<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/NCT01670045</url>
  </required_header>
  <id_info>
    <org_study_id>ML28216</org_study_id>
    <nct_id>NCT01670045</nct_id>
  </id_info>
  <brief_title>A Non-Interventional Study of RoActemra/Actemra (Tocilizumab) in Patients With Moderate to Severe Rheumatoid Arthritis</brief_title>
  <official_title>A Multi-national, Multi-center Non-interventional Study in Rheumatoid Arthritis (RA) Patients Treated With Tocilizumab</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hoffmann-La Roche</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hoffmann-La Roche</source>
  <brief_summary>
    <textblock>
      This multi-center observational study will evaluate the use and efficacy of RoActemra/Actemra&#xD;
      (tocilizumab) in patients with moderate to severe rheumatoid arthritis. Eligible patients&#xD;
      initiated on RoActemra/Actemra treatment according to the licensed label will be followed for&#xD;
      6 months.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>March 2012</start_date>
  <completion_date type="Actual">June 2014</completion_date>
  <primary_completion_date type="Actual">June 2014</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Participants Who Remained on Tocilizumab Treatment at 6 Months After Treatment Initiation</measure>
    <time_frame>Month 6</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With RA Diagnosis</measure>
    <time_frame>Baseline up to Day 5</time_frame>
    <description>Percentage of participants was reported based on the timing RA was diagnosed. Timings included more than 5 years, less than 5 years. Participants with unknown timing were reported under &quot;unknown&quot;.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Different Body Mass Index (BMI)</measure>
    <time_frame>Baseline up to Day 5</time_frame>
    <description>BMI was calculated by weight divided by height squared and measured as kilogram per square meter (kg/m^2). BMI from 16 to 18.5 = underweight, BMI from 18.5 to 25= normal weight, BMI from 25 to 30= overweight, BMI from 30 to 40 = obese.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Rheumatoid Factor Status</measure>
    <time_frame>Baseline up to Day 5</time_frame>
    <description>Percentage of participants with rheumatoid factor status was reported as &quot;positive&quot; or &quot;negative&quot;.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Anti-Citrullinated Cyclic Peptide (Anti-CCP) Status</measure>
    <time_frame>Baseline up to Day 5</time_frame>
    <description>Percentage of participants with anti-CCP status were reported as &quot;positive&quot;, negative&quot; and &quot;unknown&quot;.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With a Reduction of at Least 2.6 Units in DAS28 From Baseline</measure>
    <time_frame>Baseline, Month 1, 2, 3, 4, 5, 6</time_frame>
    <description>The DAS28 score is a measure of the participants' disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], participant's global assessment (PtGA) of disease activity [visual analog scale (VAS): 0 millimeter (mm)=no disease activity to 100 mm=maximum disease activity] and the erythrocyte sedimentation rate (ESR). DAS28 was calculated using following formulas: DAS28-ESR = 0.56*square root (sqrt) (TJC28) + 0.28*sqrt(SJC28) + 0.70*natural logarithm (ln) (ESR) + 0.014*PtGA of disease activity. A total possible score of 0 to approximately 10, with higher score indicating worse disease activity. A reduction of at least 2.6 units from Baseline in DAS28 was considered as significant clinical improvement.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Achieving a Response According to European League Against Rheumatism (EULAR) Criteria</measure>
    <time_frame>Baseline up to Month 6</time_frame>
    <description>Response was determined using EULAR criteria based upon DAS28 absolute scores at the assessment visit and the DAS28 improvement from Baseline. Participants with a score less than or equal to (≤) 3.2 and DAS28 improvement of greater than (&gt;) 1.2 points were assessed as having a 'good' response. Participants with a score ≤3.2 and DAS28 improvement of &gt;0.6 to ≤1.2 points, score of &gt;3.2 and ≤5.1 with DAS28 improvement of &gt;0.6 to ≤1.2 points, score of &gt;3.2 and ≤5.1 with DAS28 improvement of &gt;1.2 points, score of &gt;5.1 and DAS28 improvement of &gt;1.2 points were assessed as having a 'moderate' response. Participants with a score ≤3.2 and DAS28 improvement of ≤ 0.6 points, score of &gt;3.2 and ≤5.1 with DAS28 improvement of ≤ 0.6 points, score of &gt;5.1 and DAS28 improvement of &gt;0.6 to ≤1.2 points, score of &gt;5.1 and DAS28 improvement of ≤ 0.6 points were assessed as having a 'no' response.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Different Types of Simplified Disease Activity Index (SDAI)</measure>
    <time_frame>Baseline up to Month 6</time_frame>
    <description>The SDAI was calculated as [SJC (28 joints) + TJC (28 joints) + VAS patient global assessment of disease activity + VAS physician global assessment of disease activity+CRP level(milligram/deciliter {mg/dL})]. VAS assessments: 0 centimeters (cm)=no disease activity to 10 cm=maximum disease activity'. Scores ranged from 0 to 86, with higher scores also indicating increased disease activity. SDAI score ≤ 3.3 is 'remission', score &gt; 3.3 and ≤ 11 is 'low disease activity', score &gt; 11 and ≤ 26 is 'moderate disease activity', score &gt; 26 is 'high disease activity'. SDAI was reported as 'not available' for participants with no data on physical/patient global assessment of disease activity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Different Types of Clinical Disease Activity Index (CDAI)</measure>
    <time_frame>Baseline up to Month 6</time_frame>
    <description>The CDAI was calculated as [SJC (28 joints) + TJC (28 joints) + VAS patient global assessment of disease activity + VAS physician global assessment of disease activity]. VAS assessments: 0 cm =no disease activity to 100 cm=maximum disease activity'. CDAI scores ranged from 0 to 76, with higher scores indicating increased disease activity. CDAI score ≤ 2.8 is 'remission', score &gt; 2.8 and ≤ 10 is 'low disease activity', score &gt; 10 and ≤ 22 is 'moderate disease activity', score &gt; 22 is 'high disease activity'. CDAI was reported as 'not available' for participants with no data on physical/patient global assessment of disease activity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Achieving a Response According to ACR Criteria</measure>
    <time_frame>Month 1, 2, 3, 4, 5, 6</time_frame>
    <description>ACR20/50/70 percent (%) response is defined as a ≥ 20%/50%/70% improvement (reduction) compared with baseline for both TJC28 and SJC28, as well as for three of the additional five ACR core set variables: Participant's assessment of pain over the previous 24 hours: using a VAS, left end of the line 0 cm=no pain to right end of the line 10 cm=unbearable pain; Patient's global assessment of disease activity and physician's global assessment of disease activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; health assessment questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant [either C-reactive protein or erythrocyte sedimentation rate].</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Reduction/Withdrawal of Disease-modifying Anti-rheumatic Drugs (DMARDs) and/or Corticosteroids</measure>
    <time_frame>Baseline, up to Month 6</time_frame>
    <description>Participants with reduction/withdrawal of DMARDs and corticosteroids at baseline (before trial period) and up to Month 6 (during trial period) were reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Physician Global Assessment of Disease Activity at Months 3 and 6</measure>
    <time_frame>Baseline, Months 3, 6</time_frame>
    <description>Physician's global assessment of disease activity over the previous 24 hours was assessed using a VAS where left end of the line 0 mm=no disease activity to right end of the line 100 mm=maximum disease activity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Tocilizumab Dose Modifications</measure>
    <time_frame>Baseline up to Month 6</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">43</enrollment>
  <condition>Rheumatoid Arthritis</condition>
  <arm_group>
    <arm_group_label>Rheumatoid Arthritis Participants</arm_group_label>
    <description>Participants with moderate to severe rheumatoid arthritis (RA) according to the American College of Rheumatology (ACR) criteria and the Disease Activity Score based on 28 Joint Count (DAS28) who were on tocilizumab treatment within 8 weeks prior to start of study will receive tocilizumab in accordance with the licensed label recommendations, and will be observed for 6 months. The study is designed as non-interventional, no additional intervention in terms of follow-up visit, complementary examination or medication is required.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tocilizumab</intervention_name>
    <description>Tocilizumab in accordance with the licensed label recommendation.</description>
    <arm_group_label>Rheumatoid Arthritis Participants</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with rheumatoid arthritis initiating treatment with RoActemra/Actemra&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patients, &gt;/= 18 years of age&#xD;
&#xD;
          -  Moderate to severe rheumatoid arthritis according to the revised (1987) ACR criteria&#xD;
&#xD;
          -  Patient in whom the treating physician has made the decision to commence&#xD;
             RoActemra/Actemra treatment in accordance with the local label (DMARD-IR, TNF-IR or&#xD;
             need of RoActemra/Actemra monotherapy); this can include patients who have received&#xD;
             RoActemra/Actemra treatment within 8 weeks prior to the enrolment visit&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who have received RoActemra/Actemra more than 8 weeks prior to the enrolment&#xD;
             visit&#xD;
&#xD;
          -  Patients who have previously received RoActemra/Actemra in a clinical trial or for&#xD;
             compassionate use&#xD;
&#xD;
          -  Patients who have received treatment with an investigational agent within 4 weeks (or&#xD;
             5 half-lives of the investigational agent, whichever is longer) before starting&#xD;
             treatment with RoActemra/Actemra&#xD;
&#xD;
          -  Patients with a history of autoimmune disease or any joint inflammatory disease other&#xD;
             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>
      <address>
        <city>Balikpapan</city>
        <zip>76121</zip>
        <country>Indonesia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Bandung</city>
        <zip>40161</zip>
        <country>Indonesia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Central Jakarta</city>
        <zip>10430</zip>
        <country>Indonesia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Central Java</city>
        <country>Indonesia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Denpasar</city>
        <country>Indonesia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Jakarta</city>
        <country>Indonesia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Malang</city>
        <zip>65111</zip>
        <country>Indonesia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Manado</city>
        <zip>95115</zip>
        <country>Indonesia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Medan</city>
        <zip>20157</zip>
        <country>Indonesia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Indonesia</country>
  </location_countries>
  <removed_countries>
    <country>Greece</country>
  </removed_countries>
  <verification_date>September 2016</verification_date>
  <study_first_submitted>August 17, 2012</study_first_submitted>
  <study_first_submitted_qc>August 17, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 21, 2012</study_first_posted>
  <results_first_submitted>April 6, 2016</results_first_submitted>
  <results_first_submitted_qc>April 6, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">May 10, 2016</results_first_posted>
  <last_update_submitted>September 14, 2016</last_update_submitted>
  <last_update_submitted_qc>September 14, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 24, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Arthritis</mesh_term>
    <mesh_term>Arthritis, Rheumatoid</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Rheumatoid Arthritis Participants</title>
          <description>Participants with moderate to severe rheumatoid arthritis (RA) according to the American College of Rheumatology (ACR) criteria and the Disease Activity Score Based on 28 Joint Count (DAS28) who were on tocilizumab treatment within 8 weeks prior to start of study received tocilizumab in accordance with the licensed label recommendations, were observed for 6 months. The study was designed as non-interventional, no additional intervention in terms of follow-up visit, complementary examination or medication was required.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="43"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="27"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="16"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="11"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Intent-to-treat (ITT) population included all enrolled participants who received at least one dose of tocilizumab.</population>
      <group_list>
        <group group_id="B1">
          <title>Rheumatoid Arthritis Participants</title>
          <description>Participants with moderate to severe RA according to the ACR criteria and the DAS28 who were on tocilizumab treatment within 8 weeks prior to start of study received tocilizumab in accordance with the licensed label recommendations, were observed for 6 months. The study was designed as non-interventional, no additional intervention in terms of follow-up visit, complementary examination or medication was required.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="43"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="44" lower_limit="18" upper_limit="66"/>
                  </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="31"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants Who Remained on Tocilizumab Treatment at 6 Months After Treatment Initiation</title>
        <time_frame>Month 6</time_frame>
        <population>ITT.</population>
        <group_list>
          <group group_id="O1">
            <title>Rheumatoid Arthritis Participants</title>
            <description>Participants with moderate to severe RA according to the ACR criteria and the DAS28 who were on tocilizumab treatment within 8 weeks prior to start of study received tocilizumab in accordance with the licensed label recommendations, were observed for 6 months. The study was designed as non-interventional, no additional intervention in terms of follow-up visit, complementary examination or medication was required.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Remained on Tocilizumab Treatment at 6 Months After Treatment Initiation</title>
          <population>ITT.</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="43"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="63"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With RA Diagnosis</title>
        <description>Percentage of participants was reported based on the timing RA was diagnosed. Timings included more than 5 years, less than 5 years. Participants with unknown timing were reported under &quot;unknown&quot;.</description>
        <time_frame>Baseline up to Day 5</time_frame>
        <population>ITT.</population>
        <group_list>
          <group group_id="O1">
            <title>Rheumatoid Arthritis Participants</title>
            <description>Participants with moderate to severe RA according to the ACR criteria and the DAS28 who were on tocilizumab treatment within 8 weeks prior to start of study received tocilizumab in accordance with the licensed label recommendations, were observed for 6 months. The study was designed as non-interventional, no additional intervention in terms of follow-up visit, complementary examination or medication was required.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With RA Diagnosis</title>
          <description>Percentage of participants was reported based on the timing RA was diagnosed. Timings included more than 5 years, less than 5 years. Participants with unknown timing were reported under &quot;unknown&quot;.</description>
          <population>ITT.</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="43"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>More than 5 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="39.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Less than 5 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="55.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Unknown</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Different Body Mass Index (BMI)</title>
        <description>BMI was calculated by weight divided by height squared and measured as kilogram per square meter (kg/m^2). BMI from 16 to 18.5 = underweight, BMI from 18.5 to 25= normal weight, BMI from 25 to 30= overweight, BMI from 30 to 40 = obese.</description>
        <time_frame>Baseline up to Day 5</time_frame>
        <population>ITT.</population>
        <group_list>
          <group group_id="O1">
            <title>Rheumatoid Arthritis Participants</title>
            <description>Participants with moderate to severe RA according to the ACR criteria and the DAS28 who were on tocilizumab treatment within 8 weeks prior to start of study received tocilizumab in accordance with the licensed label recommendations, were observed for 6 months. The study was designed as non-interventional, no additional intervention in terms of follow-up visit, complementary examination or medication was required.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Different Body Mass Index (BMI)</title>
          <description>BMI was calculated by weight divided by height squared and measured as kilogram per square meter (kg/m^2). BMI from 16 to 18.5 = underweight, BMI from 18.5 to 25= normal weight, BMI from 25 to 30= overweight, BMI from 30 to 40 = obese.</description>
          <population>ITT.</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="43"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Underweight</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Normal weight</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="39.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Overweight</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Obese</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Rheumatoid Factor Status</title>
        <description>Percentage of participants with rheumatoid factor status was reported as &quot;positive&quot; or &quot;negative&quot;.</description>
        <time_frame>Baseline up to Day 5</time_frame>
        <population>ITT.</population>
        <group_list>
          <group group_id="O1">
            <title>Rheumatoid Arthritis Participants</title>
            <description>Participants with moderate to severe RA according to the ACR criteria and the DAS28 who were on tocilizumab treatment within 8 weeks prior to start of study received tocilizumab in accordance with the licensed label recommendations, were observed for 6 months. The study was designed as non-interventional, no additional intervention in terms of follow-up visit, complementary examination or medication was required.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Rheumatoid Factor Status</title>
          <description>Percentage of participants with rheumatoid factor status was reported as &quot;positive&quot; or &quot;negative&quot;.</description>
          <population>ITT.</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="43"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Positive</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="41.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Negative</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="58.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Anti-Citrullinated Cyclic Peptide (Anti-CCP) Status</title>
        <description>Percentage of participants with anti-CCP status were reported as &quot;positive&quot;, negative&quot; and &quot;unknown&quot;.</description>
        <time_frame>Baseline up to Day 5</time_frame>
        <population>ITT.</population>
        <group_list>
          <group group_id="O1">
            <title>Rheumatoid Arthritis Participants</title>
            <description>Participants with moderate to severe RA according to the ACR criteria and the DAS28 who were on tocilizumab treatment within 8 weeks prior to start of study received tocilizumab in accordance with the licensed label recommendations, were observed for 6 months. The study was designed as non-interventional, no additional intervention in terms of follow-up visit, complementary examination or medication was required.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Anti-Citrullinated Cyclic Peptide (Anti-CCP) Status</title>
          <description>Percentage of participants with anti-CCP status were reported as &quot;positive&quot;, negative&quot; and &quot;unknown&quot;.</description>
          <population>ITT.</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="43"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Positive</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="81.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Negative</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Unknown</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With a Reduction of at Least 2.6 Units in DAS28 From Baseline</title>
        <description>The DAS28 score is a measure of the participants' disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], participant's global assessment (PtGA) of disease activity [visual analog scale (VAS): 0 millimeter (mm)=no disease activity to 100 mm=maximum disease activity] and the erythrocyte sedimentation rate (ESR). DAS28 was calculated using following formulas: DAS28-ESR = 0.56*square root (sqrt) (TJC28) + 0.28*sqrt(SJC28) + 0.70*natural logarithm (ln) (ESR) + 0.014*PtGA of disease activity. A total possible score of 0 to approximately 10, with higher score indicating worse disease activity. A reduction of at least 2.6 units from Baseline in DAS28 was considered as significant clinical improvement.</description>
        <time_frame>Baseline, Month 1, 2, 3, 4, 5, 6</time_frame>
        <population>ITT.</population>
        <group_list>
          <group group_id="O1">
            <title>Rheumatoid Arthritis Participants</title>
            <description>Participants with moderate to severe RA according to the ACR criteria and the DAS28 who were on tocilizumab treatment within 8 weeks prior to start of study received tocilizumab in accordance with the licensed label recommendations, were observed for 6 months. The study was designed as non-interventional, no additional intervention in terms of follow-up visit, complementary examination or medication was required.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With a Reduction of at Least 2.6 Units in DAS28 From Baseline</title>
          <description>The DAS28 score is a measure of the participants' disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], participant's global assessment (PtGA) of disease activity [visual analog scale (VAS): 0 millimeter (mm)=no disease activity to 100 mm=maximum disease activity] and the erythrocyte sedimentation rate (ESR). DAS28 was calculated using following formulas: DAS28-ESR = 0.56*square root (sqrt) (TJC28) + 0.28*sqrt(SJC28) + 0.70*natural logarithm (ln) (ESR) + 0.014*PtGA of disease activity. A total possible score of 0 to approximately 10, with higher score indicating worse disease activity. A reduction of at least 2.6 units from Baseline in DAS28 was considered as significant clinical improvement.</description>
          <population>ITT.</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="43"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Month 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="41.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 5</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="55.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="63"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Achieving a Response According to European League Against Rheumatism (EULAR) Criteria</title>
        <description>Response was determined using EULAR criteria based upon DAS28 absolute scores at the assessment visit and the DAS28 improvement from Baseline. Participants with a score less than or equal to (≤) 3.2 and DAS28 improvement of greater than (&gt;) 1.2 points were assessed as having a 'good' response. Participants with a score ≤3.2 and DAS28 improvement of &gt;0.6 to ≤1.2 points, score of &gt;3.2 and ≤5.1 with DAS28 improvement of &gt;0.6 to ≤1.2 points, score of &gt;3.2 and ≤5.1 with DAS28 improvement of &gt;1.2 points, score of &gt;5.1 and DAS28 improvement of &gt;1.2 points were assessed as having a 'moderate' response. Participants with a score ≤3.2 and DAS28 improvement of ≤ 0.6 points, score of &gt;3.2 and ≤5.1 with DAS28 improvement of ≤ 0.6 points, score of &gt;5.1 and DAS28 improvement of &gt;0.6 to ≤1.2 points, score of &gt;5.1 and DAS28 improvement of ≤ 0.6 points were assessed as having a 'no' response.</description>
        <time_frame>Baseline up to Month 6</time_frame>
        <population>ITT.</population>
        <group_list>
          <group group_id="O1">
            <title>Rheumatoid Arthritis Participants</title>
            <description>Participants with moderate to severe RA according to the ACR criteria and the DAS28 who were on tocilizumab treatment within 8 weeks prior to start of study received tocilizumab in accordance with the licensed label recommendations, were observed for 6 months. The study was designed as non-interventional, no additional intervention in terms of follow-up visit, complementary examination or medication was required.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Achieving a Response According to European League Against Rheumatism (EULAR) Criteria</title>
          <description>Response was determined using EULAR criteria based upon DAS28 absolute scores at the assessment visit and the DAS28 improvement from Baseline. Participants with a score less than or equal to (≤) 3.2 and DAS28 improvement of greater than (&gt;) 1.2 points were assessed as having a 'good' response. Participants with a score ≤3.2 and DAS28 improvement of &gt;0.6 to ≤1.2 points, score of &gt;3.2 and ≤5.1 with DAS28 improvement of &gt;0.6 to ≤1.2 points, score of &gt;3.2 and ≤5.1 with DAS28 improvement of &gt;1.2 points, score of &gt;5.1 and DAS28 improvement of &gt;1.2 points were assessed as having a 'moderate' response. Participants with a score ≤3.2 and DAS28 improvement of ≤ 0.6 points, score of &gt;3.2 and ≤5.1 with DAS28 improvement of ≤ 0.6 points, score of &gt;5.1 and DAS28 improvement of &gt;0.6 to ≤1.2 points, score of &gt;5.1 and DAS28 improvement of ≤ 0.6 points were assessed as having a 'no' response.</description>
          <population>ITT.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="43"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Good response</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Moderate response</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No response</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Different Types of Simplified Disease Activity Index (SDAI)</title>
        <description>The SDAI was calculated as [SJC (28 joints) + TJC (28 joints) + VAS patient global assessment of disease activity + VAS physician global assessment of disease activity+CRP level(milligram/deciliter {mg/dL})]. VAS assessments: 0 centimeters (cm)=no disease activity to 10 cm=maximum disease activity'. Scores ranged from 0 to 86, with higher scores also indicating increased disease activity. SDAI score ≤ 3.3 is 'remission', score &gt; 3.3 and ≤ 11 is 'low disease activity', score &gt; 11 and ≤ 26 is 'moderate disease activity', score &gt; 26 is 'high disease activity'. SDAI was reported as 'not available' for participants with no data on physical/patient global assessment of disease activity.</description>
        <time_frame>Baseline up to Month 6</time_frame>
        <population>ITT.</population>
        <group_list>
          <group group_id="O1">
            <title>Rheumatoid Arthritis Participants</title>
            <description>Participants with moderate to severe RA according to the ACR criteria and the DAS28 who were on tocilizumab treatment within 8 weeks prior to start of study received tocilizumab in accordance with the licensed label recommendations, were observed for 6 months. The study was designed as non-interventional, no additional intervention in terms of follow-up visit, complementary examination or medication was required.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Different Types of Simplified Disease Activity Index (SDAI)</title>
          <description>The SDAI was calculated as [SJC (28 joints) + TJC (28 joints) + VAS patient global assessment of disease activity + VAS physician global assessment of disease activity+CRP level(milligram/deciliter {mg/dL})]. VAS assessments: 0 centimeters (cm)=no disease activity to 10 cm=maximum disease activity'. Scores ranged from 0 to 86, with higher scores also indicating increased disease activity. SDAI score ≤ 3.3 is 'remission', score &gt; 3.3 and ≤ 11 is 'low disease activity', score &gt; 11 and ≤ 26 is 'moderate disease activity', score &gt; 26 is 'high disease activity'. SDAI was reported as 'not available' for participants with no data on physical/patient global assessment of disease activity.</description>
          <population>ITT.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="43"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Remission</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Low disease activity</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Moderate disease activity</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>High disease activity</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Not available</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Different Types of Clinical Disease Activity Index (CDAI)</title>
        <description>The CDAI was calculated as [SJC (28 joints) + TJC (28 joints) + VAS patient global assessment of disease activity + VAS physician global assessment of disease activity]. VAS assessments: 0 cm =no disease activity to 100 cm=maximum disease activity'. CDAI scores ranged from 0 to 76, with higher scores indicating increased disease activity. CDAI score ≤ 2.8 is 'remission', score &gt; 2.8 and ≤ 10 is 'low disease activity', score &gt; 10 and ≤ 22 is 'moderate disease activity', score &gt; 22 is 'high disease activity'. CDAI was reported as 'not available' for participants with no data on physical/patient global assessment of disease activity.</description>
        <time_frame>Baseline up to Month 6</time_frame>
        <population>ITT.</population>
        <group_list>
          <group group_id="O1">
            <title>Rheumatoid Arthritis Participants</title>
            <description>Participants with moderate to severe RA according to the ACR criteria and the DAS28 who were on tocilizumab treatment within 8 weeks prior to start of study received tocilizumab in accordance with the licensed label recommendations, were observed for 6 months. The study was designed as non-interventional, no additional intervention in terms of follow-up visit, complementary examination or medication was required.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Different Types of Clinical Disease Activity Index (CDAI)</title>
          <description>The CDAI was calculated as [SJC (28 joints) + TJC (28 joints) + VAS patient global assessment of disease activity + VAS physician global assessment of disease activity]. VAS assessments: 0 cm =no disease activity to 100 cm=maximum disease activity'. CDAI scores ranged from 0 to 76, with higher scores indicating increased disease activity. CDAI score ≤ 2.8 is 'remission', score &gt; 2.8 and ≤ 10 is 'low disease activity', score &gt; 10 and ≤ 22 is 'moderate disease activity', score &gt; 22 is 'high disease activity'. CDAI was reported as 'not available' for participants with no data on physical/patient global assessment of disease activity.</description>
          <population>ITT.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="43"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Remission</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Low disease activity</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Moderate disease activity</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>High disease activity</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Not available</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Achieving a Response According to ACR Criteria</title>
        <description>ACR20/50/70 percent (%) response is defined as a ≥ 20%/50%/70% improvement (reduction) compared with baseline for both TJC28 and SJC28, as well as for three of the additional five ACR core set variables: Participant's assessment of pain over the previous 24 hours: using a VAS, left end of the line 0 cm=no pain to right end of the line 10 cm=unbearable pain; Patient's global assessment of disease activity and physician's global assessment of disease activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; health assessment questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant [either C-reactive protein or erythrocyte sedimentation rate].</description>
        <time_frame>Month 1, 2, 3, 4, 5, 6</time_frame>
        <population>ITT.</population>
        <group_list>
          <group group_id="O1">
            <title>Rheumatoid Arthritis Participants</title>
            <description>Participants with moderate to severe RA according to the ACR criteria and the DAS28 who were on tocilizumab treatment within 8 weeks prior to start of study received tocilizumab in accordance with the licensed label recommendations, were observed for 6 months. The study was designed as non-interventional, no additional intervention in terms of follow-up visit, complementary examination or medication was required.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving a Response According to ACR Criteria</title>
          <description>ACR20/50/70 percent (%) response is defined as a ≥ 20%/50%/70% improvement (reduction) compared with baseline for both TJC28 and SJC28, as well as for three of the additional five ACR core set variables: Participant's assessment of pain over the previous 24 hours: using a VAS, left end of the line 0 cm=no pain to right end of the line 10 cm=unbearable pain; Patient's global assessment of disease activity and physician's global assessment of disease activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; health assessment questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant [either C-reactive protein or erythrocyte sedimentation rate].</description>
          <population>ITT.</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="43"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>ACR20: Month 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ACR20: Month 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="48.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ACR20: Month 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="65.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ACR20: Month 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="75.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ACR20: Month 5</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="84.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ACR20: Month 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="84.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ACR50: Month 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ACR50: Month 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ACR50: Month 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ACR50: Month 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="61.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ACR50: Month 5</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="63.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ACR50: Month 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="65.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ACR70: Month 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ACR70: Month 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ACR70: Month 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ACR70: Month 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ACR70: Month 5</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="48.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ACR70: Month 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="53.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Reduction/Withdrawal of Disease-modifying Anti-rheumatic Drugs (DMARDs) and/or Corticosteroids</title>
        <description>Participants with reduction/withdrawal of DMARDs and corticosteroids at baseline (before trial period) and up to Month 6 (during trial period) were reported.</description>
        <time_frame>Baseline, up to Month 6</time_frame>
        <population>ITT.</population>
        <group_list>
          <group group_id="O1">
            <title>Rheumatoid Arthritis Participants</title>
            <description>Participants with moderate to severe RA according to the ACR criteria and the DAS28 who were on tocilizumab treatment within 8 weeks prior to start of study received tocilizumab in accordance with the licensed label recommendations, were observed for 6 months. The study was designed as non-interventional, no additional intervention in terms of follow-up visit, complementary examination or medication was required.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Reduction/Withdrawal of Disease-modifying Anti-rheumatic Drugs (DMARDs) and/or Corticosteroids</title>
          <description>Participants with reduction/withdrawal of DMARDs and corticosteroids at baseline (before trial period) and up to Month 6 (during trial period) were reported.</description>
          <population>ITT.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="43"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>DMARDS: Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>DMARDS: up to Month 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Corticosteroid: Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Corticosteroid: up to Month 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Physician Global Assessment of Disease Activity at Months 3 and 6</title>
        <description>Physician's global assessment of disease activity over the previous 24 hours was assessed using a VAS where left end of the line 0 mm=no disease activity to right end of the line 100 mm=maximum disease activity.</description>
        <time_frame>Baseline, Months 3, 6</time_frame>
        <population>ITT. Here &quot;number of participants analyzed&quot; included evaluable participants for the outcome measure and &quot;n&quot; included evaluable participants at specified time point.</population>
        <group_list>
          <group group_id="O1">
            <title>Rheumatoid Arthritis Participants</title>
            <description>Participants with moderate to severe RA according to the ACR criteria and the DAS28 who were on tocilizumab treatment within 8 weeks prior to start of study received tocilizumab in accordance with the licensed label recommendations, were observed for 6 months. The study was designed as non-interventional, no additional intervention in terms of follow-up visit, complementary examination or medication was required.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Physician Global Assessment of Disease Activity at Months 3 and 6</title>
          <description>Physician's global assessment of disease activity over the previous 24 hours was assessed using a VAS where left end of the line 0 mm=no disease activity to right end of the line 100 mm=maximum disease activity.</description>
          <population>ITT. Here &quot;number of participants analyzed&quot; included evaluable participants for the outcome measure and &quot;n&quot; included evaluable participants at specified time point.</population>
          <units>mm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="36"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Month 3 (n=36)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-29" spread="3.11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6 (n=0)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" spread="NA">Data was not reported as there were no evaluable participants for this time point.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Tocilizumab Dose Modifications</title>
        <time_frame>Baseline up to Month 6</time_frame>
        <population>ITT.</population>
        <group_list>
          <group group_id="O1">
            <title>Rheumatoid Arthritis Participants</title>
            <description>Participants with moderate to severe RA according to the ACR criteria and the DAS28 who were on tocilizumab treatment within 8 weeks prior to start of study received tocilizumab in accordance with the licensed label recommendations, were observed for 6 months. The study was designed as non-interventional, no additional intervention in terms of follow-up visit, complementary examination or medication was required.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Tocilizumab Dose Modifications</title>
          <population>ITT.</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="43"/>
              </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_list>

    <reported_events>
      <time_frame>Baseline up to Month 6</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Rheumatoid Arthritis Participants</title>
          <description>Participants with moderate to severe RA and the DAS28 joint scores who were on tocilizumab treatment within 8 weeks prior to start of study received tocilizumab in accordance with the licensed label recommendations, were observed for 6 months. The study was designed as non-interventional, no additional intervention in terms of follow-up visit, complementary examination or medication was required.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>No coding</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="14" subjects_at_risk="43"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Arrhythmia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="43"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diarrhea</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="43"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="43"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="43"/>
              </event>
              <event>
                <sub_title>Gastropathy</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="43"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Febris</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="43"/>
              </event>
              <event>
                <sub_title>Severe pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="43"/>
              </event>
              <event>
                <sub_title>Dry Gangrene</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="43"/>
              </event>
              <event>
                <sub_title>Left below knee lower limb amputation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="43"/>
              </event>
              <event>
                <sub_title>Severe breakthrough back pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="43"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="43"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Popliteal artery thrombosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="43"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>No coding</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="43"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Neutropenia</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="43"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

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


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01670045
org study id: ML28216
nct id: NCT01670045
lead sponsor: 
This multi-center observational study will evaluate the use and efficacy of RoActemra/Actemra
      (tocilizumab) in patients with moderate to severe rheumatoid arthritis. Eligible patients
      initiated on RoActemra/Actemra treatment according to the licensed label will be followed for
      6 months.
observational model: Cohort
time perspective: Prospective
measure: Percentage of Participants Who Remained on Tocilizumab Treatment at 6 Months After Treatment Initiation
time frame: Month 6
measure: Percentage of Participants With RA Diagnosis
time frame: Baseline up to Day 5
description: Percentage of participants was reported based on the timing RA was diagnosed. Timings included more than 5 years, less than 5 years. Participants with unknown timing were reported under "unknown".
measure: Percentage of Participants With Different Body Mass Index (BMI)
time frame: Baseline up to Day 5
description: BMI was calculated by weight divided by height squared and measured as kilogram per square meter (kg/m^2). BMI from 16 to 18.5 = underweight, BMI from 18.5 to 25= normal weight, BMI from 25 to 30= overweight, BMI from 30 to 40 = obese.
measure: Percentage of Participants With Rheumatoid Factor Status
time frame: Baseline up to Day 5
description: Percentage of participants with rheumatoid factor status was reported as "positive" or "negative".
measure: Percentage of Participants With Anti-Citrullinated Cyclic Peptide (Anti-CCP) Status
time frame: Baseline up to Day 5
description: Percentage of participants with anti-CCP status were reported as "positive", negative" and "unknown".
measure: Percentage of Participants With a Reduction of at Least 2.6 Units in DAS28 From Baseline
time frame: Baseline, Month 1, 2, 3, 4, 5, 6
description: The DAS28 score is a measure of the participants' disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], participant's global assessment (PtGA) of disease activity [visual analog scale (VAS): 0 millimeter (mm)=no disease activity to 100 mm=maximum disease activity] and the erythrocyte sedimentation rate (ESR). DAS28 was calculated using following formulas: DAS28-ESR = 0.56*square root (sqrt) (TJC28) + 0.28*sqrt(SJC28) + 0.70*natural logarithm (ln) (ESR) + 0.014*PtGA of disease activity. A total possible score of 0 to approximately 10, with higher score indicating worse disease activity. A reduction of at least 2.6 units from Baseline in DAS28 was considered as significant clinical improvement.
measure: Number of Participants Achieving a Response According to European League Against Rheumatism (EULAR) Criteria
time frame: Baseline up to Month 6
description: Response was determined using EULAR criteria based upon DAS28 absolute scores at the assessment visit and the DAS28 improvement from Baseline. Participants with a score less than or equal to (≤) 3.2 and DAS28 improvement of greater than (>) 1.2 points were assessed as having a 'good' response. Participants with a score ≤3.2 and DAS28 improvement of >0.6 to ≤1.2 points, score of >3.2 and ≤5.1 with DAS28 improvement of >0.6 to ≤1.2 points, score of >3.2 and ≤5.1 with DAS28 improvement of >1.2 points, score of >5.1 and DAS28 improvement of >1.2 points were assessed as having a 'moderate' response. Participants with a score ≤3.2 and DAS28 improvement of ≤ 0.6 points, score of >3.2 and ≤5.1 with DAS28 improvement of ≤ 0.6 points, score of >5.1 and DAS28 improvement of >0.6 to ≤1.2 points, score of >5.1 and DAS28 improvement of ≤ 0.6 points were assessed as having a 'no' response.
measure: Number of Participants With Different Types of Simplified Disease Activity Index (SDAI)
time frame: Baseline up to Month 6
description: The SDAI was calculated as [SJC (28 joints) + TJC (28 joints) + VAS patient global assessment of disease activity + VAS physician global assessment of disease activity+CRP level(milligram/deciliter {mg/dL})]. VAS assessments: 0 centimeters (cm)=no disease activity to 10 cm=maximum disease activity'. Scores ranged from 0 to 86, with higher scores also indicating increased disease activity. SDAI score ≤ 3.3 is 'remission', score > 3.3 and ≤ 11 is 'low disease activity', score > 11 and ≤ 26 is 'moderate disease activity', score > 26 is 'high disease activity'. SDAI was reported as 'not available' for participants with no data on physical/patient global assessment of disease activity.
measure: Number of Participants With Different Types of Clinical Disease Activity Index (CDAI)
time frame: Baseline up to Month 6
description: The CDAI was calculated as [SJC (28 joints) + TJC (28 joints) + VAS patient global assessment of disease activity + VAS physician global assessment of disease activity]. VAS assessments: 0 cm =no disease activity to 100 cm=maximum disease activity'. CDAI scores ranged from 0 to 76, with higher scores indicating increased disease activity. CDAI score ≤ 2.8 is 'remission', score > 2.8 and ≤ 10 is 'low disease activity', score > 10 and ≤ 22 is 'moderate disease activity', score > 22 is 'high disease activity'. CDAI was reported as 'not available' for participants with no data on physical/patient global assessment of disease activity.
measure: Percentage of Participants Achieving a Response According to ACR Criteria
time frame: Month 1, 2, 3, 4, 5, 6
description: ACR20/50/70 percent (%) response is defined as a ≥ 20%/50%/70% improvement (reduction) compared with baseline for both TJC28 and SJC28, as well as for three of the additional five ACR core set variables: Participant's assessment of pain over the previous 24 hours: using a VAS, left end of the line 0 cm=no pain to right end of the line 10 cm=unbearable pain; Patient's global assessment of disease activity and physician's global assessment of disease activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; health assessment questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant [either C-reactive protein or erythrocyte sedimentation rate].
measure: Number of Participants With Reduction/Withdrawal of Disease-modifying Anti-rheumatic Drugs (DMARDs) and/or Corticosteroids
time frame: Baseline, up to Month 6
description: Participants with reduction/withdrawal of DMARDs and corticosteroids at baseline (before trial period) and up to Month 6 (during trial period) were reported.
measure: Change From Baseline in Physician Global Assessment of Disease Activity at Months 3 and 6
time frame: Baseline, Months 3, 6
description: Physician's global assessment of disease activity over the previous 24 hours was assessed using a VAS where left end of the line 0 mm=no disease activity to right end of the line 100 mm=maximum disease activity.
measure: Percentage of Participants With Tocilizumab Dose Modifications
time frame: Baseline up to Month 6
arm group label: Rheumatoid Arthritis Participants
description: Participants with moderate to severe rheumatoid arthritis (RA) according to the American College of Rheumatology (ACR) criteria and the Disease Activity Score based on 28 Joint Count (DAS28) who were on tocilizumab treatment within 8 weeks prior to start of study will receive tocilizumab in accordance with the licensed label recommendations, and will be observed for 6 months. The study is designed as non-interventional, no additional intervention in terms of follow-up visit, complementary examination or medication is required.
intervention type: Drug
intervention name: Tocilizumab
description: Tocilizumab in accordance with the licensed label recommendation.
arm group label: Rheumatoid Arthritis Participants
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: 
country: Indonesia
country: Greece
responsible party type: Sponsor
mesh term: Arthritis
mesh term: Arthritis, Rheumatoid
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 