<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/NCT01669902</url>
  </required_header>
  <id_info>
    <org_study_id>ML28247</org_study_id>
    <nct_id>NCT01669902</nct_id>
  </id_info>
  <brief_title>An Observational Study of RoActemra/Actemra (Tocilizumab) in Monotherapy in Patients With Rheumatoid Arthritis</brief_title>
  <official_title>HAQIMONO a Non-interventional National Multicenter Study, Observing RA Patients Treated With Tocilizumab in Mono-therapy, i.e. Without Combination With DMARD</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 multicenter observational study will evaluate the use of RoActemra/Actemra (tocilizumab)&#xD;
      in monotherapy in patients with active moderate to severe rheumatoid arthritis unable to use&#xD;
      methotrexate. Eligible patients initiated on RoActemra/Actemra treatment will be followed for&#xD;
      6 months.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>April 2012</start_date>
  <completion_date type="Actual">September 2014</completion_date>
  <primary_completion_date type="Actual">September 2014</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Participants on Tocilizumab Treatment at Month 6</measure>
    <time_frame>Month 6</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Dose Modifications of Tocilizumab</measure>
    <time_frame>Baseline to Month 6</time_frame>
    <description>Dose modification is any change in dose; this also included participants who stopped treatment with tocilizumab.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Swollen Joint Count (SJC)</measure>
    <time_frame>Baseline, Month 3, Month 6</time_frame>
    <description>Number of swollen joints was determined by examination of 28 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, no swelling = 0, swelling =1; total was calculated by adding all the joints for a maximum score of 28. A reduction in number of swollen joints compared to baseline indicates improvement.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tender Joint Count (TJC)</measure>
    <time_frame>Baseline, Month 3, Month 6</time_frame>
    <description>Number of tender joints was determined by examining 28 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at each visit, no tenderness = 0, tenderness = 1; total was calculated by adding all the joints for a maximum score of 28. A reduction in number of tender joints compared to baseline indicates improvement.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (4 Variables) (DAS28-4 [CRP])</measure>
    <time_frame>Baseline, Month 3, Month 6</time_frame>
    <description>DAS28-4 (CRP) was calculated from the SJC and TJC using the 28 joints count, CRP (milligram per liter [mg/L]) and patient global assessment (PtGA) of disease activity (measured on a 0 to 100 millimeter [mm] Visual Analog Scale [VAS]) where 0=no disease activity and 100=worst disease activity). DAS28-4 (CRP) was calculated using the following formula: DAS28-4 (CRP) = 0.56*square root (sqrt) (TJC28) + 0.28*sqrt(SJC28) + 0.36*ln(CRP+1) + 0.014*PtGA + 0.96. Total score range: 0 to 10, higher score indicated more disease activity. DAS28-4 (CRP) less than or equal to (&lt;= 3.2) implied low disease activity and greater than (&gt;) 3.2 to 5.1 implied moderate to high disease activity, and DAS28-4 (CRP) less than (&lt;) 2.6 = clinical remission.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Achieving Clinical Remission Based on DAS28-4 (CRP)</measure>
    <time_frame>Month 3 and Month 6</time_frame>
    <description>DAS28-4 (CRP) was calculated from the SJC and TJC using the 28 joints count, CRP (mg/L) and PtGA of disease activity (measured on a 0 to 100 mm VAS where 0=no disease activity and 100=worst disease activity). DAS28-4 (CRP) was calculated using the following formula: DAS28-4 (CRP) = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.36*ln(CRP+1) + 0.014*PtGA + 0.96. Total score range: 0 to 10, higher score indicated more disease activity. DAS28-4 (CRP) &lt;= 3.2 implied low disease activity and &gt; 3.2 to 5.1 implied moderate to high disease activity, and DAS28-4 (CRP) &lt; 2.6 = clinical remission.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR])</measure>
    <time_frame>Baseline, Month 3, Month 6</time_frame>
    <description>DAS28-4 (ESR) was calculated from SJC and TJC using 28 joints count, ESR (millimeter per hour [mm/hour]), and PtGA of disease activity (measured on a 0 to 100 mm VAS where 0=no disease activity and 100=worst disease activity). DAS28-4 (ESR) = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.70*ln(ESR) + 0.014*PtGA. Total score range: 0-10, higher score=more disease activity. DAS28-4 (ESR) &lt;= 3.2 implied low disease activity and &gt;3.2 to 5.1 implied moderate to high disease activity, and DAS28-4 (ESR) &lt;2.6 = clinical remission.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Achieving Clinical Remission Based on DAS28-4 (ESR)</measure>
    <time_frame>Month 3 and Month 6</time_frame>
    <description>DAS28-4 (ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hour), and PtGA of disease activity (measured on a 0 to 100 mm VAS where 0=no disease activity and 100=worst disease activity). DAS28-4 (ESR) = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.70*ln(ESR) + 0.014*PtGA. Total score range: 0-10, higher score=more disease activity. DAS28-4 (ESR) &lt;= 3.2 implied low disease activity and &gt;3.2 to 5.1 implied moderate to high disease activity, and DAS28-4 (ESR) &lt;2.6 = clinical remission.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With European League Against Rheumatism (EULAR) Response Based on DAS28-4 (CRP)</measure>
    <time_frame>Month 3 and Month 6</time_frame>
    <description>The DAS28-4 (CRP) [described in Outcome Measure 5] based EULAR response criteria were used to measure individual response as good, moderate, or no response depending on the extent of change from baseline in DAS28 score and the level of disease activity (low, moderate or high) reached. Good responders: change from baseline &gt;1.2 with DAS28 &lt;= 3.2; moderate responders: change from baseline &gt;1.2 with DAS28 in the range of &gt;3.2 to &lt;=5.1 or change from baseline in the range of &gt;0.6 to &lt;=1.2 with DAS28 in the range of &gt;3.2 to &lt;=5.1 or change from baseline &gt;1.2 with DAS28 &gt;5.1 or change from baseline in the range of &gt;0.6 to &lt;=1.2 with DAS28 &lt;=3.2; non-responders: change from baseline &lt;= 0.6 or change from baseline in the range of &gt;0.6 to &lt;=1.2 with DAS28 &gt;5.1 or change from baseline &lt;=0.6 with DAS28 &lt;=3.2 or in the range of &gt;3.2 to &lt;=5.1.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With EULAR Response Based on DAS28-4 (ESR)</measure>
    <time_frame>Month 3 and Month 6</time_frame>
    <description>The DAS28-4 (ESR) [described in Outcome Measure 7] based EULAR response criteria were used to measure individual response as good, moderate, or no response depending on the extent of change from baseline in DAS28 score and the level of disease activity (low, moderate or high) reached. Good responders: change from baseline &gt;1.2 with DAS28 &lt;= 3.2; moderate responders: change from baseline &gt;1.2 with DAS28 in the range of &gt;3.2 to &lt;=5.1 or change from baseline in the range of &gt;0.6 to &lt;=1.2 with DAS28 in the range of &gt;3.2 to &lt;=5.1 or change from baseline &gt;1.2 with DAS28 &gt;5.1 or change from baseline in the range of &gt;0.6 to &lt;=1.2 with DAS28 &lt;=3.2; non-responders: change from baseline &lt;= 0.6 or change from baseline in the range of &gt;0.6 to &lt;=1.2 with DAS28 &gt;5.1 or change from baseline &lt;=0.6 with DAS28 &lt;=3.2 or in the range of &gt;3.2 to &lt;=5.1.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Simplified Disease Activity Index (SDAI)</measure>
    <time_frame>Baseline, Month 3, Month 6</time_frame>
    <description>The SDAI is the numerical sum of five outcome parameters: TJC and SJC based on a 28-joint assessment, PtGA and physician global assessment (PGA) assessed on 0-10 centimeter (cm) VAS; 0 = no disease activity and 10 = worst disease activity, and CRP (mg/dL). SDAI total score = 0-86. SDAI &lt;=3.3 indicates clinical remission, &gt;3.4 to 11 = low disease activity, &gt;11 to 26 = moderate disease activity, and &gt;26 = high (or severe) disease activity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Achieving Clinical Remission Based on SDAI</measure>
    <time_frame>Month 3 and Month 6</time_frame>
    <description>The SDAI is the numerical sum of five outcome parameters: TJC and SJC based on a 28-joint assessment, PtGA and PGA assessed on 0-10 cm VAS; 0 = no disease activity and 10 = worst disease activity, and CRP (mg/dL). SDAI total score = 0-86. SDAI &lt;=3.3 indicates clinical remission, &gt;3.4 to 11 = low disease activity, &gt;11 to 26 = moderate disease activity, and &gt;26 = high (or severe) disease activity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical Disease Activity Index (CDAI)</measure>
    <time_frame>Baseline, Month 3, Month 6</time_frame>
    <description>The CDAI is the numerical sum of 4 outcome parameters: TJC and SJC based on a 28-joint assessment, PtGA and PGA 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 Achieving Clinical Remission Based on CDAI</measure>
    <time_frame>Month 3 and Month 6</time_frame>
    <description>The CDAI is the numerical sum of 4 outcome parameters: TJC and SJC based on a 28-joint assessment, PtGA and PGA 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>Number of Participants With an American College of Rheumatology (ACR) Response</measure>
    <time_frame>Baseline to Month 6</time_frame>
    <description>ACR response: improvement in tender or swollen joint counts and improvement in 3 of the following 5 criteria: 1) PGA of disease activity, 2) PtGA of disease activity, 3) patient's assessment of pain, 4) patient's assessment of functional disability via a health assessment questionnaire, and 5) CRP at each visit. ACR response is based on 66/68 total joint count.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Global Assessment (PtGA) of Disease Activity Score</measure>
    <time_frame>Baseline, Month 3, Month 6</time_frame>
    <description>Patient Global Assessment of Disease Activity was measured on a 0 to 100 mm VAS where 0=no disease activity and 100=worst disease activity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physician Global Assessment (PGA) of Disease Activity</measure>
    <time_frame>Baseline, Month 3, Month 6</time_frame>
    <description>Physician Global Assessment of Disease Activity was measured on a 0 to 100 mm VAS where 0=no disease activity and 100=worst disease activity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants in a PGA of Disease Activity Score Category</measure>
    <time_frame>Baseline, Month 3, Month 6</time_frame>
    <description>A categorical scale (Lickert scale) with the following categories: none, mild, moderate, severe and maximal was used to evaluate disease activity in clinical practice.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Global Assessment of Pain</measure>
    <time_frame>Baseline, Month 3, Month 6</time_frame>
    <description>Patient Global Assessment of Pain was assessed using a 100 mm VAS (0 to 100) where 0 = no pain to 100 = worst possible pain.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Morning Stiffness</measure>
    <time_frame>Baseline, Month 3, Month 6</time_frame>
    <description>The percentage of participants with morning stiffness (&quot;yes&quot;, &quot;no&quot;, or &quot;do not know&quot;) was assessed at each visit.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Duration of Morning Stiffness</measure>
    <time_frame>Baseline, Month 3, Month 6</time_frame>
    <description>Duration of morning stiffness was defined as the time elapsed when participant woke up in the morning and was able to resume normal activities without stiffness. Duration was recorded as less than (&lt;) 30 minutes, 30 to 60 minutes, 60 to 120 minutes, 120 to 240 minutes, more than (&gt;) 240 minutes, or whole day.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Months 3 and 6</measure>
    <time_frame>Baseline, Month 3 and Month 6</time_frame>
    <description>HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Concomitant Corticosteroids Treatment</measure>
    <time_frame>Baseline to Month 6</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Use of Disease-Modifying Anti-Rheumatic Drugs (DMARDs) During the Study</measure>
    <time_frame>Baseline to Month 6</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">107</enrollment>
  <condition>Rheumatoid Arthritis</condition>
  <arm_group>
    <arm_group_label>Cohort</arm_group_label>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with active moderate to severe rheumatoid arthritis unable to use methotrexate&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patients, &gt;/= 18 years of age&#xD;
&#xD;
          -  Moderate to severe rheumatoid arthritis according to the revised (1987) ACR criteria&#xD;
&#xD;
          -  Patients who for any reason do not take methotrexate and for whom the treating&#xD;
             physician has made a decision to prescribe RoActemra/Actemra as monotherapy; patients&#xD;
             who commenced RoActemra/Actemra as monotherapy within 8 weeks prior to the enrolment&#xD;
             visit may be included&#xD;
&#xD;
          -  Concomitant treatment with non-steroidal anti-inflammatory drug (NSAID) or&#xD;
             corticosteroids (orally or intra-articularly) is allowed&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who have received RoActemra/Actemra more than 8 weeks prior to enrolment&#xD;
             visit&#xD;
&#xD;
          -  Previous RoActemra/Actemra treatment in a clinical trial or for compassionate use&#xD;
&#xD;
          -  Concomitant DMARD treatment for rheumatoid arthritis (e.g. hyroxychloroquine,&#xD;
             sulfasalazine, methotrexate, leflunomide, gold compounds, cyclosporine)&#xD;
&#xD;
          -  Treatment with any investigational agent within 4 weeks (or 5 half-lives of&#xD;
             investigational agent, whichever is longer) before starting RoActemra/Actemra&#xD;
             treatment&#xD;
&#xD;
          -  History of autoimmune disease or any joint inflammatory disease other than rheumatoid&#xD;
             arthritis&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Clinical Trials</last_name>
    <role>Study Director</role>
    <affiliation>Hoffmann-La Roche</affiliation>
  </overall_official>
  <location>
    <facility>
      <address>
        <city>Esbjerg</city>
        <zip>6700</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Holbæk</city>
        <zip>4300</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Kolding</city>
        <zip>6000</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Køge</city>
        <zip>4600</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Svendborg</city>
        <zip>5700</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Vejle</city>
        <zip>7100</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Bergen</city>
        <zip>5053</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Gjettum</city>
        <zip>1346</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Moss</city>
        <zip>1535</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Skien</city>
        <zip>3722</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Trondheim</city>
        <zip>7030</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Falun</city>
        <zip>SE-791 82</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Farsta</city>
        <zip>541 85</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Goteborg</city>
        <zip>413 45</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Helsingborg</city>
        <zip>251 87</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Hudiksvall</city>
        <zip>824 81</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Jönköping</city>
        <zip>551 85</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Karlskrona</city>
        <zip>37185</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Karlstad</city>
        <zip>65185</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Kristianstad</city>
        <zip>29185</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Malmo</city>
        <zip>205 02</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Simrishamn</city>
        <zip>272 81</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Skoevde</city>
        <zip>54185</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Trelleborg</city>
        <zip>231 85</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Uppsala</city>
        <zip>75185</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Västerås</city>
        <zip>72189</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
    <country>Norway</country>
    <country>Sweden</country>
  </location_countries>
  <removed_countries>
    <country>United States</country>
  </removed_countries>
  <verification_date>October 2015</verification_date>
  <study_first_submitted>August 13, 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>October 21, 2015</results_first_submitted>
  <results_first_submitted_qc>October 21, 2015</results_first_submitted_qc>
  <results_first_posted type="Estimate">November 23, 2015</results_first_posted>
  <last_update_submitted>October 21, 2015</last_update_submitted>
  <last_update_submitted_qc>October 21, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 23, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Arthritis</mesh_term>
    <mesh_term>Arthritis, Rheumatoid</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Tocilizumab</title>
          <description>Participants with rheumatoid arthritis who were considered for or treated with tocilizumab monotherapy within the clinical routine were observed for a period of 6 months.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="107"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="78"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="29"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="11"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lack of Efficacy</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Safety Analysis Set included all data from all participants who received at least one injection with tocilizumab.</population>
      <group_list>
        <group group_id="B1">
          <title>Tocilizumab</title>
          <description>Participants with rheumatoid arthritis who were considered for or treated with tocilizumab monotherapy within the clinical routine were observed for a period of 6 months.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="107"/>
          </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="56.6" spread="13.3"/>
                  </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="84"/>
                  </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</title>
        <time_frame>Month 6</time_frame>
        <population>Safety Analysis Set</population>
        <group_list>
          <group group_id="O1">
            <title>Tocilizumab</title>
            <description>Participants with rheumatoid arthritis who were considered for or treated with tocilizumab monotherapy within the clinical routine were observed for a period of 6 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants on Tocilizumab Treatment at Month 6</title>
          <population>Safety Analysis Set</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="107"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="76.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Dose Modifications of Tocilizumab</title>
        <description>Dose modification is any change in dose; this also included participants who stopped treatment with tocilizumab.</description>
        <time_frame>Baseline to Month 6</time_frame>
        <population>Safety Analysis Set</population>
        <group_list>
          <group group_id="O1">
            <title>Tocilizumab</title>
            <description>Participants with rheumatoid arthritis who were considered for or treated with tocilizumab monotherapy within the clinical routine were observed for a period of 6 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Dose Modifications of Tocilizumab</title>
          <description>Dose modification is any change in dose; this also included participants who stopped treatment with tocilizumab.</description>
          <population>Safety Analysis Set</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="107"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="36.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Swollen Joint Count (SJC)</title>
        <description>Number of swollen joints was determined by examination of 28 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, no swelling = 0, swelling =1; total was calculated by adding all the joints for a maximum score of 28. A reduction in number of swollen joints compared to baseline indicates improvement.</description>
        <time_frame>Baseline, Month 3, Month 6</time_frame>
        <population>The Full Analysis Set (FAS) (swollen joint counts) included all data from all participants who had at least a baseline value and one follow up value (Month 3 or Month 6) for swollen joints. n = participants evaluable for this measure at specified timepoint.</population>
        <group_list>
          <group group_id="O1">
            <title>Tocilizumab</title>
            <description>Participants with rheumatoid arthritis who were considered for or treated with tocilizumab monotherapy within the clinical routine were observed for a period of 6 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Swollen Joint Count (SJC)</title>
          <description>Number of swollen joints was determined by examination of 28 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, no swelling = 0, swelling =1; total was calculated by adding all the joints for a maximum score of 28. A reduction in number of swollen joints compared to baseline indicates improvement.</description>
          <population>The Full Analysis Set (FAS) (swollen joint counts) included all data from all participants who had at least a baseline value and one follow up value (Month 3 or Month 6) for swollen joints. n = participants evaluable for this measure at specified timepoint.</population>
          <units>swollen joint count</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="83"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (n=83)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.6" spread="5.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 3 (n=73)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.5" spread="3.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6 (n=63)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.8" spread="2.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Tender Joint Count (TJC)</title>
        <description>Number of tender joints was determined by examining 28 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at each visit, no tenderness = 0, tenderness = 1; total was calculated by adding all the joints for a maximum score of 28. A reduction in number of tender joints compared to baseline indicates improvement.</description>
        <time_frame>Baseline, Month 3, Month 6</time_frame>
        <population>The FAS (tender joint counts) included all data from all participants who had at least a baseline value and one follow up value (Month 3 or Month 6) for tender joints. n = participants evaluable for this measure at specified timepoint.</population>
        <group_list>
          <group group_id="O1">
            <title>Tocilizumab</title>
            <description>Participants with rheumatoid arthritis who were considered for or treated with tocilizumab monotherapy within the clinical routine were observed for a period of 6 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Tender Joint Count (TJC)</title>
          <description>Number of tender joints was determined by examining 28 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at each visit, no tenderness = 0, tenderness = 1; total was calculated by adding all the joints for a maximum score of 28. A reduction in number of tender joints compared to baseline indicates improvement.</description>
          <population>The FAS (tender joint counts) included all data from all participants who had at least a baseline value and one follow up value (Month 3 or Month 6) for tender joints. n = participants evaluable for this measure at specified timepoint.</population>
          <units>tender joint count</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="83"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (n=83)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.6" spread="6.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 3 (n=73)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.5" spread="5.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6 (n=63)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.7" spread="4.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (4 Variables) (DAS28-4 [CRP])</title>
        <description>DAS28-4 (CRP) was calculated from the SJC and TJC using the 28 joints count, CRP (milligram per liter [mg/L]) and patient global assessment (PtGA) of disease activity (measured on a 0 to 100 millimeter [mm] Visual Analog Scale [VAS]) where 0=no disease activity and 100=worst disease activity). DAS28-4 (CRP) was calculated using the following formula: DAS28-4 (CRP) = 0.56*square root (sqrt) (TJC28) + 0.28*sqrt(SJC28) + 0.36*ln(CRP+1) + 0.014*PtGA + 0.96. Total score range: 0 to 10, higher score indicated more disease activity. DAS28-4 (CRP) less than or equal to (&lt;= 3.2) implied low disease activity and greater than (&gt;) 3.2 to 5.1 implied moderate to high disease activity, and DAS28-4 (CRP) less than (&lt;) 2.6 = clinical remission.</description>
        <time_frame>Baseline, Month 3, Month 6</time_frame>
        <population>The FAS (DAS28-4 [CRP]) included all data from all participants who had at least a baseline value and one follow up value (Month 3 or Month 6) for DAS28-4 [CRP] assessment. n = participants evaluable for this measure at specified timepoint.</population>
        <group_list>
          <group group_id="O1">
            <title>Tocilizumab</title>
            <description>Participants with rheumatoid arthritis who were considered for or treated with tocilizumab monotherapy within the clinical routine were observed for a period of 6 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (4 Variables) (DAS28-4 [CRP])</title>
          <description>DAS28-4 (CRP) was calculated from the SJC and TJC using the 28 joints count, CRP (milligram per liter [mg/L]) and patient global assessment (PtGA) of disease activity (measured on a 0 to 100 millimeter [mm] Visual Analog Scale [VAS]) where 0=no disease activity and 100=worst disease activity). DAS28-4 (CRP) was calculated using the following formula: DAS28-4 (CRP) = 0.56*square root (sqrt) (TJC28) + 0.28*sqrt(SJC28) + 0.36*ln(CRP+1) + 0.014*PtGA + 0.96. Total score range: 0 to 10, higher score indicated more disease activity. DAS28-4 (CRP) less than or equal to (&lt;= 3.2) implied low disease activity and greater than (&gt;) 3.2 to 5.1 implied moderate to high disease activity, and DAS28-4 (CRP) less than (&lt;) 2.6 = clinical remission.</description>
          <population>The FAS (DAS28-4 [CRP]) included all data from all participants who had at least a baseline value and one follow up value (Month 3 or Month 6) for DAS28-4 [CRP] assessment. n = participants evaluable for this measure at specified timepoint.</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="83"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (n=83)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.76" spread="1.31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 3 (n=69)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.17" spread="1.34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6 (n=60)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.98" spread="1.21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Achieving Clinical Remission Based on DAS28-4 (CRP)</title>
        <description>DAS28-4 (CRP) was calculated from the SJC and TJC using the 28 joints count, CRP (mg/L) and PtGA of disease activity (measured on a 0 to 100 mm VAS where 0=no disease activity and 100=worst disease activity). DAS28-4 (CRP) was calculated using the following formula: DAS28-4 (CRP) = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.36*ln(CRP+1) + 0.014*PtGA + 0.96. Total score range: 0 to 10, higher score indicated more disease activity. DAS28-4 (CRP) &lt;= 3.2 implied low disease activity and &gt; 3.2 to 5.1 implied moderate to high disease activity, and DAS28-4 (CRP) &lt; 2.6 = clinical remission.</description>
        <time_frame>Month 3 and Month 6</time_frame>
        <population>FAS (DAS28-4 [CRP]). N (number of participants analyzed) = participants evaluable for this measure. n = participants evaluable for this measure at specified timepoint.</population>
        <group_list>
          <group group_id="O1">
            <title>Tocilizumab</title>
            <description>Participants with rheumatoid arthritis who were considered for or treated with tocilizumab monotherapy within the clinical routine were observed for a period of 6 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving Clinical Remission Based on DAS28-4 (CRP)</title>
          <description>DAS28-4 (CRP) was calculated from the SJC and TJC using the 28 joints count, CRP (mg/L) and PtGA of disease activity (measured on a 0 to 100 mm VAS where 0=no disease activity and 100=worst disease activity). DAS28-4 (CRP) was calculated using the following formula: DAS28-4 (CRP) = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.36*ln(CRP+1) + 0.014*PtGA + 0.96. Total score range: 0 to 10, higher score indicated more disease activity. DAS28-4 (CRP) &lt;= 3.2 implied low disease activity and &gt; 3.2 to 5.1 implied moderate to high disease activity, and DAS28-4 (CRP) &lt; 2.6 = clinical remission.</description>
          <population>FAS (DAS28-4 [CRP]). N (number of participants analyzed) = participants evaluable for this measure. n = participants evaluable for this measure at specified timepoint.</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="69"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Month 3 (n=69): Clinical remission</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="36.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6 (n=60): Clinical remission</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR])</title>
        <description>DAS28-4 (ESR) was calculated from SJC and TJC using 28 joints count, ESR (millimeter per hour [mm/hour]), and PtGA of disease activity (measured on a 0 to 100 mm VAS where 0=no disease activity and 100=worst disease activity). DAS28-4 (ESR) = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.70*ln(ESR) + 0.014*PtGA. Total score range: 0-10, higher score=more disease activity. DAS28-4 (ESR) &lt;= 3.2 implied low disease activity and &gt;3.2 to 5.1 implied moderate to high disease activity, and DAS28-4 (ESR) &lt;2.6 = clinical remission.</description>
        <time_frame>Baseline, Month 3, Month 6</time_frame>
        <population>The FAS (DAS28-4 [ESR]) included all data from all participants who had at least a baseline value and one follow up value (Month 3 or Month 6) for DAS28-4 [ESR] assessment. n = participants evaluable for this measure at specified timepoint.</population>
        <group_list>
          <group group_id="O1">
            <title>Tocilizumab</title>
            <description>Participants with rheumatoid arthritis who were considered for or treated with tocilizumab monotherapy within the clinical routine were observed for a period of 6 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR])</title>
          <description>DAS28-4 (ESR) was calculated from SJC and TJC using 28 joints count, ESR (millimeter per hour [mm/hour]), and PtGA of disease activity (measured on a 0 to 100 mm VAS where 0=no disease activity and 100=worst disease activity). DAS28-4 (ESR) = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.70*ln(ESR) + 0.014*PtGA. Total score range: 0-10, higher score=more disease activity. DAS28-4 (ESR) &lt;= 3.2 implied low disease activity and &gt;3.2 to 5.1 implied moderate to high disease activity, and DAS28-4 (ESR) &lt;2.6 = clinical remission.</description>
          <population>The FAS (DAS28-4 [ESR]) included all data from all participants who had at least a baseline value and one follow up value (Month 3 or Month 6) for DAS28-4 [ESR] assessment. n = participants evaluable for this measure at specified timepoint.</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="59"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (n=59)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.03" spread="1.39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 3 (n=49)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.98" spread="1.41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6 (n=45)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.64" spread="1.34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Achieving Clinical Remission Based on DAS28-4 (ESR)</title>
        <description>DAS28-4 (ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hour), and PtGA of disease activity (measured on a 0 to 100 mm VAS where 0=no disease activity and 100=worst disease activity). DAS28-4 (ESR) = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.70*ln(ESR) + 0.014*PtGA. Total score range: 0-10, higher score=more disease activity. DAS28-4 (ESR) &lt;= 3.2 implied low disease activity and &gt;3.2 to 5.1 implied moderate to high disease activity, and DAS28-4 (ESR) &lt;2.6 = clinical remission.</description>
        <time_frame>Month 3 and Month 6</time_frame>
        <population>FAS (DAS28-4 [ESR]). N (number of participants analyzed) = participants evaluable for this measure. n = participants evaluable for this measure at specified timepoint.</population>
        <group_list>
          <group group_id="O1">
            <title>Tocilizumab</title>
            <description>Participants with rheumatoid arthritis who were considered for or treated with tocilizumab monotherapy within the clinical routine were observed for a period of 6 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving Clinical Remission Based on DAS28-4 (ESR)</title>
          <description>DAS28-4 (ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hour), and PtGA of disease activity (measured on a 0 to 100 mm VAS where 0=no disease activity and 100=worst disease activity). DAS28-4 (ESR) = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.70*ln(ESR) + 0.014*PtGA. Total score range: 0-10, higher score=more disease activity. DAS28-4 (ESR) &lt;= 3.2 implied low disease activity and &gt;3.2 to 5.1 implied moderate to high disease activity, and DAS28-4 (ESR) &lt;2.6 = clinical remission.</description>
          <population>FAS (DAS28-4 [ESR]). N (number of participants analyzed) = participants evaluable for this measure. n = participants evaluable for this measure at specified timepoint.</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="49"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Month 3 (n=49): Clinical remission</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="38.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6 (n=45) : Clinical remission</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="57.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With European League Against Rheumatism (EULAR) Response Based on DAS28-4 (CRP)</title>
        <description>The DAS28-4 (CRP) [described in Outcome Measure 5] based EULAR response criteria were used to measure individual response as good, moderate, or no response depending on the extent of change from baseline in DAS28 score and the level of disease activity (low, moderate or high) reached. Good responders: change from baseline &gt;1.2 with DAS28 &lt;= 3.2; moderate responders: change from baseline &gt;1.2 with DAS28 in the range of &gt;3.2 to &lt;=5.1 or change from baseline in the range of &gt;0.6 to &lt;=1.2 with DAS28 in the range of &gt;3.2 to &lt;=5.1 or change from baseline &gt;1.2 with DAS28 &gt;5.1 or change from baseline in the range of &gt;0.6 to &lt;=1.2 with DAS28 &lt;=3.2; non-responders: change from baseline &lt;= 0.6 or change from baseline in the range of &gt;0.6 to &lt;=1.2 with DAS28 &gt;5.1 or change from baseline &lt;=0.6 with DAS28 &lt;=3.2 or in the range of &gt;3.2 to &lt;=5.1.</description>
        <time_frame>Month 3 and Month 6</time_frame>
        <population>FAS (DAS28-4 [CRP]). N (number of participants analyzed) = participants evaluable for this measure. n = participants evaluable for this measure at specified timepoint.</population>
        <group_list>
          <group group_id="O1">
            <title>Tocilizumab</title>
            <description>Participants with rheumatoid arthritis who were considered for or treated with tocilizumab monotherapy within the clinical routine were observed for a period of 6 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With European League Against Rheumatism (EULAR) Response Based on DAS28-4 (CRP)</title>
          <description>The DAS28-4 (CRP) [described in Outcome Measure 5] based EULAR response criteria were used to measure individual response as good, moderate, or no response depending on the extent of change from baseline in DAS28 score and the level of disease activity (low, moderate or high) reached. Good responders: change from baseline &gt;1.2 with DAS28 &lt;= 3.2; moderate responders: change from baseline &gt;1.2 with DAS28 in the range of &gt;3.2 to &lt;=5.1 or change from baseline in the range of &gt;0.6 to &lt;=1.2 with DAS28 in the range of &gt;3.2 to &lt;=5.1 or change from baseline &gt;1.2 with DAS28 &gt;5.1 or change from baseline in the range of &gt;0.6 to &lt;=1.2 with DAS28 &lt;=3.2; non-responders: change from baseline &lt;= 0.6 or change from baseline in the range of &gt;0.6 to &lt;=1.2 with DAS28 &gt;5.1 or change from baseline &lt;=0.6 with DAS28 &lt;=3.2 or in the range of &gt;3.2 to &lt;=5.1.</description>
          <population>FAS (DAS28-4 [CRP]). N (number of participants analyzed) = participants evaluable for this measure. n = participants evaluable for this measure at specified timepoint.</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="69"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Month 3: Good response (n=69)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="43.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 3: Moderate response (n=69)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="33.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 3: No response (n=69)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6: Good response (n=60)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="43.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6: Moderate response (n=60)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="33.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6: No response (n=60)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With EULAR Response Based on DAS28-4 (ESR)</title>
        <description>The DAS28-4 (ESR) [described in Outcome Measure 7] based EULAR response criteria were used to measure individual response as good, moderate, or no response depending on the extent of change from baseline in DAS28 score and the level of disease activity (low, moderate or high) reached. Good responders: change from baseline &gt;1.2 with DAS28 &lt;= 3.2; moderate responders: change from baseline &gt;1.2 with DAS28 in the range of &gt;3.2 to &lt;=5.1 or change from baseline in the range of &gt;0.6 to &lt;=1.2 with DAS28 in the range of &gt;3.2 to &lt;=5.1 or change from baseline &gt;1.2 with DAS28 &gt;5.1 or change from baseline in the range of &gt;0.6 to &lt;=1.2 with DAS28 &lt;=3.2; non-responders: change from baseline &lt;= 0.6 or change from baseline in the range of &gt;0.6 to &lt;=1.2 with DAS28 &gt;5.1 or change from baseline &lt;=0.6 with DAS28 &lt;=3.2 or in the range of &gt;3.2 to &lt;=5.1.</description>
        <time_frame>Month 3 and Month 6</time_frame>
        <population>FAS (DAS28-4 [ESR]). N (number of participants analyzed) = participants evaluable for this measure. n = participants evaluable for this measure at specified timepoint.</population>
        <group_list>
          <group group_id="O1">
            <title>Tocilizumab</title>
            <description>Participants with rheumatoid arthritis who were considered for or treated with tocilizumab monotherapy within the clinical routine were observed for a period of 6 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With EULAR Response Based on DAS28-4 (ESR)</title>
          <description>The DAS28-4 (ESR) [described in Outcome Measure 7] based EULAR response criteria were used to measure individual response as good, moderate, or no response depending on the extent of change from baseline in DAS28 score and the level of disease activity (low, moderate or high) reached. Good responders: change from baseline &gt;1.2 with DAS28 &lt;= 3.2; moderate responders: change from baseline &gt;1.2 with DAS28 in the range of &gt;3.2 to &lt;=5.1 or change from baseline in the range of &gt;0.6 to &lt;=1.2 with DAS28 in the range of &gt;3.2 to &lt;=5.1 or change from baseline &gt;1.2 with DAS28 &gt;5.1 or change from baseline in the range of &gt;0.6 to &lt;=1.2 with DAS28 &lt;=3.2; non-responders: change from baseline &lt;= 0.6 or change from baseline in the range of &gt;0.6 to &lt;=1.2 with DAS28 &gt;5.1 or change from baseline &lt;=0.6 with DAS28 &lt;=3.2 or in the range of &gt;3.2 to &lt;=5.1.</description>
          <population>FAS (DAS28-4 [ESR]). N (number of participants analyzed) = participants evaluable for this measure. n = participants evaluable for this measure at specified timepoint.</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="49"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Month 3: Good response (n=49)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="51.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 3: Moderate response (n=49)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="34.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 3: No response (n=49)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6: Good response (n=45)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="55.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6: Moderate response (n=45)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6: No response (n=45)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Simplified Disease Activity Index (SDAI)</title>
        <description>The SDAI is the numerical sum of five outcome parameters: TJC and SJC based on a 28-joint assessment, PtGA and physician global assessment (PGA) assessed on 0-10 centimeter (cm) VAS; 0 = no disease activity and 10 = worst disease activity, and CRP (mg/dL). SDAI total score = 0-86. SDAI &lt;=3.3 indicates clinical remission, &gt;3.4 to 11 = low disease activity, &gt;11 to 26 = moderate disease activity, and &gt;26 = high (or severe) disease activity.</description>
        <time_frame>Baseline, Month 3, Month 6</time_frame>
        <population>The FAS (SDAI) included all data from all participants who had at least a baseline value and one follow up value (Month 3 or Month 6) for SDAI. n = participants evaluable for this measure at specified timepoint.</population>
        <group_list>
          <group group_id="O1">
            <title>Tocilizumab</title>
            <description>Participants with rheumatoid arthritis who were considered for or treated with tocilizumab monotherapy within the clinical routine were observed for a period of 6 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Simplified Disease Activity Index (SDAI)</title>
          <description>The SDAI is the numerical sum of five outcome parameters: TJC and SJC based on a 28-joint assessment, PtGA and physician global assessment (PGA) assessed on 0-10 centimeter (cm) VAS; 0 = no disease activity and 10 = worst disease activity, and CRP (mg/dL). SDAI total score = 0-86. SDAI &lt;=3.3 indicates clinical remission, &gt;3.4 to 11 = low disease activity, &gt;11 to 26 = moderate disease activity, and &gt;26 = high (or severe) disease activity.</description>
          <population>The FAS (SDAI) included all data from all participants who had at least a baseline value and one follow up value (Month 3 or Month 6) for SDAI. n = participants evaluable for this measure at specified timepoint.</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="34"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (n=34)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22.46" spread="11.33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 3 (n=31)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.48" spread="9.18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6 (n=24)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.73" spread="11.74"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Achieving Clinical Remission Based on SDAI</title>
        <description>The SDAI is the numerical sum of five outcome parameters: TJC and SJC based on a 28-joint assessment, PtGA and PGA assessed on 0-10 cm VAS; 0 = no disease activity and 10 = worst disease activity, and CRP (mg/dL). SDAI total score = 0-86. SDAI &lt;=3.3 indicates clinical remission, &gt;3.4 to 11 = low disease activity, &gt;11 to 26 = moderate disease activity, and &gt;26 = high (or severe) disease activity.</description>
        <time_frame>Month 3 and Month 6</time_frame>
        <population>FAS (SDAI). N (number of participants analyzed) = participants evaluable for this measure. n = participants evaluable for this measure at specified timepoint.</population>
        <group_list>
          <group group_id="O1">
            <title>Tocilizumab</title>
            <description>Participants with rheumatoid arthritis who were considered for or treated with tocilizumab monotherapy within the clinical routine were observed for a period of 6 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving Clinical Remission Based on SDAI</title>
          <description>The SDAI is the numerical sum of five outcome parameters: TJC and SJC based on a 28-joint assessment, PtGA and PGA assessed on 0-10 cm VAS; 0 = no disease activity and 10 = worst disease activity, and CRP (mg/dL). SDAI total score = 0-86. SDAI &lt;=3.3 indicates clinical remission, &gt;3.4 to 11 = low disease activity, &gt;11 to 26 = moderate disease activity, and &gt;26 = high (or severe) disease activity.</description>
          <population>FAS (SDAI). N (number of participants analyzed) = participants evaluable for this measure. n = participants evaluable for this measure at specified timepoint.</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="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Month 3 (n=31): Clinical remission</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6 (n=24): Clinical remission</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Clinical Disease Activity Index (CDAI)</title>
        <description>The CDAI is the numerical sum of 4 outcome parameters: TJC and SJC based on a 28-joint assessment, PtGA and PGA 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, Month 6</time_frame>
        <population>The FAS (CDAI) included all data from all participants who had at least a baseline value and one follow up value (Month 3 or Month 6) for CDAI. n = participants evaluable for this measure at specified timepoint.</population>
        <group_list>
          <group group_id="O1">
            <title>Tocilizumab</title>
            <description>Participants with rheumatoid arthritis who were considered for or treated with tocilizumab monotherapy within the clinical routine were observed for a period of 6 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Clinical Disease Activity Index (CDAI)</title>
          <description>The CDAI is the numerical sum of 4 outcome parameters: TJC and SJC based on a 28-joint assessment, PtGA and PGA 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>The FAS (CDAI) included all data from all participants who had at least a baseline value and one follow up value (Month 3 or Month 6) for CDAI. n = participants evaluable for this measure at specified timepoint.</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="35"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (n=35)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.3" spread="10.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 3 (n=33)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.9" spread="8.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6 (n=24)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.4" spread="11.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Achieving Clinical Remission Based on CDAI</title>
        <description>The CDAI is the numerical sum of 4 outcome parameters: TJC and SJC based on a 28-joint assessment, PtGA and PGA 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>Month 3 and Month 6</time_frame>
        <population>FAS (CDAI). N (number of participants analyzed) = participants evaluable for this measure. n = participants evaluable for this measure at specified timepoint.</population>
        <group_list>
          <group group_id="O1">
            <title>Tocilizumab</title>
            <description>Participants with rheumatoid arthritis who were considered for or treated with tocilizumab monotherapy within the clinical routine were observed for a period of 6 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving Clinical Remission Based on CDAI</title>
          <description>The CDAI is the numerical sum of 4 outcome parameters: TJC and SJC based on a 28-joint assessment, PtGA and PGA 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>FAS (CDAI). N (number of participants analyzed) = participants evaluable for this measure. n = participants evaluable for this measure at specified timepoint.</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="33"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Month 3 (n=33): Clinical remission</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 3 (n=24): Clinical remission</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With an American College of Rheumatology (ACR) Response</title>
        <description>ACR response: improvement in tender or swollen joint counts and improvement in 3 of the following 5 criteria: 1) PGA of disease activity, 2) PtGA of disease activity, 3) patient's assessment of pain, 4) patient's assessment of functional disability via a health assessment questionnaire, and 5) CRP at each visit. ACR response is based on 66/68 total joint count.</description>
        <time_frame>Baseline to Month 6</time_frame>
        <population>Data for ACR response was not reported because in clinical practice the 66/68 joint evaluation needed for this is not performed in the Sweden, Denmark and Norway, the 28 joint count is performed instead.</population>
        <group_list>
          <group group_id="O1">
            <title>Tocilizumab</title>
            <description>Participants with rheumatoid arthritis who were considered for or treated with tocilizumab monotherapy within the clinical routine were observed for a period of 6 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With an American College of Rheumatology (ACR) Response</title>
          <description>ACR response: improvement in tender or swollen joint counts and improvement in 3 of the following 5 criteria: 1) PGA of disease activity, 2) PtGA of disease activity, 3) patient's assessment of pain, 4) patient's assessment of functional disability via a health assessment questionnaire, and 5) CRP at each visit. ACR response is based on 66/68 total joint count.</description>
          <population>Data for ACR response was not reported because in clinical practice the 66/68 joint evaluation needed for this is not performed in the Sweden, Denmark and Norway, the 28 joint count is performed instead.</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>Patient Global Assessment (PtGA) of Disease Activity Score</title>
        <description>Patient Global Assessment of Disease Activity was measured on a 0 to 100 mm VAS where 0=no disease activity and 100=worst disease activity.</description>
        <time_frame>Baseline, Month 3, Month 6</time_frame>
        <population>The FAS (VAS disease activity [patient]) included all data from all participants who had at least a baseline value and one follow up value (Month 3 or Month 6) for VAS disease activity (patient). n = participants evaluable for this measure at specified timepoint.</population>
        <group_list>
          <group group_id="O1">
            <title>Tocilizumab</title>
            <description>Participants with rheumatoid arthritis who were considered for or treated with tocilizumab monotherapy within the clinical routine were observed for a period of 6 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Patient Global Assessment (PtGA) of Disease Activity Score</title>
          <description>Patient Global Assessment of Disease Activity was measured on a 0 to 100 mm VAS where 0=no disease activity and 100=worst disease activity.</description>
          <population>The FAS (VAS disease activity [patient]) included all data from all participants who had at least a baseline value and one follow up value (Month 3 or Month 6) for VAS disease activity (patient). n = participants evaluable for this measure at specified timepoint.</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="87"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (n=87)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="61.6" spread="21.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 3 (n=77)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="41.3" spread="25.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6 (n=69)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="41.6" spread="26.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Physician Global Assessment (PGA) of Disease Activity</title>
        <description>Physician Global Assessment of Disease Activity was measured on a 0 to 100 mm VAS where 0=no disease activity and 100=worst disease activity.</description>
        <time_frame>Baseline, Month 3, Month 6</time_frame>
        <population>The FAS (VAS disease activity [physician] included all data from all participants who had at least a baseline value and one follow up value (Month 3 or Month 6) for VAS disease activity (physician). n = participants evaluable for this measure at specified timepoint.</population>
        <group_list>
          <group group_id="O1">
            <title>Tocilizumab</title>
            <description>Participants with rheumatoid arthritis who were considered for or treated with tocilizumab monotherapy within the clinical routine were observed for a period of 6 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Physician Global Assessment (PGA) of Disease Activity</title>
          <description>Physician Global Assessment of Disease Activity was measured on a 0 to 100 mm VAS where 0=no disease activity and 100=worst disease activity.</description>
          <population>The FAS (VAS disease activity [physician] included all data from all participants who had at least a baseline value and one follow up value (Month 3 or Month 6) for VAS disease activity (physician). n = participants evaluable for this measure at specified timepoint.</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="42"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (n=42)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="34.0" spread="16.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 3 (n=37)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19.1" spread="17.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6 (n=30)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.2" spread="14.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants in a PGA of Disease Activity Score Category</title>
        <description>A categorical scale (Lickert scale) with the following categories: none, mild, moderate, severe and maximal was used to evaluate disease activity in clinical practice.</description>
        <time_frame>Baseline, Month 3, Month 6</time_frame>
        <population>FAS (categorical scale [physician]) included all data from all participants who had at least a baseline value and one follow up value (Month 3 or Month 6) for rheumatoid arthritis illness categorical scale (physician). n = participants evaluable for this measure at specified timepoint.</population>
        <group_list>
          <group group_id="O1">
            <title>Tocilizumab</title>
            <description>Participants with rheumatoid arthritis who were considered for or treated with tocilizumab monotherapy within the clinical routine were observed for a period of 6 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants in a PGA of Disease Activity Score Category</title>
          <description>A categorical scale (Lickert scale) with the following categories: none, mild, moderate, severe and maximal was used to evaluate disease activity in clinical practice.</description>
          <population>FAS (categorical scale [physician]) included all data from all participants who had at least a baseline value and one follow up value (Month 3 or Month 6) for rheumatoid arthritis illness categorical scale (physician). n = participants evaluable for this measure at specified timepoint.</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="51"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline: Mild (n=51)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline: Moderate (n=51)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="56.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline: Severe (n=51)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="33.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline: Maximal (n=51)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 3: None (n=46)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 3: Mild (n=46)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="52.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 3: Moderate (n=46)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 3: Severe (n=46)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6: None (n=41)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6: Mild (n=46)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="78.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6: Moderate (n=46)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6: Severe (n=46)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Patient Global Assessment of Pain</title>
        <description>Patient Global Assessment of Pain was assessed using a 100 mm VAS (0 to 100) where 0 = no pain to 100 = worst possible pain.</description>
        <time_frame>Baseline, Month 3, Month 6</time_frame>
        <population>The FAS (VAS pain) included all data from all participants who had at least a baseline value and one follow up value (Month 3 or Month 6) for VAS pain. n = participants evaluable for this measure at specified timepoint.</population>
        <group_list>
          <group group_id="O1">
            <title>Tocilizumab</title>
            <description>Participants with rheumatoid arthritis who were considered for or treated with tocilizumab monotherapy within the clinical routine were observed for a period of 6 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Patient Global Assessment of Pain</title>
          <description>Patient Global Assessment of Pain was assessed using a 100 mm VAS (0 to 100) where 0 = no pain to 100 = worst possible pain.</description>
          <population>The FAS (VAS pain) included all data from all participants who had at least a baseline value and one follow up value (Month 3 or Month 6) for VAS pain. n = participants evaluable for this measure at specified timepoint.</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="83"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (n=83)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="60.5" spread="22.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 3 (n=73)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="38.4" spread="24.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6 (n=68)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="39.9" spread="27.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Morning Stiffness</title>
        <description>The percentage of participants with morning stiffness (&quot;yes&quot;, &quot;no&quot;, or &quot;do not know&quot;) was assessed at each visit.</description>
        <time_frame>Baseline, Month 3, Month 6</time_frame>
        <population>FAS (morning stiffness) included all data from all participants who had at least a baseline value and one follow up value (Month 3 or 6) for morning stiffness. n = participants evaluable for this measure at specified timepoint.</population>
        <group_list>
          <group group_id="O1">
            <title>Tocilizumab</title>
            <description>Participants with rheumatoid arthritis who were considered for or treated with tocilizumab monotherapy within the clinical routine were observed for a period of 6 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Morning Stiffness</title>
          <description>The percentage of participants with morning stiffness (&quot;yes&quot;, &quot;no&quot;, or &quot;do not know&quot;) was assessed at each visit.</description>
          <population>FAS (morning stiffness) included all data from all participants who had at least a baseline value and one follow up value (Month 3 or 6) for morning stiffness. n = participants evaluable for this measure at specified timepoint.</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="89"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline: Yes (n=89)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="55.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline: No (n=89)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline: Do Not Know (n=89)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="36.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 3: Yes (n=80)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="47.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 3: No (n=80)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 3: Do Not Know (n=80)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="48.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6: Yes (n=68)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="36.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6: No (n=68)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6: Do Not Know (n=68)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="48.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Duration of Morning Stiffness</title>
        <description>Duration of morning stiffness was defined as the time elapsed when participant woke up in the morning and was able to resume normal activities without stiffness. Duration was recorded as less than (&lt;) 30 minutes, 30 to 60 minutes, 60 to 120 minutes, 120 to 240 minutes, more than (&gt;) 240 minutes, or whole day.</description>
        <time_frame>Baseline, Month 3, Month 6</time_frame>
        <population>FAS (morning stiffness). N (number of participants analyzed) = participants evaluable for this measure. n = participants evaluable for this measure at specified timepoint.</population>
        <group_list>
          <group group_id="O1">
            <title>Tocilizumab</title>
            <description>Participants with rheumatoid arthritis who were considered for or treated with tocilizumab monotherapy within the clinical routine were observed for a period of 6 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Duration of Morning Stiffness</title>
          <description>Duration of morning stiffness was defined as the time elapsed when participant woke up in the morning and was able to resume normal activities without stiffness. Duration was recorded as less than (&lt;) 30 minutes, 30 to 60 minutes, 60 to 120 minutes, 120 to 240 minutes, more than (&gt;) 240 minutes, or whole day.</description>
          <population>FAS (morning stiffness). N (number of participants analyzed) = participants evaluable for this measure. n = participants evaluable for this measure at specified timepoint.</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="49"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline: &lt;30 minutes (n=49)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline: 30 to 60 minutes (n=49)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline: 60 to 120 minutes (n=49)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline: 120 to 240 minutes (n=49)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline: &gt;240 minutes (n=49)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline: whole day (n=49)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 3: &lt;30 minutes (n=38)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 3: 30 to 60 minutes (n=38)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 3: 60 to 120 minutes (n=38)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 3: 120 to 240 minutes (n=38)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 3: &gt;240 minutes (n=38)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 3: whole day (n=38)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6: &lt;30 minutes (n=25)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="44.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6: 30 to 60 minutes (n=25)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6: 60 to 120 minutes (n=25)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6: 120 to 240 minutes (n=25)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6: &gt;240 minutes (n=25)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6: whole day (n=25)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Months 3 and 6</title>
        <description>HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.</description>
        <time_frame>Baseline, Month 3 and Month 6</time_frame>
        <population>The FAS (HAQ) included all data from all participants who had at least a baseline value and one follow up value (Month 3 or Month 6) for HAQ.</population>
        <group_list>
          <group group_id="O1">
            <title>Tocilizumab</title>
            <description>Participants with rheumatoid arthritis who were considered for or treated with tocilizumab monotherapy within the clinical routine were observed for a period of 6 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Months 3 and 6</title>
          <description>HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.</description>
          <population>The FAS (HAQ) included all data from all participants who had at least a baseline value and one follow up value (Month 3 or Month 6) for HAQ.</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="82"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (n=82)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.29" spread="0.62"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Month 3 (n=72)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.29" spread="0.53"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Month 6 (n=58)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.21" spread="0.59"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Change at Month 3</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>Wilcoxon signed rank test</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Change at Month 6</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.0357</p_value>
            <method>Wilcoxon signed rank test</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Concomitant Corticosteroids Treatment</title>
        <time_frame>Baseline to Month 6</time_frame>
        <population>Safety Analysis Set</population>
        <group_list>
          <group group_id="O1">
            <title>Tocilizumab</title>
            <description>Participants with rheumatoid arthritis who were considered for or treated with tocilizumab monotherapy within the clinical routine were observed for a period of 6 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Concomitant Corticosteroids Treatment</title>
          <population>Safety Analysis Set</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="107"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Use of Disease-Modifying Anti-Rheumatic Drugs (DMARDs) During the Study</title>
        <time_frame>Baseline to Month 6</time_frame>
        <population>Safety Analysis Set</population>
        <group_list>
          <group group_id="O1">
            <title>Tocilizumab</title>
            <description>Participants with rheumatoid arthritis who were considered for or treated with tocilizumab monotherapy within the clinical routine were observed for a period of 6 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Use of Disease-Modifying Anti-Rheumatic Drugs (DMARDs) During the Study</title>
          <population>Safety Analysis Set</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="107"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Baseline to Month 6</time_frame>
      <desc>Safety Analysis Set</desc>
      <group_list>
        <group group_id="E1">
          <title>Tocilizumab</title>
          <description>Participants with rheumatoid arthritis who were considered for or treated with tocilizumab monotherapy within the clinical routine were observed for a period of 6 months.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 17.1</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="107"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="107"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Cardiac failure</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="107"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Gastric haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="107"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Ear infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="107"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Acetabulum fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Joint dislocation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Upper limb fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="107"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Blood lactic acid increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>C-reactive protein increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="107"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Rheumatoid arthritis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="107"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="107"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Femoral artery occlusion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="107"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 17.1</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="13" subjects_at_risk="107"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="107"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="107"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

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


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01669902
org study id: ML28247
nct id: NCT01669902
lead sponsor: 
This multicenter observational study will evaluate the use of RoActemra/Actemra (tocilizumab)
      in monotherapy in patients with active moderate to severe rheumatoid arthritis unable to use
      methotrexate. Eligible patients initiated on RoActemra/Actemra treatment will be followed for
      6 months.
observational model: Cohort
time perspective: Prospective
measure: Percentage of Participants on Tocilizumab Treatment at Month 6
time frame: Month 6
measure: Percentage of Participants With Dose Modifications of Tocilizumab
time frame: Baseline to Month 6
description: Dose modification is any change in dose; this also included participants who stopped treatment with tocilizumab.
measure: Swollen Joint Count (SJC)
time frame: Baseline, Month 3, Month 6
description: Number of swollen joints was determined by examination of 28 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, no swelling = 0, swelling =1; total was calculated by adding all the joints for a maximum score of 28. A reduction in number of swollen joints compared to baseline indicates improvement.
measure: Tender Joint Count (TJC)
time frame: Baseline, Month 3, Month 6
description: Number of tender joints was determined by examining 28 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at each visit, no tenderness = 0, tenderness = 1; total was calculated by adding all the joints for a maximum score of 28. A reduction in number of tender joints compared to baseline indicates improvement.
measure: Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (4 Variables) (DAS28-4 [CRP])
time frame: Baseline, Month 3, Month 6
description: DAS28-4 (CRP) was calculated from the SJC and TJC using the 28 joints count, CRP (milligram per liter [mg/L]) and patient global assessment (PtGA) of disease activity (measured on a 0 to 100 millimeter [mm] Visual Analog Scale [VAS]) where 0=no disease activity and 100=worst disease activity). DAS28-4 (CRP) was calculated using the following formula: DAS28-4 (CRP) = 0.56*square root (sqrt) (TJC28) + 0.28*sqrt(SJC28) + 0.36*ln(CRP+1) + 0.014*PtGA + 0.96. Total score range: 0 to 10, higher score indicated more disease activity. DAS28-4 (CRP) less than or equal to (<= 3.2) implied low disease activity and greater than (>) 3.2 to 5.1 implied moderate to high disease activity, and DAS28-4 (CRP) less than (<) 2.6 = clinical remission.
measure: Percentage of Participants Achieving Clinical Remission Based on DAS28-4 (CRP)
time frame: Month 3 and Month 6
description: DAS28-4 (CRP) was calculated from the SJC and TJC using the 28 joints count, CRP (mg/L) and PtGA of disease activity (measured on a 0 to 100 mm VAS where 0=no disease activity and 100=worst disease activity). DAS28-4 (CRP) was calculated using the following formula: DAS28-4 (CRP) = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.36*ln(CRP+1) + 0.014*PtGA + 0.96. Total score range: 0 to 10, higher score indicated more disease activity. DAS28-4 (CRP) <= 3.2 implied low disease activity and > 3.2 to 5.1 implied moderate to high disease activity, and DAS28-4 (CRP) < 2.6 = clinical remission.
measure: Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR])
time frame: Baseline, Month 3, Month 6
description: DAS28-4 (ESR) was calculated from SJC and TJC using 28 joints count, ESR (millimeter per hour [mm/hour]), and PtGA of disease activity (measured on a 0 to 100 mm VAS where 0=no disease activity and 100=worst disease activity). DAS28-4 (ESR) = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.70*ln(ESR) + 0.014*PtGA. Total score range: 0-10, higher score=more disease activity. DAS28-4 (ESR) <= 3.2 implied low disease activity and >3.2 to 5.1 implied moderate to high disease activity, and DAS28-4 (ESR) <2.6 = clinical remission.
measure: Percentage of Participants Achieving Clinical Remission Based on DAS28-4 (ESR)
time frame: Month 3 and Month 6
description: DAS28-4 (ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hour), and PtGA of disease activity (measured on a 0 to 100 mm VAS where 0=no disease activity and 100=worst disease activity). DAS28-4 (ESR) = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.70*ln(ESR) + 0.014*PtGA. Total score range: 0-10, higher score=more disease activity. DAS28-4 (ESR) <= 3.2 implied low disease activity and >3.2 to 5.1 implied moderate to high disease activity, and DAS28-4 (ESR) <2.6 = clinical remission.
measure: Percentage of Participants With European League Against Rheumatism (EULAR) Response Based on DAS28-4 (CRP)
time frame: Month 3 and Month 6
description: The DAS28-4 (CRP) [described in Outcome Measure 5] based EULAR response criteria were used to measure individual response as good, moderate, or no response depending on the extent of change from baseline in DAS28 score and the level of disease activity (low, moderate or high) reached. Good responders: change from baseline >1.2 with DAS28 <= 3.2; moderate responders: change from baseline >1.2 with DAS28 in the range of >3.2 to <=5.1 or change from baseline in the range of >0.6 to <=1.2 with DAS28 in the range of >3.2 to <=5.1 or change from baseline >1.2 with DAS28 >5.1 or change from baseline in the range of >0.6 to <=1.2 with DAS28 <=3.2; non-responders: change from baseline <= 0.6 or change from baseline in the range of >0.6 to <=1.2 with DAS28 >5.1 or change from baseline <=0.6 with DAS28 <=3.2 or in the range of >3.2 to <=5.1.
measure: Percentage of Participants With EULAR Response Based on DAS28-4 (ESR)
time frame: Month 3 and Month 6
description: The DAS28-4 (ESR) [described in Outcome Measure 7] based EULAR response criteria were used to measure individual response as good, moderate, or no response depending on the extent of change from baseline in DAS28 score and the level of disease activity (low, moderate or high) reached. Good responders: change from baseline >1.2 with DAS28 <= 3.2; moderate responders: change from baseline >1.2 with DAS28 in the range of >3.2 to <=5.1 or change from baseline in the range of >0.6 to <=1.2 with DAS28 in the range of >3.2 to <=5.1 or change from baseline >1.2 with DAS28 >5.1 or change from baseline in the range of >0.6 to <=1.2 with DAS28 <=3.2; non-responders: change from baseline <= 0.6 or change from baseline in the range of >0.6 to <=1.2 with DAS28 >5.1 or change from baseline <=0.6 with DAS28 <=3.2 or in the range of >3.2 to <=5.1.
measure: Simplified Disease Activity Index (SDAI)
time frame: Baseline, Month 3, Month 6
description: The SDAI is the numerical sum of five outcome parameters: TJC and SJC based on a 28-joint assessment, PtGA and physician global assessment (PGA) assessed on 0-10 centimeter (cm) VAS; 0 = no disease activity and 10 = worst disease activity, and CRP (mg/dL). SDAI total score = 0-86. SDAI <=3.3 indicates clinical remission, >3.4 to 11 = low disease activity, >11 to 26 = moderate disease activity, and >26 = high (or severe) disease activity.
measure: Percentage of Participants Achieving Clinical Remission Based on SDAI
time frame: Month 3 and Month 6
description: The SDAI is the numerical sum of five outcome parameters: TJC and SJC based on a 28-joint assessment, PtGA and PGA assessed on 0-10 cm VAS; 0 = no disease activity and 10 = worst disease activity, and CRP (mg/dL). SDAI total score = 0-86. SDAI <=3.3 indicates clinical remission, >3.4 to 11 = low disease activity, >11 to 26 = moderate disease activity, and >26 = high (or severe) disease activity.
measure: Clinical Disease Activity Index (CDAI)
time frame: Baseline, Month 3, Month 6
description: The CDAI is the numerical sum of 4 outcome parameters: TJC and SJC based on a 28-joint assessment, PtGA and PGA 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 Achieving Clinical Remission Based on CDAI
time frame: Month 3 and Month 6
description: The CDAI is the numerical sum of 4 outcome parameters: TJC and SJC based on a 28-joint assessment, PtGA and PGA 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: Number of Participants With an American College of Rheumatology (ACR) Response
time frame: Baseline to Month 6
description: ACR response: improvement in tender or swollen joint counts and improvement in 3 of the following 5 criteria: 1) PGA of disease activity, 2) PtGA of disease activity, 3) patient's assessment of pain, 4) patient's assessment of functional disability via a health assessment questionnaire, and 5) CRP at each visit. ACR response is based on 66/68 total joint count.
measure: Patient Global Assessment (PtGA) of Disease Activity Score
time frame: Baseline, Month 3, Month 6
description: Patient Global Assessment of Disease Activity was measured on a 0 to 100 mm VAS where 0=no disease activity and 100=worst disease activity.
measure: Physician Global Assessment (PGA) of Disease Activity
time frame: Baseline, Month 3, Month 6
description: Physician Global Assessment of Disease Activity was measured on a 0 to 100 mm VAS where 0=no disease activity and 100=worst disease activity.
measure: Percentage of Participants in a PGA of Disease Activity Score Category
time frame: Baseline, Month 3, Month 6
description: A categorical scale (Lickert scale) with the following categories: none, mild, moderate, severe and maximal was used to evaluate disease activity in clinical practice.
measure: Patient Global Assessment of Pain
time frame: Baseline, Month 3, Month 6
description: Patient Global Assessment of Pain was assessed using a 100 mm VAS (0 to 100) where 0 = no pain to 100 = worst possible pain.
measure: Percentage of Participants With Morning Stiffness
time frame: Baseline, Month 3, Month 6
description: The percentage of participants with morning stiffness ("yes", "no", or "do not know") was assessed at each visit.
measure: Percentage of Participants With Duration of Morning Stiffness
time frame: Baseline, Month 3, Month 6
description: Duration of morning stiffness was defined as the time elapsed when participant woke up in the morning and was able to resume normal activities without stiffness. Duration was recorded as less than (<) 30 minutes, 30 to 60 minutes, 60 to 120 minutes, 120 to 240 minutes, more than (>) 240 minutes, or whole day.
measure: Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Months 3 and 6
time frame: Baseline, Month 3 and Month 6
description: HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.
measure: Percentage of Participants With Concomitant Corticosteroids Treatment
time frame: Baseline to Month 6
measure: Number of Participants With Use of Disease-Modifying Anti-Rheumatic Drugs (DMARDs) During the Study
time frame: Baseline to Month 6
arm group label: Cohort
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Clinical Trials
role: Study Director
affiliation: Hoffmann-La Roche
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country: Denmark
country: Norway
country: Sweden
country: United States
responsible party type: Sponsor
mesh term: Arthritis
mesh term: Arthritis, Rheumatoid
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 