<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/NCT01672970</url>
  </required_header>
  <id_info>
    <org_study_id>ML28212</org_study_id>
    <nct_id>NCT01672970</nct_id>
  </id_info>
  <brief_title>A Non-Interventional Study of RoActemra/Actemra in Patients With Moderate to Severe Rheumatoid Arthritis</brief_title>
  <official_title>Multicenter, Post-marketing, Non-interventional, Observational Study in RA Patients Treated With Tocilizumab.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hoffmann-La Roche</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hoffmann-La Roche</source>
  <brief_summary>
    <textblock>
      This multi-center observational study will evaluate the use of RoActemra/Actemra&#xD;
      (tocilizumab) in patients with rheumatoid arthritis. Eligible patients initiated on&#xD;
      RoActemra/Actemra treatment according to the local label will be followed for 6 months.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 2012</start_date>
  <completion_date type="Actual">January 2015</completion_date>
  <primary_completion_date type="Actual">January 2015</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 TCZ Treatment at 6 Months After Treatment Initiation</measure>
    <time_frame>6 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Systemic Manifestations of RA at Baseline</measure>
    <time_frame>Baseline</time_frame>
    <description>Systemic manifestations of RA at baseline included anemia, fatigue, conventional risk factor(s) for cardiovascular disease, C-reactive protein (CRP) above upper limit of normal rheumatoid nodules, rheumatoid vasculitis, and interstitial lung disease.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Who Stopped DMARDs Prior to Start of Study and at Baseline</measure>
    <time_frame>Prior to study (8 weeks) to Baseline</time_frame>
    <description>DMARDs exposure was evaluated for all participants. &quot;Prior DMARDs treatment&quot; included participants, who were treated with DMARDs 8 weeks according to physician's discretion before being included in the study. &quot;DMARDs treatment at baseline&quot; included participants who were receiving DMARDs when they were included in the study and continued with this concomitant medication in addition to TCZ.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Reason for DMARDs Withdrawal at Baseline</measure>
    <time_frame>Baseline</time_frame>
    <description>DMARDs exposure was evaluated for all participants. DMARDs treatment at baseline included participants, who were receiving DMARDs when they were included in the study and discontinued at baseline and not used as concomitant medication to TCZ.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Previous Biologic RA Treatments Received by Participants</measure>
    <time_frame>Baseline</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Duration of Previous Biologic RA Treatments</measure>
    <time_frame>Baseline</time_frame>
    <description>The duration of previous biologic RA treatments was classified in to two categories: less than (&lt;) 6 months and greater than (&gt;) 6 months.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Reasons for Termination of Previous Biologic RA Treatments</measure>
    <time_frame>Baseline</time_frame>
    <description>Lack of efficacy was determined as per physicians' discretion. Intolerance was defined as the participant could not be treated due to safety reason (adverse events).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Reasons for Dose Modification for TCZ</measure>
    <time_frame>6 months</time_frame>
    <description>Only those participants that had dose modifications were reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Dose of TCZ at 6 Months</measure>
    <time_frame>6 months</time_frame>
    <description>TCZ was administered every 4 weeks according to the label. Due to the observational nature of the study, the suggested schedule was subject to changes according to physician and participant considerations.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Dosing Interval of Treatment at 6 Months</measure>
    <time_frame>6 months</time_frame>
    <description>TCZ was administered every 4 weeks according to the label. Due to the observational nature of the study, the suggested schedule was subject to changes according to physician and participant considerations.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Discontinued From Tocilizumab for Safety And Efficacy Reasons</measure>
    <time_frame>6 months</time_frame>
    <description>The safety variable measured the number of participants who discontinued TCZ due to adverse reactions to TCZ, and the efficacy variable measured the participants who discontinued from TCZ due to lack of efficacy according to criteria of the treating physician.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Restoration of Initial Dosing Regimen of TCZ</measure>
    <time_frame>6 months</time_frame>
    <description>The number of participants who reported restoration of initial dosing regimen of TCZ for 84.00, 133.00, 158.00, 2.3.00 and 206.00 days, were reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Adhered to the Dosing Regimen Recommended by Physician for TCZ</measure>
    <time_frame>6 months</time_frame>
    <description>A participant's adherence was calculated based on the adverse event or laboratory abnormality experienced by the participants who required dose modifications as per local TCZ label or protocol.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants on Tocilizumab Monotherapy</measure>
    <time_frame>6 months</time_frame>
    <description>TCZ was administered every 4 weeks according to the label. Due to the observational nature of the study, the suggested schedule was subject to changes according to physician and participant considerations.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Reason for DMARD Withdrawal</measure>
    <time_frame>6 months</time_frame>
    <description>Objective intolerance was determined by medical observation; subjective intolerance was determined by the participant; lack of efficacy was determined by physician discretion.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Tender Joint Count (28 Joints) at Months 3 and 6</measure>
    <time_frame>Baseline, 3 and 6 months</time_frame>
    <description>The number of tender joints was recorded on the joint assessment form, no tenderness = 0, tenderness = 1, for 28 joints and joints were classified as tender/not tender giving a total possible tender joint count score of 0 to 28.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Tender Joint Count (68 Joints) at Months 3 and 6</measure>
    <time_frame>Baseline, 3 and 6 months</time_frame>
    <description>The number of tender joints was recorded on the joint assessment form, no tenderness = 0, tenderness = 1, for 68 joints and joints were classified as tender/not tender giving a total possible tender joint count score of 0 to 68.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Swollen Joint Count (28 Joints) at Months 3 and 6</measure>
    <time_frame>Baseline, 3 and 6 months</time_frame>
    <description>The number of swollen joints was recorded on the joint assessment form, no swelling = 0, swelling =1, for 28 joints and were classified as swollen/not swollen giving a total possible swollen joint count score of 0 to 28.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Swollen Joint Count (66 Joints) at Months 3 and 6</measure>
    <time_frame>Baseline, 3 and 6 months</time_frame>
    <description>The number of swollen joints was recorded on the joint assessment form, no swelling = 0, swelling =1, for 66 joints and were classified as swollen/not swollen giving a total possible swollen joint count score of 0 to 66.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Disease Activity Score Based on 28 Joint Count (DAS28) at Months 3 and 6</measure>
    <time_frame>Baseline, 3 and 6 months</time_frame>
    <description>DAS28 was calculated from SJC and TJC using 28 joints count, erythrocyte sedimentation rate (ESR) (millimeter per hour [mm/hr]), and Participant's Global Assessment (PGH) of disease activity (measured on a 0 to 100 mm Visual Analogue Scale (VAS) where 0=no disease activity and 100=worst disease activity). DAS28 was calculated using following formula: DAS28 = 0.56*square root (sqrt) (TJC28) + 0.28*sqrt(SJC28) + 0.70*natural logarithm (ln) (ESR) + 0.014*PGH of disease activity. Total score range: 0-10, higher score=more disease activity. DAS28 &lt;3.2 implied low disease activity, DAS &gt;3.2 to 5.1 implied moderate disease activity and DAS &gt;5.1 implied high disease activity, and DAS28 &lt;2.6 = clinical remission.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With European League Against Rheumatism (EULAR) Response</measure>
    <time_frame>Visit 2 (Month 1), Visit 3 (Month 2), Visit 4 (Month 3), Visit 5 (Month 4), Visit 6 (Month 5), Visit 7 (Months 6) and Visit 8 (Final Visit; within 2 weeks after 6months observation period)</time_frame>
    <description>Clinical response assessed as per EULAR categorical DAS28 response criteria was defined as clinically meaningful improvement at a particular time point. EULAR response was based on change from baseline (CFB) in the DAS28 score and also on the actual DAS28 score at the time point so was more reflective of the current status of the participant. The DAS28 score was a measure of the participant's disease activity, based on the TJC (28 joints), SJC (28 joints), PGH (mm), and ESR (mm/hr). DAS28 total scores ranged from 0 to approximately 10. Scores &lt;2.6 = best disease control and scores &gt;5.1 = worse disease control. A negative CFB indicated clinically meaningful improvement. EULAR Good response: DAS28 &lt;=3.2 and a CFB &lt;-1.2. EULAR Moderate response: DAS28 &gt;3.2 to ≤ 5.1 or a CFB &lt; -0.6 to ≥ -1.2. EULAR No response: DAS28 ≤3.2 or CFB greater than or equal to (&gt;=) -0.6, DAS28 &gt;3.2 to &lt;=5.1 or CFB &gt;=-0.6 and DAS28 &gt;5.1 or CFB &gt;=-0.6.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Simplified Disease Activity Index (SDAI) Score at Months 3 and 6</measure>
    <time_frame>Baseline, 3 and 6 months</time_frame>
    <description>The SDAI was a combined index for measuring disease activity in RA which reflected the numerical sum of five outcome parameters: TJC and SJC based on a 28-joint assessment, PGH and physician's global assessment (PhGH) of disease activity, assessed on 0-100 mm VAS where 0 = no disease activity and 100 = worst disease activity, and C-reactive protein (CRP) (milligrams per deciliter [mg/dL]). SDAI total score = 0-86. A SDAI score of &lt;=3.3 represented clinical remission, a score of &gt;3.4 to &lt;=11.0 represented low disease activity, a score of &gt;11 to &lt;=26.0 represented moderate disease activity and a score of &gt;26.0 represented high (or severe) disease.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Clinical Disease Activity Index (CDAI) Score at Months 3 and 6</measure>
    <time_frame>Baseline, 3 and 6 months</time_frame>
    <description>The CDAI was a combined index for measuring disease activity in RA and used to evaluate disease activity in the absence of laboratory testing of CRP and ESR. It was the numerical sum of 4 outcome parameters: TJC and SJC based on a 28-joint assessment, PGH and PhGH (assessed on 0-100 mm VAS); VAS (0 = no disease activity and 100 = worst disease activity). CDAI total score = 0-76. A CDAI score of &lt;=2.8 represented clinical remission, a score of &gt;2.8 to &lt;=10.0 represented low disease activity, a score of &gt;10.0 to &lt;=22.0 represented moderate disease activity and a score of &gt;22.0 represented high (or severe) disease.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Who Achieved 20 Percent (%) Improvement in ACR (ACR20) Response</measure>
    <time_frame>Baseline, 3 and 6 months</time_frame>
    <description>ACR response was calculated based on total joint count evaluation (28 or 66/68 joint count) and other clinical and laboratory assessments. A positive ACR20 response required at least a 20% improvement (reduction) compared to baseline in swollen joint count (66 joints) and tender joint count (68 joints) and at least 3 of the following 5 assessments: participant's global assessment of pain, PGH, PhGH (all 3 assessed at 0 [good] to 100 mm [worst] VAS scale), participant assessment of disability measured by the Health Assessment Questionnaire-Disability Index (HAQ-DI) (assessed on a 0 to 3 scale, where higher scores represented higher disease activity), Acute phase reactant (CRP or ESR). A reduction in the level of and acute phase reactants was considered an improvement.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Who Achieved 50% Improvement in ACR (ACR50) Response</measure>
    <time_frame>Baseline, 3 and 6 months</time_frame>
    <description>ACR response was calculated based on total joint count evaluation (28 or 66/68 joint count) and other clinical and laboratory assessments. A positive ACR50 response required at least a 50% improvement (reduction) compared to baseline in swollen joint count (66 joints) and tender joint count (68 joints) and at least 3 of the following 5 assessments: (participant's global assessment of pain, PGH, PhGH (all 3 assessed at 0 [good] to 100 mm [worst] VAS scale), participant assessment of disability measured by the Health Assessment Questionnaire-Disability Index (HAQ-DI) (assessed on a 0 to 3 scale, where higher scores represented higher disease activity), and acute phase reactant (CRP or ESR). A reduction in the level of acute phase reactants was considered an improvement.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Who Achieved 70% Improvement in ACR (ACR70) Response</measure>
    <time_frame>Baseline, 3 and 6 months</time_frame>
    <description>ACR response was calculated based on total joint count evaluation (28 or 66/68 joint count) and other clinical and laboratory assessments. A positive ACR70 response required at least a 70% improvement (reduction) compared to baseline in swollen joint count (66 joints) and tender joint count (68 joints) and at least 3 of the following 5 assessments: (participant's global assessment of pain, PGH, PhGH (all 3 assessed at 0 [good] to 100 mm [worst] VAS scale), participant assessment of disability measured by the Health Assessment Questionnaire-Disability Index (HAQ-DI) (assessed on a 0 to 3 scale, where higher scores represented higher disease activity), and acute phase reactant (CRP or ESR). A reduction in the level of acute phase reactants was considered an improvement.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Who Achieved 90% Improvement in ACR (ACR90) Response</measure>
    <time_frame>Baseline, 3 and 6 months</time_frame>
    <description>ACR response was calculated based on total joint count evaluation (28 or 66/68 joint count) and other clinical and laboratory assessments. A positive ACR90 response required at least a 90% improvement (reduction) compared to baseline in swollen joint count (66 joints) and tender joint count (68 joints) and at least 3 of the following 5 assessments: (participant's global assessment of pain, PGH, PhGH (all 3 assessed at 0 [good] to 100 mm [worst] VAS scale), participant assessment of disability measured by the Health Assessment Questionnaire-Disability Index (HAQ-DI) (assessed on a 0 to 3 scale, where higher scores represented higher disease activity), and acute phase reactant (CRP or ESR). A reduction in the level of acute phase reactants was considered an improvement.</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, 3 and 6 months</time_frame>
    <description>The physician's global assessment of disease activity was assessed using a 0 to 100 mm horizontal VAS by the physician. The left-hand extreme of the line equals 0 mm, and is described as &quot;no disease activity&quot; (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as &quot;maximum disease activity&quot; (maximum arthritis disease activity). A negative change from Baseline indicated improvement.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Participant Global Assessment of Disease Activity at Months 3 and 6</measure>
    <time_frame>Baseline, 3 and 6 months</time_frame>
    <description>The Participant's Global Assessment of Disease Activity was assessed using a 0 to 100 mm horizontal VAS by the participant. The left-hand extreme of the line equals 0 mm, and is described as &quot;no disease activity&quot; (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as &quot;maximum disease activity&quot; (maximum arthritis disease activity). A negative change from Baseline indicated improvement.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Months 3 and 6</measure>
    <time_frame>Baseline, 3 and 6 months</time_frame>
    <description>The HAQ-DI was a participant self-reported questionnaire for assessing the extent of a participant's functional ability. It consisted of 20 questions in 8 categories (dressing and grooming, rising, eating, walking, reach, grip, hygiene, and carrying out daily activities). Each question had 4 response options, ranging from 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. The HAQ-DI scale was an average of all the scores and ranged from 0 to 3, where higher scores represented higher disease activity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Participant's Assessment of Fatigue Using VAS at Months 3 and 6</measure>
    <time_frame>Baseline, 3 and 6 months</time_frame>
    <description>Fatigue was evaluated by a VAS. Participants marked on a 100 mm horizontal VAS the level of fatigue that they have experienced, ranging from 0 (no fatigue) to 100 (extreme fatigue).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Participant's Assessment of RA-Related Pain Using VAS at Months 3 and 6</measure>
    <time_frame>Baseline, 3 and 6 months</time_frame>
    <description>Severity of pain was evaluated by a VAS. Participants marked on a 100 mm horizontal VAS the severity of pain that they had experienced because of their RA, ranging from 0 (no pain) to 100 (unbearable pain).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Particpant's Assessment of RA Morning Stiffness Assessed Using VAS at Months 3 and 6</measure>
    <time_frame>Baseline, 3 and 6 months</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 as limber as he/she would be during a day involving typical activities. Morning stiffness was assessed on a 100 mm VAS, where 0= none and 100= very severe.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">291</enrollment>
  <condition>Rheumatoid Arthritis</condition>
  <arm_group>
    <arm_group_label>Cohort</arm_group_label>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with rheumatoid arthritis initiated on treatment with RoActemra/Actemra&#xD;
        (tocilizumab)&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patients, &gt;/= 18 years of age&#xD;
&#xD;
          -  Moderate to severe rheumatoid arthritis according to the revised (1987) ACR criteria&#xD;
&#xD;
          -  Patients in whom the treating physician has made the decision to commence&#xD;
             RoActemra/Actemra treatment (in accordance with the local label); this can include&#xD;
             patients who have received RoActemra/Actemra treatment within 8 week prior to the&#xD;
             enrolment visit&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who have received RoActemra/Actemra more than 8 weeks prior to the enrolment&#xD;
             visit&#xD;
&#xD;
          -  Patients who have previously received RoActemra/Actemra in a clinical trial or for&#xD;
             compassionate use&#xD;
&#xD;
          -  Treatment with any investigational agent within 4 weeks (or 5 half-lives of the&#xD;
             investigational agent, whichever is longer) before starting treatment with&#xD;
             RoActemra/Actemra&#xD;
&#xD;
          -  History of autoimmune disease or any joint inflammatory disease other than rheumatoid&#xD;
             arthritis&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Clinical Trials</last_name>
    <role>Study Director</role>
    <affiliation>Hoffmann-La Roche</affiliation>
  </overall_official>
  <location>
    <facility>
      <address>
        <city>Budapest</city>
        <zip>1023</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Budapest</city>
        <zip>1027</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Budapest</city>
        <zip>1062</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Debrecen</city>
        <zip>4032</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Debrecen</city>
        <zip>4043</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Eger</city>
        <zip>3300</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Esztergom</city>
        <zip>2500</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Gyor</city>
        <zip>9004</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Gyula</city>
        <zip>5700</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Heviz</city>
        <zip>8380</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Kecskemet</city>
        <zip>6000</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Kistarcsa</city>
        <zip>2143</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Miskolc</city>
        <zip>3529</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Nyiregyhaza</city>
        <zip>4400</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Pécs</city>
        <zip>7632</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Szeged</city>
        <zip>6724</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Szekesfehervar</city>
        <zip>8000</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Szolnok</city>
        <zip>5000</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Szombathely</city>
        <zip>9700</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Veszprem</city>
        <zip>8200</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Hungary</country>
  </location_countries>
  <verification_date>February 2016</verification_date>
  <study_first_submitted>August 22, 2012</study_first_submitted>
  <study_first_submitted_qc>August 22, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 27, 2012</study_first_posted>
  <results_first_submitted>January 28, 2016</results_first_submitted>
  <results_first_submitted_qc>February 29, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">March 28, 2016</results_first_posted>
  <last_update_submitted>February 29, 2016</last_update_submitted>
  <last_update_submitted_qc>February 29, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 28, 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 Participants</title>
          <description>Participants with moderate to severe rheumatoid arthritis (RA), according to the American College of Rheumatology (ACR) criteria, in whom the attending physician decided to start treatment with tocilizumab (TCZ) (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment 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="291"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Treated</title>
              <participants_list>
                <participants group_id="P1" count="290"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="244"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="47"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lack of Efficacy</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="18"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Enrolled but not treated</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Full analysis set (FAS) population included all participants who received at least one dose of tocilizumab and provided evaluable data.</population>
      <group_list>
        <group group_id="B1">
          <title>Rheumatoid Arthritis Participants</title>
          <description>Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment 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="290"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <description>Age was missing for one participant.</description>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="56.14" spread="12.26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex/Gender, Customized</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Female</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="261"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Male</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Missing</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants on TCZ Treatment at 6 Months After Treatment Initiation</title>
        <time_frame>6 months</time_frame>
        <population>FAS population</population>
        <group_list>
          <group group_id="O1">
            <title>RA Participants</title>
            <description>Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants on TCZ Treatment at 6 Months After Treatment Initiation</title>
          <population>FAS population</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="290"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="81" lower_limit="76.8" upper_limit="86"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Systemic Manifestations of RA at Baseline</title>
        <description>Systemic manifestations of RA at baseline included anemia, fatigue, conventional risk factor(s) for cardiovascular disease, C-reactive protein (CRP) above upper limit of normal rheumatoid nodules, rheumatoid vasculitis, and interstitial lung disease.</description>
        <time_frame>Baseline</time_frame>
        <population>FAS population</population>
        <group_list>
          <group group_id="O1">
            <title>RA Participants</title>
            <description>Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Systemic Manifestations of RA at Baseline</title>
          <description>Systemic manifestations of RA at baseline included anemia, fatigue, conventional risk factor(s) for cardiovascular disease, C-reactive protein (CRP) above upper limit of normal rheumatoid nodules, rheumatoid vasculitis, and interstitial lung disease.</description>
          <population>FAS population</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="290"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.8" lower_limit="10" upper_limit="18.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Who Stopped DMARDs Prior to Start of Study and at Baseline</title>
        <description>DMARDs exposure was evaluated for all participants. &quot;Prior DMARDs treatment&quot; included participants, who were treated with DMARDs 8 weeks according to physician's discretion before being included in the study. &quot;DMARDs treatment at baseline&quot; included participants who were receiving DMARDs when they were included in the study and continued with this concomitant medication in addition to TCZ.</description>
        <time_frame>Prior to study (8 weeks) to Baseline</time_frame>
        <population>FAS population</population>
        <group_list>
          <group group_id="O1">
            <title>RA Participants</title>
            <description>Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Stopped DMARDs Prior to Start of Study and at Baseline</title>
          <description>DMARDs exposure was evaluated for all participants. &quot;Prior DMARDs treatment&quot; included participants, who were treated with DMARDs 8 weeks according to physician's discretion before being included in the study. &quot;DMARDs treatment at baseline&quot; included participants who were receiving DMARDs when they were included in the study and continued with this concomitant medication in addition to TCZ.</description>
          <population>FAS population</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="290"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="60.70" lower_limit="54.8" upper_limit="66.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Reason for DMARDs Withdrawal at Baseline</title>
        <description>DMARDs exposure was evaluated for all participants. DMARDs treatment at baseline included participants, who were receiving DMARDs when they were included in the study and discontinued at baseline and not used as concomitant medication to TCZ.</description>
        <time_frame>Baseline</time_frame>
        <population>FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>RA Participants</title>
            <description>Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Reason for DMARDs Withdrawal at Baseline</title>
          <description>DMARDs exposure was evaluated for all participants. DMARDs treatment at baseline included participants, who were receiving DMARDs when they were included in the study and discontinued at baseline and not used as concomitant medication to TCZ.</description>
          <population>FAS population. Here, number of participants analyzed = participants who were evaluable 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="176"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Lack of efficacy</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Intolerance</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Unspecified</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Unknown</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Previous Biologic RA Treatments Received by Participants</title>
        <time_frame>Baseline</time_frame>
        <population>FAS population</population>
        <group_list>
          <group group_id="O1">
            <title>RA Participants</title>
            <description>Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Previous Biologic RA Treatments Received by Participants</title>
          <population>FAS population</population>
          <units>biologic treatments</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="290"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Aceclofenac/Indometacin</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Abatacept</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Aceclofenac</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Adalimumab</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="83"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Aspirin</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Azathiopirin</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Betamethasone</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Betamethasone/dipropionate/betamethasone sodium ph</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Celecoxib</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Certolizumab pegol</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="63"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Chloropyramine</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Chloroquine</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ciclosporin</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Dexibuprofen</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Diclofenac</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Diclofenac/orphenadrine</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Dipyrone</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Etanercept</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="77"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Etoricoxib</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Flurbiprofen</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Gold</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Golimumab</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hydroxychloroquine</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="95"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ibuprofen</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Indometacin</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Infliximab</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="66"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ketoprofen</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Leflunomide</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="174"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Meloxicam</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Methotrexate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="294"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Methylprednisolone</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="277"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Nabumetone</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Naproxen</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Naproxen sodium</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Niflumic acid</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Nimesulide</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Paracetamol</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Paracetamol/Tramadol</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Penicillamine</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Penicillin G sodium</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Phenylbutazone</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Piroxicam</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Prednisolone</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Rituximab</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sulfasalazine</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="171"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Tocilizumab</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Tramadol</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Triamcinolone</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Triamcinolone acetonide</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Triamcinolone hexacetonide</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Valdecoxib</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Duration of Previous Biologic RA Treatments</title>
        <description>The duration of previous biologic RA treatments was classified in to two categories: less than (&lt;) 6 months and greater than (&gt;) 6 months.</description>
        <time_frame>Baseline</time_frame>
        <population>Per protocol population included all participants who had a valid tocilizumab administration assessment at 6-month time window and without any protocol violations.</population>
        <group_list>
          <group group_id="O1">
            <title>RA Participants</title>
            <description>Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Duration of Previous Biologic RA Treatments</title>
          <description>The duration of previous biologic RA treatments was classified in to two categories: less than (&lt;) 6 months and greater than (&gt;) 6 months.</description>
          <population>Per protocol population included all participants who had a valid tocilizumab administration assessment at 6-month time window and without any protocol violations.</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="232"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>&lt;6 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>&gt;6 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Reasons for Termination of Previous Biologic RA Treatments</title>
        <description>Lack of efficacy was determined as per physicians' discretion. Intolerance was defined as the participant could not be treated due to safety reason (adverse events).</description>
        <time_frame>Baseline</time_frame>
        <population>FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>RA Participants</title>
            <description>Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Reasons for Termination of Previous Biologic RA Treatments</title>
          <description>Lack of efficacy was determined as per physicians' discretion. Intolerance was defined as the participant could not be treated due to safety reason (adverse events).</description>
          <population>FAS population. Here, number of participants analyzed = participants who were evaluable 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="170"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Lack of efficacy</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Intolerance</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Unspecified</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Unknown</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Reasons for Dose Modification for TCZ</title>
        <description>Only those participants that had dose modifications were reported.</description>
        <time_frame>6 months</time_frame>
        <population>FAS population</population>
        <group_list>
          <group group_id="O1">
            <title>RA Participants</title>
            <description>Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Reasons for Dose Modification for TCZ</title>
          <description>Only those participants that had dose modifications were reported.</description>
          <population>FAS population</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="290"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Adverse event</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Normalization of absolute neutrophil count</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Unspecified</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Dose of TCZ at 6 Months</title>
        <description>TCZ was administered every 4 weeks according to the label. Due to the observational nature of the study, the suggested schedule was subject to changes according to physician and participant considerations.</description>
        <time_frame>6 months</time_frame>
        <population>FAS population. Here number of participants analyzed = participants available for the analysis of this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>RA Participants</title>
            <description>Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Dose of TCZ at 6 Months</title>
          <description>TCZ was administered every 4 weeks according to the label. Due to the observational nature of the study, the suggested schedule was subject to changes according to physician and participant considerations.</description>
          <population>FAS population. Here number of participants analyzed = participants available for the analysis of this outcome measure.</population>
          <units>milligrams per kilogram {mg/kg)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="237"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.8926" spread="0.57949"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Dosing Interval of Treatment at 6 Months</title>
        <description>TCZ was administered every 4 weeks according to the label. Due to the observational nature of the study, the suggested schedule was subject to changes according to physician and participant considerations.</description>
        <time_frame>6 months</time_frame>
        <population>FAS population. Here number of participants analyzed = participants available for the analysis of this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>RA Participants</title>
            <description>Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Dosing Interval of Treatment at 6 Months</title>
          <description>TCZ was administered every 4 weeks according to the label. Due to the observational nature of the study, the suggested schedule was subject to changes according to physician and participant considerations.</description>
          <population>FAS population. Here number of participants analyzed = participants available for the analysis of this 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="284"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31.79" spread="5.81"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Discontinued From Tocilizumab for Safety And Efficacy Reasons</title>
        <description>The safety variable measured the number of participants who discontinued TCZ due to adverse reactions to TCZ, and the efficacy variable measured the participants who discontinued from TCZ due to lack of efficacy according to criteria of the treating physician.</description>
        <time_frame>6 months</time_frame>
        <population>FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>RA Participants</title>
            <description>Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Discontinued From Tocilizumab for Safety And Efficacy Reasons</title>
          <description>The safety variable measured the number of participants who discontinued TCZ due to adverse reactions to TCZ, and the efficacy variable measured the participants who discontinued from TCZ due to lack of efficacy according to criteria of the treating physician.</description>
          <population>FAS population. Here, number of participants analyzed = participants who were evaluable 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="46"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Intolerable adverse events</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lack of efficacy</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other Unspecified reason</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Restoration of Initial Dosing Regimen of TCZ</title>
        <description>The number of participants who reported restoration of initial dosing regimen of TCZ for 84.00, 133.00, 158.00, 2.3.00 and 206.00 days, were reported.</description>
        <time_frame>6 months</time_frame>
        <population>Per protocol population</population>
        <group_list>
          <group group_id="O1">
            <title>RA Participants</title>
            <description>Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Restoration of Initial Dosing Regimen of TCZ</title>
          <description>The number of participants who reported restoration of initial dosing regimen of TCZ for 84.00, 133.00, 158.00, 2.3.00 and 206.00 days, were reported.</description>
          <population>Per protocol population</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="232"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>84.00 days</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>133.00 days</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>158.00 days</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>203.00 days</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>206.00 days</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Adhered to the Dosing Regimen Recommended by Physician for TCZ</title>
        <description>A participant's adherence was calculated based on the adverse event or laboratory abnormality experienced by the participants who required dose modifications as per local TCZ label or protocol.</description>
        <time_frame>6 months</time_frame>
        <population>FAS population</population>
        <group_list>
          <group group_id="O1">
            <title>RA Participants</title>
            <description>Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Adhered to the Dosing Regimen Recommended by Physician for TCZ</title>
          <description>A participant's adherence was calculated based on the adverse event or laboratory abnormality experienced by the participants who required dose modifications as per local TCZ label or protocol.</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="290"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Adverse events</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other reasons</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants on Tocilizumab Monotherapy</title>
        <description>TCZ was administered every 4 weeks according to the label. Due to the observational nature of the study, the suggested schedule was subject to changes according to physician and participant considerations.</description>
        <time_frame>6 months</time_frame>
        <population>FAS population</population>
        <group_list>
          <group group_id="O1">
            <title>RA Participants</title>
            <description>Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants on Tocilizumab Monotherapy</title>
          <description>TCZ was administered every 4 weeks according to the label. Due to the observational nature of the study, the suggested schedule was subject to changes according to physician and participant considerations.</description>
          <population>FAS population</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="290"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40.0" lower_limit="34.3" upper_limit="45.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Reason for DMARD Withdrawal</title>
        <description>Objective intolerance was determined by medical observation; subjective intolerance was determined by the participant; lack of efficacy was determined by physician discretion.</description>
        <time_frame>6 months</time_frame>
        <population>FAS population. Here number of participants analyzed = participants available for the analysis of this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>RA Participants</title>
            <description>Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Reason for DMARD Withdrawal</title>
          <description>Objective intolerance was determined by medical observation; subjective intolerance was determined by the participant; lack of efficacy was determined by physician discretion.</description>
          <population>FAS population. Here number of participants analyzed = participants available for the analysis of 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="73"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Lack of efficacy</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Intolerance</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="67.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Oher unspecified reason</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Withdrew informed consent</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Tender Joint Count (28 Joints) at Months 3 and 6</title>
        <description>The number of tender joints was recorded on the joint assessment form, no tenderness = 0, tenderness = 1, for 28 joints and joints were classified as tender/not tender giving a total possible tender joint count score of 0 to 28.</description>
        <time_frame>Baseline, 3 and 6 months</time_frame>
        <population>FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure. Here &quot;n&quot;= participants who were evaluable for each category.</population>
        <group_list>
          <group group_id="O1">
            <title>RA Participants</title>
            <description>Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Tender Joint Count (28 Joints) at Months 3 and 6</title>
          <description>The number of tender joints was recorded on the joint assessment form, no tenderness = 0, tenderness = 1, for 28 joints and joints were classified as tender/not tender giving a total possible tender joint count score of 0 to 28.</description>
          <population>FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure. Here &quot;n&quot;= participants who were evaluable for each category.</population>
          <units>joint count</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="259"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Month 3 (n=259)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-10.2703" spread="7.41544"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6 (n=215)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-10.6744" spread="7.64432"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Statistical analysis at Month 3</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.000</p_value>
            <method>Wilcoxon Signed Rank Test</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Statistical Analysis at Month 6</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.000</p_value>
            <method>Wilcoxon Signed Rank Test</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Tender Joint Count (68 Joints) at Months 3 and 6</title>
        <description>The number of tender joints was recorded on the joint assessment form, no tenderness = 0, tenderness = 1, for 68 joints and joints were classified as tender/not tender giving a total possible tender joint count score of 0 to 68.</description>
        <time_frame>Baseline, 3 and 6 months</time_frame>
        <population>FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure. Here &quot;n&quot;= participants who were evaluable for each category.</population>
        <group_list>
          <group group_id="O1">
            <title>RA Participants</title>
            <description>Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Tender Joint Count (68 Joints) at Months 3 and 6</title>
          <description>The number of tender joints was recorded on the joint assessment form, no tenderness = 0, tenderness = 1, for 68 joints and joints were classified as tender/not tender giving a total possible tender joint count score of 0 to 68.</description>
          <population>FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure. Here &quot;n&quot;= participants who were evaluable for each category.</population>
          <units>joint count</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="23"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Month 3 (n=23)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-48.2904" spread="49.94400"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6 (n=21)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-60.0820" spread="51.74519"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Statistical Analysis at Month 3</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.001</p_value>
            <method>Wilcoxon Signed Rank Test</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Statistical Analysis at Month 6</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.005</p_value>
            <method>Wilcoxon Signed Rank Test</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Swollen Joint Count (28 Joints) at Months 3 and 6</title>
        <description>The number of swollen joints was recorded on the joint assessment form, no swelling = 0, swelling =1, for 28 joints and were classified as swollen/not swollen giving a total possible swollen joint count score of 0 to 28.</description>
        <time_frame>Baseline, 3 and 6 months</time_frame>
        <population>FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure. Here &quot;n&quot;= participants who were evaluable for each category.</population>
        <group_list>
          <group group_id="O1">
            <title>RA Participants</title>
            <description>Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Swollen Joint Count (28 Joints) at Months 3 and 6</title>
          <description>The number of swollen joints was recorded on the joint assessment form, no swelling = 0, swelling =1, for 28 joints and were classified as swollen/not swollen giving a total possible swollen joint count score of 0 to 28.</description>
          <population>FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure. Here &quot;n&quot;= participants who were evaluable for each category.</population>
          <units>joint count</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="259"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Month 3 (n=259)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-6.6641" spread="6.22130"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6 (n=215)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-7.0651" spread="6.28047"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Statistical Analysis at Month 3</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.000</p_value>
            <method>Wilcoxon Signed Rank Test</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Statistical Analysis at Month 6</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.000</p_value>
            <method>Wilcoxon Signed Rank Test</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Swollen Joint Count (66 Joints) at Months 3 and 6</title>
        <description>The number of swollen joints was recorded on the joint assessment form, no swelling = 0, swelling =1, for 66 joints and were classified as swollen/not swollen giving a total possible swollen joint count score of 0 to 66.</description>
        <time_frame>Baseline, 3 and 6 months</time_frame>
        <population>FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure. Here &quot;n&quot;= participants who were evaluable for each category.</population>
        <group_list>
          <group group_id="O1">
            <title>RA Participants</title>
            <description>Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Swollen Joint Count (66 Joints) at Months 3 and 6</title>
          <description>The number of swollen joints was recorded on the joint assessment form, no swelling = 0, swelling =1, for 66 joints and were classified as swollen/not swollen giving a total possible swollen joint count score of 0 to 66.</description>
          <population>FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure. Here &quot;n&quot;= participants who were evaluable for each category.</population>
          <units>joint count</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Month 3 (n=20)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-70.6711" spread="35.24487"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6 (n=17)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-80.9244" spread="27.34339"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Statistical Analysis at Month 3</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.000</p_value>
            <method>Wilcoxon Signed Rank Test</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.001</p_value>
            <method>Wilcoxon Signed Rank Test</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Disease Activity Score Based on 28 Joint Count (DAS28) at Months 3 and 6</title>
        <description>DAS28 was calculated from SJC and TJC using 28 joints count, erythrocyte sedimentation rate (ESR) (millimeter per hour [mm/hr]), and Participant's Global Assessment (PGH) of disease activity (measured on a 0 to 100 mm Visual Analogue Scale (VAS) where 0=no disease activity and 100=worst disease activity). DAS28 was calculated using following formula: DAS28 = 0.56*square root (sqrt) (TJC28) + 0.28*sqrt(SJC28) + 0.70*natural logarithm (ln) (ESR) + 0.014*PGH of disease activity. Total score range: 0-10, higher score=more disease activity. DAS28 &lt;3.2 implied low disease activity, DAS &gt;3.2 to 5.1 implied moderate disease activity and DAS &gt;5.1 implied high disease activity, and DAS28 &lt;2.6 = clinical remission.</description>
        <time_frame>Baseline, 3 and 6 months</time_frame>
        <population>FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure. Here &quot;n&quot;= participants who were evaluable for each category.</population>
        <group_list>
          <group group_id="O1">
            <title>RA Participants</title>
            <description>Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Disease Activity Score Based on 28 Joint Count (DAS28) at Months 3 and 6</title>
          <description>DAS28 was calculated from SJC and TJC using 28 joints count, erythrocyte sedimentation rate (ESR) (millimeter per hour [mm/hr]), and Participant's Global Assessment (PGH) of disease activity (measured on a 0 to 100 mm Visual Analogue Scale (VAS) where 0=no disease activity and 100=worst disease activity). DAS28 was calculated using following formula: DAS28 = 0.56*square root (sqrt) (TJC28) + 0.28*sqrt(SJC28) + 0.70*natural logarithm (ln) (ESR) + 0.014*PGH of disease activity. Total score range: 0-10, higher score=more disease activity. DAS28 &lt;3.2 implied low disease activity, DAS &gt;3.2 to 5.1 implied moderate disease activity and DAS &gt;5.1 implied high disease activity, and DAS28 &lt;2.6 = clinical remission.</description>
          <population>FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure. Here &quot;n&quot;= participants who were evaluable for each category.</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="250"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Month 3 (n=250)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.6156" spread="1.23416"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6 (n=209)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.2703" spread="1.09059"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With European League Against Rheumatism (EULAR) Response</title>
        <description>Clinical response assessed as per EULAR categorical DAS28 response criteria was defined as clinically meaningful improvement at a particular time point. EULAR response was based on change from baseline (CFB) in the DAS28 score and also on the actual DAS28 score at the time point so was more reflective of the current status of the participant. The DAS28 score was a measure of the participant's disease activity, based on the TJC (28 joints), SJC (28 joints), PGH (mm), and ESR (mm/hr). DAS28 total scores ranged from 0 to approximately 10. Scores &lt;2.6 = best disease control and scores &gt;5.1 = worse disease control. A negative CFB indicated clinically meaningful improvement. EULAR Good response: DAS28 &lt;=3.2 and a CFB &lt;-1.2. EULAR Moderate response: DAS28 &gt;3.2 to ≤ 5.1 or a CFB &lt; -0.6 to ≥ -1.2. EULAR No response: DAS28 ≤3.2 or CFB greater than or equal to (&gt;=) -0.6, DAS28 &gt;3.2 to &lt;=5.1 or CFB &gt;=-0.6 and DAS28 &gt;5.1 or CFB &gt;=-0.6.</description>
        <time_frame>Visit 2 (Month 1), Visit 3 (Month 2), Visit 4 (Month 3), Visit 5 (Month 4), Visit 6 (Month 5), Visit 7 (Months 6) and Visit 8 (Final Visit; within 2 weeks after 6months observation period)</time_frame>
        <population>FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>RA Participants</title>
            <description>Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With European League Against Rheumatism (EULAR) Response</title>
          <description>Clinical response assessed as per EULAR categorical DAS28 response criteria was defined as clinically meaningful improvement at a particular time point. EULAR response was based on change from baseline (CFB) in the DAS28 score and also on the actual DAS28 score at the time point so was more reflective of the current status of the participant. The DAS28 score was a measure of the participant's disease activity, based on the TJC (28 joints), SJC (28 joints), PGH (mm), and ESR (mm/hr). DAS28 total scores ranged from 0 to approximately 10. Scores &lt;2.6 = best disease control and scores &gt;5.1 = worse disease control. A negative CFB indicated clinically meaningful improvement. EULAR Good response: DAS28 &lt;=3.2 and a CFB &lt;-1.2. EULAR Moderate response: DAS28 &gt;3.2 to ≤ 5.1 or a CFB &lt; -0.6 to ≥ -1.2. EULAR No response: DAS28 ≤3.2 or CFB greater than or equal to (&gt;=) -0.6, DAS28 &gt;3.2 to &lt;=5.1 or CFB &gt;=-0.6 and DAS28 &gt;5.1 or CFB &gt;=-0.6.</description>
          <population>FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure.</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="252"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Visit 2 (Month 1)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="75.2" lower_limit="69.8" upper_limit="80.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 3 (Month 2)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.2" lower_limit="4.5" upper_limit="10.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 4 (Month 3)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.1" lower_limit="1.4" upper_limit="5.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 5 (Month 4)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.7" lower_limit="0.1" upper_limit="2.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 6 (Month 5)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.3" lower_limit="0.0" upper_limit="1.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 7 (Month 6)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.3" lower_limit="0.0" upper_limit="1.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 8 (Final Visit)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="0.0" upper_limit="1.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Simplified Disease Activity Index (SDAI) Score at Months 3 and 6</title>
        <description>The SDAI was a combined index for measuring disease activity in RA which reflected the numerical sum of five outcome parameters: TJC and SJC based on a 28-joint assessment, PGH and physician's global assessment (PhGH) of disease activity, assessed on 0-100 mm VAS where 0 = no disease activity and 100 = worst disease activity, and C-reactive protein (CRP) (milligrams per deciliter [mg/dL]). SDAI total score = 0-86. A SDAI score of &lt;=3.3 represented clinical remission, a score of &gt;3.4 to &lt;=11.0 represented low disease activity, a score of &gt;11 to &lt;=26.0 represented moderate disease activity and a score of &gt;26.0 represented high (or severe) disease.</description>
        <time_frame>Baseline, 3 and 6 months</time_frame>
        <population>FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure. Here &quot;n&quot;= participants who were evaluable for each category.</population>
        <group_list>
          <group group_id="O1">
            <title>RA Participants</title>
            <description>Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Simplified Disease Activity Index (SDAI) Score at Months 3 and 6</title>
          <description>The SDAI was a combined index for measuring disease activity in RA which reflected the numerical sum of five outcome parameters: TJC and SJC based on a 28-joint assessment, PGH and physician's global assessment (PhGH) of disease activity, assessed on 0-100 mm VAS where 0 = no disease activity and 100 = worst disease activity, and C-reactive protein (CRP) (milligrams per deciliter [mg/dL]). SDAI total score = 0-86. A SDAI score of &lt;=3.3 represented clinical remission, a score of &gt;3.4 to &lt;=11.0 represented low disease activity, a score of &gt;11 to &lt;=26.0 represented moderate disease activity and a score of &gt;26.0 represented high (or severe) disease.</description>
          <population>FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure. Here &quot;n&quot;= participants who were evaluable for each category.</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="185"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Month 3 (n=185)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-45.4383" spread="38.24144"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6 (n=148)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-47.5846" spread="33.88556"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Statistical Analysis at Month 3</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.000</p_value>
            <method>Wilcoxon Signed Ranks Test</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Statistical Analysis at Month 6</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.000</p_value>
            <method>Wilcoxon Signed Ranks Test</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Clinical Disease Activity Index (CDAI) Score at Months 3 and 6</title>
        <description>The CDAI was a combined index for measuring disease activity in RA and used to evaluate disease activity in the absence of laboratory testing of CRP and ESR. It was the numerical sum of 4 outcome parameters: TJC and SJC based on a 28-joint assessment, PGH and PhGH (assessed on 0-100 mm VAS); VAS (0 = no disease activity and 100 = worst disease activity). CDAI total score = 0-76. A CDAI score of &lt;=2.8 represented clinical remission, a score of &gt;2.8 to &lt;=10.0 represented low disease activity, a score of &gt;10.0 to &lt;=22.0 represented moderate disease activity and a score of &gt;22.0 represented high (or severe) disease.</description>
        <time_frame>Baseline, 3 and 6 months</time_frame>
        <population>FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure. Here &quot;n&quot;= participants who were evaluable for each category.</population>
        <group_list>
          <group group_id="O1">
            <title>RA Participants</title>
            <description>Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Clinical Disease Activity Index (CDAI) Score at Months 3 and 6</title>
          <description>The CDAI was a combined index for measuring disease activity in RA and used to evaluate disease activity in the absence of laboratory testing of CRP and ESR. It was the numerical sum of 4 outcome parameters: TJC and SJC based on a 28-joint assessment, PGH and PhGH (assessed on 0-100 mm VAS); VAS (0 = no disease activity and 100 = worst disease activity). CDAI total score = 0-76. A CDAI score of &lt;=2.8 represented clinical remission, a score of &gt;2.8 to &lt;=10.0 represented low disease activity, a score of &gt;10.0 to &lt;=22.0 represented moderate disease activity and a score of &gt;22.0 represented high (or severe) disease.</description>
          <population>FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure. Here &quot;n&quot;= participants who were evaluable for each category.</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="206"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Month 3 (n=206)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-24.6068" spread="14.41937"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6 (n=173)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-26.0046" spread="14.58529"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Statistical Analysis at Month 3</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.000</p_value>
            <method>Wilcoxon Signed Ranks Test</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Statistical Analysis at Month 6</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.000</p_value>
            <method>Wilcoxon Signed Ranks Test</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Who Achieved 20 Percent (%) Improvement in ACR (ACR20) Response</title>
        <description>ACR response was calculated based on total joint count evaluation (28 or 66/68 joint count) and other clinical and laboratory assessments. A positive ACR20 response required at least a 20% improvement (reduction) compared to baseline in swollen joint count (66 joints) and tender joint count (68 joints) and at least 3 of the following 5 assessments: participant's global assessment of pain, PGH, PhGH (all 3 assessed at 0 [good] to 100 mm [worst] VAS scale), participant assessment of disability measured by the Health Assessment Questionnaire-Disability Index (HAQ-DI) (assessed on a 0 to 3 scale, where higher scores represented higher disease activity), Acute phase reactant (CRP or ESR). A reduction in the level of and acute phase reactants was considered an improvement.</description>
        <time_frame>Baseline, 3 and 6 months</time_frame>
        <population>FAS population</population>
        <group_list>
          <group group_id="O1">
            <title>RA Participants</title>
            <description>Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Achieved 20 Percent (%) Improvement in ACR (ACR20) Response</title>
          <description>ACR response was calculated based on total joint count evaluation (28 or 66/68 joint count) and other clinical and laboratory assessments. A positive ACR20 response required at least a 20% improvement (reduction) compared to baseline in swollen joint count (66 joints) and tender joint count (68 joints) and at least 3 of the following 5 assessments: participant's global assessment of pain, PGH, PhGH (all 3 assessed at 0 [good] to 100 mm [worst] VAS scale), participant assessment of disability measured by the Health Assessment Questionnaire-Disability Index (HAQ-DI) (assessed on a 0 to 3 scale, where higher scores represented higher disease activity), Acute phase reactant (CRP or ESR). A reduction in the level of and acute phase reactants was considered an improvement.</description>
          <population>FAS population</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="290"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Month 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.80" lower_limit="1.9" upper_limit="6.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.5" lower_limit="2.4" upper_limit="7.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Who Achieved 50% Improvement in ACR (ACR50) Response</title>
        <description>ACR response was calculated based on total joint count evaluation (28 or 66/68 joint count) and other clinical and laboratory assessments. A positive ACR50 response required at least a 50% improvement (reduction) compared to baseline in swollen joint count (66 joints) and tender joint count (68 joints) and at least 3 of the following 5 assessments: (participant's global assessment of pain, PGH, PhGH (all 3 assessed at 0 [good] to 100 mm [worst] VAS scale), participant assessment of disability measured by the Health Assessment Questionnaire-Disability Index (HAQ-DI) (assessed on a 0 to 3 scale, where higher scores represented higher disease activity), and acute phase reactant (CRP or ESR). A reduction in the level of acute phase reactants was considered an improvement.</description>
        <time_frame>Baseline, 3 and 6 months</time_frame>
        <population>FAS population</population>
        <group_list>
          <group group_id="O1">
            <title>RA Participants</title>
            <description>Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Achieved 50% Improvement in ACR (ACR50) Response</title>
          <description>ACR response was calculated based on total joint count evaluation (28 or 66/68 joint count) and other clinical and laboratory assessments. A positive ACR50 response required at least a 50% improvement (reduction) compared to baseline in swollen joint count (66 joints) and tender joint count (68 joints) and at least 3 of the following 5 assessments: (participant's global assessment of pain, PGH, PhGH (all 3 assessed at 0 [good] to 100 mm [worst] VAS scale), participant assessment of disability measured by the Health Assessment Questionnaire-Disability Index (HAQ-DI) (assessed on a 0 to 3 scale, where higher scores represented higher disease activity), and acute phase reactant (CRP or ESR). A reduction in the level of acute phase reactants was considered an improvement.</description>
          <population>FAS population</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="290"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Month 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.10" lower_limit="1.4" upper_limit="5.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.70" lower_limit="0.6" upper_limit="4.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Who Achieved 70% Improvement in ACR (ACR70) Response</title>
        <description>ACR response was calculated based on total joint count evaluation (28 or 66/68 joint count) and other clinical and laboratory assessments. A positive ACR70 response required at least a 70% improvement (reduction) compared to baseline in swollen joint count (66 joints) and tender joint count (68 joints) and at least 3 of the following 5 assessments: (participant's global assessment of pain, PGH, PhGH (all 3 assessed at 0 [good] to 100 mm [worst] VAS scale), participant assessment of disability measured by the Health Assessment Questionnaire-Disability Index (HAQ-DI) (assessed on a 0 to 3 scale, where higher scores represented higher disease activity), and acute phase reactant (CRP or ESR). A reduction in the level of acute phase reactants was considered an improvement.</description>
        <time_frame>Baseline, 3 and 6 months</time_frame>
        <population>FAS population</population>
        <group_list>
          <group group_id="O1">
            <title>RA Participants</title>
            <description>Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Achieved 70% Improvement in ACR (ACR70) Response</title>
          <description>ACR response was calculated based on total joint count evaluation (28 or 66/68 joint count) and other clinical and laboratory assessments. A positive ACR70 response required at least a 70% improvement (reduction) compared to baseline in swollen joint count (66 joints) and tender joint count (68 joints) and at least 3 of the following 5 assessments: (participant's global assessment of pain, PGH, PhGH (all 3 assessed at 0 [good] to 100 mm [worst] VAS scale), participant assessment of disability measured by the Health Assessment Questionnaire-Disability Index (HAQ-DI) (assessed on a 0 to 3 scale, where higher scores represented higher disease activity), and acute phase reactant (CRP or ESR). A reduction in the level of acute phase reactants was considered an improvement.</description>
          <population>FAS population</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="290"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Month 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.40" lower_limit="0.4" upper_limit="3.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.40" lower_limit="0.4" upper_limit="3.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Who Achieved 90% Improvement in ACR (ACR90) Response</title>
        <description>ACR response was calculated based on total joint count evaluation (28 or 66/68 joint count) and other clinical and laboratory assessments. A positive ACR90 response required at least a 90% improvement (reduction) compared to baseline in swollen joint count (66 joints) and tender joint count (68 joints) and at least 3 of the following 5 assessments: (participant's global assessment of pain, PGH, PhGH (all 3 assessed at 0 [good] to 100 mm [worst] VAS scale), participant assessment of disability measured by the Health Assessment Questionnaire-Disability Index (HAQ-DI) (assessed on a 0 to 3 scale, where higher scores represented higher disease activity), and acute phase reactant (CRP or ESR). A reduction in the level of acute phase reactants was considered an improvement.</description>
        <time_frame>Baseline, 3 and 6 months</time_frame>
        <population>FAS population</population>
        <group_list>
          <group group_id="O1">
            <title>RA Participants</title>
            <description>Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Achieved 90% Improvement in ACR (ACR90) Response</title>
          <description>ACR response was calculated based on total joint count evaluation (28 or 66/68 joint count) and other clinical and laboratory assessments. A positive ACR90 response required at least a 90% improvement (reduction) compared to baseline in swollen joint count (66 joints) and tender joint count (68 joints) and at least 3 of the following 5 assessments: (participant's global assessment of pain, PGH, PhGH (all 3 assessed at 0 [good] to 100 mm [worst] VAS scale), participant assessment of disability measured by the Health Assessment Questionnaire-Disability Index (HAQ-DI) (assessed on a 0 to 3 scale, where higher scores represented higher disease activity), and acute phase reactant (CRP or ESR). A reduction in the level of acute phase reactants was considered an improvement.</description>
          <population>FAS population</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="290"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Month 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.70" lower_limit="0.1" upper_limit="2.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.70" lower_limit="0.1" upper_limit="2.5"/>
                  </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's global assessment of disease activity was assessed using a 0 to 100 mm horizontal VAS by the physician. The left-hand extreme of the line equals 0 mm, and is described as &quot;no disease activity&quot; (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as &quot;maximum disease activity&quot; (maximum arthritis disease activity). A negative change from Baseline indicated improvement.</description>
        <time_frame>Baseline, 3 and 6 months</time_frame>
        <population>FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure. Here &quot;n&quot;= participants who were evaluable for each category.</population>
        <group_list>
          <group group_id="O1">
            <title>RA Participants</title>
            <description>Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment 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's global assessment of disease activity was assessed using a 0 to 100 mm horizontal VAS by the physician. The left-hand extreme of the line equals 0 mm, and is described as &quot;no disease activity&quot; (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as &quot;maximum disease activity&quot; (maximum arthritis disease activity). A negative change from Baseline indicated improvement.</description>
          <population>FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure. Here &quot;n&quot;= participants who were evaluable for each category.</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="214"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Month 3 (n=214)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-37.3832" spread="21.41701"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6 (n=177)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-43.9096" spread="20.78387"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Statistical Analysis at Month 3</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.000</p_value>
            <method>Wilcoxon Signed Ranks Test</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Statistical Analysis at Month 6</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.000</p_value>
            <method>Wilcoxon Signed Ranks Test</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Participant Global Assessment of Disease Activity at Months 3 and 6</title>
        <description>The Participant's Global Assessment of Disease Activity was assessed using a 0 to 100 mm horizontal VAS by the participant. The left-hand extreme of the line equals 0 mm, and is described as &quot;no disease activity&quot; (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as &quot;maximum disease activity&quot; (maximum arthritis disease activity). A negative change from Baseline indicated improvement.</description>
        <time_frame>Baseline, 3 and 6 months</time_frame>
        <population>FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure. Here &quot;n&quot;= participants who were evaluable for each category.</population>
        <group_list>
          <group group_id="O1">
            <title>RA Participants</title>
            <description>Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Participant Global Assessment of Disease Activity at Months 3 and 6</title>
          <description>The Participant's Global Assessment of Disease Activity was assessed using a 0 to 100 mm horizontal VAS by the participant. The left-hand extreme of the line equals 0 mm, and is described as &quot;no disease activity&quot; (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as &quot;maximum disease activity&quot; (maximum arthritis disease activity). A negative change from Baseline indicated improvement.</description>
          <population>FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure. Here &quot;n&quot;= participants who were evaluable for each category.</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="238"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Month 3 (n=238)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-33.2437" spread="24.64703"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6 (n=201)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-39.3930" spread="25.06551"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Statistical Analysis at Month 3</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.000</p_value>
            <method>Wilcoxon Signed Ranks Test</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Statistical Analysis at Month 6</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.000</p_value>
            <method>Wilcoxon Signed Ranks Test</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Months 3 and 6</title>
        <description>The HAQ-DI was a participant self-reported questionnaire for assessing the extent of a participant's functional ability. It consisted of 20 questions in 8 categories (dressing and grooming, rising, eating, walking, reach, grip, hygiene, and carrying out daily activities). Each question had 4 response options, ranging from 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. The HAQ-DI scale was an average of all the scores and ranged from 0 to 3, where higher scores represented higher disease activity.</description>
        <time_frame>Baseline, 3 and 6 months</time_frame>
        <population>FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure. Here &quot;n&quot;= participants who were evaluable for each category.</population>
        <group_list>
          <group group_id="O1">
            <title>RA Participants</title>
            <description>Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Months 3 and 6</title>
          <description>The HAQ-DI was a participant self-reported questionnaire for assessing the extent of a participant's functional ability. It consisted of 20 questions in 8 categories (dressing and grooming, rising, eating, walking, reach, grip, hygiene, and carrying out daily activities). Each question had 4 response options, ranging from 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. The HAQ-DI scale was an average of all the scores and ranged from 0 to 3, where higher scores represented higher disease activity.</description>
          <population>FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure. Here &quot;n&quot;= participants who were evaluable for each category.</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="205"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Month 3 (n=205)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.4766" spread="0.62768"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6 (n=173)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.5497" spread="0.63257"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Statistical Analysis at Month 3</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.000</p_value>
            <method>Wilcoxon Signed Ranks Test</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Statistical Analysis at Month 6</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.000</p_value>
            <method>Wilcoxon Signed Ranks Test</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Participant's Assessment of Fatigue Using VAS at Months 3 and 6</title>
        <description>Fatigue was evaluated by a VAS. Participants marked on a 100 mm horizontal VAS the level of fatigue that they have experienced, ranging from 0 (no fatigue) to 100 (extreme fatigue).</description>
        <time_frame>Baseline, 3 and 6 months</time_frame>
        <population>FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure. Here &quot;n&quot;= participants who were evaluable for each category.</population>
        <group_list>
          <group group_id="O1">
            <title>RA Participants</title>
            <description>Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Participant's Assessment of Fatigue Using VAS at Months 3 and 6</title>
          <description>Fatigue was evaluated by a VAS. Participants marked on a 100 mm horizontal VAS the level of fatigue that they have experienced, ranging from 0 (no fatigue) to 100 (extreme fatigue).</description>
          <population>FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure. Here &quot;n&quot;= participants who were evaluable for each category.</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="198"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Month 3 (n=198)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-26.4192" spread="26.05482"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6 (n=162)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-32.5000" spread="25.94984"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Statistical Analysis at Month 3</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.000</p_value>
            <method>Wilcoxon Signed Rank Test</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Statistical Analysis at Month 6</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.000</p_value>
            <method>Wilcoxon Signed Rank Test</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Participant's Assessment of RA-Related Pain Using VAS at Months 3 and 6</title>
        <description>Severity of pain was evaluated by a VAS. Participants marked on a 100 mm horizontal VAS the severity of pain that they had experienced because of their RA, ranging from 0 (no pain) to 100 (unbearable pain).</description>
        <time_frame>Baseline, 3 and 6 months</time_frame>
        <population>FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure. Here &quot;n&quot;= participants who were evaluable for each category.</population>
        <group_list>
          <group group_id="O1">
            <title>RA Participants</title>
            <description>Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Participant's Assessment of RA-Related Pain Using VAS at Months 3 and 6</title>
          <description>Severity of pain was evaluated by a VAS. Participants marked on a 100 mm horizontal VAS the severity of pain that they had experienced because of their RA, ranging from 0 (no pain) to 100 (unbearable pain).</description>
          <population>FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure. Here &quot;n&quot;= participants who were evaluable for each category.</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="239"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Month 3 (n=239)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-31.0586" spread="23.45828"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6 (n=194)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-36.9948" spread="25.95782"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Statistical Analysis at Month 3</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.000</p_value>
            <method>Wilcoxon Signed Rank Test</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Statistical Analysis at Month 6</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.000</p_value>
            <method>Wilcoxon Signed Rank Test</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Particpant's Assessment of RA Morning Stiffness Assessed Using VAS at Months 3 and 6</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 as limber as he/she would be during a day involving typical activities. Morning stiffness was assessed on a 100 mm VAS, where 0= none and 100= very severe.</description>
        <time_frame>Baseline, 3 and 6 months</time_frame>
        <population>FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure. Here &quot;n&quot;= participants who were evaluable for each category.</population>
        <group_list>
          <group group_id="O1">
            <title>RA Participants</title>
            <description>Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Particpant's Assessment of RA Morning Stiffness Assessed Using VAS at Months 3 and 6</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 as limber as he/she would be during a day involving typical activities. Morning stiffness was assessed on a 100 mm VAS, where 0= none and 100= very severe.</description>
          <population>FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure. Here &quot;n&quot;= participants who were evaluable for each category.</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="151"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Month 3 (n=151)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-25.7285" spread="26.61877"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6 (n=117)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-32.5043" spread="26.08792"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Statistical Analysis at Month 3</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.000</p_value>
            <method>Wilcoxon Signed Rank Test</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Statistical Analysis at Month 6</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.000</p_value>
            <method>Wilcoxon Signed Rank Test</method>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Up to 6 months</time_frame>
      <desc>FAS population</desc>
      <group_list>
        <group group_id="E1">
          <title>Rheumatoid Arthritis Participants</title>
          <description>Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA (18.1)</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="17" subjects_at_risk="290"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Leucocytosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Neutropenia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Pancytopenia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="290"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Vertigo</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="290"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Keratitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Diplopia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Ulcerative keratitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Corneal disorders</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="290"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaphylactic reaction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="290"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Skin infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Erysipelas</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="290"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Glomerular filtration rate increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Hepatic enzyme increased</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Neutrophil count increase</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="290"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Acute myeloid leukaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Basal cell carcinoma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="290"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Hypotonia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="290"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Skin ulcer</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="290"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Knee arthroplasty</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="290"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Embolism</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Thrombosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="290"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA (18.1)</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="108" subjects_at_risk="290"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Granulocytopenia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Leukopenia</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Neutropenia</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Thrombocytopenia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="290"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Extrasystoles</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="290"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Conjunctival haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="290"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Abdominal pain lower</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Stomatitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="290"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Chest pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Drug ineffective</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Oedema</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Oedema peripheral</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="290"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Hepatobiliary disease</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="290"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Acarodermatitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Cystitis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Erysipelas</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Fungal skin infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Furuncle</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Herpes zoster</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Oral herpes</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Pharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Tooth abscess</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Tracheitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Viral infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="290"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Ankle fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Foot fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Humerus fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Wound</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="290"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Blood cholesterol increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Blood pressure increased</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Blood triglycerides increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Gamma-glutamyl transferase increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Hepatic enzyme increased</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Liver function test abnormal</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Lymphocyte count increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Mycobacterium tuberculosis complex test positive</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Neutrophil count decreased</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Platelet count decreased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Transaminases increased</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Weight decreased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="290"/>
              </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="1" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Hyperlipidaemia</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Hyperuricaemia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="290"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Osteoarthritis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="290"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Cervicobrachial syndrome</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Hypotonia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Trigeminal neuralgia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="290"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Haematuria</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Renal failure</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="290"/>
              </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="290"/>
              </event>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="290"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Cutaneous vasculitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Dyshidrotic eczema</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Erythema</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Psoriasis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Rash pruritic</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Skin lesion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Skin ulcer</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Urticaria</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="290"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Cholecystectomy</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Tooth extraction</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="290"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="290"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Medical Communications</name_or_title>
      <organization>Hoffmann-LaRoche</organization>
      <phone>800-821-8590</phone>
      <email>genentech@druginfo.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01672970
org study id: ML28212
nct id: NCT01672970
lead sponsor: 
This multi-center observational study will evaluate the use of RoActemra/Actemra
      (tocilizumab) in patients with rheumatoid arthritis. Eligible patients initiated on
      RoActemra/Actemra treatment according to the local label will be followed for 6 months.
observational model: Cohort
time perspective: Prospective
measure: Percentage of Participants on TCZ Treatment at 6 Months After Treatment Initiation
time frame: 6 months
measure: Percentage of Participants With Systemic Manifestations of RA at Baseline
time frame: Baseline
description: Systemic manifestations of RA at baseline included anemia, fatigue, conventional risk factor(s) for cardiovascular disease, C-reactive protein (CRP) above upper limit of normal rheumatoid nodules, rheumatoid vasculitis, and interstitial lung disease.
measure: Percentage of Participants Who Stopped DMARDs Prior to Start of Study and at Baseline
time frame: Prior to study (8 weeks) to Baseline
description: DMARDs exposure was evaluated for all participants. "Prior DMARDs treatment" included participants, who were treated with DMARDs 8 weeks according to physician's discretion before being included in the study. "DMARDs treatment at baseline" included participants who were receiving DMARDs when they were included in the study and continued with this concomitant medication in addition to TCZ.
measure: Percentage of Participants With Reason for DMARDs Withdrawal at Baseline
time frame: Baseline
description: DMARDs exposure was evaluated for all participants. DMARDs treatment at baseline included participants, who were receiving DMARDs when they were included in the study and discontinued at baseline and not used as concomitant medication to TCZ.
measure: Number of Previous Biologic RA Treatments Received by Participants
time frame: Baseline
measure: Percentage of Participants With Duration of Previous Biologic RA Treatments
time frame: Baseline
description: The duration of previous biologic RA treatments was classified in to two categories: less than (<) 6 months and greater than (>) 6 months.
measure: Percentage of Participants With Reasons for Termination of Previous Biologic RA Treatments
time frame: Baseline
description: Lack of efficacy was determined as per physicians' discretion. Intolerance was defined as the participant could not be treated due to safety reason (adverse events).
measure: Number of Participants With Reasons for Dose Modification for TCZ
time frame: 6 months
description: Only those participants that had dose modifications were reported.
measure: Mean Dose of TCZ at 6 Months
time frame: 6 months
description: TCZ was administered every 4 weeks according to the label. Due to the observational nature of the study, the suggested schedule was subject to changes according to physician and participant considerations.
measure: Mean Dosing Interval of Treatment at 6 Months
time frame: 6 months
description: TCZ was administered every 4 weeks according to the label. Due to the observational nature of the study, the suggested schedule was subject to changes according to physician and participant considerations.
measure: Percentage of Participants Discontinued From Tocilizumab for Safety And Efficacy Reasons
time frame: 6 months
description: The safety variable measured the number of participants who discontinued TCZ due to adverse reactions to TCZ, and the efficacy variable measured the participants who discontinued from TCZ due to lack of efficacy according to criteria of the treating physician.
measure: Number of Participants With Restoration of Initial Dosing Regimen of TCZ
time frame: 6 months
description: The number of participants who reported restoration of initial dosing regimen of TCZ for 84.00, 133.00, 158.00, 2.3.00 and 206.00 days, were reported.
measure: Percentage of Participants Adhered to the Dosing Regimen Recommended by Physician for TCZ
time frame: 6 months
description: A participant's adherence was calculated based on the adverse event or laboratory abnormality experienced by the participants who required dose modifications as per local TCZ label or protocol.
measure: Percentage of Participants on Tocilizumab Monotherapy
time frame: 6 months
description: TCZ was administered every 4 weeks according to the label. Due to the observational nature of the study, the suggested schedule was subject to changes according to physician and participant considerations.
measure: Percentage of Participants With Reason for DMARD Withdrawal
time frame: 6 months
description: Objective intolerance was determined by medical observation; subjective intolerance was determined by the participant; lack of efficacy was determined by physician discretion.
measure: Change From Baseline in Tender Joint Count (28 Joints) at Months 3 and 6
time frame: Baseline, 3 and 6 months
description: The number of tender joints was recorded on the joint assessment form, no tenderness = 0, tenderness = 1, for 28 joints and joints were classified as tender/not tender giving a total possible tender joint count score of 0 to 28.
measure: Change From Baseline in Tender Joint Count (68 Joints) at Months 3 and 6
time frame: Baseline, 3 and 6 months
description: The number of tender joints was recorded on the joint assessment form, no tenderness = 0, tenderness = 1, for 68 joints and joints were classified as tender/not tender giving a total possible tender joint count score of 0 to 68.
measure: Change From Baseline in Swollen Joint Count (28 Joints) at Months 3 and 6
time frame: Baseline, 3 and 6 months
description: The number of swollen joints was recorded on the joint assessment form, no swelling = 0, swelling =1, for 28 joints and were classified as swollen/not swollen giving a total possible swollen joint count score of 0 to 28.
measure: Change From Baseline in Swollen Joint Count (66 Joints) at Months 3 and 6
time frame: Baseline, 3 and 6 months
description: The number of swollen joints was recorded on the joint assessment form, no swelling = 0, swelling =1, for 66 joints and were classified as swollen/not swollen giving a total possible swollen joint count score of 0 to 66.
measure: Change From Baseline in Disease Activity Score Based on 28 Joint Count (DAS28) at Months 3 and 6
time frame: Baseline, 3 and 6 months
description: DAS28 was calculated from SJC and TJC using 28 joints count, erythrocyte sedimentation rate (ESR) (millimeter per hour [mm/hr]), and Participant's Global Assessment (PGH) of disease activity (measured on a 0 to 100 mm Visual Analogue Scale (VAS) where 0=no disease activity and 100=worst disease activity). DAS28 was calculated using following formula: DAS28 = 0.56*square root (sqrt) (TJC28) + 0.28*sqrt(SJC28) + 0.70*natural logarithm (ln) (ESR) + 0.014*PGH of disease activity. Total score range: 0-10, higher score=more disease activity. DAS28 <3.2 implied low disease activity, DAS >3.2 to 5.1 implied moderate disease activity and DAS >5.1 implied high disease activity, and DAS28 <2.6 = clinical remission.
measure: Percentage of Participants With European League Against Rheumatism (EULAR) Response
time frame: Visit 2 (Month 1), Visit 3 (Month 2), Visit 4 (Month 3), Visit 5 (Month 4), Visit 6 (Month 5), Visit 7 (Months 6) and Visit 8 (Final Visit; within 2 weeks after 6months observation period)
description: Clinical response assessed as per EULAR categorical DAS28 response criteria was defined as clinically meaningful improvement at a particular time point. EULAR response was based on change from baseline (CFB) in the DAS28 score and also on the actual DAS28 score at the time point so was more reflective of the current status of the participant. The DAS28 score was a measure of the participant's disease activity, based on the TJC (28 joints), SJC (28 joints), PGH (mm), and ESR (mm/hr). DAS28 total scores ranged from 0 to approximately 10. Scores <2.6 = best disease control and scores >5.1 = worse disease control. A negative CFB indicated clinically meaningful improvement. EULAR Good response: DAS28 <=3.2 and a CFB <-1.2. EULAR Moderate response: DAS28 >3.2 to ≤ 5.1 or a CFB < -0.6 to ≥ -1.2. EULAR No response: DAS28 ≤3.2 or CFB greater than or equal to (>=) -0.6, DAS28 >3.2 to <=5.1 or CFB >=-0.6 and DAS28 >5.1 or CFB >=-0.6.
measure: Change From Baseline in Simplified Disease Activity Index (SDAI) Score at Months 3 and 6
time frame: Baseline, 3 and 6 months
description: The SDAI was a combined index for measuring disease activity in RA which reflected the numerical sum of five outcome parameters: TJC and SJC based on a 28-joint assessment, PGH and physician's global assessment (PhGH) of disease activity, assessed on 0-100 mm VAS where 0 = no disease activity and 100 = worst disease activity, and C-reactive protein (CRP) (milligrams per deciliter [mg/dL]). SDAI total score = 0-86. A SDAI score of <=3.3 represented clinical remission, a score of >3.4 to <=11.0 represented low disease activity, a score of >11 to <=26.0 represented moderate disease activity and a score of >26.0 represented high (or severe) disease.
measure: Change From Baseline in Clinical Disease Activity Index (CDAI) Score at Months 3 and 6
time frame: Baseline, 3 and 6 months
description: The CDAI was a combined index for measuring disease activity in RA and used to evaluate disease activity in the absence of laboratory testing of CRP and ESR. It was the numerical sum of 4 outcome parameters: TJC and SJC based on a 28-joint assessment, PGH and PhGH (assessed on 0-100 mm VAS); VAS (0 = no disease activity and 100 = worst disease activity). CDAI total score = 0-76. A CDAI score of <=2.8 represented clinical remission, a score of >2.8 to <=10.0 represented low disease activity, a score of >10.0 to <=22.0 represented moderate disease activity and a score of >22.0 represented high (or severe) disease.
measure: Percentage of Participants Who Achieved 20 Percent (%) Improvement in ACR (ACR20) Response
time frame: Baseline, 3 and 6 months
description: ACR response was calculated based on total joint count evaluation (28 or 66/68 joint count) and other clinical and laboratory assessments. A positive ACR20 response required at least a 20% improvement (reduction) compared to baseline in swollen joint count (66 joints) and tender joint count (68 joints) and at least 3 of the following 5 assessments: participant's global assessment of pain, PGH, PhGH (all 3 assessed at 0 [good] to 100 mm [worst] VAS scale), participant assessment of disability measured by the Health Assessment Questionnaire-Disability Index (HAQ-DI) (assessed on a 0 to 3 scale, where higher scores represented higher disease activity), Acute phase reactant (CRP or ESR). A reduction in the level of and acute phase reactants was considered an improvement.
measure: Percentage of Participants Who Achieved 50% Improvement in ACR (ACR50) Response
time frame: Baseline, 3 and 6 months
description: ACR response was calculated based on total joint count evaluation (28 or 66/68 joint count) and other clinical and laboratory assessments. A positive ACR50 response required at least a 50% improvement (reduction) compared to baseline in swollen joint count (66 joints) and tender joint count (68 joints) and at least 3 of the following 5 assessments: (participant's global assessment of pain, PGH, PhGH (all 3 assessed at 0 [good] to 100 mm [worst] VAS scale), participant assessment of disability measured by the Health Assessment Questionnaire-Disability Index (HAQ-DI) (assessed on a 0 to 3 scale, where higher scores represented higher disease activity), and acute phase reactant (CRP or ESR). A reduction in the level of acute phase reactants was considered an improvement.
measure: Percentage of Participants Who Achieved 70% Improvement in ACR (ACR70) Response
time frame: Baseline, 3 and 6 months
description: ACR response was calculated based on total joint count evaluation (28 or 66/68 joint count) and other clinical and laboratory assessments. A positive ACR70 response required at least a 70% improvement (reduction) compared to baseline in swollen joint count (66 joints) and tender joint count (68 joints) and at least 3 of the following 5 assessments: (participant's global assessment of pain, PGH, PhGH (all 3 assessed at 0 [good] to 100 mm [worst] VAS scale), participant assessment of disability measured by the Health Assessment Questionnaire-Disability Index (HAQ-DI) (assessed on a 0 to 3 scale, where higher scores represented higher disease activity), and acute phase reactant (CRP or ESR). A reduction in the level of acute phase reactants was considered an improvement.
measure: Percentage of Participants Who Achieved 90% Improvement in ACR (ACR90) Response
time frame: Baseline, 3 and 6 months
description: ACR response was calculated based on total joint count evaluation (28 or 66/68 joint count) and other clinical and laboratory assessments. A positive ACR90 response required at least a 90% improvement (reduction) compared to baseline in swollen joint count (66 joints) and tender joint count (68 joints) and at least 3 of the following 5 assessments: (participant's global assessment of pain, PGH, PhGH (all 3 assessed at 0 [good] to 100 mm [worst] VAS scale), participant assessment of disability measured by the Health Assessment Questionnaire-Disability Index (HAQ-DI) (assessed on a 0 to 3 scale, where higher scores represented higher disease activity), and acute phase reactant (CRP or ESR). A reduction in the level of acute phase reactants was considered an improvement.
measure: Change From Baseline in Physician Global Assessment of Disease Activity at Months 3 and 6
time frame: Baseline, 3 and 6 months
description: The physician's global assessment of disease activity was assessed using a 0 to 100 mm horizontal VAS by the physician. The left-hand extreme of the line equals 0 mm, and is described as "no disease activity" (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as "maximum disease activity" (maximum arthritis disease activity). A negative change from Baseline indicated improvement.
measure: Change From Baseline in Participant Global Assessment of Disease Activity at Months 3 and 6
time frame: Baseline, 3 and 6 months
description: The Participant's Global Assessment of Disease Activity was assessed using a 0 to 100 mm horizontal VAS by the participant. The left-hand extreme of the line equals 0 mm, and is described as "no disease activity" (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as "maximum disease activity" (maximum arthritis disease activity). A negative change from Baseline indicated improvement.
measure: Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Months 3 and 6
time frame: Baseline, 3 and 6 months
description: The HAQ-DI was a participant self-reported questionnaire for assessing the extent of a participant's functional ability. It consisted of 20 questions in 8 categories (dressing and grooming, rising, eating, walking, reach, grip, hygiene, and carrying out daily activities). Each question had 4 response options, ranging from 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. The HAQ-DI scale was an average of all the scores and ranged from 0 to 3, where higher scores represented higher disease activity.
measure: Change From Baseline in Participant's Assessment of Fatigue Using VAS at Months 3 and 6
time frame: Baseline, 3 and 6 months
description: Fatigue was evaluated by a VAS. Participants marked on a 100 mm horizontal VAS the level of fatigue that they have experienced, ranging from 0 (no fatigue) to 100 (extreme fatigue).
measure: Change From Baseline in Participant's Assessment of RA-Related Pain Using VAS at Months 3 and 6
time frame: Baseline, 3 and 6 months
description: Severity of pain was evaluated by a VAS. Participants marked on a 100 mm horizontal VAS the severity of pain that they had experienced because of their RA, ranging from 0 (no pain) to 100 (unbearable pain).
measure: Change From Baseline in Particpant's Assessment of RA Morning Stiffness Assessed Using VAS at Months 3 and 6
time frame: Baseline, 3 and 6 months
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 as limber as he/she would be during a day involving typical activities. Morning stiffness was assessed on a 100 mm VAS, where 0= none and 100= very severe.
arm group label: Cohort
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Clinical Trials
role: Study Director
affiliation: Hoffmann-La Roche
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country: Hungary
responsible party type: Sponsor
mesh term: Arthritis
mesh term: Arthritis, Rheumatoid
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 