weeks (or 5 half-lives of the investigational agent, whichever is longer)&#xD;
             before starting treatment with tocilizumab.&#xD;
&#xD;
          -  History of autoimmune disease or any joint inflammatory disease other than RA.&#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>Campsie</city>
        <state>New South Wales</state>
        <zip>2194</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Coffs Harbour</city>
        <state>New South Wales</state>
        <zip>2450</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>New Lambton</city>
        <state>New South Wales</state>
        <zip>2305</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Woodville</city>
        <state>South Australia</state>
        <zip>5011</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Heidelberg</city>
        <state>Victoria</state>
        <zip>3084</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Morwell</city>
        <state>Victoria</state>
        <zip>3842</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Shenton Park</city>
        <state>Western Australia</state>
        <zip>6008</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
  </location_countries>
  <verification_date>June 2016</verification_date>
  <study_first_submitted>September 5, 2012</study_first_submitted>
  <study_first_submitted_qc>September 7, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 12, 2012</study_first_posted>
  <results_first_submitted>April 20, 2016</results_first_submitted>
  <results_first_submitted_qc>June 10, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">July 21, 2016</results_first_posted>
  <last_update_submitted>June 10, 2016</last_update_submitted>
  <last_update_submitted_qc>June 10, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 21, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Arthritis</mesh_term>
    <mesh_term>Arthritis, Rheumatoid</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Rheumatoid Arthritis (RA) Participants (All Groups)</title>
          <description>Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 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="37"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="32"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lack of Efficacy</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other</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): All enrolled participants who received at least 1 dose of tocilizumab.</population>
      <group_list>
        <group group_id="B1">
          <title>RA Participants (All Groups)</title>
          <description>Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="37"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="59.3" spread="10.62"/>
                  </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="21"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants on Tocilizumab Treatment at Month 6 After Treatment Initiation</title>
        <description>Percentage of participants on tocilizumab treatment at Month 6 was calculated as: [(participants on tocilizumab treatment at Month 6) divided by (participants evaluable for primary objective)] multiplied by 100.</description>
        <time_frame>Month 6</time_frame>
        <population>FAS population</population>
        <group_list>
          <group group_id="O1">
            <title>RA Participants (Biologic Naïve Group)</title>
            <description>Participants with severe RA, and no prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.</description>
          </group>
          <group group_id="O2">
            <title>RA Participants (Biologic Exposed Group)</title>
            <description>Participants with severe RA, with prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.</description>
          </group>
          <group group_id="O3">
            <title>RA Participants (Monotherapy Group)</title>
            <description>Participants with severe RA, were prescribed with tocilizumab alone, in accordance with routine clinic practice and were observed for 6 months.</description>
          </group>
          <group group_id="O4">
            <title>RA Participants (Combination Therapy Group)</title>
            <description>Participants with severe RA, were prescribed with disease-modifying anti-rheumatic drug (DMARD) at the time of first dose of tocilizumab, in accordance with routine clinic practice and were observed for 6 months.</description>
          </group>
          <group group_id="O5">
            <title>RA Participants (All Groups)</title>
            <description>Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants on Tocilizumab Treatment at Month 6 After Treatment Initiation</title>
          <description>Percentage of participants on tocilizumab treatment at Month 6 was calculated as: [(participants on tocilizumab treatment at Month 6) divided by (participants evaluable for primary objective)] multiplied by 100.</description>
          <population>FAS population</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="29"/>
                <count group_id="O2" value="8"/>
                <count group_id="O3" value="5"/>
                <count group_id="O4" value="32"/>
                <count group_id="O5" value="37"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="79.3"/>
                    <measurement group_id="O2" value="100"/>
                    <measurement group_id="O3" value="80"/>
                    <measurement group_id="O4" value="84.4"/>
                    <measurement group_id="O5" value="83.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Patient Assessment of Pain Using Visual Analog Scale (VAS) at Baseline</title>
        <description>Participants measured the pain intensity due to RA on a 100 millimeter (mm) VAS, where the responses were on a continuous range from 0 = no pain to 100 = unbearable pain.</description>
        <time_frame>Baseline</time_frame>
        <population>FAS population. Here, Number of participants analyzed = participants evaluable for the outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>RA Participants (Biologic Naïve Group)</title>
            <description>Participants with severe RA, and no prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.</description>
          </group>
          <group group_id="O2">
            <title>RA Participants (Biologic Exposed Group)</title>
            <description>Participants with severe RA, with prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.</description>
          </group>
          <group group_id="O3">
            <title>RA Participants (Monotherapy Group)</title>
            <description>Participants with severe RA, were prescribed with tocilizumab alone, in accordance with routine clinic practice and were observed for 6 months.</description>
          </group>
          <group group_id="O4">
            <title>RA Participants (Combination Therapy Group)</title>
            <description>Participants with severe RA, were prescribed with DMARD at the time of first dose of tocilizumab, in accordance with routine clinic practice and were observed for 6 months.</description>
          </group>
          <group group_id="O5">
            <title>RA Participants (All Groups)</title>
            <description>Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Patient Assessment of Pain Using Visual Analog Scale (VAS) at Baseline</title>
          <description>Participants measured the pain intensity due to RA on a 100 millimeter (mm) VAS, where the responses were on a continuous range from 0 = no pain to 100 = unbearable pain.</description>
          <population>FAS population. Here, Number of participants analyzed = participants evaluable for the outcome measure.</population>
          <units>millimeters (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="25"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="3"/>
                <count group_id="O4" value="28"/>
                <count group_id="O5" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="60.1" spread="31.08"/>
                    <measurement group_id="O2" value="47.2" spread="31.93"/>
                    <measurement group_id="O3" value="79.3" spread="19.55"/>
                    <measurement group_id="O4" value="55.3" spread="31.49"/>
                    <measurement group_id="O5" value="57.6" spread="31.14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Patient Global Assessment of Disease Activity Using VAS at Baseline</title>
        <description>The patient's global assessment of disease activity was measured using a 100 mm VAS, where the responses were on a continuous range from 0 = managing very well to 100 = managing very poorly.</description>
        <time_frame>Baseline</time_frame>
        <population>FAS population. Here, Number of participants analyzed = participants evaluable for the outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>RA Participants (Biologic Naïve Group)</title>
            <description>Participants with severe RA, and no prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.</description>
          </group>
          <group group_id="O2">
            <title>RA Participants (Biologic Exposed Group)</title>
            <description>Participants with severe RA, with prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.</description>
          </group>
          <group group_id="O3">
            <title>RA Participants (Monotherapy Group)</title>
            <description>Participants with severe RA, were prescribed with tocilizumab alone, in accordance with routine clinic practice and were observed for 6 months.</description>
          </group>
          <group group_id="O4">
            <title>RA Participants (Combination Therapy Group)</title>
            <description>Participants with severe RA, were prescribed with DMARD at the time of first dose of tocilizumab, in accordance with routine clinic practice and were observed for 6 months.</description>
          </group>
          <group group_id="O5">
            <title>RA Participants (All Groups)</title>
            <description>Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Patient Global Assessment of Disease Activity Using VAS at Baseline</title>
          <description>The patient's global assessment of disease activity was measured using a 100 mm VAS, where the responses were on a continuous range from 0 = managing very well to 100 = managing very poorly.</description>
          <population>FAS population. Here, Number of participants analyzed = participants evaluable for the outcome measure.</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="24"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="3"/>
                <count group_id="O4" value="27"/>
                <count group_id="O5" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="69.6" spread="29.71"/>
                    <measurement group_id="O2" value="59.0" spread="33.03"/>
                    <measurement group_id="O3" value="85.0" spread="11.36"/>
                    <measurement group_id="O4" value="65.5" spread="31.02"/>
                    <measurement group_id="O5" value="67.5" spread="30.11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Physician Global Assessment of Disease Activity Using VAS at Baseline</title>
        <description>Physician global assessment of disease activity was assessed on a 100 mm VAS, where 0 = no arthritis activity to 100 = extremely active arthritis.</description>
        <time_frame>Baseline</time_frame>
        <population>FAS population. Here, Number of participants analyzed = participants evaluable for the outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>RA Participants (Biologic Naïve Group)</title>
            <description>Participants with severe RA, and no prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.</description>
          </group>
          <group group_id="O2">
            <title>RA Participants (Biologic Exposed Group)</title>
            <description>Participants with severe RA, with prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.</description>
          </group>
          <group group_id="O3">
            <title>RA Participants (Monotherapy Group)</title>
            <description>Participants with severe RA, were prescribed with tocilizumab alone, in accordance with routine clinic practice and were observed for 6 months.</description>
          </group>
          <group group_id="O4">
            <title>RA Participants (Combination Therapy Group)</title>
            <description>Participants with severe RA, were prescribed with DMARD at the time of first dose of tocilizumab, in accordance with routine clinic practice and were observed for 6 months.</description>
          </group>
          <group group_id="O5">
            <title>RA Participants (All Groups)</title>
            <description>Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Physician Global Assessment of Disease Activity Using VAS at Baseline</title>
          <description>Physician global assessment of disease activity was assessed on a 100 mm VAS, where 0 = no arthritis activity to 100 = extremely active arthritis.</description>
          <population>FAS population. Here, Number of participants analyzed = participants evaluable for the outcome measure.</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="25"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="3"/>
                <count group_id="O4" value="28"/>
                <count group_id="O5" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="65.2" spread="24.53"/>
                    <measurement group_id="O2" value="63.3" spread="9.61"/>
                    <measurement group_id="O3" value="69.0" spread="9.00"/>
                    <measurement group_id="O4" value="64.4" spread="23.33"/>
                    <measurement group_id="O5" value="64.9" spread="22.30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Health Assessment Questionnaire Disability Index (HAQ-DI) Scores at Baseline</title>
        <description>The HAQ-DI is a questionnaire that measures functional status (disability) and health-related quality of life. It measures the participant's ability to perform everyday tasks. The index consists of 20 questions regarding the function of the upper and lower extremities. These questions are summarized in 8 categories: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and common activities over past week. Each question is evaluated according to the degree of severity on a 4-point scale. Total score for HAQ-DI is the average of all questions and ranges from 0 = without any difficulty to 3 = unable to do.</description>
        <time_frame>Baseline</time_frame>
        <population>FAS population. Here, Number of participants analyzed = participants evaluable for the outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>RA Participants (Biologic Naïve Group)</title>
            <description>Participants with severe RA, and no prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.</description>
          </group>
          <group group_id="O2">
            <title>RA Participants (Biologic Exposed Group)</title>
            <description>Participants with severe RA, with prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.</description>
          </group>
          <group group_id="O3">
            <title>RA Participants (Monotherapy Group)</title>
            <description>Participants with severe RA, were prescribed with tocilizumab alone, in accordance with routine clinic practice and were observed for 6 months.</description>
          </group>
          <group group_id="O4">
            <title>RA Participants (Combination Therapy Group)</title>
            <description>Participants with severe RA, were prescribed with DMARD at the time of first dose of tocilizumab, in accordance with routine clinic practice and were observed for 6 months.</description>
          </group>
          <group group_id="O5">
            <title>RA Participants (All Groups)</title>
            <description>Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Health Assessment Questionnaire Disability Index (HAQ-DI) Scores at Baseline</title>
          <description>The HAQ-DI is a questionnaire that measures functional status (disability) and health-related quality of life. It measures the participant's ability to perform everyday tasks. The index consists of 20 questions regarding the function of the upper and lower extremities. These questions are summarized in 8 categories: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and common activities over past week. Each question is evaluated according to the degree of severity on a 4-point scale. Total score for HAQ-DI is the average of all questions and ranges from 0 = without any difficulty to 3 = unable to do.</description>
          <population>FAS population. Here, Number of participants analyzed = participants evaluable for the outcome measure.</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="24"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="3"/>
                <count group_id="O4" value="27"/>
                <count group_id="O5" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.7" spread="0.86"/>
                    <measurement group_id="O2" value="1.7" spread="0.98"/>
                    <measurement group_id="O3" value="1.7" spread="0.59"/>
                    <measurement group_id="O4" value="1.7" spread="0.90"/>
                    <measurement group_id="O5" value="1.7" spread="0.87"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Tender Joint Count (TJC) and Swollen Joint Count (SJC) at Baseline</title>
        <description>TJC was determined by examining 28 and 68 joints and identifying the joints that were painful under pressure or to passive motion. Tenderness was recorded on the joint assessment form at baseline, no tenderness = 0, tenderness = 1. SJC was determined by examining 28 and 66 joints and identifying when swelling was present. Swelling was recorded on the joint assessment form at baseline, no swelling = 0, swelling =1.</description>
        <time_frame>Baseline</time_frame>
        <population>FAS population. Here, Number of participants analyzed = participants evaluable for the outcome measure and n= participants with available data for the specified category.</population>
        <group_list>
          <group group_id="O1">
            <title>RA Participants (Biologic Naïve Group)</title>
            <description>Participants with severe RA, and no prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.</description>
          </group>
          <group group_id="O2">
            <title>RA Participants (Biologic Exposed Group)</title>
            <description>Participants with severe RA, with prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.</description>
          </group>
          <group group_id="O3">
            <title>RA Participants (Monotherapy Group)</title>
            <description>Participants with severe RA, were prescribed with tocilizumab alone, in accordance with routine clinic practice and were observed for 6 months.</description>
          </group>
          <group group_id="O4">
            <title>RA Participants (Combination Therapy Group)</title>
            <description>Participants with severe RA, were prescribed with DMARD at the time of first dose of tocilizumab, in accordance with routine clinic practice and were observed for 6 months.</description>
          </group>
          <group group_id="O5">
            <title>RA Participants (All Groups)</title>
            <description>Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Tender Joint Count (TJC) and Swollen Joint Count (SJC) at Baseline</title>
          <description>TJC was determined by examining 28 and 68 joints and identifying the joints that were painful under pressure or to passive motion. Tenderness was recorded on the joint assessment form at baseline, no tenderness = 0, tenderness = 1. SJC was determined by examining 28 and 66 joints and identifying when swelling was present. Swelling was recorded on the joint assessment form at baseline, no swelling = 0, swelling =1.</description>
          <population>FAS population. Here, Number of participants analyzed = participants evaluable for the outcome measure and n= participants with available data for the specified category.</population>
          <units>joint counts</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="27"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="4"/>
                <count group_id="O4" value="29"/>
                <count group_id="O5" value="33"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>TJC28 (n= 27, 6, 4, 29, 33)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.6" spread="7.68"/>
                    <measurement group_id="O2" value="14.7" spread="8.48"/>
                    <measurement group_id="O3" value="13.0" spread="8.41"/>
                    <measurement group_id="O4" value="15.8" spread="7.69"/>
                    <measurement group_id="O5" value="15.4" spread="7.70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TJC68 (n= 18, 5, 2, 21, 23)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="34.4" spread="16.97"/>
                    <measurement group_id="O2" value="24.2" spread="18.43"/>
                    <measurement group_id="O3" value="26.0" spread="7.07"/>
                    <measurement group_id="O4" value="32.8" spread="18.07"/>
                    <measurement group_id="O5" value="32.2" spread="17.40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SJC28 (n= 27, 6, 4, 29, 33)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.0" spread="6.66"/>
                    <measurement group_id="O2" value="14.0" spread="7.51"/>
                    <measurement group_id="O3" value="12.5" spread="3.79"/>
                    <measurement group_id="O4" value="14.2" spread="7.03"/>
                    <measurement group_id="O5" value="14.0" spread="6.70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SJC66 (n= 18, 5, 2, 21, 23)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27.7" spread="13.73"/>
                    <measurement group_id="O2" value="21.0" spread="13.62"/>
                    <measurement group_id="O3" value="26.5" spread="7.78"/>
                    <measurement group_id="O4" value="26.2" spread="14.25"/>
                    <measurement group_id="O5" value="26.3" spread="13.69"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Erythrocyte Sedimentation Rate (ESR) at Baseline</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 millimeters per hour (mm/hr). A decrease in the level indicates reduction in inflammation and therefore improvement.</description>
        <time_frame>Baseline</time_frame>
        <population>FAS population. Here, Number of participants analyzed = participants evaluable for the outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>RA Participants (Biologic Naïve Group)</title>
            <description>Participants with severe RA, and no prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.</description>
          </group>
          <group group_id="O2">
            <title>RA Participants (Biologic Exposed Group)</title>
            <description>Participants with severe RA, with prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.</description>
          </group>
          <group group_id="O3">
            <title>RA Participants (Monotherapy Group)</title>
            <description>Participants with severe RA, were prescribed with tocilizumab alone, in accordance with routine clinic practice and were observed for 6 months.</description>
          </group>
          <group group_id="O4">
            <title>RA Participants (Combination Therapy Group)</title>
            <description>Participants with severe RA, were prescribed with DMARD at the time of first dose of tocilizumab, in accordance with routine clinic practice and were observed for 6 months.</description>
          </group>
          <group group_id="O5">
            <title>RA Participants (All Groups)</title>
            <description>Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Erythrocyte Sedimentation Rate (ESR) at Baseline</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 millimeters per hour (mm/hr). A decrease in the level indicates reduction in inflammation and therefore improvement.</description>
          <population>FAS population. Here, Number of participants analyzed = participants evaluable for the outcome measure.</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="29"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="5"/>
                <count group_id="O4" value="30"/>
                <count group_id="O5" value="35"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27.0" spread="24.79"/>
                    <measurement group_id="O2" value="35.2" spread="36.78"/>
                    <measurement group_id="O3" value="34.8" spread="26.79"/>
                    <measurement group_id="O4" value="27.3" spread="27.04"/>
                    <measurement group_id="O5" value="28.4" spread="26.74"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>C-Reactive Protein (CRP) at Baseline</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. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.</description>
        <time_frame>Baseline</time_frame>
        <population>FAS population.</population>
        <group_list>
          <group group_id="O1">
            <title>RA Participants (Biologic Naïve Group)</title>
            <description>Participants with severe RA, and no prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.</description>
          </group>
          <group group_id="O2">
            <title>RA Participants (Biologic Exposed Group)</title>
            <description>Participants with severe RA, with prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.</description>
          </group>
          <group group_id="O3">
            <title>RA Participants (Monotherapy Group)</title>
            <description>Participants with severe RA, were prescribed with tocilizumab alone, in accordance with routine clinic practice and were observed for 6 months.</description>
          </group>
          <group group_id="O4">
            <title>RA Participants (Combination Therapy Group)</title>
            <description>Participants with severe RA, were prescribed with DMARD at the time of first dose of tocilizumab, in accordance with routine clinic practice and were observed for 6 months.</description>
          </group>
          <group group_id="O5">
            <title>RA Participants (All Groups)</title>
            <description>Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.</description>
          </group>
        </group_list>
        <measure>
          <title>C-Reactive Protein (CRP) at Baseline</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. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.</description>
          <population>FAS population.</population>
          <units>milligrams per liter (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="29"/>
                <count group_id="O2" value="8"/>
                <count group_id="O3" value="5"/>
                <count group_id="O4" value="32"/>
                <count group_id="O5" value="37"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.3" spread="17.36"/>
                    <measurement group_id="O2" value="22.6" spread="42.91"/>
                    <measurement group_id="O3" value="22.5" spread="24.30"/>
                    <measurement group_id="O4" value="16.0" spread="24.84"/>
                    <measurement group_id="O5" value="16.9" spread="24.53"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Starting Tocilizumab After Stopping a Biologic Treatment or After Failing DMARDs</title>
        <time_frame>Baseline</time_frame>
        <population>FAS population.</population>
        <group_list>
          <group group_id="O1">
            <title>RA Participants (Biologic Naïve Group)</title>
            <description>Participants with severe RA, and no prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.</description>
          </group>
          <group group_id="O2">
            <title>RA Participants (Biologic Exposed Group)</title>
            <description>Participants with severe RA, with prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.</description>
          </group>
          <group group_id="O3">
            <title>RA Participants (Monotherapy Group)</title>
            <description>Participants with severe RA, were prescribed with tocilizumab alone, in accordance with routine clinic practice and were observed for 6 months.</description>
          </group>
          <group group_id="O4">
            <title>RA Participants (Combination Therapy Group)</title>
            <description>Participants with severe RA, were prescribed with disease-modifying anti-rheumatic drug (DMARD) at the time of first dose of tocilizumab, in accordance with routine clinic practice and were observed for 6 months.</description>
          </group>
          <group group_id="O5">
            <title>RA Participants (All Groups)</title>
            <description>Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Starting Tocilizumab After Stopping a Biologic Treatment or After Failing DMARDs</title>
          <population>FAS population.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="29"/>
                <count group_id="O2" value="8"/>
                <count group_id="O3" value="5"/>
                <count group_id="O4" value="32"/>
                <count group_id="O5" value="37"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Previous biologic therapy</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="100"/>
                    <measurement group_id="O3" value="40"/>
                    <measurement group_id="O4" value="18.8"/>
                    <measurement group_id="O5" value="21.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Previous DMARD therapy</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31.0"/>
                    <measurement group_id="O2" value="7.5"/>
                    <measurement group_id="O3" value="100"/>
                    <measurement group_id="O4" value="34.4"/>
                    <measurement group_id="O5" value="43.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Median Dose at Month 6</title>
        <time_frame>Month 6</time_frame>
        <population>FAS population. Here Number of participants analyzed = participants evaluable for the outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>RA Participants (Biologic Naïve Group)</title>
            <description>Participants with severe RA, and no prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.</description>
          </group>
          <group group_id="O2">
            <title>RA Participants (Biologic Exposed Group)</title>
            <description>Participants with severe RA, with prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.</description>
          </group>
          <group group_id="O3">
            <title>RA Participants (Monotherapy Group)</title>
            <description>Participants with severe RA, were prescribed with tocilizumab alone, in accordance with routine clinic practice and were observed for 6 months.</description>
          </group>
          <group group_id="O4">
            <title>RA Participants (Combination Therapy Group)</title>
            <description>Participants with severe RA, were prescribed with DMARD at the time of first dose of tocilizumab, in accordance with routine clinic practice and were observed for 6 months.</description>
          </group>
          <group group_id="O5">
            <title>RA Participants (All Groups)</title>
            <description>Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Median Dose at Month 6</title>
          <population>FAS population. Here Number of participants analyzed = participants evaluable for the outcome measure.</population>
          <units>milligram per kilogram (mg/kg)</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="23"/>
                <count group_id="O2" value="8"/>
                <count group_id="O3" value="4"/>
                <count group_id="O4" value="27"/>
                <count group_id="O5" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8" lower_limit="7" upper_limit="8"/>
                    <measurement group_id="O2" value="8" lower_limit="8" upper_limit="8"/>
                    <measurement group_id="O3" value="8" lower_limit="8" upper_limit="8"/>
                    <measurement group_id="O4" value="8" lower_limit="7" upper_limit="8"/>
                    <measurement group_id="O5" value="8" lower_limit="7" upper_limit="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Tocilizumab Dose Changed According to the Reason for Change</title>
        <description>Percentage of participants with increase or decrease in tocilizumab administration according to the reason for dose modification was reported.</description>
        <time_frame>Baseline up to Month 6</time_frame>
        <population>FAS population.</population>
        <group_list>
          <group group_id="O1">
            <title>RA Participants (Biologic Naïve Group)</title>
            <description>Participants with severe RA, and no prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.</description>
          </group>
          <group group_id="O2">
            <title>RA Participants (Biologic Exposed Group)</title>
            <description>Participants with severe RA, with prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.</description>
          </group>
          <group group_id="O3">
            <title>RA Participants (Monotherapy Group)</title>
            <description>Participants with severe RA, were prescribed with tocilizumab alone, in accordance with routine clinic practice and were observed for 6 months.</description>
          </group>
          <group group_id="O4">
            <title>RA Participants (Combination Therapy Group)</title>
            <description>Participants with severe RA, were prescribed with DMARD at the time of first dose of tocilizumab, in accordance with routine clinic practice and were observed for 6 months.</description>
          </group>
          <group group_id="O5">
            <title>RA Participants (All Groups)</title>
            <description>Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Tocilizumab Dose Changed According to the Reason for Change</title>
          <description>Percentage of participants with increase or decrease in tocilizumab administration according to the reason for dose modification was reported.</description>
          <population>FAS population.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="29"/>
                <count group_id="O2" value="8"/>
                <count group_id="O3" value="5"/>
                <count group_id="O4" value="32"/>
                <count group_id="O5" value="37"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Increase in dose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="12.5"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="3.1"/>
                    <measurement group_id="O5" value="2.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Decrease in dose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.4"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="3.1"/>
                    <measurement group_id="O5" value="2.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Reason:Unspecified</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.4"/>
                    <measurement group_id="O2" value="12.5"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="6.3"/>
                    <measurement group_id="O5" value="5.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Dosing Interval at Month 6</title>
        <description>The time interval between two successive doses in days was reported.</description>
        <time_frame>Month 6</time_frame>
        <population>FAS population. Here, Number of participants analyzed = participants evaluable for the outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>RA Participants (Biologic Naïve Group)</title>
            <description>Participants with severe RA, and no prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.</description>
          </group>
          <group group_id="O2">
            <title>RA Participants (Biologic Exposed Group)</title>
            <description>Participants with severe RA, with prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.</description>
          </group>
          <group group_id="O3">
            <title>RA Participants (Monotherapy Group)</title>
            <description>Participants with severe RA, were prescribed with tocilizumab alone, in accordance with routine clinic practice and were observed for 6 months.</description>
          </group>
          <group group_id="O4">
            <title>RA Participants (Combination Therapy Group)</title>
            <description>Participants with severe RA, were prescribed with DMARD at the time of first dose of tocilizumab, in accordance with routine clinic practice and were observed for 6 months.</description>
          </group>
          <group group_id="O5">
            <title>RA Participants (All Groups)</title>
            <description>Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Dosing Interval at Month 6</title>
          <description>The time interval between two successive doses in days was reported.</description>
          <population>FAS population. Here, Number of participants analyzed = participants evaluable for the outcome measure.</population>
          <units>days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="28"/>
                <count group_id="O2" value="8"/>
                <count group_id="O3" value="5"/>
                <count group_id="O4" value="31"/>
                <count group_id="O5" value="36"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30.97" spread="3.803"/>
                    <measurement group_id="O2" value="32.10" spread="3.783"/>
                    <measurement group_id="O3" value="29.63" spread="1.505"/>
                    <measurement group_id="O4" value="31.48" spread="3.978"/>
                    <measurement group_id="O5" value="31.22" spread="3.775"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Reasons Who Discontinued Tocilizumab</title>
        <time_frame>Baseline up to Month 6</time_frame>
        <population>FAS population. Here, Number of Participants Analyzed (N) signifies participants who discontinued tocilizumab treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>RA Participants (Biologic Naïve Group)</title>
            <description>Participants with severe RA, and no prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.</description>
          </group>
          <group group_id="O2">
            <title>RA Participants (Biologic Exposed Group)</title>
            <description>Participants with severe RA, with prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.</description>
          </group>
          <group group_id="O3">
            <title>RA Participants (Monotherapy Group)</title>
            <description>Participants with severe RA, were prescribed with tocilizumab alone, in accordance with routine clinic practice and were observed for 6 months.</description>
          </group>
          <group group_id="O4">
            <title>RA Participants (Combination Therapy Group)</title>
            <description>Participants with severe RA, were prescribed with DMARD at the time of first dose of tocilizumab, in accordance with routine clinic practice and were observed for 6 months.</description>
          </group>
          <group group_id="O5">
            <title>RA Participants (All Groups)</title>
            <description>Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Reasons Who Discontinued Tocilizumab</title>
          <population>FAS population. Here, Number of Participants Analyzed (N) signifies participants who discontinued tocilizumab treatment.</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="5"/>
                <count group_id="O2" value="0"/>
                <count group_id="O3" value="1"/>
                <count group_id="O4" value="4"/>
                <count group_id="O5" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Lack of efficacy</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="25.0"/>
                    <measurement group_id="O5" value="20.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Adverse event</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40.0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="50.0"/>
                    <measurement group_id="O5" value="40.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Unspecified</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40.0"/>
                    <measurement group_id="O3" value="100.0"/>
                    <measurement group_id="O4" value="25.0"/>
                    <measurement group_id="O5" value="40.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Restoration of Initial Dosing Regimen</title>
        <time_frame>Baseline up to Month 6</time_frame>
        <population>Analysis was not performed due to inadequate data available for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>RA Participants (Biologic Naïve Group)</title>
            <description>Participants with severe RA, and no prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.</description>
          </group>
          <group group_id="O2">
            <title>RA Participants (Biologic Exposed Group)</title>
            <description>Participants with severe RA, with prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.</description>
          </group>
          <group group_id="O3">
            <title>RA Participants (Monotherapy Group)</title>
            <description>Participants with severe RA, were prescribed with tocilizumab alone, in accordance with routine clinic practice and were observed for 6 months.</description>
          </group>
          <group group_id="O4">
            <title>RA Participants (Combination Therapy Group)</title>
            <description>Participants with severe RA, were prescribed with DMARD at the time of first dose of tocilizumab, in accordance with routine clinic practice and were observed for 6 months.</description>
          </group>
          <group group_id="O5">
            <title>RA Participants (All Groups)</title>
            <description>Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Restoration of Initial Dosing Regimen</title>
          <population>Analysis was not performed due to inadequate data available for this outcome measure.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
                <count group_id="O3" value="0"/>
                <count group_id="O4" value="0"/>
                <count group_id="O5" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants by Reason for Choice of Monotherapy at Baseline</title>
        <time_frame>Baseline up to Month 6</time_frame>
        <population>Analysis was not performed as the data was not collected on case report form.</population>
        <group_list>
          <group group_id="O1">
            <title>RA Participants (Biologic Naïve Group)</title>
            <description>Participants with severe RA, and no prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.</description>
          </group>
          <group group_id="O2">
            <title>RA Participants (Biologic Exposed Group)</title>
            <description>Participants with severe RA, with prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.</description>
          </group>
          <group group_id="O3">
            <title>RA Participants (Monotherapy Group)</title>
            <description>Participants with severe RA, were prescribed with tocilizumab alone, in accordance with routine clinic practice and were observed for 6 months.</description>
          </group>
          <group group_id="O4">
            <title>RA Participants (Combination Therapy Group)</title>
            <description>Participants with severe RA, were prescribed with DMARD at the time of first dose of tocilizumab, in accordance with routine clinic practice and were observed for 6 months.</description>
          </group>
          <group group_id="O5">
            <title>RA Participants (All Groups)</title>
            <description>Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants by Reason for Choice of Monotherapy at Baseline</title>
          <population>Analysis was not performed as the data was not collected on case report form.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
                <count group_id="O3" value="0"/>
                <count group_id="O4" value="0"/>
                <count group_id="O5" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants on Tocilizumab Monotherapy (8 mg/Kg) at Baseline and at Month 6</title>
        <time_frame>Baseline, Month 6</time_frame>
        <population>FAS population. n= participants with available data at the specified visit.</population>
        <group_list>
          <group group_id="O1">
            <title>RA Participants (Biologic Naïve Group)</title>
            <description>Participants with severe RA, and no prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.</description>
          </group>
          <group group_id="O2">
            <title>RA Participants (Biologic Exposed Group)</title>
            <description>Participants with severe RA, with prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.</description>
          </group>
          <group group_id="O3">
            <title>RA Participants (Monotherapy Group)</title>
            <description>Participants with severe RA, were prescribed with tocilizumab alone, in accordance with routine clinic practice and were observed for 6 months.</description>
          </group>
          <group group_id="O4">
            <title>RA Participants (Combination Therapy Group)</title>
            <description>Participants with severe RA, were prescribed with DMARD at the time of first dose of tocilizumab, in accordance with routine clinic practice and were observed for 6 months.</description>
          </group>
          <group group_id="O5">
            <title>RA Participants (All Groups)</title>
            <description>Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants on Tocilizumab Monotherapy (8 mg/Kg) at Baseline and at Month 6</title>
          <population>FAS population. n= participants with available data at the specified visit.</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="29"/>
                <count group_id="O2" value="8"/>
                <count group_id="O3" value="5"/>
                <count group_id="O4" value="32"/>
                <count group_id="O5" value="37"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (n=29,8,5,32,37)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="93.1"/>
                    <measurement group_id="O2" value="100"/>
                    <measurement group_id="O3" value="100.0"/>
                    <measurement group_id="O4" value="93.8"/>
                    <measurement group_id="O5" value="94.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6 (n=20,8,4,24,28)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="87.0"/>
                    <measurement group_id="O2" value="100"/>
                    <measurement group_id="O3" value="100.0"/>
                    <measurement group_id="O4" value="88.9"/>
                    <measurement group_id="O5" value="90.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Duration of Tocilizumab Treatment</title>
        <time_frame>Baseline up to Month 6</time_frame>
        <population>FAS population.</population>
        <group_list>
          <group group_id="O1">
            <title>RA Participants (Biologic Naïve Group)</title>
            <description>Participants with severe RA, and no prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.</description>
          </group>
          <group group_id="O2">
            <title>RA Participants (Biologic Exposed Group)</title>
            <description>Participants with severe RA, with prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.</description>
          </group>
          <group group_id="O3">
            <title>RA Participants (Monotherapy Group)</title>
            <description>Participants with severe RA, were prescribed with tocilizumab alone, in accordance with routine clinic practice and were observed for 6 months.</description>
          </group>
          <group group_id="O4">
            <title>RA Participants (Combination Therapy Group)</title>
            <description>Participants with severe RA, were prescribed with DMARD at the time of first dose of tocilizumab, in accordance with routine clinic practice and were observed for 6 months.</description>
          </group>
          <group group_id="O5">
            <title>RA Participants (All Groups)</title>
            <description>Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Duration of Tocilizumab Treatment</title>
          <population>FAS population.</population>
          <units>days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="29"/>
                <count group_id="O2" value="8"/>
                <count group_id="O3" value="5"/>
                <count group_id="O4" value="32"/>
                <count group_id="O5" value="37"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="181.1" spread="56.31"/>
                    <measurement group_id="O2" value="211.3" spread="28.17"/>
                    <measurement group_id="O3" value="174.8" spread="48.43"/>
                    <measurement group_id="O4" value="189.7" spread="53.79"/>
                    <measurement group_id="O5" value="187.6" spread="52.71"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants by Duration of Morning Stiffness</title>
        <description>Duration of morning stiffness was defined as the time elapsed between the time of usual awakening (even if not in the morning) and the time the participant was able to resume normal activities without stiffness. The participant assessment of morning stiffness was measured using a ruler on a 100 mm VAS by 1 of the six categories: less than (&lt;) 30 minutes, between 30 and 240 minutes, greater than (&gt;) 240 minutes and whole day.</description>
        <time_frame>Baseline, Month 3, Month 6</time_frame>
        <population>FAS population. Here, n= participants with available data at specified visit.</population>
        <group_list>
          <group group_id="O1">
            <title>RA Participants (Biologic Naïve Group)</title>
            <description>Participants with severe RA, and no prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.</description>
          </group>
          <group group_id="O2">
            <title>RA Participants (Biologic Exposed Group)</title>
            <description>Participants with severe RA, with prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.</description>
          </group>
          <group group_id="O3">
            <title>RA Participants (Monotherapy Group)</title>
            <description>Participants with severe RA, were prescribed with tocilizumab alone, in accordance with routine clinic practice and were observed for 6 months.</description>
          </group>
          <group group_id="O4">
            <title>RA Participants (Combination Therapy Group)</title>
            <description>Participants with severe RA, were prescribed with DMARD at the time of first dose of tocilizumab, in accordance with routine clinic practice and were observed for 6 months.</description>
          </group>
          <group group_id="O5">
            <title>RA Participants (All Groups)</title>
            <description>Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants by Duration of Morning Stiffness</title>
          <description>Duration of morning stiffness was defined as the time elapsed between the time of usual awakening (even if not in the morning) and the time the participant was able to resume normal activities without stiffness. The participant assessment of morning stiffness was measured using a ruler on a 100 mm VAS by 1 of the six categories: less than (&lt;) 30 minutes, between 30 and 240 minutes, greater than (&gt;) 240 minutes and whole day.</description>
          <population>FAS population. Here, n= participants with available data at specified visit.</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="29"/>
                <count group_id="O2" value="8"/>
                <count group_id="O3" value="5"/>
                <count group_id="O4" value="32"/>
                <count group_id="O5" value="37"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline ( &lt; 30 minutes) (n= 22, 6, 2, 26, 28)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.5"/>
                    <measurement group_id="O2" value="16.7"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="7.7"/>
                    <measurement group_id="O5" value="7.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 3 (&lt; 30 minutes) (n=13, 4, 3, 14, 17)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30.8"/>
                    <measurement group_id="O2" value="75.0"/>
                    <measurement group_id="O3" value="33.3"/>
                    <measurement group_id="O4" value="42.9"/>
                    <measurement group_id="O5" value="41.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6 (&lt; 30 minutes) (n= 12, 3, 3, 12, 15)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="33.3"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="33.3"/>
                    <measurement group_id="O5" value="26.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline (30-60 minutes) (n= 22, 6, 2, 26, 28)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.6"/>
                    <measurement group_id="O2" value="16.7"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="15.4"/>
                    <measurement group_id="O5" value="14.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 3 (30-60 minutes) (n= 13, 4, 3, 14, 17)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="53.8"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="33.3"/>
                    <measurement group_id="O4" value="42.9"/>
                    <measurement group_id="O5" value="41.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6 (30-60 minutes) (n= 12, 3, 3, 12, 15)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.7"/>
                    <measurement group_id="O2" value="66.7"/>
                    <measurement group_id="O3" value="66.7"/>
                    <measurement group_id="O4" value="16.7"/>
                    <measurement group_id="O5" value="26.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline (60-120 minutes) (n= 22, 6, 2, 26, 28)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.2"/>
                    <measurement group_id="O2" value="16.7"/>
                    <measurement group_id="O3" value="50.0"/>
                    <measurement group_id="O4" value="15.4"/>
                    <measurement group_id="O5" value="17.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 3 (60-120 minutes) (n= 13, 4, 3, 14, 17)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.7"/>
                    <measurement group_id="O2" value="25.0"/>
                    <measurement group_id="O3" value="33.3"/>
                    <measurement group_id="O4" value="7.1"/>
                    <measurement group_id="O5" value="11.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6 (60-120 minutes) (n= 12, 3, 3, 12, 15)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.3"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="8.3"/>
                    <measurement group_id="O5" value="6.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline (120-240 minutes) (n= 22, 6, 2, 26, 28)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31.8"/>
                    <measurement group_id="O2" value="33.3"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="34.6"/>
                    <measurement group_id="O5" value="32.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 3 (120-240 minutes) (n= 13, 4, 3, 14, 17)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6 (120-240 minutes) (n=12, 3, 3, 12, 15)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25.0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="25.0"/>
                    <measurement group_id="O5" value="20.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline (&gt; 240 minutes) (n= 22, 6, 2, 26, 28)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22.7"/>
                    <measurement group_id="O2" value="16.7"/>
                    <measurement group_id="O3" value="50.0"/>
                    <measurement group_id="O4" value="19.2"/>
                    <measurement group_id="O5" value="21.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 3 (&gt; 240 minutes) (n= 13, 4, 3, 14, 17)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6 (&gt; 240 minutes) (n= 12, 3, 3, 12, 15)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.3"/>
                    <measurement group_id="O2" value="33.3"/>
                    <measurement group_id="O3" value="33.3"/>
                    <measurement group_id="O4" value="8.3"/>
                    <measurement group_id="O5" value="13.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline (whole day) (n= 22, 6, 2, 26, 28)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="7.7"/>
                    <measurement group_id="O5" value="7.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 3 (whole day) (n= 13, 4, 3, 14, 17)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.7"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="7.1"/>
                    <measurement group_id="O5" value="5.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6 (whole day) (n= 12, 3, 3, 12, 15)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.3"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="8.3"/>
                    <measurement group_id="O5" value="6.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With and Without Morning Stiffness</title>
        <description>Morning stiffness was defined by the time elapsed between the time of usual awakening (even if not in the morning) and the time the participant was able to resume normal activities without stiffness. The participant assessed morning stiffness based on the following criteria:&#xD;
Presence of participant's joints stiff when woke up that day, measured as yes or no&#xD;
Duration of morning stiffness, measured using a ruler on a 100 mm VAS by 1 of the six categories: &lt; 30 minutes, between 30 and 240 minutes, &gt; 240 minutes, and the whole day.&#xD;
Severity of morning stiffness measured using a ruler on a 100 mm VAS where the responses were on a continuous range from 0 = no stiffness to 100 = maximum stiffness.</description>
        <time_frame>Baseline, Month 3, Month 6</time_frame>
        <population>FAS population. Here, Number of participants analyzed = participants evaluable for the outcome measure and n= participants with available data at the specified visit.</population>
        <group_list>
          <group group_id="O1">
            <title>RA Participants (Biologic Naïve Group)</title>
            <description>Participants with severe RA, and no prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.</description>
          </group>
          <group group_id="O2">
            <title>RA Participants (Biologic Exposed Group)</title>
            <description>Participants with severe RA, with prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.</description>
          </group>
          <group group_id="O3">
            <title>RA Participants (Monotherapy Group)</title>
            <description>Participants with severe RA, were prescribed with tocilizumab alone, in accordance with routine clinic practice and were observed for 6 months.</description>
          </group>
          <group group_id="O4">
            <title>RA Participants (Combination Therapy Group)</title>
            <description>Participants with severe RA, were prescribed with DMARD at the time of first dose of tocilizumab, in accordance with routine clinic practice and were observed for 6 months.</description>
          </group>
          <group group_id="O5">
            <title>RA Participants (All Groups)</title>
            <description>Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With and Without Morning Stiffness</title>
          <description>Morning stiffness was defined by the time elapsed between the time of usual awakening (even if not in the morning) and the time the participant was able to resume normal activities without stiffness. The participant assessed morning stiffness based on the following criteria:&#xD;
Presence of participant's joints stiff when woke up that day, measured as yes or no&#xD;
Duration of morning stiffness, measured using a ruler on a 100 mm VAS by 1 of the six categories: &lt; 30 minutes, between 30 and 240 minutes, &gt; 240 minutes, and the whole day.&#xD;
Severity of morning stiffness measured using a ruler on a 100 mm VAS where the responses were on a continuous range from 0 = no stiffness to 100 = maximum stiffness.</description>
          <population>FAS population. Here, Number of participants analyzed = participants evaluable for the outcome measure and n= participants with available data at the specified visit.</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="24"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="4"/>
                <count group_id="O4" value="27"/>
                <count group_id="O5" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline(with morning stiffness)(n=24,6,3,27,30)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="95.8"/>
                    <measurement group_id="O2" value="100"/>
                    <measurement group_id="O3" value="100"/>
                    <measurement group_id="O4" value="96.3"/>
                    <measurement group_id="O5" value="96.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline(without morningstiffness)(n=24,6,3,27,30)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.2"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="3.7"/>
                    <measurement group_id="O5" value="3.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 3(with morning stiffness)(n=14,5,4,15,19)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="92.9"/>
                    <measurement group_id="O2" value="100"/>
                    <measurement group_id="O3" value="100"/>
                    <measurement group_id="O4" value="93.3"/>
                    <measurement group_id="O5" value="94.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 3(without morning stiffness)(n=14,5,4,15,19)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="6.7"/>
                    <measurement group_id="O5" value="5.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6(with morning stiffness)(n=14,3,4,13,17)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="92.9"/>
                    <measurement group_id="O2" value="100"/>
                    <measurement group_id="O3" value="100"/>
                    <measurement group_id="O4" value="92.3"/>
                    <measurement group_id="O5" value="94.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6(without morning stiffness)(n=14,3,4,13,17)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="7.7"/>
                    <measurement group_id="O5" value="5.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Adhering to Local Label for Adverse Events</title>
        <description>Percentage of participants who adhered to local label/protocol for the management of adverse events is reported.</description>
        <time_frame>Baseline up to Month 6</time_frame>
        <population>FAS population. Number of participants analyzed = participants with available data for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>RA Participants (Biologic Naïve Group)</title>
            <description>Participants with severe RA, and no prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.</description>
          </group>
          <group group_id="O2">
            <title>RA Participants (Biologic Exposed Group)</title>
            <description>Participants with severe RA, with prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.</description>
          </group>
          <group group_id="O3">
            <title>RA Participants (Monotherapy Group)</title>
            <description>Participants with severe RA, were prescribed with tocilizumab alone, in accordance with routine clinic practice and were observed for 6 months.</description>
          </group>
          <group group_id="O4">
            <title>RA Participants (Combination Therapy Group)</title>
            <description>Participants with severe RA, were prescribed with DMARD at the time of first dose of tocilizumab, in accordance with routine clinic practice and were observed for 6 months.</description>
          </group>
          <group group_id="O5">
            <title>RA Participants (All Groups)</title>
            <description>Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Adhering to Local Label for Adverse Events</title>
          <description>Percentage of participants who adhered to local label/protocol for the management of adverse events is reported.</description>
          <population>FAS population. Number of participants analyzed = participants with available data for this outcome measure.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4"/>
                <count group_id="O2" value="1"/>
                <count group_id="O3" value="1"/>
                <count group_id="O4" value="4"/>
                <count group_id="O5" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100"/>
                    <measurement group_id="O2" value="100"/>
                    <measurement group_id="O3" value="100"/>
                    <measurement group_id="O4" value="75"/>
                    <measurement group_id="O5" value="80"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Disease Activity Score Based on 28 Joint Count (DAS28) Score by Visit</title>
        <description>The DAS28 score is a measurement of RA activity on a 0 to 10 scale, with higher scores representing higher disease activity, and calculated as DAS28 = 0.56 x √TJC28 + 0.28 x √SJC28 + 0.70 x natural logarithm (ln) (CRP + 1) + 0.014 x PGH + 0.96, where TJC28 = tender joint count on 28 units, SJC28 = swollen joint count on 28 units, CRP = serum concentration of c-reactive protein (after converting units to mg/dL), PGH = patient global assessment of disease activity, which was measured on a 100 mm VAS, where 0 = managing very well and 100 = managing very poorly. A score of less than 2.6 represents clinical remission, a score of greater than or equal to 2.6 and less than or equal to 3.2 represents low disease activity, a score of greater than 3.2 and less than or equal to 5.1 represents moderate disease activity, and a score of greater than 5.1 represents high (or severe) disease.</description>
        <time_frame>Baseline, Month 3, Month 6</time_frame>
        <population>FAS population. Here, Number of participants analyzed = Participants evaluable for the outcome measure and n= participants with DAS28 score available at the specified visit.</population>
        <group_list>
          <group group_id="O1">
            <title>RA Participants (Biologic Naïve Group)</title>
            <description>Participants with severe RA, and no prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.</description>
          </group>
          <group group_id="O2">
            <title>RA Participants (Biologic Exposed Group)</title>
            <description>Participants with severe RA, with prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.</description>
          </group>
          <group group_id="O3">
            <title>RA Participants (Monotherapy Group)</title>
            <description>Participants with severe RA, were prescribed with tocilizumab alone, in accordance with routine clinic practice and were observed for 6 months.</description>
          </group>
          <group group_id="O4">
            <title>RA Participants (Combination Therapy Group)</title>
            <description>Participants with severe RA, were prescribed with DMARD at the time of first dose of tocilizumab, in accordance with routine clinic practice and were observed for 6 months.</description>
          </group>
          <group group_id="O5">
            <title>RA Participants (All Groups)</title>
            <description>Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Disease Activity Score Based on 28 Joint Count (DAS28) Score by Visit</title>
          <description>The DAS28 score is a measurement of RA activity on a 0 to 10 scale, with higher scores representing higher disease activity, and calculated as DAS28 = 0.56 x √TJC28 + 0.28 x √SJC28 + 0.70 x natural logarithm (ln) (CRP + 1) + 0.014 x PGH + 0.96, where TJC28 = tender joint count on 28 units, SJC28 = swollen joint count on 28 units, CRP = serum concentration of c-reactive protein (after converting units to mg/dL), PGH = patient global assessment of disease activity, which was measured on a 100 mm VAS, where 0 = managing very well and 100 = managing very poorly. A score of less than 2.6 represents clinical remission, a score of greater than or equal to 2.6 and less than or equal to 3.2 represents low disease activity, a score of greater than 3.2 and less than or equal to 5.1 represents moderate disease activity, and a score of greater than 5.1 represents high (or severe) disease.</description>
          <population>FAS population. Here, Number of participants analyzed = Participants evaluable for the outcome measure and n= participants with DAS28 score available at the specified visit.</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 group_id="O2" value="6"/>
                <count group_id="O3" value="3"/>
                <count group_id="O4" value="25"/>
                <count group_id="O5" value="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (n=22, 6, 3, 25, 28)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.34" spread="1.611"/>
                    <measurement group_id="O2" value="6.04" spread="1.272"/>
                    <measurement group_id="O3" value="6.73" spread="0.868"/>
                    <measurement group_id="O4" value="6.22" spread="1.592"/>
                    <measurement group_id="O5" value="6.28" spread="1.528"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 3 (n=13, 4, 2, 15, 17)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.69" spread="1.274"/>
                    <measurement group_id="O2" value="2.98" spread="1.250"/>
                    <measurement group_id="O3" value="3.61" spread="0.151"/>
                    <measurement group_id="O4" value="2.64" spread="1.275"/>
                    <measurement group_id="O5" value="2.76" spread="1.236"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6 (n=12, 2, 2, 12, 14)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.02" spread="1.459"/>
                    <measurement group_id="O2" value="2.75" spread="1.420"/>
                    <measurement group_id="O3" value="3.49" spread="0.380"/>
                    <measurement group_id="O4" value="2.89" spread="1.502"/>
                    <measurement group_id="O5" value="2.98" spread="1.402"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Achieving Good European League Against Rheumatism (EULAR) Response at Month 3 and Month 6</title>
        <description>Clinical response was assessed according to EULAR criteria that classified the participant according to individual changes in DAS28 score as good, moderate, or no response. The DAS28 score is a measurement of RA activity on a 0 to 10 scale, with higher scores represent higher disease activity, and calculated as DAS28 = 0.56 x √TJC28 + 0.28 x √SJC28 + 0.36 x ln(CRP + 1) + 0.014 x PGH + 0.96, where TJC28 = tender joint count on 28 units, SJC28 = swollen joint count on 28 units, CRP = serum concentration of c-reactive protein (after converting units to mg/dL), PGH = patient's global assessment of disease activity, which was measured on a 100 mm VAS, where 0 = managing very well and 100 = managing very poorly. Good responders experienced a change from baseline of greater than 1.2 with a DAS28 score less than or equal to 3.2.</description>
        <time_frame>Month 3 and Month 6</time_frame>
        <population>FAS population. Here, Number of participants analyzed = participants evaluable for the outcome measure and n= participants with EULAR response available at specified visit.</population>
        <group_list>
          <group group_id="O1">
            <title>RA Participants (Biologic Naïve Group)</title>
            <description>Participants with severe RA, and no prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.</description>
          </group>
          <group group_id="O2">
            <title>RA Participants (Biologic Exposed Group)</title>
            <description>Participants with severe RA, with prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.</description>
          </group>
          <group group_id="O3">
            <title>RA Participants (Monotherapy Group)</title>
            <description>Participants with severe RA, were prescribed with tocilizumab alone, in accordance with routine clinic practice and were observed for 6 months.</description>
          </group>
          <group group_id="O4">
            <title>RA Participants (Combination Therapy Group)</title>
            <description>Participants with severe RA, were prescribed with DMARD at the time of first dose of tocilizumab, in accordance with routine clinic practice and were observed for 6 months.</description>
          </group>
          <group group_id="O5">
            <title>RA Participants (All Groups)</title>
            <description>Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving Good European League Against Rheumatism (EULAR) Response at Month 3 and Month 6</title>
          <description>Clinical response was assessed according to EULAR criteria that classified the participant according to individual changes in DAS28 score as good, moderate, or no response. The DAS28 score is a measurement of RA activity on a 0 to 10 scale, with higher scores represent higher disease activity, and calculated as DAS28 = 0.56 x √TJC28 + 0.28 x √SJC28 + 0.36 x ln(CRP + 1) + 0.014 x PGH + 0.96, where TJC28 = tender joint count on 28 units, SJC28 = swollen joint count on 28 units, CRP = serum concentration of c-reactive protein (after converting units to mg/dL), PGH = patient's global assessment of disease activity, which was measured on a 100 mm VAS, where 0 = managing very well and 100 = managing very poorly. Good responders experienced a change from baseline of greater than 1.2 with a DAS28 score less than or equal to 3.2.</description>
          <population>FAS population. Here, Number of participants analyzed = participants evaluable for the outcome measure and n= participants with EULAR response available at specified visit.</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="11"/>
                <count group_id="O2" value="3"/>
                <count group_id="O3" value="1"/>
                <count group_id="O4" value="13"/>
                <count group_id="O5" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Month 3 (n= 11, 3, 1, 13, 14)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="63.6"/>
                    <measurement group_id="O2" value="66.7"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="69.2"/>
                    <measurement group_id="O5" value="64.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6 (n= 10, 1,1, 10, 11)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="50.0"/>
                    <measurement group_id="O2" value="100"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="60.0"/>
                    <measurement group_id="O5" value="54.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Clinical Disease Activity Index (CDAI) Score by Visit</title>
        <description>The CDAI is a combined index for measuring disease activity in RA and calculated as CDAI = TJC28 + SJC28 + PGH (in centimeters) + PhGH (in centimeters), where TJC28 = tender joint count on 28 units, SJC28 = swollen joint count on 28 units, PGH = patient's global assessment of disease activity, assessed on a 100 mm VAS, where 0 = managing very well and 100 = managing very poorly, and PhGH = physician global assessment of disease activity, assessed on a 100 mm VAS, where 0 = no arthritis activity and 100 = extremely active arthritis; with a total score ranged from 0-76. Higher scores indicate greater disease activity. CDAI score of less than or equal to 2.8 represents clinical remission, score of less than or equal to 10.0 represents low disease activity, score of less than or equal to 22.0 represents moderate disease activity, and score of greater than 22.0 represents high (or severe) disease.</description>
        <time_frame>Baseline, Month 3, Month 6</time_frame>
        <population>FAS population. Here, Number of participants analyzed = participants evaluable for the outcome measure and n= participants with CDAI score available at specified visit.</population>
        <group_list>
          <group group_id="O1">
            <title>RA Participants (Biologic Naïve Group)</title>
            <description>Participants with severe RA, and no prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.</description>
          </group>
          <group group_id="O2">
            <title>RA Participants (Biologic Exposed Group)</title>
            <description>Participants with severe RA, with prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.</description>
          </group>
          <group group_id="O3">
            <title>RA Participants (Monotherapy Group)</title>
            <description>Participants with severe RA, were prescribed with tocilizumab alone, in accordance with routine clinic practice and were observed for 6 months.</description>
          </group>
          <group group_id="O4">
            <title>RA Participants (Combination Therapy Group)</title>
            <description>Participants with severe RA, were prescribed with DMARD at the time of first dose of tocilizumab, in accordance with routine clinic practice and were observed for 6 months.</description>
          </group>
          <group group_id="O5">
            <title>RA Participants (All Groups)</title>
            <description>Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Clinical Disease Activity Index (CDAI) Score by Visit</title>
          <description>The CDAI is a combined index for measuring disease activity in RA and calculated as CDAI = TJC28 + SJC28 + PGH (in centimeters) + PhGH (in centimeters), where TJC28 = tender joint count on 28 units, SJC28 = swollen joint count on 28 units, PGH = patient's global assessment of disease activity, assessed on a 100 mm VAS, where 0 = managing very well and 100 = managing very poorly, and PhGH = physician global assessment of disease activity, assessed on a 100 mm VAS, where 0 = no arthritis activity and 100 = extremely active arthritis; with a total score ranged from 0-76. Higher scores indicate greater disease activity. CDAI score of less than or equal to 2.8 represents clinical remission, score of less than or equal to 10.0 represents low disease activity, score of less than or equal to 22.0 represents moderate disease activity, and score of greater than 22.0 represents high (or severe) disease.</description>
          <population>FAS population. Here, Number of participants analyzed = participants evaluable for the outcome measure and n= participants with CDAI score available at specified visit.</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 group_id="O2" value="6"/>
                <count group_id="O3" value="4"/>
                <count group_id="O4" value="25"/>
                <count group_id="O5" value="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (n= 22, 6, 3, 25, 28)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="46.41" spread="16.482"/>
                    <measurement group_id="O2" value="40.90" spread="18.277"/>
                    <measurement group_id="O3" value="45.40" spread="4.900"/>
                    <measurement group_id="O4" value="45.21" spread="17.643"/>
                    <measurement group_id="O5" value="45.23" spread="16.687"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 3 (n= 13, 5, 4, 14, 18)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.37" spread="10.970"/>
                    <measurement group_id="O2" value="16.00" spread="5.632"/>
                    <measurement group_id="O3" value="13.05" spread="7.468"/>
                    <measurement group_id="O4" value="13.47" spread="10.564"/>
                    <measurement group_id="O5" value="13.38" spread="9.758"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6 (n= 13, 3, 4, 12, 16)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.20" spread="15.017"/>
                    <measurement group_id="O2" value="14.93" spread="4.140"/>
                    <measurement group_id="O3" value="11.30" spread="7.338"/>
                    <measurement group_id="O4" value="14.27" spread="15.254"/>
                    <measurement group_id="O5" value="13.53" spread="13.534"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in TJC and SJC at Month 3 and Month 6</title>
        <description>TJC was determined by examining 28 and 68 joints 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 baseline, no tenderness = 0, tenderness = 1. SJC was determined by examination of 28 and 66 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at baseline, no swelling = 0, swelling =1.</description>
        <time_frame>Baseline, Month 3, Month 6</time_frame>
        <population>FAS population. Here, Number of participants analyzed = participants evaluable for the outcome measure and n= participants with available data at the specified visit.</population>
        <group_list>
          <group group_id="O1">
            <title>RA Participants (Biologic Naïve Group)</title>
            <description>Participants with severe RA, and no prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.</description>
          </group>
          <group group_id="O2">
            <title>RA Participants (Biologic Exposed Group)</title>
            <description>Participants with severe RA, with prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.</description>
          </group>
          <group group_id="O3">
            <title>RA Participants (Monotherapy Group)</title>
            <description>Participants with severe RA, were prescribed with tocilizumab alone, in accordance with routine clinic practice and were observed for 6 months.</description>
          </group>
          <group group_id="O4">
            <title>RA Participants (Combination Therapy Group)</title>
            <description>Participants with severe RA, were prescribed with DMARD at the time of first dose of tocilizumab, in accordance with routine clinic practice and were observed for 6 months.</description>
          </group>
          <group group_id="O5">
            <title>RA Participants (All Groups)</title>
            <description>Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in TJC and SJC at Month 3 and Month 6</title>
          <description>TJC was determined by examining 28 and 68 joints 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 baseline, no tenderness = 0, tenderness = 1. SJC was determined by examination of 28 and 66 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at baseline, no swelling = 0, swelling =1.</description>
          <population>FAS population. Here, Number of participants analyzed = participants evaluable for the outcome measure and n= participants with available data at the specified visit.</population>
          <units>joint counts</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="27"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="4"/>
                <count group_id="O4" value="29"/>
                <count group_id="O5" value="33"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>TJC28: Baseline (n= 27, 6, 4, 29, 33)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.6" spread="7.68"/>
                    <measurement group_id="O2" value="14.7" spread="8.48"/>
                    <measurement group_id="O3" value="13.0" spread="8.41"/>
                    <measurement group_id="O4" value="15.8" spread="7.69"/>
                    <measurement group_id="O5" value="15.4" spread="7.70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TJC28: Change at Month 3 (n= 14, 4, 3, 15, 18)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-13.9" spread="5.17"/>
                    <measurement group_id="O2" value="-11.0" spread="6.78"/>
                    <measurement group_id="O3" value="-7.0" spread="5.57"/>
                    <measurement group_id="O4" value="-14.5" spread="4.70"/>
                    <measurement group_id="O5" value="-13.2" spread="5.48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TJC28: Change at Month 6 (n= 14, 2, 3, 13, 16)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-11.1" spread="8.56"/>
                    <measurement group_id="O2" value="-15.0" spread="7.07"/>
                    <measurement group_id="O3" value="-8.3" spread="6.66"/>
                    <measurement group_id="O4" value="-12.3" spread="8.67"/>
                    <measurement group_id="O5" value="-11.6" spread="8.29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TJC68: Baseline (n= 18, 5, 2, 21, 23 )</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="34.4" spread="16.97"/>
                    <measurement group_id="O2" value="24.2" spread="18.43"/>
                    <measurement group_id="O3" value="26.0" spread="7.07"/>
                    <measurement group_id="O4" value="32.8" spread="18.07"/>
                    <measurement group_id="O5" value="32.2" spread="17.40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TJC68: Change at Month 3 (n= 11, 3, 2, 12, 14)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-30.5" spread="8.13"/>
                    <measurement group_id="O2" value="-12.3" spread="6.66"/>
                    <measurement group_id="O3" value="-18.0" spread="12.73"/>
                    <measurement group_id="O4" value="-28.1" spread="10.42"/>
                    <measurement group_id="O5" value="-26.6" spread="10.85"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TJC68: Change at Month 6 (n= 11, 1, 2, 10, 12 )</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-27.5" spread="17.41"/>
                    <measurement group_id="O2" value="-17.0" spread="NA">SD not calculable because only 1 participant was evaluated.</measurement>
                    <measurement group_id="O3" value="-21.5" spread="6.36"/>
                    <measurement group_id="O4" value="-27.7" spread="18.34"/>
                    <measurement group_id="O5" value="-26.7" spread="16.88"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SJC28: Baseline (n= 27, 6, 4, 29, 33)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.0" spread="6.66"/>
                    <measurement group_id="O2" value="14.0" spread="7.51"/>
                    <measurement group_id="O3" value="12.5" spread="3.79"/>
                    <measurement group_id="O4" value="14.2" spread="7.03"/>
                    <measurement group_id="O5" value="14.0" spread="6.70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SJC28: Change at Month 3 (n= 14, 4, 3, 15, 18)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-13.8" spread="4.54"/>
                    <measurement group_id="O2" value="-10.5" spread="6.81"/>
                    <measurement group_id="O3" value="-9.3" spread="5.51"/>
                    <measurement group_id="O4" value="-13.8" spread="4.86"/>
                    <measurement group_id="O5" value="-13.1" spread="5.09"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SJC28: Change at Month 6 (n= 14, 2, 3, 13, 16)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-10.8" spread="6.34"/>
                    <measurement group_id="O2" value="-13.5" spread="4.95"/>
                    <measurement group_id="O3" value="-11.7" spread="2.89"/>
                    <measurement group_id="O4" value="-11.0" spread="6.72"/>
                    <measurement group_id="O5" value="-11.1" spread="6.11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SJC66: Baseline (n= 18, 5, 2, 21, 23)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27.7" spread="13.73"/>
                    <measurement group_id="O2" value="21.0" spread="13.62"/>
                    <measurement group_id="O3" value="26.5" spread="7.78"/>
                    <measurement group_id="O4" value="26.2" spread="14.25"/>
                    <measurement group_id="O5" value="26.3" spread="13.69"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SJC66: Change at Month 3 (n= 11, 3, 2, 12, 14)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-27.2" spread="9.58"/>
                    <measurement group_id="O2" value="-12.7" spread="5.51"/>
                    <measurement group_id="O3" value="-18.5" spread="13.44"/>
                    <measurement group_id="O4" value="-25.0" spread="10.54"/>
                    <measurement group_id="O5" value="-24.1" spread="10.65"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SJC66: Change at Month 6 (n= 11, 1, 2, 10, 12)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-26.0" spread="13.80"/>
                    <measurement group_id="O2" value="-17.0" spread="NA">SD not calculable because only 1 participant was evaluated.</measurement>
                    <measurement group_id="O3" value="-21.5" spread="6.36"/>
                    <measurement group_id="O4" value="-26.0" spread="14.54"/>
                    <measurement group_id="O5" value="-25.3" spread="13.41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Simplified Disease Activity Index (SDAI) Score by Visit</title>
        <description>The SDAI is a combined index for measuring disease activity in RA and calculated as SDAI = TJC28 + SJC28 + PGH (in centimeters) + PhGH (in centimeters) + CRP (in mg/dL), where TJC28 = tender joint count on 28 units, SJC28 = swollen joint count on 28 units, PGH = patient's global assessment of disease activity, assessed on a 100 mm VAS, where 0 = managing very well and 100 = managing very poorly, PhGH = physician global assessment of disease activity, assessed on a 100 mm VAS, where 0 = no arthritis activity and 100 = extremely active arthritis, CRP = serum concentration of c-reactive protein; with a total SDAI score ranged from 0-86. Higher scores indicate greater disease activity. SDAI scores of less than or equal to 3.3 represents clinical remission, less than or equal to 11.0 represents low disease activity, less than or equal to 26.0 represents moderate disease activity, and greater than 26.0 represents high (or severe) disease.</description>
        <time_frame>Baseline, Month 3, Month 6</time_frame>
        <population>FAS population. Here, Number of participants analyzed = participants evaluable for the outcome measure and n= participants with SDAI score available at the specified visit.</population>
        <group_list>
          <group group_id="O1">
            <title>RA Participants (Biologic Naïve Group)</title>
            <description>Participants with severe RA, and no prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.</description>
          </group>
          <group group_id="O2">
            <title>RA Participants (Biologic Exposed Group)</title>
            <description>Participants with severe RA, with prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.</description>
          </group>
          <group group_id="O3">
            <title>RA Participants (Monotherapy Group)</title>
            <description>Participants with severe RA, were prescribed with tocilizumab alone, in accordance with routine clinic practice and were observed for 6 months.</description>
          </group>
          <group group_id="O4">
            <title>RA Participants (Combination Therapy Group)</title>
            <description>Participants with severe RA, were prescribed with DMARD at the time of first dose of tocilizumab, in accordance with routine clinic practice and were observed for 6 months.</description>
          </group>
          <group group_id="O5">
            <title>RA Participants (All Groups)</title>
            <description>Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Simplified Disease Activity Index (SDAI) Score by Visit</title>
          <description>The SDAI is a combined index for measuring disease activity in RA and calculated as SDAI = TJC28 + SJC28 + PGH (in centimeters) + PhGH (in centimeters) + CRP (in mg/dL), where TJC28 = tender joint count on 28 units, SJC28 = swollen joint count on 28 units, PGH = patient's global assessment of disease activity, assessed on a 100 mm VAS, where 0 = managing very well and 100 = managing very poorly, PhGH = physician global assessment of disease activity, assessed on a 100 mm VAS, where 0 = no arthritis activity and 100 = extremely active arthritis, CRP = serum concentration of c-reactive protein; with a total SDAI score ranged from 0-86. Higher scores indicate greater disease activity. SDAI scores of less than or equal to 3.3 represents clinical remission, less than or equal to 11.0 represents low disease activity, less than or equal to 26.0 represents moderate disease activity, and greater than 26.0 represents high (or severe) disease.</description>
          <population>FAS population. Here, Number of participants analyzed = participants evaluable for the outcome measure and n= participants with SDAI score available at the specified visit.</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 group_id="O2" value="6"/>
                <count group_id="O3" value="3"/>
                <count group_id="O4" value="25"/>
                <count group_id="O5" value="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (n= 22, 6, 3, 25, 28)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="48.01" spread="16.853"/>
                    <measurement group_id="O2" value="43.57" spread="14.898"/>
                    <measurement group_id="O3" value="47.07" spread="6.689"/>
                    <measurement group_id="O4" value="47.06" spread="17.173"/>
                    <measurement group_id="O5" value="47.06" spread="16.293"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 3 (n= 11, 4, 2, 13, 15)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.29" spread="11.602"/>
                    <measurement group_id="O2" value="15.16" spread="6.066"/>
                    <measurement group_id="O3" value="14.95" spread="3.536"/>
                    <measurement group_id="O4" value="13.61" spread="10.997"/>
                    <measurement group_id="O5" value="13.79" spread="10.236"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6 (n= 12, 2, 2, 12, 14)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.55" spread="15.357"/>
                    <measurement group_id="O2" value="14.65" spread="5.798"/>
                    <measurement group_id="O3" value="13.70" spread="7.142"/>
                    <measurement group_id="O4" value="14.70" spread="15.301"/>
                    <measurement group_id="O5" value="14.56" spread="14.218"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With an American College of Rheumatology (ACR) 20%, 50%, or 70% (ACR20/50/70) Response at Month 3 and Month 6 From the Start of Tocilizumab Treatment</title>
        <description>ACR 20,50 or 70 response=an improvement of ≥ 20%, ≥ 50% or ≥ 70% respectively, as compared to baseline in TJC28 and SJC28, and 20%, 50% or 70% improvement in at least 3 of the 5 following measures: Patient's Assessment of Pain over the previous 24 hours, PGA, PhGA, HAQ, and acute phase reactant (either CRP or ESR). TJC and SJC, based on 28-joint assessments. Number of tender joints and swollen joints were recorded on the joint assessment form at baseline, no tenderness = 0 and tenderness = 1, no swelling = 0 and swelling =1, respectively. HAQ measures functional status (disability) and health-related quality of life with 20 questions, summarized in 8 categories: dressing and grooming, arising, eating, walking, hygiene, reach, grip and common activities over past week, 0=without difficulty to 3=unable to do. Patient's assessment of pain assessed using a VAS; 0=no pain, 100=unbearable pain; PGA and PhGA, assessed using VAS ; 0= no disease activity, 100=maximum disease activity.</description>
        <time_frame>Month 3 and Month 6</time_frame>
        <population>FAS population. Here, Number of participants analyzed = participants evaluable for the outcome measure and n= participants with available data for the specified visit.</population>
        <group_list>
          <group group_id="O1">
            <title>RA Participants (Biologic Naïve Group)</title>
            <description>Participants with severe RA, and no prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.</description>
          </group>
          <group group_id="O2">
            <title>RA Participants (Biologic Exposed Group)</title>
            <description>Participants with severe RA, with prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.</description>
          </group>
          <group group_id="O3">
            <title>RA Participants (Monotherapy Group)</title>
            <description>Participants with severe RA, were prescribed with tocilizumab alone, in accordance with routine clinic practice and were observed for 6 months.</description>
          </group>
          <group group_id="O4">
            <title>RA Participants (Combination Therapy Group)</title>
            <description>Participants with severe RA, were prescribed with DMARD at the time of first dose of tocilizumab, in accordance with routine clinic practice and were observed for 6 months.</description>
          </group>
          <group group_id="O5">
            <title>RA Participants (All Groups)</title>
            <description>Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With an American College of Rheumatology (ACR) 20%, 50%, or 70% (ACR20/50/70) Response at Month 3 and Month 6 From the Start of Tocilizumab Treatment</title>
          <description>ACR 20,50 or 70 response=an improvement of ≥ 20%, ≥ 50% or ≥ 70% respectively, as compared to baseline in TJC28 and SJC28, and 20%, 50% or 70% improvement in at least 3 of the 5 following measures: Patient's Assessment of Pain over the previous 24 hours, PGA, PhGA, HAQ, and acute phase reactant (either CRP or ESR). TJC and SJC, based on 28-joint assessments. Number of tender joints and swollen joints were recorded on the joint assessment form at baseline, no tenderness = 0 and tenderness = 1, no swelling = 0 and swelling =1, respectively. HAQ measures functional status (disability) and health-related quality of life with 20 questions, summarized in 8 categories: dressing and grooming, arising, eating, walking, hygiene, reach, grip and common activities over past week, 0=without difficulty to 3=unable to do. Patient's assessment of pain assessed using a VAS; 0=no pain, 100=unbearable pain; PGA and PhGA, assessed using VAS ; 0= no disease activity, 100=maximum disease activity.</description>
          <population>FAS population. Here, Number of participants analyzed = participants evaluable for the outcome measure and n= participants with available data for the specified visit.</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="11"/>
                <count group_id="O2" value="3"/>
                <count group_id="O3" value="2"/>
                <count group_id="O4" value="12"/>
                <count group_id="O5" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Month 3: ACR20 responders (n= 11, 3, 2, 12, 14)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="90.9" lower_limit="58.7" upper_limit="99.8"/>
                    <measurement group_id="O2" value="100.0" lower_limit="29.2" upper_limit="100"/>
                    <measurement group_id="O3" value="100.0" lower_limit="15.8" upper_limit="100"/>
                    <measurement group_id="O4" value="91.7" lower_limit="61.5" upper_limit="99.8"/>
                    <measurement group_id="O5" value="92.9" lower_limit="66.1" upper_limit="99.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6: ACR20 responders (n= 10, 1, 2, 9, 11)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="80.0" lower_limit="44.4" upper_limit="97.5"/>
                    <measurement group_id="O2" value="100.0" lower_limit="2.5" upper_limit="100.0"/>
                    <measurement group_id="O3" value="100.0" lower_limit="15.8" upper_limit="100"/>
                    <measurement group_id="O4" value="77.8" lower_limit="40.0" upper_limit="97.2"/>
                    <measurement group_id="O5" value="81.8" lower_limit="48.2" upper_limit="97.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 3: ACR50 responders (n= 11, 3, 2, 12, 14)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="63.6" lower_limit="30.8" upper_limit="89.1"/>
                    <measurement group_id="O2" value="33.3" lower_limit="0.8" upper_limit="90.6"/>
                    <measurement group_id="O3" value="0.0" lower_limit="0.0" upper_limit="84.2"/>
                    <measurement group_id="O4" value="66.7" lower_limit="34.9" upper_limit="90.1"/>
                    <measurement group_id="O5" value="57.1" lower_limit="28.9" upper_limit="82.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6: ACR50 responders (n= 10, 1, 2, 9, 11)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="70.0" lower_limit="34.8" upper_limit="93.3"/>
                    <measurement group_id="O2" value="0.0" lower_limit="0.0" upper_limit="97.5"/>
                    <measurement group_id="O3" value="50.0" lower_limit="1.3" upper_limit="98.7"/>
                    <measurement group_id="O4" value="66.7" lower_limit="29.9" upper_limit="92.5"/>
                    <measurement group_id="O5" value="63.6" lower_limit="30.8" upper_limit="89.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 3: ACR70 responders (n= 11, 3, 2, 12, 14)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="36.4" lower_limit="10.9" upper_limit="69.2"/>
                    <measurement group_id="O2" value="0.0" lower_limit="0.0" upper_limit="70.8"/>
                    <measurement group_id="O3" value="0.0" lower_limit="0.0" upper_limit="84.2"/>
                    <measurement group_id="O4" value="33.3" lower_limit="9.9" upper_limit="65.1"/>
                    <measurement group_id="O5" value="28.6" lower_limit="8.4" upper_limit="58.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6: ACR70 responders (n= 10, 1, 2, 9, 11)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="50.0" lower_limit="18.7" upper_limit="81.3"/>
                    <measurement group_id="O2" value="0.0" lower_limit="0.0" upper_limit="97.5"/>
                    <measurement group_id="O3" value="0.0" lower_limit="0.0" upper_limit="84.2"/>
                    <measurement group_id="O4" value="55.6" lower_limit="21.2" upper_limit="86.3"/>
                    <measurement group_id="O5" value="45.5" lower_limit="16.7" upper_limit="76.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Physician Global Assessment of Disease Activity at Months 3 and 6</title>
        <description>The physician global assessment of disease activity was evaluated using a 100 mm VAS where 0 = no arthritis activity and 100 = extremely active arthritis. Higher scores indicated increased level of disease.</description>
        <time_frame>Baseline, Month 3, Month 6</time_frame>
        <population>FAS population. Here, Number of participants analyzed = participants evaluable for the outcome measure and n= participants with available data at the specified visit.</population>
        <group_list>
          <group group_id="O1">
            <title>RA Participants (Biologic Naïve Group)</title>
            <description>Participants with severe RA, and no prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.</description>
          </group>
          <group group_id="O2">
            <title>RA Participants (Biologic Exposed Group)</title>
            <description>Participants with severe RA, with prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.</description>
          </group>
          <group group_id="O3">
            <title>RA Participants (Monotherapy Group)</title>
            <description>Participants with severe RA, were prescribed with tocilizumab alone, in accordance with routine clinic practice and were observed for 6 months.</description>
          </group>
          <group group_id="O4">
            <title>RA Participants (Combination Therapy Group)</title>
            <description>Participants with severe RA, were prescribed with DMARD at the time of first dose of tocilizumab, in accordance with routine clinic practice and were observed for 6 months.</description>
          </group>
          <group group_id="O5">
            <title>RA Participants (All Groups)</title>
            <description>Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Physician Global Assessment of Disease Activity at Months 3 and 6</title>
          <description>The physician global assessment of disease activity was evaluated using a 100 mm VAS where 0 = no arthritis activity and 100 = extremely active arthritis. Higher scores indicated increased level of disease.</description>
          <population>FAS population. Here, Number of participants analyzed = participants evaluable for the outcome measure and n= participants with available data at the specified visit.</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="25"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="3"/>
                <count group_id="O4" value="28"/>
                <count group_id="O5" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (n= 25, 6, 3, 28, 31)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="65.2" spread="24.53"/>
                    <measurement group_id="O2" value="63.3" spread="9.61"/>
                    <measurement group_id="O3" value="69.0" spread="9.00"/>
                    <measurement group_id="O4" value="64.4" spread="23.33"/>
                    <measurement group_id="O5" value="64.9" spread="22.30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Month 3 (n= 13, 4, 2, 15, 17)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-40.8" spread="24.07"/>
                    <measurement group_id="O2" value="-33.8" spread="11.56"/>
                    <measurement group_id="O3" value="-43.5" spread="4.95"/>
                    <measurement group_id="O4" value="-38.6" spread="23.05"/>
                    <measurement group_id="O5" value="-39.2" spread="21.66"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Month 6 (n= 13, 2, 2, 13, 15)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-35.2" spread="28.12"/>
                    <measurement group_id="O2" value="-38.5" spread="13.44"/>
                    <measurement group_id="O3" value="-45.5" spread="23.33"/>
                    <measurement group_id="O4" value="-34.2" spread="27.27"/>
                    <measurement group_id="O5" value="-35.7" spread="26.31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Patient Global Assessment of Disease Activity at Months 3 and 6</title>
        <description>The patient's global assessment of disease activity was measured using a 100 mm VAS, where the responses were on a continuous range from 0= managing very well and 100 = managing very poorly.</description>
        <time_frame>Baseline, Month 3, Month 6</time_frame>
        <population>FAS population. Here, Number of participants analyzed = participants evaluable for the outcome measure and n= participants with available data at the specified visit.</population>
        <group_list>
          <group group_id="O1">
            <title>RA Participants (Biologic Naïve Group)</title>
            <description>Participants with severe RA, and no prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.</description>
          </group>
          <group group_id="O2">
            <title>RA Participants (Biologic Exposed Group)</title>
            <description>Participants with severe RA, with prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.</description>
          </group>
          <group group_id="O3">
            <title>RA Participants (Monotherapy Group)</title>
            <description>Participants with severe RA, were prescribed with tocilizumab alone, in accordance with routine clinic practice and were observed for 6 months.</description>
          </group>
          <group group_id="O4">
            <title>RA Participants (Combination Therapy Group)</title>
            <description>Participants with severe RA, were prescribed with DMARD at the time of first dose of tocilizumab, in accordance with routine clinic practice and were observed for 6 months.</description>
          </group>
          <group group_id="O5">
            <title>RA Participants (All Groups)</title>
            <description>Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Patient Global Assessment of Disease Activity at Months 3 and 6</title>
          <description>The patient's global assessment of disease activity was measured using a 100 mm VAS, where the responses were on a continuous range from 0= managing very well and 100 = managing very poorly.</description>
          <population>FAS population. Here, Number of participants analyzed = participants evaluable for the outcome measure and n= participants with available data at the specified visit.</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="24"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="3"/>
                <count group_id="O4" value="27"/>
                <count group_id="O5" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (n=24, 6, 3, 27, 30)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="69.6" spread="29.71"/>
                    <measurement group_id="O2" value="59.0" spread="33.03"/>
                    <measurement group_id="O3" value="85.0" spread="11.36"/>
                    <measurement group_id="O4" value="65.5" spread="31.02"/>
                    <measurement group_id="O5" value="67.5" spread="30.11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Month 3 (n= 16, 4, 2, 18, 20 )</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-43.2" spread="35.87"/>
                    <measurement group_id="O2" value="-34.5" spread="18.70"/>
                    <measurement group_id="O3" value="-50.0" spread="16.97"/>
                    <measurement group_id="O4" value="-40.5" spread="34.42"/>
                    <measurement group_id="O5" value="-41.5" spread="32.92"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Month 6 (n= 13, 2, 2, 13, 15)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-26.4" spread="31.28"/>
                    <measurement group_id="O2" value="-37.0" spread="33.94"/>
                    <measurement group_id="O3" value="-32.0" spread="26.87"/>
                    <measurement group_id="O4" value="-27.2" spread="32.05"/>
                    <measurement group_id="O5" value="-27.8" spread="30.57"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in HAQ-DI Score at Months 3 and 6</title>
        <description>The HAQ-DI is a questionnaire that measures functional status (disability) and health-related quality of life. It measures the participant's ability to perform everyday tasks. The index consists of 20 questions regarding the function of the upper and lower extremities. These questions are summarized in 8 categories: dressing and grooming, arising, eating, walking, hygiene, reach, grip and common activities over past week. Each question was evaluated according to the degree of severity on a 4-point scale ranging from 0 = without any difficulty to 3 = unable to do. Total score is the sum of each question, which ranges from 0 to 60, where higher scores represent higher disease activity. The change from baseline in HAQ-DI score at Month 3 and Month 6 was calculated as the difference between HAQ-D1 score reported at baseline and the HAQ-D1 score reported at Month 3 and Month 6.</description>
        <time_frame>Baseline, Month 3, Month 6</time_frame>
        <population>FAS population. Here, Number of participants analyzed = participants evaluable for the outcome measure and n = participants with available HAQ-DI score at specified visit.</population>
        <group_list>
          <group group_id="O1">
            <title>RA Participants (Biologic Naïve Group)</title>
            <description>Participants with severe RA, and no prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.</description>
          </group>
          <group group_id="O2">
            <title>RA Participants (Biologic Exposed Group)</title>
            <description>Participants with severe RA, with prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.</description>
          </group>
          <group group_id="O3">
            <title>RA Participants (Monotherapy Group)</title>
            <description>Participants with severe RA, were prescribed with tocilizumab alone, in accordance with routine clinic practice and were observed for 6 months.</description>
          </group>
          <group group_id="O4">
            <title>RA Participants (Combination Therapy Group)</title>
            <description>Participants with severe RA, were prescribed with DMARD at the time of first dose of tocilizumab, in accordance with routine clinic practice and were observed for 6 months.</description>
          </group>
          <group group_id="O5">
            <title>RA Participants (All Groups)</title>
            <description>Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in HAQ-DI Score at Months 3 and 6</title>
          <description>The HAQ-DI is a questionnaire that measures functional status (disability) and health-related quality of life. It measures the participant's ability to perform everyday tasks. The index consists of 20 questions regarding the function of the upper and lower extremities. These questions are summarized in 8 categories: dressing and grooming, arising, eating, walking, hygiene, reach, grip and common activities over past week. Each question was evaluated according to the degree of severity on a 4-point scale ranging from 0 = without any difficulty to 3 = unable to do. Total score is the sum of each question, which ranges from 0 to 60, where higher scores represent higher disease activity. The change from baseline in HAQ-DI score at Month 3 and Month 6 was calculated as the difference between HAQ-D1 score reported at baseline and the HAQ-D1 score reported at Month 3 and Month 6.</description>
          <population>FAS population. Here, Number of participants analyzed = participants evaluable for the outcome measure and n = participants with available HAQ-DI score at specified visit.</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="24"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="3"/>
                <count group_id="O4" value="27"/>
                <count group_id="O5" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (n= 24, 6, 3, 27, 30)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.7" spread="0.86"/>
                    <measurement group_id="O2" value="1.7" spread="0.98"/>
                    <measurement group_id="O3" value="1.7" spread="0.59"/>
                    <measurement group_id="O4" value="1.7" spread="0.90"/>
                    <measurement group_id="O5" value="1.7" spread="0.87"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Month 3 (n= 16, 4, 2, 18, 20)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.5" spread="0.94"/>
                    <measurement group_id="O2" value="-0.4" spread="0.37"/>
                    <measurement group_id="O3" value="-0.3" spread="0.35"/>
                    <measurement group_id="O4" value="-0.5" spread="0.89"/>
                    <measurement group_id="O5" value="-0.5" spread="0.85"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Month 6 (n= 12, 2, 2, 12, 14)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.3" spread="0.48"/>
                    <measurement group_id="O2" value="-0.6" spread="0.35"/>
                    <measurement group_id="O3" value="-0.4" spread="0.09"/>
                    <measurement group_id="O4" value="-0.3" spread="0.51"/>
                    <measurement group_id="O5" value="-0.3" spread="0.46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in VAS-Fatigue at Months 3 and 6</title>
        <description>Participants measured the level of fatigue due to RA using a 100 mm VAS, where the responses were on a continuous range from 0 = no fatigue to 100 = extreme fatigue.</description>
        <time_frame>Baseline, Month 3, Month 6</time_frame>
        <population>FAS population. Here, Number of participants analyzed = participants evaluable for the outcome measure and n= participants with available data at the specified visit.</population>
        <group_list>
          <group group_id="O1">
            <title>RA Participants (Biologic Naïve Group)</title>
            <description>Participants with severe RA, and no prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.</description>
          </group>
          <group group_id="O2">
            <title>RA Participants (Biologic Exposed Group)</title>
            <description>Participants with severe RA, with prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.</description>
          </group>
          <group group_id="O3">
            <title>RA Participants (Monotherapy Group)</title>
            <description>Participants with severe RA, were prescribed with tocilizumab alone, in accordance with routine clinic practice and were observed for 6 months.</description>
          </group>
          <group group_id="O4">
            <title>RA Participants (Combination Therapy Group)</title>
            <description>Participants with severe RA, were prescribed with DMARD at the time of first dose of tocilizumab, in accordance with routine clinic practice and were observed for 6 months.</description>
          </group>
          <group group_id="O5">
            <title>RA Participants (All Groups)</title>
            <description>Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in VAS-Fatigue at Months 3 and 6</title>
          <description>Participants measured the level of fatigue due to RA using a 100 mm VAS, where the responses were on a continuous range from 0 = no fatigue to 100 = extreme fatigue.</description>
          <population>FAS population. Here, Number of participants analyzed = participants evaluable for the outcome measure and n= participants with available data at the specified visit.</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="25"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="3"/>
                <count group_id="O4" value="28"/>
                <count group_id="O5" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (n= 25, 6, 3, 28, 31)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="59.0" spread="34.35"/>
                    <measurement group_id="O2" value="67.8" spread="27.01"/>
                    <measurement group_id="O3" value="86.3" spread="8.08"/>
                    <measurement group_id="O4" value="58.0" spread="33.35"/>
                    <measurement group_id="O5" value="60.7" spread="32.84"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Month 3 (n= 16, 4, 2, 18, 20)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-23.2" spread="29.90"/>
                    <measurement group_id="O2" value="-37.8" spread="24.93"/>
                    <measurement group_id="O3" value="-38.5" spread="13.44"/>
                    <measurement group_id="O4" value="-24.7" spread="30.13"/>
                    <measurement group_id="O5" value="-26.1" spread="28.98"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Month 6 (n=12, 2, 2, 12, 14)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-19.8" spread="29.81"/>
                    <measurement group_id="O2" value="-34.0" spread="22.63"/>
                    <measurement group_id="O3" value="-51.5" spread="2.12"/>
                    <measurement group_id="O4" value="-16.8" spread="27.91"/>
                    <measurement group_id="O5" value="-21.8" spread="28.60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Patient's Assessment of Pain at Months 3 and 6</title>
        <description>Participants measured the pain intensity due to RA using a 100 mm VAS, where the responses were on a continuous range from 0 = no pain to 100 = unbearable pain.</description>
        <time_frame>Baseline, Month 3, Month 6</time_frame>
        <population>FAS population. Here, Number of participants analyzed = participants evaluable for the outcome measure and n = participants with available data for the specified visit.</population>
        <group_list>
          <group group_id="O1">
            <title>RA Participants (Biologic Naïve Group)</title>
            <description>Participants with severe RA, and no prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.</description>
          </group>
          <group group_id="O2">
            <title>RA Participants (Biologic Exposed Group)</title>
            <description>Participants with severe RA, with prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.</description>
          </group>
          <group group_id="O3">
            <title>RA Participants (Monotherapy Group)</title>
            <description>Participants with severe RA, were prescribed with tocilizumab alone, in accordance with routine clinic practice and were observed for 6 months.</description>
          </group>
          <group group_id="O4">
            <title>RA Participants (Combination Therapy Group)</title>
            <description>Participants with severe RA, were prescribed with DMARD at the time of first dose of tocilizumab, in accordance with routine clinic practice and were observed for 6 months.</description>
          </group>
          <group group_id="O5">
            <title>RA Participants (All Groups)</title>
            <description>Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Patient's Assessment of Pain at Months 3 and 6</title>
          <description>Participants measured the pain intensity due to RA using a 100 mm VAS, where the responses were on a continuous range from 0 = no pain to 100 = unbearable pain.</description>
          <population>FAS population. Here, Number of participants analyzed = participants evaluable for the outcome measure and n = participants with available data for the specified visit.</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="25"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="3"/>
                <count group_id="O4" value="28"/>
                <count group_id="O5" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (n= 25, 6, 3, 28, 31)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="60.1" spread="31.08"/>
                    <measurement group_id="O2" value="47.2" spread="31.93"/>
                    <measurement group_id="O3" value="79.3" spread="19.55"/>
                    <measurement group_id="O4" value="55.3" spread="31.49"/>
                    <measurement group_id="O5" value="57.6" spread="31.14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Month 3 (n= 16, 4, 2, 18, 20)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-35.6" spread="39.39"/>
                    <measurement group_id="O2" value="-15.8" spread="26.99"/>
                    <measurement group_id="O3" value="-39.5" spread="14.85"/>
                    <measurement group_id="O4" value="-30.8" spread="39.38"/>
                    <measurement group_id="O5" value="-31.17" spread="37.50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Month 6 (n= 13, 2, 2, 13, 15)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-32.3" spread="34.88"/>
                    <measurement group_id="O2" value="-47.0" spread="14.14"/>
                    <measurement group_id="O3" value="-51.5" spread="7.78"/>
                    <measurement group_id="O4" value="-31.6" spread="34.68"/>
                    <measurement group_id="O5" value="-34.3" spread="32.93"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Participant Assessment of Morning Stiffness Using VAS at Months 3 and 6</title>
        <description>The participant assessment of morning stiffness was measured using a ruler on a 100 mm VAS, where the responses were on a continuous range from 0 = no stiffness and 100 = maximum stiffness.</description>
        <time_frame>Baseline, Month 3, Month 6</time_frame>
        <population>FAS population. Here, Number of participants analyzed = participants evaluable for the outcome measure and n= participants with available data at the specified visit.</population>
        <group_list>
          <group group_id="O1">
            <title>RA Participants (Biologic Naïve Group)</title>
            <description>Participants with severe RA, and no prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.</description>
          </group>
          <group group_id="O2">
            <title>RA Participants (Biologic Exposed Group)</title>
            <description>Participants with severe RA, with prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.</description>
          </group>
          <group group_id="O3">
            <title>RA Participants (Monotherapy Group)</title>
            <description>Participants with severe RA, were prescribed with tocilizumab alone, in accordance with routine clinic practice and were observed for 6 months.</description>
          </group>
          <group group_id="O4">
            <title>RA Participants (Combination Therapy Group)</title>
            <description>Participants with severe RA, were prescribed with DMARD at the time of first dose of tocilizumab, in accordance with routine clinic practice and were observed for 6 months.</description>
          </group>
          <group group_id="O5">
            <title>RA Participants (All Groups)</title>
            <description>Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Participant Assessment of Morning Stiffness Using VAS at Months 3 and 6</title>
          <description>The participant assessment of morning stiffness was measured using a ruler on a 100 mm VAS, where the responses were on a continuous range from 0 = no stiffness and 100 = maximum stiffness.</description>
          <population>FAS population. Here, Number of participants analyzed = participants evaluable for the outcome measure and n= participants with available data at the specified visit.</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="25"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="3"/>
                <count group_id="O4" value="28"/>
                <count group_id="O5" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (n= 25, 6, 3, 28, 31)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="65.6" spread="31.29"/>
                    <measurement group_id="O2" value="57.3" spread="29.92"/>
                    <measurement group_id="O3" value="77.3" spread="22.03"/>
                    <measurement group_id="O4" value="62.5" spread="31.46"/>
                    <measurement group_id="O5" value="64.0" spread="30.71"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Month 3 (n= 15, 4, 2, 17, 19)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-30.7" spread="37.88"/>
                    <measurement group_id="O2" value="-34.0" spread="17.80"/>
                    <measurement group_id="O3" value="-42.5" spread="14.85"/>
                    <measurement group_id="O4" value="-30.1" spread="35.86"/>
                    <measurement group_id="O5" value="-31.4" spread="34.21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Month 6 (n= 12, 2, 2, 12, 14)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-30.2" spread="35.88"/>
                    <measurement group_id="O2" value="-38.0" spread="14.14"/>
                    <measurement group_id="O3" value="-31.5" spread="4.95"/>
                    <measurement group_id="O4" value="-31.3" spread="36.23"/>
                    <measurement group_id="O5" value="-31.3" spread="33.35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse events (AEs) were recorded from enrollment up to 6 months (final visit).</time_frame>
      <group_list>
        <group group_id="E1">
          <title>RA Participants (All Groups)</title>
          <description>Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA (Unspecified)</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Mycoplasma infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Cerebrovascular accident</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Chronic obstructive pulmonary disease</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA (Unspecified)</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="12" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Neutropenia</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Contusion</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Infusion related reaction</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Hypercholesterolaemia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Paraesthesia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="37"/>
              </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>HoffmannLaRoche</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/NCT01683604
org study id: ML28144
nct id: NCT01683604
lead sponsor: 
This multi-center, observational study will evaluate the treatment patterns in clinical
      practice, efficacy and safety of tocilizumab in participants with rheumatoid arthritis (RA)
      who have had an inadequate response (or were intolerant to) treatment with non-biological
      disease-modifying anti-rheumatic drugs (DMARDs) or with one biological agent. Data will be
      collected from each eligible participant initiated on tocilizumab treatment by their treating
      physician according to approved label for 6 months from start of treatment.
observational model: Cohort
time perspective: Prospective
measure: Percentage of Participants on Tocilizumab Treatment at Month 6 After Treatment Initiation
time frame: Month 6
description: Percentage of participants on tocilizumab treatment at Month 6 was calculated as: [(participants on tocilizumab treatment at Month 6) divided by (participants evaluable for primary objective)] multiplied by 100.
measure: Patient Assessment of Pain Using Visual Analog Scale (VAS) at Baseline
time frame: Baseline
description: Participants measured the pain intensity due to RA on a 100 millimeter (mm) VAS, where the responses were on a continuous range from 0 = no pain to 100 = unbearable pain.
measure: Patient Global Assessment of Disease Activity Using VAS at Baseline
time frame: Baseline
description: The patient's global assessment of disease activity was measured using a 100 mm VAS, where the responses were on a continuous range from 0 = managing very well to 100 = managing very poorly.
measure: Physician Global Assessment of Disease Activity Using VAS at Baseline
time frame: Baseline
description: Physician global assessment of disease activity was assessed on a 100 mm VAS, where 0 = no arthritis activity to 100 = extremely active arthritis.
measure: Health Assessment Questionnaire Disability Index (HAQ-DI) Scores at Baseline
time frame: Baseline
description: The HAQ-DI is a questionnaire that measures functional status (disability) and health-related quality of life. It measures the participant's ability to perform everyday tasks. The index consists of 20 questions regarding the function of the upper and lower extremities. These questions are summarized in 8 categories: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and common activities over past week. Each question is evaluated according to the degree of severity on a 4-point scale. Total score for HAQ-DI is the average of all questions and ranges from 0 = without any difficulty to 3 = unable to do.
measure: Tender Joint Count (TJC) and Swollen Joint Count (SJC) at Baseline
time frame: Baseline
description: TJC was determined by examining 28 and 68 joints and identifying the joints that were painful under pressure or to passive motion. Tenderness was recorded on the joint assessment form at baseline, no tenderness = 0, tenderness = 1. SJC was determined by examining 28 and 66 joints and identifying when swelling was present. Swelling was recorded on the joint assessment form at baseline, no swelling = 0, swelling =1.
measure: Erythrocyte Sedimentation Rate (ESR) at Baseline
time frame: Baseline
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 millimeters per hour (mm/hr). A decrease in the level indicates reduction in inflammation and therefore improvement.
measure: C-Reactive Protein (CRP) at Baseline
time frame: Baseline
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. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.
measure: Percentage of Participants Starting Tocilizumab After Stopping a Biologic Treatment or After Failing DMARDs
time frame: Baseline
measure: Median Dose at Month 6
time frame: Month 6
measure: Percentage of Participants With Tocilizumab Dose Changed According to the Reason for Change
time frame: Baseline up to Month 6
description: Percentage of participants with increase or decrease in tocilizumab administration according to the reason for dose modification was reported.
measure: Mean Dosing Interval at Month 6
time frame: Month 6
description: The time interval between two successive doses in days was reported.
measure: Percentage of Participants With Reasons Who Discontinued Tocilizumab
time frame: Baseline up to Month 6
measure: Time to Restoration of Initial Dosing Regimen
time frame: Baseline up to Month 6
measure: Percentage of Participants by Reason for Choice of Monotherapy at Baseline
time frame: Baseline up to Month 6
measure: Percentage of Participants on Tocilizumab Monotherapy (8 mg/Kg) at Baseline and at Month 6
time frame: Baseline, Month 6
measure: Duration of Tocilizumab Treatment
time frame: Baseline up to Month 6
measure: Percentage of Participants by Duration of Morning Stiffness
time frame: Baseline, Month 3, Month 6
description: Duration of morning stiffness was defined as the time elapsed between the time of usual awakening (even if not in the morning) and the time the participant was able to resume normal activities without stiffness. The participant assessment of morning stiffness was measured using a ruler on a 100 mm VAS by 1 of the six categories: less than (<) 30 minutes, between 30 and 240 minutes, greater than (>) 240 minutes and whole day.
measure: Percentage of Participants With and Without Morning Stiffness
time frame: Baseline, Month 3, Month 6
description: Morning stiffness was defined by the time elapsed between the time of usual awakening (even if not in the morning) and the time the participant was able to resume normal activities without stiffness. The participant assessed morning stiffness based on the following criteria:
Presence of participant's joints stiff when woke up that day, measured as yes or no
Duration of morning stiffness, measured using a ruler on a 100 mm VAS by 1 of the six categories: < 30 minutes, between 30 and 240 minutes, > 240 minutes, and the whole day.
Severity of morning stiffness measured using a ruler on a 100 mm VAS where the responses were on a continuous range from 0 = no stiffness to 100 = maximum stiffness.
measure: Percentage of Participants Adhering to Local Label for Adverse Events
time frame: Baseline up to Month 6
description: Percentage of participants who adhered to local label/protocol for the management of adverse events is reported.
measure: Disease Activity Score Based on 28 Joint Count (DAS28) Score by Visit
time frame: Baseline, Month 3, Month 6
description: The DAS28 score is a measurement of RA activity on a 0 to 10 scale, with higher scores representing higher disease activity, and calculated as DAS28 = 0.56 x √TJC28 + 0.28 x √SJC28 + 0.70 x natural logarithm (ln) (CRP + 1) + 0.014 x PGH + 0.96, where TJC28 = tender joint count on 28 units, SJC28 = swollen joint count on 28 units, CRP = serum concentration of c-reactive protein (after converting units to mg/dL), PGH = patient global assessment of disease activity, which was measured on a 100 mm VAS, where 0 = managing very well and 100 = managing very poorly. A score of less than 2.6 represents clinical remission, a score of greater than or equal to 2.6 and less than or equal to 3.2 represents low disease activity, a score of greater than 3.2 and less than or equal to 5.1 represents moderate disease activity, and a score of greater than 5.1 represents high (or severe) disease.
measure: Percentage of Participants Achieving Good European League Against Rheumatism (EULAR) Response at Month 3 and Month 6
time frame: Month 3 and Month 6
description: Clinical response was assessed according to EULAR criteria that classified the participant according to individual changes in DAS28 score as good, moderate, or no response. The DAS28 score is a measurement of RA activity on a 0 to 10 scale, with higher scores represent higher disease activity, and calculated as DAS28 = 0.56 x √TJC28 + 0.28 x √SJC28 + 0.36 x ln(CRP + 1) + 0.014 x PGH + 0.96, where TJC28 = tender joint count on 28 units, SJC28 = swollen joint count on 28 units, CRP = serum concentration of c-reactive protein (after converting units to mg/dL), PGH = patient's global assessment of disease activity, which was measured on a 100 mm VAS, where 0 = managing very well and 100 = managing very poorly. Good responders experienced a change from baseline of greater than 1.2 with a DAS28 score less than or equal to 3.2.
measure: Clinical Disease Activity Index (CDAI) Score by Visit
time frame: Baseline, Month 3, Month 6
description: The CDAI is a combined index for measuring disease activity in RA and calculated as CDAI = TJC28 + SJC28 + PGH (in centimeters) + PhGH (in centimeters), where TJC28 = tender joint count on 28 units, SJC28 = swollen joint count on 28 units, PGH = patient's global assessment of disease activity, assessed on a 100 mm VAS, where 0 = managing very well and 100 = managing very poorly, and PhGH = physician global assessment of disease activity, assessed on a 100 mm VAS, where 0 = no arthritis activity and 100 = extremely active arthritis; with a total score ranged from 0-76. Higher scores indicate greater disease activity. CDAI score of less than or equal to 2.8 represents clinical remission, score of less than or equal to 10.0 represents low disease activity, score of less than or equal to 22.0 represents moderate disease activity, and score of greater than 22.0 represents high (or severe) disease.
measure: Change From Baseline in TJC and SJC at Month 3 and Month 6
time frame: Baseline, Month 3, Month 6
description: TJC was determined by examining 28 and 68 joints 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 baseline, no tenderness = 0, tenderness = 1. SJC was determined by examination of 28 and 66 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at baseline, no swelling = 0, swelling =1.
measure: Simplified Disease Activity Index (SDAI) Score by Visit
time frame: Baseline, Month 3, Month 6
description: The SDAI is a combined index for measuring disease activity in RA and calculated as SDAI = TJC28 + SJC28 + PGH (in centimeters) + PhGH (in centimeters) + CRP (in mg/dL), where TJC28 = tender joint count on 28 units, SJC28 = swollen joint count on 28 units, PGH = patient's global assessment of disease activity, assessed on a 100 mm VAS, where 0 = managing very well and 100 = managing very poorly, PhGH = physician global assessment of disease activity, assessed on a 100 mm VAS, where 0 = no arthritis activity and 100 = extremely active arthritis, CRP = serum concentration of c-reactive protein; with a total SDAI score ranged from 0-86. Higher scores indicate greater disease activity. SDAI scores of less than or equal to 3.3 represents clinical remission, less than or equal to 11.0 represents low disease activity, less than or equal to 26.0 represents moderate disease activity, and greater than 26.0 represents high (or severe) disease.
measure: Percentage of Participants With an American College of Rheumatology (ACR) 20%, 50%, or 70% (ACR20/50/70) Response at Month 3 and Month 6 From the Start of Tocilizumab Treatment
time frame: Month 3 and Month 6
description: ACR 20,50 or 70 response=an improvement of ≥ 20%, ≥ 50% or ≥ 70% respectively, as compared to baseline in TJC28 and SJC28, and 20%, 50% or 70% improvement in at least 3 of the 5 following measures: Patient's Assessment of Pain over the previous 24 hours, PGA, PhGA, HAQ, and acute phase reactant (either CRP or ESR). TJC and SJC, based on 28-joint assessments. Number of tender joints and swollen joints were recorded on the joint assessment form at baseline, no tenderness = 0 and tenderness = 1, no swelling = 0 and swelling =1, respectively. HAQ measures functional status (disability) and health-related quality of life with 20 questions, summarized in 8 categories: dressing and grooming, arising, eating, walking, hygiene, reach, grip and common activities over past week, 0=without difficulty to 3=unable to do. Patient's assessment of pain assessed using a VAS; 0=no pain, 100=unbearable pain; PGA and PhGA, assessed using VAS ; 0= no disease activity, 100=maximum disease activity.
measure: Change From Baseline in Physician Global Assessment of Disease Activity at Months 3 and 6
time frame: Baseline, Month 3, Month 6
description: The physician global assessment of disease activity was evaluated using a 100 mm VAS where 0 = no arthritis activity and 100 = extremely active arthritis. Higher scores indicated increased level of disease.
measure: Change From Baseline in Patient Global Assessment of Disease Activity at Months 3 and 6
time frame: Baseline, Month 3, Month 6
description: The patient's global assessment of disease activity was measured using a 100 mm VAS, where the responses were on a continuous range from 0= managing very well and 100 = managing very poorly.
measure: Change From Baseline in HAQ-DI Score at Months 3 and 6
time frame: Baseline, Month 3, Month 6
description: The HAQ-DI is a questionnaire that measures functional status (disability) and health-related quality of life. It measures the participant's ability to perform everyday tasks. The index consists of 20 questions regarding the function of the upper and lower extremities. These questions are summarized in 8 categories: dressing and grooming, arising, eating, walking, hygiene, reach, grip and common activities over past week. Each question was evaluated according to the degree of severity on a 4-point scale ranging from 0 = without any difficulty to 3 = unable to do. Total score is the sum of each question, which ranges from 0 to 60, where higher scores represent higher disease activity. The change from baseline in HAQ-DI score at Month 3 and Month 6 was calculated as the difference between HAQ-D1 score reported at baseline and the HAQ-D1 score reported at Month 3 and Month 6.
measure: Change From Baseline in VAS-Fatigue at Months 3 and 6
time frame: Baseline, Month 3, Month 6
description: Participants measured the level of fatigue due to RA using a 100 mm VAS, where the responses were on a continuous range from 0 = no fatigue to 100 = extreme fatigue.
measure: Change From Baseline in Patient's Assessment of Pain at Months 3 and 6
time frame: Baseline, Month 3, Month 6
description: Participants measured the pain intensity due to RA using a 100 mm VAS, where the responses were on a continuous range from 0 = no pain to 100 = unbearable pain.
measure: Change From Baseline in Participant Assessment of Morning Stiffness Using VAS at Months 3 and 6
time frame: Baseline, Month 3, Month 6
description: The participant assessment of morning stiffness was measured using a ruler on a 100 mm VAS, where the responses were on a continuous range from 0 = no stiffness and 100 = maximum stiffness.
arm group label: Rheumatoid Arthritis (RA) Participants (All Groups)
description: Participants with severe RA were prescribed with tocilizumab in accordance with routine clinic practice, and were observed for 6 months.
intervention type: Other
intervention name: Observational study
arm group label: Rheumatoid Arthritis (RA) Participants (All Groups)
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: 
facility: 
facility: 
facility: 
facility: 
country: Australia
responsible party type: Sponsor
mesh term: Arthritis
mesh term: Arthritis, Rheumatoid
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 