<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/NCT01705730</url>
  </required_header>
  <id_info>
    <org_study_id>ML28269</org_study_id>
    <nct_id>NCT01705730</nct_id>
  </id_info>
  <brief_title>A Non-Interventional Study of Rheumatoid Arthritis Patients Treated With RoActemra/Actemra (Tocilizumab) in Monotherapy</brief_title>
  <official_title>Mon-ACT: A Multi-center, Non-interventional Study in Rheumatoid Arthritis (RA) Patients Treated With Tocilizumab in Monotherapy</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 observational study will evaluate the use and efficacy of RoActemra/Actemra&#xD;
      (tocilizumab) in monotherapy in routine clinical practice in participants with rheumatoid&#xD;
      arthritis. Eligible participants initiated on RoActemra/Actemra treatment according to the&#xD;
      licensed label will be followed for 6 months.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 31, 2012</start_date>
  <completion_date type="Actual">December 12, 2014</completion_date>
  <primary_completion_date type="Actual">December 12, 2014</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Participants on Tocilizumab Treatment at Month 6 After Treatment Initiation</measure>
    <time_frame>Month 6 after treatment initiation</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 included anemia, fatigue, conventional risk factors for cardiovascular disease, C-Reactive Protein (CRP) above upper limit of normal, rheumatoid nodules, rheumatoid vasculitis and interstitial lung disease. Participants were included if they experienced at least any one of the conditions.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Disease-Modifying Antirheumatic Drugs (DMARDs) Intolerance and Inadequate Response</measure>
    <time_frame>Baseline</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Inadequate Response to Other Biologics</measure>
    <time_frame>Baseline</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Addition of Disease-Modifying Anti-rheumatic Drugs (DMARDs)</measure>
    <time_frame>Month 6</time_frame>
    <description>The time to DMARD addition equals to the time (days) between tocilizumab start and first start date of DMARDs.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Who Had DMARDs During Study</measure>
    <time_frame>Month 6</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Dose Reductions</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Starting Tocilizumab After Failing DMARDs</measure>
    <time_frame>Baseline</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Starting Tocilizumab After Stopping Other Biologic Agents</measure>
    <time_frame>Baseline</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Reduction/Withdrawal of Corticosteroids</measure>
    <time_frame>Month 6</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Dose Modifications Per Participant at Month 6</measure>
    <time_frame>Month 6</time_frame>
    <description>Number of dose modification per participant at Month 6 was reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Dosing Interval Per Participant at Month 6</measure>
    <time_frame>Month 6</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Discontinued From Tocilizumab for Safety Versus Efficacy</measure>
    <time_frame>Month 6</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time for Restoration of Initial Dosing Regimen</measure>
    <time_frame>Month 6</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Who Were Not Adhering to Recommended Dosing Regimen</measure>
    <time_frame>Month 6</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Who Were Not Adhering to Recommended Management of AEs</measure>
    <time_frame>Month 6</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Still on Tocilizumab Monotherapy at Month 6</measure>
    <time_frame>Month 6</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Reason for Choice of Monotherapy at Baseline</measure>
    <time_frame>Baseline</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tender Joint Count (TJC)</measure>
    <time_frame>Baseline, Month 3, 6</time_frame>
    <description>TJC was determined by examining 28 and 68 joints and identifying the joints that were painful under pressure or to passive motion. Tenderness was recorded on the joint assessment form at baseline, no tenderness = 0, tenderness = 1.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Swollen Joint Count (SJC)</measure>
    <time_frame>Baseline, Month 3, 6</time_frame>
    <description>SJC was determined by examining 28 and 66 joints and identifying when swelling was present. Swelling was recorded on the joint assessment form at baseline, no swelling = 0, swelling =1.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Disease Activity Score-28 (DAS28)</measure>
    <time_frame>Baseline, Month 3, 6</time_frame>
    <description>DAS28 was calculated from SJC and TJC using 28 joints count, erythrocyte sedimentation rate (ESR) (millimeter per hour [mm/hr]), and patient global assessment of disease activity (PGH) (measured on a 0 to 100 millimeter (mm) Visual Analogue Scale (VAS) where 0=no disease activity and 100=worst disease activity). DAS28 is a measurement of RA activity on a 0 to 10 scale: a score greater than (&gt;) 5.1 indicates high disease activity; a score between 3.2 and 5.1 indicates moderate disease activity; a score of less than 3.2 indicates low disease activity; a score of less than (&lt;) 2.6 is considered remission.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Good European League Against Rheumatism (EULAR) Response at Month 3 and Month 6</measure>
    <time_frame>Month 3, 6</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. 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. The DAS28 score was a measure of the participant's disease activity, based on the TJC (28 joints), SJC (28 joints), PGH, and ESR. 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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With American College of Rheumatology (ACR) Response at Month 3 and Month 6</measure>
    <time_frame>Month 3, 6</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: patient'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. ACR50, ACR70, ACR90 require a 50%, 70%, 90% improvement from baseline respectively.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Disease Activity According to Clinical Disease Activity Index (CDAI) Response</measure>
    <time_frame>Baseline, Month 3, 6</time_frame>
    <description>CDAI is the numerical sum of 4 outcome parameters: TJC and SJC based on a 28-joint assessment, PGH and physician global assessment of disease activity (PhGH) assessed on 0-10 cm VAS; 0 = no disease activity and 10 = worst disease activity. CDAI total score = 0-76. CDAI &lt;= 2.8 indicates clinical remission, &gt;2.8 to 10 = low disease activity, &gt;10 to 22 = moderate disease activity, and &gt;22 = high (or severe) disease activity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Disease Activity According to Simplified Disease Activity Index (SDAI) Response</measure>
    <time_frame>Baseline, Month 3, 6</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 PhGH, assessed on 0-100 mm VAS where 0 = no disease activity and 100 = worst disease activity, and C-reactive protein (CRP). SDAI total score = 0-86. A SDAI score &lt;/= 3.3 represented clinical remission, a score of between 3.4 and 11.0 represented low disease activity, a score between 11 and 26.0 represented moderate disease activity and a score &gt; 26.0 represented high (or severe) disease.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Patient's Global Assessment of Disease Activity at Month 3 and Month 6</measure>
    <time_frame>Baseline, Month 3, 6</time_frame>
    <description>The Patient Global Assessment of disease activity provides an overall assessment of how RA affects the participant using a visual analogue score, where 0 indicates they are managing very well and 100 indicates they are managing very poorly. A decrease in the score indicates improvement.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Physician Global Assessment of Disease Activity at Month 3 and Month 6</measure>
    <time_frame>Baseline, Month 3, 6</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 Health Assessment Questionnaire (HAQ) at Month 3 and Month 6</measure>
    <time_frame>Baseline, Month 3, 6</time_frame>
    <description>The HAQ 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 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 VAS-Fatigue at Month 3 and Month 6</measure>
    <time_frame>Baseline, Month 3, 6</time_frame>
    <description>The VAS-fatigue provides an overall assessment of the level of fatigue that the participant is experiencing using a visual analogue score, where 0 indicates no fatigue and 100 indicates extreme fatigue. A decrease in the score indicates improvement.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Patient's Global Assessment of Pain at Month 3 and Month 6</measure>
    <time_frame>Baseline, Month 3, 6</time_frame>
    <description>The Patient Global Assessment of pain provides an overall assessment of the severity of pain that the participant is experiencing using a visual analogue score, where 0 indicates no pain and 100 indicates unbearable pain. A decrease in the score indicates improvement.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in VAS-Morning Stiffness at Month 3 and Month 6</measure>
    <time_frame>Baseline, Month 3, 6</time_frame>
    <description>Morning stiffness was defined by the time elapsed between the time of usual awakening (even if not in the morning) and the time the participant was 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>
  <secondary_outcome>
    <measure>Percentage of Participants With an Adverse Event (AEs), Serious Adverse Events (SAEs), AEs of Special Interest (AESIs)</measure>
    <time_frame>Month 6</time_frame>
    <description>An AE was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. An Serious Adverse Events (SAEs) is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or results in a congenital anomaly/birth defect. AESI included- serious/medically significant infections; myocardial Infarction/acute coronary syndrome; gastrointestinal perforations; malignancies; anaphylaxis/hypersensitivity reactions; demyelinating disorders; stroke; serious/medically significant bleeding events; serious/medically significant hepatic events.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With AEs Leading to Dose Modifications</measure>
    <time_frame>Month 6</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>C-reactive Protein (CRP]) Level</measure>
    <time_frame>Baseline, Month 3, 6</time_frame>
    <description>CRP is an acute phase reactant and is a measure of inflammation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Erythrocyte Sedimentation Rate (ESR) Level</measure>
    <time_frame>Baseline, Month 3, 6</time_frame>
    <description>ESR is an acute phase reactant and is a measure of inflammation.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">71</enrollment>
  <condition>Rheumatoid Arthritis</condition>
  <arm_group>
    <arm_group_label>Tocilizumab</arm_group_label>
    <description>Participants with rheumatoid arthritis (RA) received tocilizumab monotherapy according to individualized physician-prescribed regimens.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>tocilizumab</intervention_name>
    <description>Participants received tocilizumab monotherapy according to individualized physician-prescribed regimens.</description>
    <arm_group_label>Tocilizumab</arm_group_label>
    <other_name>Actemra</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Participants with rheumatoid arthritis initiating treatment with RoActemra/Actemra in&#xD;
        monotherapy&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult participants, &gt;/= 18 years of age&#xD;
&#xD;
          -  Moderate to severe rheumatoid arthritis according to the revised (1987) ACR criteria&#xD;
&#xD;
          -  Participants in whom the treating physician has made the decision to commence&#xD;
             RoActemra/Actemra treatment in monotherapy in accordance with the local label and the&#xD;
             reimbursement criteria indicating that RoActemra/Actemra can be given in monotherapy&#xD;
             in case of methotrexate intolerance or where continued treatment with methotrexate is&#xD;
             inappropriate; this can include participants who have received RoActemra/Actemra&#xD;
             treatment within 8 weeks prior to the enrolment visit&#xD;
&#xD;
          -  Concomitant treatment with NSAIDs and/or corticosteroids is allowed&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participants who have received RoActemra/Actemra more than 8 weeks prior to the&#xD;
             enrolment visit&#xD;
&#xD;
          -  Participants who have previously received RoActemra/Actemra in a clinical trial or for&#xD;
             compassionate use&#xD;
&#xD;
          -  Participants receiving concomitant DMARD treatment for rheumatoid arthritis at&#xD;
             baseline (e.g. hydroxychloroquine, sulfasalazine, methotrexate, leflunomide, gold&#xD;
             compounds, cyclosporine) will be excluded from the study&#xD;
&#xD;
          -  Participants who have received treatment with an investigational agent within 4 weeks&#xD;
             (or 5 half-lives of the investigational agent, whichever is longer) before starting&#xD;
             treatment with RoActemra/Actemra&#xD;
&#xD;
          -  Participants with a history of autoimmune disease or any joint inflammatory disease&#xD;
             other than rheumatoid 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>
      <name>ASZ Aalst</name>
      <address>
        <city>Aalst</city>
        <zip>9300</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CH EpiCURA Site Ath</name>
      <address>
        <city>Ath</city>
        <zip>7800</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Brugmann (Victor Horta)</name>
      <address>
        <city>Bruxelles</city>
        <zip>1020</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Erasme; Neurologie</name>
      <address>
        <city>Bruxelles</city>
        <zip>1070</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Reumaclinic</name>
      <address>
        <city>Genk</city>
        <zip>3600</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GHdC Site Saint-Joseph</name>
      <address>
        <city>Gilly (Charleroi)</city>
        <zip>6000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinique Notre Dame de Grâce</name>
      <address>
        <city>Gosselies</city>
        <zip>6041</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CH Jolimont - Lobbes (Jolimont)</name>
      <address>
        <city>Haine-Saint-Paul</city>
        <zip>7100</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AZ Groeninge</name>
      <address>
        <city>Kortrijk</city>
        <zip>8500</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chr de La Citadelle</name>
      <address>
        <city>Liège</city>
        <zip>4000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinique Saint-Joseph</name>
      <address>
        <city>Liège</city>
        <zip>4000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Ambroise Paré</name>
      <address>
        <city>Mons</city>
        <zip>7000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AZ Damiaan</name>
      <address>
        <city>Oostende</city>
        <zip>8400</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinique St Pierre asbl</name>
      <address>
        <city>Ottignies</city>
        <zip>1340</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AZ Delta (Campus Wilgenstraat)</name>
      <address>
        <city>Roeselare</city>
        <zip>8800</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AZ Turnhout Sint Jozef</name>
      <address>
        <city>Turnhout</city>
        <zip>2300</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sint Augustinus Wilrijk</name>
      <address>
        <city>Wilrijk</city>
        <zip>2610</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>August 2018</verification_date>
  <study_first_submitted>October 10, 2012</study_first_submitted>
  <study_first_submitted_qc>October 10, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 12, 2012</study_first_posted>
  <results_first_submitted>November 8, 2016</results_first_submitted>
  <results_first_submitted_qc>August 30, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">September 4, 2018</results_first_posted>
  <last_update_submitted>August 30, 2018</last_update_submitted>
  <last_update_submitted_qc>August 30, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">September 4, 2018</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>
      <pre_assignment_details>A total of 71 participants were enrolled in the study. Out of 71 participants, 68 received at least one dose of tocilizumab during the study and were included in the full analysis set.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Tocilizumab</title>
          <description>Participants with RA received tocilizumab monotherapy according to individualized physician-prescribed regimens.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="68">Participants who received study drug</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="59"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lack of Efficacy</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Reason not Specified</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Full analysis set included all participants that received at least one dose of tocilizumab during the study.</population>
      <group_list>
        <group group_id="B1">
          <title>Tocilizumab</title>
          <description>Participants with RA received tocilizumab monotherapy according to individualized physician-prescribed regimens.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="68"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="59.3" spread="12.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="45"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants on Tocilizumab Treatment at Month 6 After Treatment Initiation</title>
        <time_frame>Month 6 after treatment initiation</time_frame>
        <population>Full analysis set included all participants that received at least one dose of tocilizumab during the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Tocilizumab</title>
            <description>Participants with RA received tocilizumab monotherapy according to individualized physician-prescribed regimens.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants on Tocilizumab Treatment at Month 6 After Treatment Initiation</title>
          <population>Full analysis set included all participants that received at least one dose of tocilizumab during the study.</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="68"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="79.4" lower_limit="67.9" upper_limit="88.3"/>
                  </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 included anemia, fatigue, conventional risk factors for cardiovascular disease, C-Reactive Protein (CRP) above upper limit of normal, rheumatoid nodules, rheumatoid vasculitis and interstitial lung disease. Participants were included if they experienced at least any one of the conditions.</description>
        <time_frame>Baseline</time_frame>
        <population>Data for this outcome measure was not collected.</population>
        <group_list>
          <group group_id="O1">
            <title>Tocilizumab</title>
            <description>Participants with RA received tocilizumab monotherapy according to individualized physician-prescribed regimens.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Systemic Manifestations of RA at Baseline</title>
          <description>Systemic manifestations of RA included anemia, fatigue, conventional risk factors for cardiovascular disease, C-Reactive Protein (CRP) above upper limit of normal, rheumatoid nodules, rheumatoid vasculitis and interstitial lung disease. Participants were included if they experienced at least any one of the conditions.</description>
          <population>Data for this outcome measure was not collected.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Disease-Modifying Antirheumatic Drugs (DMARDs) Intolerance and Inadequate Response</title>
        <time_frame>Baseline</time_frame>
        <population>Full analysis set included all participants that received at least one dose of tocilizumab during the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Tocilizumab</title>
            <description>Participants with RA received tocilizumab monotherapy according to individualized physician-prescribed regimens.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Disease-Modifying Antirheumatic Drugs (DMARDs) Intolerance and Inadequate Response</title>
          <population>Full analysis set included all participants that received at least one dose of tocilizumab during the study.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="68"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>DMARD Intolerance</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Inadequate Response</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Inadequate Response to Other Biologics</title>
        <time_frame>Baseline</time_frame>
        <population>Full analysis set included all participants that received at least one dose of tocilizumab during the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Tocilizumab</title>
            <description>Participants with RA received tocilizumab monotherapy according to individualized physician-prescribed regimens.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Inadequate Response to Other Biologics</title>
          <population>Full analysis set included all participants that received at least one dose of tocilizumab during the study.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="68"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Addition of Disease-Modifying Anti-rheumatic Drugs (DMARDs)</title>
        <description>The time to DMARD addition equals to the time (days) between tocilizumab start and first start date of DMARDs.</description>
        <time_frame>Month 6</time_frame>
        <population>Full analysis set included all participants that received at least one dose of tocilizumab during the study. Here, number of participants analyzed are the participants who had addition of DMARDs during study.</population>
        <group_list>
          <group group_id="O1">
            <title>Tocilizumab</title>
            <description>Participants with RA received tocilizumab monotherapy according to individualized physician-prescribed regimens.</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Addition of Disease-Modifying Anti-rheumatic Drugs (DMARDs)</title>
          <description>The time to DMARD addition equals to the time (days) between tocilizumab start and first start date of DMARDs.</description>
          <population>Full analysis set included all participants that received at least one dose of tocilizumab during the study. Here, number of participants analyzed are the participants who had addition of DMARDs during study.</population>
          <units>days</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="84" lower_limit="84" upper_limit="84"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Who Had DMARDs During Study</title>
        <time_frame>Month 6</time_frame>
        <population>Full analysis set included all participants that received at least one dose of tocilizumab during the study. Here, number of participants analyzed signifies those participants who had addition of DMARDs during study.</population>
        <group_list>
          <group group_id="O1">
            <title>Tocilizumab</title>
            <description>Participants with RA received tocilizumab monotherapy according to individualized physician-prescribed regimens.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Had DMARDs During Study</title>
          <population>Full analysis set included all participants that received at least one dose of tocilizumab during the study. Here, number of participants analyzed signifies those participants who had addition of DMARDs during study.</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="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Hydroxychoroquine</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sulfasalazine</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Methotrexate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Leflunomide</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Gold compunds</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cyclosporine</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Azatioprine</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other DMARD</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Dose Reductions</title>
        <time_frame>6 months</time_frame>
        <population>Full analysis set included all participants that received at least one dose of tocilizumab during the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Tocilizumab</title>
            <description>Participants with RA received tocilizumab monotherapy according to individualized physician-prescribed regimens.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Dose Reductions</title>
          <population>Full analysis set included all participants that received at least one dose of tocilizumab during the study.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="68"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Starting Tocilizumab After Failing DMARDs</title>
        <time_frame>Baseline</time_frame>
        <population>Full analysis set included all participants that received at least one dose of tocilizumab during the study</population>
        <group_list>
          <group group_id="O1">
            <title>Tocilizumab</title>
            <description>Participants with RA received tocilizumab monotherapy according to individualized physician-prescribed regimens.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Starting Tocilizumab After Failing DMARDs</title>
          <population>Full analysis set included all participants that received at least one dose of tocilizumab during the study</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="68"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Starting Tocilizumab After Stopping Other Biologic Agents</title>
        <time_frame>Baseline</time_frame>
        <population>Full analysis set included all participants that received at least one dose of tocilizumab during the study</population>
        <group_list>
          <group group_id="O1">
            <title>Tocilizumab</title>
            <description>Participants with RA received tocilizumab monotherapy according to individualized physician-prescribed regimens.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Starting Tocilizumab After Stopping Other Biologic Agents</title>
          <population>Full analysis set included all participants that received at least one dose of tocilizumab during the study</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="68"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Reduction/Withdrawal of Corticosteroids</title>
        <time_frame>Month 6</time_frame>
        <population>Data was not collected for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Tocilizumab</title>
            <description>Participants with RA received tocilizumab monotherapy according to individualized physician-prescribed regimens.</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Reduction/Withdrawal of Corticosteroids</title>
          <population>Data was not collected for this outcome measure.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Dose Modifications Per Participant at Month 6</title>
        <description>Number of dose modification per participant at Month 6 was reported.</description>
        <time_frame>Month 6</time_frame>
        <population>Full analysis set included all participants that received at least one dose of tocilizumab during the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Tocilizumab</title>
            <description>Participants with RA received tocilizumab monotherapy according to individualized physician-prescribed regimens.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Dose Modifications Per Participant at Month 6</title>
          <description>Number of dose modification per participant at Month 6 was reported.</description>
          <population>Full analysis set included all participants that received at least one dose of tocilizumab during the study.</population>
          <units>number of dose modifications</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="68"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.1" spread="0.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Dosing Interval Per Participant at Month 6</title>
        <time_frame>Month 6</time_frame>
        <population>Full analysis set included all participants that received at least one dose of tocilizumab during the study. Analysis was performed only participants reaching 6 month visit.</population>
        <group_list>
          <group group_id="O1">
            <title>Tocilizumab</title>
            <description>Participants with RA received tocilizumab monotherapy according to individualized physician-prescribed regimens.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Dosing Interval Per Participant at Month 6</title>
          <population>Full analysis set included all participants that received at least one dose of tocilizumab during the study. Analysis was performed only participants reaching 6 month visit.</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="54"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25.86" spread="2.64"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Discontinued From Tocilizumab for Safety Versus Efficacy</title>
        <time_frame>Month 6</time_frame>
        <population>Full analysis set included all participants that received at least one dose of tocilizumab during the study. Here, number of participants analyzed signifies the participants who were evaluable for the outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Tocilizumab</title>
            <description>Participants with RA received tocilizumab monotherapy according to individualized physician-prescribed regimens.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Discontinued From Tocilizumab for Safety Versus Efficacy</title>
          <population>Full analysis set included all participants that received at least one dose of tocilizumab during the study. Here, number of participants analyzed signifies the participants who were evaluable for the outcome measure.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Adverse Event</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="61.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lack of efficacy</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time for Restoration of Initial Dosing Regimen</title>
        <time_frame>Month 6</time_frame>
        <population>Full analysis set included all participants that received at least one dose of tocilizumab during the study. Here, number of participants analyzed signifies number of participants evaluated for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Tocilizumab</title>
            <description>Participants with RA received tocilizumab monotherapy according to individualized physician-prescribed regimens.</description>
          </group>
        </group_list>
        <measure>
          <title>Time for Restoration of Initial Dosing Regimen</title>
          <population>Full analysis set included all participants that received at least one dose of tocilizumab during the study. Here, number of participants analyzed signifies number of participants evaluated for this outcome measure.</population>
          <units>days</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" lower_limit="NA" upper_limit="NA">Median and full range could not be reached as less than 50% of the participants restored to initial dosing regimen.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Who Were Not Adhering to Recommended Dosing Regimen</title>
        <time_frame>Month 6</time_frame>
        <population>Full analysis set included all participants that received at least one dose of tocilizumab during the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Tocilizumab</title>
            <description>Participants with RA received tocilizumab monotherapy according to individualized physician-prescribed regimens.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Were Not Adhering to Recommended Dosing Regimen</title>
          <population>Full analysis set included all participants that received at least one dose of tocilizumab during the study.</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="68"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.6" lower_limit="11.7" upper_limit="32.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Who Were Not Adhering to Recommended Management of AEs</title>
        <time_frame>Month 6</time_frame>
        <population>Only participants experiencing 'adverse events and/or abnormal laboratory tests requiring modification of drug dosage' are taken into account for this analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Tocilizumab</title>
            <description>Participants with RA received tocilizumab monotherapy according to individualized physician-prescribed regimens.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Were Not Adhering to Recommended Management of AEs</title>
          <population>Only participants experiencing 'adverse events and/or abnormal laboratory tests requiring modification of drug dosage' are taken into account for this analysis.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Still on Tocilizumab Monotherapy at Month 6</title>
        <time_frame>Month 6</time_frame>
        <population>Full analysis set included all participants that received at least one dose of tocilizumab during the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Tocilizumab</title>
            <description>Participants with RA received tocilizumab monotherapy according to individualized physician-prescribed regimens.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Still on Tocilizumab Monotherapy at Month 6</title>
          <population>Full analysis set included all participants that received at least one dose of tocilizumab during the study.</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="68"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="98.1" lower_limit="90.0" upper_limit="99.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Reason for Choice of Monotherapy at Baseline</title>
        <time_frame>Baseline</time_frame>
        <population>Full analysis set included all participants that received at least one dose of tocilizumab during the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Tocilizumab</title>
            <description>Participants with RA received tocilizumab monotherapy according to individualized physician-prescribed regimens.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Reason for Choice of Monotherapy at Baseline</title>
          <population>Full analysis set included all participants that received at least one dose of tocilizumab during the study.</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="68"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>MTX Intolerance</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="61.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Continued MTX not Appropriate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="38.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Tender Joint Count (TJC)</title>
        <description>TJC was determined by examining 28 and 68 joints and identifying the joints that were painful under pressure or to passive motion. Tenderness was recorded on the joint assessment form at baseline, no tenderness = 0, tenderness = 1.</description>
        <time_frame>Baseline, Month 3, 6</time_frame>
        <population>Full analysis set included all participants that received at least one dose of tocilizumab during the study. Here, n signifies the number of participants who were evaluated for the specified time points.</population>
        <group_list>
          <group group_id="O1">
            <title>Tocilizumab</title>
            <description>Participants with RA received tocilizumab monotherapy according to individualized physician-prescribed regimens.</description>
          </group>
        </group_list>
        <measure>
          <title>Tender Joint Count (TJC)</title>
          <description>TJC was determined by examining 28 and 68 joints and identifying the joints that were painful under pressure or to passive motion. Tenderness was recorded on the joint assessment form at baseline, no tenderness = 0, tenderness = 1.</description>
          <population>Full analysis set included all participants that received at least one dose of tocilizumab during the study. Here, n signifies the number of participants who were evaluated for the specified time points.</population>
          <units>tender joints</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="68"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline for TJC28 (n=47)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.3" spread="6.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 3 for TJC28 (n=29)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.9" spread="5.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6 for TJC 28 (n=17)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.2" spread="3.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline for TJC68 (n=7)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.6" spread="3.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 3 for TJC68 (n=10)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.0" spread="2.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6 for TJC68 (n=1)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" spread="NA">Standard deviation was not estimable for TJC68 as only 1 participant was evaluated at Month 6.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Swollen Joint Count (SJC)</title>
        <description>SJC was determined by examining 28 and 66 joints and identifying when swelling was present. Swelling was recorded on the joint assessment form at baseline, no swelling = 0, swelling =1.</description>
        <time_frame>Baseline, Month 3, 6</time_frame>
        <population>Full analysis set included all participants that received at least one dose of tocilizumab during the study. Here, n signifies the number of participants who were evaluated for the specified time points.</population>
        <group_list>
          <group group_id="O1">
            <title>Tocilizumab</title>
            <description>Participants with RA received tocilizumab monotherapy according to individualized physician-prescribed regimens.</description>
          </group>
        </group_list>
        <measure>
          <title>Swollen Joint Count (SJC)</title>
          <description>SJC was determined by examining 28 and 66 joints and identifying when swelling was present. Swelling was recorded on the joint assessment form at baseline, no swelling = 0, swelling =1.</description>
          <population>Full analysis set included all participants that received at least one dose of tocilizumab during the study. Here, n signifies the number of participants who were evaluated for the specified time points.</population>
          <units>swollen joints</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="68"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline for SJC28 (n=47)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.9" spread="5.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 3 for SJC28 (n=29)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.5" spread="3.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6 for SJC 28 (n=17)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.9" spread="1.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline for SJC66 (n=7)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.9" spread="4.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 3 for SJC66 (n=10)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.6" spread="1.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6 for SJC66 (n=1)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" spread="NA">Standard deviation was not estimable for SJC66 as 1 participant was evaluated at Month 6.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Disease Activity Score-28 (DAS28)</title>
        <description>DAS28 was calculated from SJC and TJC using 28 joints count, erythrocyte sedimentation rate (ESR) (millimeter per hour [mm/hr]), and patient global assessment of disease activity (PGH) (measured on a 0 to 100 millimeter (mm) Visual Analogue Scale (VAS) where 0=no disease activity and 100=worst disease activity). DAS28 is a measurement of RA activity on a 0 to 10 scale: a score greater than (&gt;) 5.1 indicates high disease activity; a score between 3.2 and 5.1 indicates moderate disease activity; a score of less than 3.2 indicates low disease activity; a score of less than (&lt;) 2.6 is considered remission.</description>
        <time_frame>Baseline, Month 3, 6</time_frame>
        <population>Full analysis set included all participants that received at least one dose of tocilizumab during the study. Here, n signifies the number of participants who were evaluated for the specified time points.</population>
        <group_list>
          <group group_id="O1">
            <title>Tocilizumab</title>
            <description>Participants with RA received tocilizumab monotherapy according to individualized physician-prescribed regimens.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Disease Activity Score-28 (DAS28)</title>
          <description>DAS28 was calculated from SJC and TJC using 28 joints count, erythrocyte sedimentation rate (ESR) (millimeter per hour [mm/hr]), and patient global assessment of disease activity (PGH) (measured on a 0 to 100 millimeter (mm) Visual Analogue Scale (VAS) where 0=no disease activity and 100=worst disease activity). DAS28 is a measurement of RA activity on a 0 to 10 scale: a score greater than (&gt;) 5.1 indicates high disease activity; a score between 3.2 and 5.1 indicates moderate disease activity; a score of less than 3.2 indicates low disease activity; a score of less than (&lt;) 2.6 is considered remission.</description>
          <population>Full analysis set included all participants that received at least one dose of tocilizumab during the study. Here, n signifies the number of participants who were evaluated for the specified time points.</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="68"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>LDA at Baseline (n=38)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>LDA at Month 3 (n=19)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="73.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>LDA at Month 6 (n=11)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="81.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Remission at Baseline (n=38)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Remission at Month 3 (n=19)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="68.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Remission at Month 6 (n=11)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="81.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Good European League Against Rheumatism (EULAR) Response at Month 3 and Month 6</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. 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. The DAS28 score was a measure of the participant's disease activity, based on the TJC (28 joints), SJC (28 joints), PGH, and ESR. 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.</description>
        <time_frame>Month 3, 6</time_frame>
        <population>Full analysis set included all participants that received at least one dose of tocilizumab during the study. Here, n signifies the number of participants who were evaluated for the specified time points.</population>
        <group_list>
          <group group_id="O1">
            <title>Tocilizumab</title>
            <description>Participants with RA received tocilizumab monotherapy according to individualized physician-prescribed regimens.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Good European League Against Rheumatism (EULAR) Response at Month 3 and Month 6</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. 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. The DAS28 score was a measure of the participant's disease activity, based on the TJC (28 joints), SJC (28 joints), PGH, and ESR. 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.</description>
          <population>Full analysis set included all participants that received at least one dose of tocilizumab during the study. Here, n signifies the number of participants who were evaluated for the specified time points.</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="68"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Month 3 (n=10)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="90"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6 (n=5)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="80"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With American College of Rheumatology (ACR) Response at Month 3 and Month 6</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: patient'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. ACR50, ACR70, ACR90 require a 50%, 70%, 90% improvement from baseline respectively.</description>
        <time_frame>Month 3, 6</time_frame>
        <population>The ACR analysis was not performed because the Health Assessment Questionnaire (HAQ) disability index score is needed; only HAQ total score expressed in % was available.</population>
        <group_list>
          <group group_id="O1">
            <title>Tocilizumab</title>
            <description>Participants with RA received tocilizumab monotherapy according to individualized physician-prescribed regimens.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With American College of Rheumatology (ACR) Response at Month 3 and Month 6</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: patient'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. ACR50, ACR70, ACR90 require a 50%, 70%, 90% improvement from baseline respectively.</description>
          <population>The ACR analysis was not performed because the Health Assessment Questionnaire (HAQ) disability index score is needed; only HAQ total score expressed in % was available.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Disease Activity According to Clinical Disease Activity Index (CDAI) Response</title>
        <description>CDAI is the numerical sum of 4 outcome parameters: TJC and SJC based on a 28-joint assessment, PGH and physician global assessment of disease activity (PhGH) assessed on 0-10 cm VAS; 0 = no disease activity and 10 = worst disease activity. CDAI total score = 0-76. CDAI &lt;= 2.8 indicates clinical remission, &gt;2.8 to 10 = low disease activity, &gt;10 to 22 = moderate disease activity, and &gt;22 = high (or severe) disease activity.</description>
        <time_frame>Baseline, Month 3, 6</time_frame>
        <population>Full analysis set included all participants that received at least one dose of tocilizumab during the study. Here, n signifies the number of participants who were evaluated for the specified time points.</population>
        <group_list>
          <group group_id="O1">
            <title>Tocilizumab</title>
            <description>Participants with RA received tocilizumab monotherapy according to individualized physician-prescribed regimens.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Disease Activity According to Clinical Disease Activity Index (CDAI) Response</title>
          <description>CDAI is the numerical sum of 4 outcome parameters: TJC and SJC based on a 28-joint assessment, PGH and physician global assessment of disease activity (PhGH) assessed on 0-10 cm VAS; 0 = no disease activity and 10 = worst disease activity. CDAI total score = 0-76. CDAI &lt;= 2.8 indicates clinical remission, &gt;2.8 to 10 = low disease activity, &gt;10 to 22 = moderate disease activity, and &gt;22 = high (or severe) disease activity.</description>
          <population>Full analysis set included all participants that received at least one dose of tocilizumab during the study. Here, n signifies the number of participants who were evaluated for the specified time points.</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="68"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline Remission (n=30)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Remission at Month 3 (n=8)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="75.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Remission at Month 6 (n=4)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="75.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline LDA (n=30)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>LDA at Month 3 (n=8)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>LDA at Month 6 (n=4)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline Moderate Disease Activity (n=30)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="50.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Moderate Disease Activity at Month 3 (n=8)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Moderate Disease Activity at Month 6 (n=4)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline High Disease Activity (n=30)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="36.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>High Disease Activity at Month 3 (n=8)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>High Disease Activity at Month 6 (n=4)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Disease Activity According to Simplified Disease Activity Index (SDAI) Response</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 PhGH, assessed on 0-100 mm VAS where 0 = no disease activity and 100 = worst disease activity, and C-reactive protein (CRP). SDAI total score = 0-86. A SDAI score &lt;/= 3.3 represented clinical remission, a score of between 3.4 and 11.0 represented low disease activity, a score between 11 and 26.0 represented moderate disease activity and a score &gt; 26.0 represented high (or severe) disease.</description>
        <time_frame>Baseline, Month 3, 6</time_frame>
        <population>Full analysis set included all participants that received at least one dose of tocilizumab during the study. Here, n signifies the number of participants who were evaluated for the specified time points.</population>
        <group_list>
          <group group_id="O1">
            <title>Tocilizumab</title>
            <description>Participants with RA received tocilizumab monotherapy according to individualized physician-prescribed regimens.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Disease Activity According to Simplified Disease Activity Index (SDAI) Response</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 PhGH, assessed on 0-100 mm VAS where 0 = no disease activity and 100 = worst disease activity, and C-reactive protein (CRP). SDAI total score = 0-86. A SDAI score &lt;/= 3.3 represented clinical remission, a score of between 3.4 and 11.0 represented low disease activity, a score between 11 and 26.0 represented moderate disease activity and a score &gt; 26.0 represented high (or severe) disease.</description>
          <population>Full analysis set included all participants that received at least one dose of tocilizumab during the study. Here, n signifies the number of participants who were evaluated for the specified time points.</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="68"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline Remission (n=28)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Remission at Month 3 (n=8)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="75.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Remission at Month 6 (n=4)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="75.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline LDA (n=28)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>LDA at Month 3 (n=8)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>LDA at Month 6 (n=4)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline Moderate Disease Activity (n=28)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="46.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Moderate Disease Activity at Month 3 (n=8)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Moderate Disease Activity at Month 6 (n=4)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline High Disease Activity (n=28)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>High Disease Activity at Month 3 (n=8)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>High Disease Activity at Month 6 (n=4)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Patient's Global Assessment of Disease Activity at Month 3 and Month 6</title>
        <description>The Patient Global Assessment of disease activity provides an overall assessment of how RA affects the participant using a visual analogue score, where 0 indicates they are managing very well and 100 indicates they are managing very poorly. A decrease in the score indicates improvement.</description>
        <time_frame>Baseline, Month 3, 6</time_frame>
        <population>Full analysis set included all participants that received at least one dose of tocilizumab during the study. Here, n signifies the number of participants who were evaluated for the specified time points.</population>
        <group_list>
          <group group_id="O1">
            <title>Tocilizumab</title>
            <description>Participants with RA received tocilizumab monotherapy according to individualized physician-prescribed regimens.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Patient's Global Assessment of Disease Activity at Month 3 and Month 6</title>
          <description>The Patient Global Assessment of disease activity provides an overall assessment of how RA affects the participant using a visual analogue score, where 0 indicates they are managing very well and 100 indicates they are managing very poorly. A decrease in the score indicates improvement.</description>
          <population>Full analysis set included all participants that received at least one dose of tocilizumab during the study. Here, n signifies the number of participants who were evaluated for the specified time points.</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="68"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (n=40)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="65.6" spread="15.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Month 3 (n=12)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-27.8" spread="27.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Month 6 (n=7)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-30.1" spread="16.2"/>
                  </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 Month 3 and Month 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, Month 3, 6</time_frame>
        <population>Full analysis set included all participants that received at least one dose of tocilizumab during the study. Here, n signifies the number of participants who were evaluated for the specified time points.</population>
        <group_list>
          <group group_id="O1">
            <title>Tocilizumab</title>
            <description>Participants with RA received tocilizumab monotherapy according to individualized physician-prescribed regimens.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Physician Global Assessment of Disease Activity at Month 3 and Month 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>Full analysis set included all participants that received at least one dose of tocilizumab during the study. Here, n signifies the number of participants who were evaluated for the specified time points.</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="68"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (n=34)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="57.6" spread="23.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Month (n=9)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-41.9" spread="22.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Month (n=3)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-53.0" spread="20.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Health Assessment Questionnaire (HAQ) at Month 3 and Month 6</title>
        <description>The HAQ 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 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, Month 3, 6</time_frame>
        <population>Full analysis set included all participants that received at least one dose of tocilizumab during the study. Here, n signifies the number of participants who were evaluated for the specified time points.</population>
        <group_list>
          <group group_id="O1">
            <title>Tocilizumab</title>
            <description>Participants with RA received tocilizumab monotherapy according to individualized physician-prescribed regimens.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Health Assessment Questionnaire (HAQ) at Month 3 and Month 6</title>
          <description>The HAQ 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 scale was an average of all the scores and ranged from 0 to 3, where higher scores represented higher disease activity.</description>
          <population>Full analysis set included all participants that received at least one dose of tocilizumab during the study. Here, n signifies the number of participants who were evaluated for the specified time points.</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="68"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (n=42)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="41.11" spread="19.40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Month 3 (n=13)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-23.59" spread="29.09"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Month 6 (n=6)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-11.94" spread="19.87"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in VAS-Fatigue at Month 3 and Month 6</title>
        <description>The VAS-fatigue provides an overall assessment of the level of fatigue that the participant is experiencing using a visual analogue score, where 0 indicates no fatigue and 100 indicates extreme fatigue. A decrease in the score indicates improvement.</description>
        <time_frame>Baseline, Month 3, 6</time_frame>
        <population>Full analysis set included all participants that received at least one dose of tocilizumab during the study. Here, n signifies the number of participants who were evaluated for the specified time points.</population>
        <group_list>
          <group group_id="O1">
            <title>Tocilizumab</title>
            <description>Participants with RA received tocilizumab monotherapy according to individualized physician-prescribed regimens.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in VAS-Fatigue at Month 3 and Month 6</title>
          <description>The VAS-fatigue provides an overall assessment of the level of fatigue that the participant is experiencing using a visual analogue score, where 0 indicates no fatigue and 100 indicates extreme fatigue. A decrease in the score indicates improvement.</description>
          <population>Full analysis set included all participants that received at least one dose of tocilizumab during the study. Here, n signifies the number of participants who were evaluated for the specified time points.</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="68"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (n=31)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="64" spread="16.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Month 3 (n=9)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-19.3" spread="18.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Month 6 (n=5)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-38.4" spread="21.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Patient's Global Assessment of Pain at Month 3 and Month 6</title>
        <description>The Patient Global Assessment of pain provides an overall assessment of the severity of pain that the participant is experiencing using a visual analogue score, where 0 indicates no pain and 100 indicates unbearable pain. A decrease in the score indicates improvement.</description>
        <time_frame>Baseline, Month 3, 6</time_frame>
        <population>Full analysis set included all participants that received at least one dose of tocilizumab during the study. Here, n signifies the number of participants who were evaluated for the specified time points.</population>
        <group_list>
          <group group_id="O1">
            <title>Tocilizumab</title>
            <description>Participants with RA received tocilizumab monotherapy according to individualized physician-prescribed regimens.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Patient's Global Assessment of Pain at Month 3 and Month 6</title>
          <description>The Patient Global Assessment of pain provides an overall assessment of the severity of pain that the participant is experiencing using a visual analogue score, where 0 indicates no pain and 100 indicates unbearable pain. A decrease in the score indicates improvement.</description>
          <population>Full analysis set included all participants that received at least one dose of tocilizumab during the study. Here, n signifies the number of participants who were evaluated for the specified time points.</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="68"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (n=34)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="60.6" spread="22.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Month 3 (n=9)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-31.8" spread="25.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Month 6 (n=4)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-33.0" spread="18.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in VAS-Morning Stiffness at Month 3 and Month 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, Month 3, 6</time_frame>
        <population>Full analysis set included all participants that received at least one dose of tocilizumab during the study. Here, n signifies the number of participants who were evaluated for the specified time points.</population>
        <group_list>
          <group group_id="O1">
            <title>Tocilizumab</title>
            <description>Participants with RA received tocilizumab monotherapy according to individualized physician-prescribed regimens.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in VAS-Morning Stiffness at Month 3 and Month 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>Full analysis set included all participants that received at least one dose of tocilizumab during the study. Here, n signifies the number of participants who were evaluated for the specified time points.</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="68"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (n=22)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="37.8" spread="22.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Month 3 (n=5)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-7.6" spread="26.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Month 6 (n=3)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-30.3" spread="18.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With an Adverse Event (AEs), Serious Adverse Events (SAEs), AEs of Special Interest (AESIs)</title>
        <description>An AE was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. An Serious Adverse Events (SAEs) is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or results in a congenital anomaly/birth defect. AESI included- serious/medically significant infections; myocardial Infarction/acute coronary syndrome; gastrointestinal perforations; malignancies; anaphylaxis/hypersensitivity reactions; demyelinating disorders; stroke; serious/medically significant bleeding events; serious/medically significant hepatic events.</description>
        <time_frame>Month 6</time_frame>
        <population>Safety population included all participants that received a dose of study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Tocilizumab</title>
            <description>Participants with RA received tocilizumab monotherapy according to individualized physician-prescribed regimens.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With an Adverse Event (AEs), Serious Adverse Events (SAEs), AEs of Special Interest (AESIs)</title>
          <description>An AE was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. An Serious Adverse Events (SAEs) is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or results in a congenital anomaly/birth defect. AESI included- serious/medically significant infections; myocardial Infarction/acute coronary syndrome; gastrointestinal perforations; malignancies; anaphylaxis/hypersensitivity reactions; demyelinating disorders; stroke; serious/medically significant bleeding events; serious/medically significant hepatic events.</description>
          <population>Safety population included all participants that received a dose of study drug.</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="68"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>AE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="61.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SAE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AESI</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With AEs Leading to Dose Modifications</title>
        <time_frame>Month 6</time_frame>
        <population>Safety population included all participants that received a dose of study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Tocilizumab</title>
            <description>Participants with RA received tocilizumab monotherapy according to individualized physician-prescribed regimens.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With AEs Leading to Dose Modifications</title>
          <population>Safety population included all participants that received a dose of study drug.</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="68"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>C-reactive Protein (CRP]) Level</title>
        <description>CRP is an acute phase reactant and is a measure of inflammation.</description>
        <time_frame>Baseline, Month 3, 6</time_frame>
        <population>Full analysis set included all participants that received at least one dose of tocilizumab during the study. Here, n signifies the number of participants who were evaluated for the specified time points.</population>
        <group_list>
          <group group_id="O1">
            <title>Tocilizumab</title>
            <description>Participants with RA received tocilizumab monotherapy according to individualized physician-prescribed regimens.</description>
          </group>
        </group_list>
        <measure>
          <title>C-reactive Protein (CRP]) Level</title>
          <description>CRP is an acute phase reactant and is a measure of inflammation.</description>
          <population>Full analysis set included all participants that received at least one dose of tocilizumab during the study. Here, n signifies the number of participants who were evaluated for the specified time points.</population>
          <units>milligram per liter (mg/L)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="68"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (n= 51)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.94" spread="20.71"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 3 (n= 52)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.04" spread="18.95"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6 (n= 28)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.49" spread="3.16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Erythrocyte Sedimentation Rate (ESR) Level</title>
        <description>ESR is an acute phase reactant and is a measure of inflammation.</description>
        <time_frame>Baseline, Month 3, 6</time_frame>
        <population>Full analysis set included all participants that received at least one dose of tocilizumab during the study. Here, n signifies the number of participants who were evaluated for the specified time points.</population>
        <group_list>
          <group group_id="O1">
            <title>Tocilizumab</title>
            <description>Participants with RA received tocilizumab monotherapy according to individualized physician-prescribed regimens.</description>
          </group>
        </group_list>
        <measure>
          <title>Erythrocyte Sedimentation Rate (ESR) Level</title>
          <description>ESR is an acute phase reactant and is a measure of inflammation.</description>
          <population>Full analysis set included all participants that received at least one dose of tocilizumab during the study. Here, n signifies the number of participants who were evaluated for the specified time points.</population>
          <units>millimeter per hour (mm/hr)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="68"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (n= 42)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24.31" spread="24.68"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 3 (n= 38)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.71" spread="23.84"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6 (n= 17)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.88" spread="15.07"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Month 6</time_frame>
      <desc>An AE was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug.</desc>
      <group_list>
        <group group_id="E1">
          <title>Tocilizumab</title>
          <description>Participants with RA received tocilizumab monotherapy according to individualized physician-prescribed regimens.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 16.0</default_vocab>
        <default_assessment>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="3" subjects_at_risk="68"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Sarcoidosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="68"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="68"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Infarction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="68"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="68"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Medical Communications</name_or_title>
      <organization>Hoffmann-La Roche</organization>
      <phone>1-800-821-8590</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/NCT01705730
org study id: ML28269
nct id: NCT01705730
lead sponsor: 
This observational study will evaluate the use and efficacy of RoActemra/Actemra
      (tocilizumab) in monotherapy in routine clinical practice in participants with rheumatoid
      arthritis. Eligible participants initiated on RoActemra/Actemra treatment according to the
      licensed label will be followed for 6 months.
observational model: Cohort
time perspective: Prospective
measure: Percentage of Participants on Tocilizumab Treatment at Month 6 After Treatment Initiation
time frame: Month 6 after treatment initiation
measure: Percentage of Participants With Systemic Manifestations of RA at Baseline
time frame: Baseline
description: Systemic manifestations of RA included anemia, fatigue, conventional risk factors for cardiovascular disease, C-Reactive Protein (CRP) above upper limit of normal, rheumatoid nodules, rheumatoid vasculitis and interstitial lung disease. Participants were included if they experienced at least any one of the conditions.
measure: Number of Participants With Disease-Modifying Antirheumatic Drugs (DMARDs) Intolerance and Inadequate Response
time frame: Baseline
measure: Number of Participants With Inadequate Response to Other Biologics
time frame: Baseline
measure: Time to Addition of Disease-Modifying Anti-rheumatic Drugs (DMARDs)
time frame: Month 6
description: The time to DMARD addition equals to the time (days) between tocilizumab start and first start date of DMARDs.
measure: Percentage of Participants Who Had DMARDs During Study
time frame: Month 6
measure: Number of Participants With Dose Reductions
time frame: 6 months
measure: Number of Participants With Starting Tocilizumab After Failing DMARDs
time frame: Baseline
measure: Number of Participants With Starting Tocilizumab After Stopping Other Biologic Agents
time frame: Baseline
measure: Time to Reduction/Withdrawal of Corticosteroids
time frame: Month 6
measure: Number of Dose Modifications Per Participant at Month 6
time frame: Month 6
description: Number of dose modification per participant at Month 6 was reported.
measure: Mean Dosing Interval Per Participant at Month 6
time frame: Month 6
measure: Percentage of Participants Discontinued From Tocilizumab for Safety Versus Efficacy
time frame: Month 6
measure: Time for Restoration of Initial Dosing Regimen
time frame: Month 6
measure: Percentage of Participants Who Were Not Adhering to Recommended Dosing Regimen
time frame: Month 6
measure: Number of Participants Who Were Not Adhering to Recommended Management of AEs
time frame: Month 6
measure: Percentage of Participants Still on Tocilizumab Monotherapy at Month 6
time frame: Month 6
measure: Percentage of Participants With Reason for Choice of Monotherapy at Baseline
time frame: Baseline
measure: Tender Joint Count (TJC)
time frame: Baseline, Month 3, 6
description: TJC was determined by examining 28 and 68 joints and identifying the joints that were painful under pressure or to passive motion. Tenderness was recorded on the joint assessment form at baseline, no tenderness = 0, tenderness = 1.
measure: Swollen Joint Count (SJC)
time frame: Baseline, Month 3, 6
description: SJC was determined by examining 28 and 66 joints and identifying when swelling was present. Swelling was recorded on the joint assessment form at baseline, no swelling = 0, swelling =1.
measure: Percentage of Participants With Disease Activity Score-28 (DAS28)
time frame: Baseline, Month 3, 6
description: DAS28 was calculated from SJC and TJC using 28 joints count, erythrocyte sedimentation rate (ESR) (millimeter per hour [mm/hr]), and patient global assessment of disease activity (PGH) (measured on a 0 to 100 millimeter (mm) Visual Analogue Scale (VAS) where 0=no disease activity and 100=worst disease activity). DAS28 is a measurement of RA activity on a 0 to 10 scale: a score greater than (>) 5.1 indicates high disease activity; a score between 3.2 and 5.1 indicates moderate disease activity; a score of less than 3.2 indicates low disease activity; a score of less than (<) 2.6 is considered remission.
measure: Percentage of Participants With Good European League Against Rheumatism (EULAR) Response at Month 3 and Month 6
time frame: Month 3, 6
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. 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. The DAS28 score was a measure of the participant's disease activity, based on the TJC (28 joints), SJC (28 joints), PGH, and ESR. 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.
measure: Percentage of Participants With American College of Rheumatology (ACR) Response at Month 3 and Month 6
time frame: Month 3, 6
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: patient'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. ACR50, ACR70, ACR90 require a 50%, 70%, 90% improvement from baseline respectively.
measure: Percentage of Participants With Disease Activity According to Clinical Disease Activity Index (CDAI) Response
time frame: Baseline, Month 3, 6
description: CDAI is the numerical sum of 4 outcome parameters: TJC and SJC based on a 28-joint assessment, PGH and physician global assessment of disease activity (PhGH) assessed on 0-10 cm VAS; 0 = no disease activity and 10 = worst disease activity. CDAI total score = 0-76. CDAI <= 2.8 indicates clinical remission, >2.8 to 10 = low disease activity, >10 to 22 = moderate disease activity, and >22 = high (or severe) disease activity.
measure: Percentage of Participants With Disease Activity According to Simplified Disease Activity Index (SDAI) Response
time frame: Baseline, Month 3, 6
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 PhGH, assessed on 0-100 mm VAS where 0 = no disease activity and 100 = worst disease activity, and C-reactive protein (CRP). SDAI total score = 0-86. A SDAI score </= 3.3 represented clinical remission, a score of between 3.4 and 11.0 represented low disease activity, a score between 11 and 26.0 represented moderate disease activity and a score > 26.0 represented high (or severe) disease.
measure: Change From Baseline in Patient's Global Assessment of Disease Activity at Month 3 and Month 6
time frame: Baseline, Month 3, 6
description: The Patient Global Assessment of disease activity provides an overall assessment of how RA affects the participant using a visual analogue score, where 0 indicates they are managing very well and 100 indicates they are managing very poorly. A decrease in the score indicates improvement.
measure: Change From Baseline in Physician Global Assessment of Disease Activity at Month 3 and Month 6
time frame: Baseline, Month 3, 6
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 Health Assessment Questionnaire (HAQ) at Month 3 and Month 6
time frame: Baseline, Month 3, 6
description: The HAQ 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 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 VAS-Fatigue at Month 3 and Month 6
time frame: Baseline, Month 3, 6
description: The VAS-fatigue provides an overall assessment of the level of fatigue that the participant is experiencing using a visual analogue score, where 0 indicates no fatigue and 100 indicates extreme fatigue. A decrease in the score indicates improvement.
measure: Change From Baseline in Patient's Global Assessment of Pain at Month 3 and Month 6
time frame: Baseline, Month 3, 6
description: The Patient Global Assessment of pain provides an overall assessment of the severity of pain that the participant is experiencing using a visual analogue score, where 0 indicates no pain and 100 indicates unbearable pain. A decrease in the score indicates improvement.
measure: Change From Baseline in VAS-Morning Stiffness at Month 3 and Month 6
time frame: Baseline, Month 3, 6
description: Morning stiffness was defined by the time elapsed between the time of usual awakening (even if not in the morning) and the time the participant was 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.
measure: Percentage of Participants With an Adverse Event (AEs), Serious Adverse Events (SAEs), AEs of Special Interest (AESIs)
time frame: Month 6
description: An AE was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. An Serious Adverse Events (SAEs) is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or results in a congenital anomaly/birth defect. AESI included- serious/medically significant infections; myocardial Infarction/acute coronary syndrome; gastrointestinal perforations; malignancies; anaphylaxis/hypersensitivity reactions; demyelinating disorders; stroke; serious/medically significant bleeding events; serious/medically significant hepatic events.
measure: Percentage of Participants With AEs Leading to Dose Modifications
time frame: Month 6
measure: C-reactive Protein (CRP]) Level
time frame: Baseline, Month 3, 6
description: CRP is an acute phase reactant and is a measure of inflammation.
measure: Erythrocyte Sedimentation Rate (ESR) Level
time frame: Baseline, Month 3, 6
description: ESR is an acute phase reactant and is a measure of inflammation.
arm group label: Tocilizumab
description: Participants with rheumatoid arthritis (RA) received tocilizumab monotherapy according to individualized physician-prescribed regimens.
intervention type: Drug
intervention name: tocilizumab
description: Participants received tocilizumab monotherapy according to individualized physician-prescribed regimens.
arm group label: Tocilizumab
other name: Actemra
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Clinical Trials
role: Study Director
affiliation: Hoffmann-La Roche
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Belgium
responsible party type: Sponsor
mesh term: Arthritis
mesh term: Arthritis, Rheumatoid
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 