<clinical_study>
  <!-- This xml conforms to an XML Schema at:
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  <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/NCT01664104</url>
  </required_header>
  <id_info>
    <org_study_id>ML28336</org_study_id>
    <nct_id>NCT01664104</nct_id>
  </id_info>
  <brief_title>A Study to Evaluate Tocilizumab Treatment in a Real-Life Setting</brief_title>
  <official_title>CRP and BMI Study: Evaluation in Real Life of Clinical Remission Rate and Correlation Between CRP and BMI in Patients Treated With Tocilizumab</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hoffmann-La Roche</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hoffmann-La Roche</source>
  <brief_summary>
    <textblock>
      This observational, multi-center study will evaluate the treatment regimen, treatment&#xD;
      responses and safety of tocilizumab therapy in a routine clinical practice in participants&#xD;
      with moderate to severe rheumatoid arthritis (RA). Data will be collected for 6 months with a&#xD;
      maximum study duration of 18 months.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>June 2012</start_date>
  <completion_date type="Actual">December 2013</completion_date>
  <primary_completion_date type="Actual">December 2013</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Participants on TCZ Treatment at Month 6</measure>
    <time_frame>Month 6</time_frame>
    <description>Percentage of participants on TCZ treatment at Month 6 was calculated as: [(participants on TCZ treatment at Month 6) divided by (participants evaluable for primary objective)] multiplied by 100. Confidence interval was computed based on the Clopper-Pearson method.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants by TCZ Dose at Month 6</measure>
    <time_frame>Month 6</time_frame>
    <description>TCZ dose at Month 6 was calculated over the total number of participants evaluable for the primary objective and who did not interrupt TCZ. Percentage of participants on TCZ dose at Month 6 was calculated as the [(participants with specified TCZ dose at 6 months) divided by (participants who did not interrupt TCZ at Month 6)] multiplied by 100.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Starting TCZ After Inadequate Response (IR) to a Biologic Treatment or After Intolerance or IR to Disease-Modifying Anti-Rheumatic Drugs (DMARDs)</measure>
    <time_frame>Baseline</time_frame>
    <description>Participants with at least 1 treatment with biologic agent not equal missing and which is not ongoing or with a stop date lower or equal to first TCZ administration had IR to biologic treatment. Participants with at least 1 treatment with DMARDs with a stop date lower or equal to first TCZ administration had IR to DMARDs. Participants with a biologic and DMARDs interruption or with a biologic interruption and ongoing treatment with DMARDs were classified in &quot;IR to biologic group&quot;. Participants with DMARDs interruption or ongoing DMARDs and adding TCZ without a biologic interruption were classified in the &quot;DMARDs intolerance and/or IR&quot; group.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time Elapsed From Diagnosis of RA</measure>
    <time_frame>Baseline (assessed retrospectively)</time_frame>
    <description>Time elapsed from diagnosis of RA in years was calculated as the (difference between the date of enrollment visit and the date of first diagnosis of RA) divided by 365.25.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Assessment of Pain Using Visual Analog Scale (VAS) at Baseline</measure>
    <time_frame>Baseline</time_frame>
    <description>Participants measured the pain intensity due to RA on a 100 millimeter (mm) VAS, where the responses were on a continuous range from 0 mm = no pain to 100 mm = unbearable pain.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Global Assessment of Disease Activity (PGH) Using VAS at Baseline</measure>
    <time_frame>Baseline</time_frame>
    <description>The PGH was measured using a 100 mm VAS, where the responses were on a continuous range from 0 mm = managing very well to 100 mm = managing very poorly.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physician Global Assessment of Disease Activity (PhGH) Using VAS at Baseline</measure>
    <time_frame>Baseline</time_frame>
    <description>The PhGH was measured on a 100 mm VAS, where 0 mm = no arthritis activity to 100 mm = extremely active arthritis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Participant Assessment of Morning Stiffness Using VAS at Baseline</measure>
    <time_frame>Baseline</time_frame>
    <description>The participant assessment of morning stiffness was measured using a ruler on a 100 mm VAS, where the responses were on a continuous range from 0 mm = no stiffness and 100 mm = maximum stiffness.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Participant Assessment of Fatigue Using VAS at Baseline</measure>
    <time_frame>Baseline</time_frame>
    <description>Participants measured the level of fatigue due to RA using a 100 mm VAS, where the responses were on a continuous range from 0 mm = no fatigue to 100 mm = extreme fatigue.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health Assessment Questionnaire Disability Index (HAQ-DI) Score at Baseline</measure>
    <time_frame>Baseline</time_frame>
    <description>The HAQ-DI is a questionnaire that measures functional status (disability) and health-related quality of life (QoL). It measures the participant's ability to perform everyday tasks. The index consists of 20 questions regarding the function of the upper and lower extremities. These questions are summarized in 8 categories: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and common activities over past week. Each question was evaluated according to the degree of severity on a 4-point scale ranging from 0 = without any difficulty to 3 = unable to do. Total score for HAQ-DI is the average of all questions and ranges from 0 to 3, where higher scores represent higher disease activity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tender Joint Count (TJC) at Baseline</measure>
    <time_frame>Baseline</time_frame>
    <description>TJC was determined by examining 28 joints and identifying the joints that were painful under pressure or to passive motion. Tenderness was recorded on the joint assessment form at baseline; no tenderness = 0 and tenderness = 1.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Swollen Joint Count (SJC) at Baseline</measure>
    <time_frame>Baseline</time_frame>
    <description>SJC was determined by examining 28 joints and identifying when swelling was present. Swelling was recorded on the joint assessment form at baseline; no swelling = 0 and swelling = 1.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Erythrocyte Sedimentation Rate (ESR) at Baseline</measure>
    <time_frame>Baseline</time_frame>
    <description>ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 millimeter per hour (mm/hour). A decrease in the level indicates reduction in inflammation and therefore improvement.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>C-Reactive Protein (CRP) at Baseline</measure>
    <time_frame>Baseline</time_frame>
    <description>The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Presence of Extra-Articular Systemic Features of RA at Baseline</measure>
    <time_frame>Baseline</time_frame>
    <description>Extra-articular systemic features referred to anemia, fatigue as well as a wide range of co-morbidities such as osteoporosis and other iatrogenic complications. Percentage of participants with any of the extra-articular systemic feature are reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Evidence of Structural Joint Damage at Baseline</measure>
    <time_frame>Baseline</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Previous RA-Related Surgical Procedures at Baseline</measure>
    <time_frame>Baseline</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Positive Rheumatoid Factor (RF) at Baseline</measure>
    <time_frame>Baseline</time_frame>
    <description>RF is the auto antibody directed against immunoglobulin G and its concentration is observed in human serum or plasma. RF value higher than 20 units per milliliter is considered positive.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Anti-Citrullinated Cyclic Peptide at Baseline</measure>
    <time_frame>Baseline</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants by Duration of Morning Stiffness at Baseline</measure>
    <time_frame>Baseline</time_frame>
    <description>Duration of morning stiffness was defined as the time elapsed between the time of usual awakening (even if not in the morning) and the time the participant was able to resume normal activities without stiffness. The participant reported the duration of morning stiffness in the case report form by ticking 1 of the following categories: no morning stiffness, less than (&lt;) 30 minutes, 30 - 60 minutes, 60 - 120 minutes, 120 - 240 minutes, greater than (&gt;) 240 minutes, and the whole day. 'Not estimable' represented that the participants were not able to quantify it.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With TCZ Dose Change According to the Reason for Change</measure>
    <time_frame>Baseline up to Month 6</time_frame>
    <description>Number of participants with TCZ dose change (increase or decrease with respect to starting dose) was reported by reason for change.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants by Number of TCZ Dose Modifications Per Participant</measure>
    <time_frame>Baseline up to Month 6</time_frame>
    <description>The number of TCZ dose modifications per participant was calculated as the number of times that the participant changed the prescribed dose with respect to the dose planned at enrollment/previous administration. If the participant did not change the prescribed dose, the values were set at missing.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time in Days Elapsed Between TCZ Infusions</measure>
    <time_frame>Baseline up to Month 6 (assessed retrospectively and prospectively at each administration [approximately 1 month apart] up to administration 8</time_frame>
    <description>The time elapsed in days between TCZ infusions was calculated as the difference between the date of TCZ infusion and the date of the previous administration.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With TCZ Infusion Interruption</measure>
    <time_frame>Baseline up to Month 6</time_frame>
    <description>The percentage of participants with at least one infusion interruption was reported as &quot;Yes&quot;. Participants with unknown infusion interruption were set to &quot;No&quot;.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Who Discontinued TCZ by Reason for Discontinuation</measure>
    <time_frame>Baseline up to Month 6</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With TCZ Reintroduction</measure>
    <time_frame>Baseline up to Month 6</time_frame>
    <description>The percentage of participants with at least one TCZ reintroduction was reported as &quot;Yes&quot;. Participants with unknown TCZ reintroduction were set to &quot;No&quot;.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants by Reason for Choice of TCZ Monotherapy at Baseline</measure>
    <time_frame>Baseline</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Disease Activity Score Based on 28 Joint Count (DAS28) Score at Month 3 and Month 6</measure>
    <time_frame>Baseline, Month 3, and Month 6</time_frame>
    <description>DAS28 score is a measurement of RA activity on a 0 to 10 scale, with higher scores representing higher disease activity, and calculated as DAS28 = 0.56 x √TJC28 + 0.28 x √SJC28 + 0.36 x natural logarithm (ln) (CRP + 1) + 0.014 x PGH + 0.96, where TJC28 = tender joint count on 28 units, SJC28 = swollen joint count on 28 units, CRP = serum concentration of c-reactive protein (after converting units to mg/dL), PGH = patient global assessment of disease activity, which was measured on a 100 mm VAS, where 0 mm = managing very well and 100 mm = managing very poorly (√ = square root). A score of &lt; 2.6 represents clinical remission, a score of greater than or equal to (≥) 2.6 and less than or equal to (≤) 3.2 represents low disease activity, a score of &gt; 3.2 and ≤ 5.1 represents moderate disease activity and a score of &gt; 5.1 represents high (or severe) disease activity. Change from baseline = DAS28 at Month X - DAS28 at baseline. Here X = 3 and 6 for Change at Months 3 and 6, respectively.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Simplified Disease Activity Index (SDAI) Score at Month 3 and Month 6</measure>
    <time_frame>Baseline, Month 3, and Month 6</time_frame>
    <description>SDAI is a combined index for measuring disease activity in RA and calculated as SDAI = TJC28 + SJC28 + PGH (in cm) + PhGH (in cm) + CRP (in mg/dL), where TJC28 = tender joint count on 28 units, SJC28 = swollen joint count on 28 units, PGH = patient's global assessment of disease activity, assessed on a 100 mm VAS, where 0 = managing very well and 100 = managing very poorly, PhGH = physician global assessment of disease activity, assessed on a 100 mm VAS, where 0 mm = no arthritis activity and 100 mm = extremely active arthritis, CRP = serum concentration of C-reactive protein. SDAI total score ranged from 0-86. Higher scores represent greater disease activity. SDAI scores of ≤ 3.3 represents clinical remission, ≤ 11.0 represents low disease activity , ≤ 26.0 represents moderate disease activity, and &gt; 26.0 represents high (or severe) disease activity. Change from baseline = SDAI score at Month X - SDAI score at baseline. Here X = 3 and 6 for Change at Months 3 and 6, respectively.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Clinical Disease Activity Index (CDAI) Score at Month 3 and Month 6</measure>
    <time_frame>Baseline, Month 3, and Month 6</time_frame>
    <description>The CDAI is a combined index for measuring disease activity in RA and calculated as CDAI = TJC28 + SJC28 + PGH (in cm) + PhGH (in cm), where TJC28 = tender joint count on 28 units, SJC28 = swollen joint count on 28 units, PGH = patient's global assessment of disease activity, assessed on a 100 mm VAS, where 0 = managing very well and 100 = managing very poorly, and PhGH = physician global assessment of disease activity, assessed on a 100 mm VAS, where 0 mm = no arthritis activity and 100 mm = extremely active arthritis. CDAI total score ranged from 0-76. Higher scores indicate greater disease activity. CDAI score of ≤ 2.8 represents clinical remission, score of ≤ 10.0 represents low disease activity, score of ≤ 22.0 represents moderate disease activity, and score of &gt; 22.0 represents high (or severe) disease activity. Change from baseline = CDAI score at Month X - CDAI score at baseline. Here X = 3 and 6 for Change at Months 3 and 6, respectively.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants by DAS28 Class at the Start of TCZ Treatment and After Month 3 and Month 6</measure>
    <time_frame>Baseline, Month 3, and Month 6</time_frame>
    <description>DAS28 score is a measurement of RA activity on a 0 to 10 scale and calculated as DAS28 = 0.56 x √TJC28 + 0.28 x √SJC28 + 0.36 x ln(CRP + 1) + 0.014 x PGH + 0.96, where TJC28 = tender joint count on 28 units, SJC28 = swollen joint count on 28 units, CRP = serum concentration of c-reactive protein (after converting units to mg/dL), PGH = patient's global assessment of disease activity, which was measured on a 100 mm VAS, where 0 mm = managing very well and 100 mm = managing very poorly. Higher scores represent greater disease activity. A score of &lt; 2.6 represents clinical remission, a score of ≥ 2.6 and ≤ 3.2 represents low disease activity, a score of &gt;3.2 and ≤ 5.1 represents moderate disease activity, and a score of &gt; 5.1 represents high (or severe) disease activity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants by SDAI Class at the Start of TCZ Treatment and After Month 3 and Month 6</measure>
    <time_frame>Baseline, Month 3, and Month 6</time_frame>
    <description>SDAI is a combined index for measuring disease activity in RA and calculated as SDAI = TJC28 + SJC28 + PGH (in cm) + PhGH (in cm) + CRP (in mg/dL), where TJC28 = tender joint count on 28 units, SJC28 = swollen joint count on 28 units, PGH = patient's global assessment of disease activity, assessed on a 100 mm VAS, where 0 mm = managing very well and 100 mm = managing very poorly, PhGH = physician global assessment of disease activity, assessed on a 100 mm VAS, where 0 = no arthritis activity and 100 = extremely active arthritis, CRP = serum concentration of C-reactive protein. SDAI total score ranged from 0-86. Higher scores represent greater disease activity. SDAI scores of ≤ 3.3 represents clinical remission, ≤ 11.0 represents low disease activity, ≤ 26.0 represents moderate disease activity, and &gt; 26.0 represents high (or severe) disease activity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants by CDAI Class at the Start of TCZ Treatment and After Month 3 and Month 6</measure>
    <time_frame>Baseline, Month 3, and Month 6</time_frame>
    <description>CDAI is a combined index for measuring disease activity in RA and calculated as CDAI = TJC28 + SJC28 + PGH (in cm) + PhGH (in cm), where TJC28 = tender joint count on 28 units, SJC28 = swollen joint count on 28 units, PGH = patient's global assessment of disease activity, assessed on a 100 mm VAS, where 0 mm = managing very well and 100 mm = managing very poorly, and PhGH = physician global assessment of disease activity, assessed on a 100 mm VAS, where 0 mm = no arthritis activity and 100 mm = extremely active arthritis. CDAI total score ranged from 0-76. Higher scores indicate greater disease activity. CDAI score of ≤ 2.8 represents clinical remission, score of ≤ 10.0 represents low disease activity, score of ≤ 22.0 represents moderate disease activity, and score of &gt; 22.0 represents high (or severe) disease activity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With an American College of Rheumatology (ACR) 20%, 50%, 70%, or 90% (ACR20/50/70/90) Response After Month 3 and Month 6 From the Start of TCZ Treatment</measure>
    <time_frame>Month 3 and Month 6</time_frame>
    <description>ACR20, 50, 70 or 90 response = an improvement of ≥20%, ≥50%, ≥70% or ≥90% respectively, as compared to baseline in TJC28 and SJC28, and 20/50/70/90%, improvement in at least 3 of 5 following measures: Patient's Assessment of Pain over previous 24 hours, PGH, PhGH, HAQ, and acute phase reactant (either CRP or ESR). TJC and SJC, based on 28-joint assessments. Number of tender joints and swollen joints were recorded on joint assessment form at baseline; no tenderness = 0 and tenderness = 28, no swelling = 0 and swelling = 28, respectively. HAQ measures functional status (disability) and health-related QoL with 20 questions, summarized in 8 categories: dressing and grooming, arising, eating, walking, hygiene, reach, grip and common activities over past week, 0= without difficulty to 3= unable to do. Patient's assessment of pain assessed using VAS; 0 mm = no pain, 100 mm = unbearable pain; PGH and PhGH, assessed using VAS; 0 mm = no disease activity, 100 mm = maximum disease activity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline to Month 6 in TJC</measure>
    <time_frame>Baseline and Month 6</time_frame>
    <description>TJC 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 baseline and at Month 6. No tenderness = 0 and tenderness = 1.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline to Month 6 in SJC</measure>
    <time_frame>Baseline and Month 6</time_frame>
    <description>SJC 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 baseline and at Month 6. No swelling = 0 and swelling = 1.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline to Month 6 in PGH</measure>
    <time_frame>Baseline and Month 6</time_frame>
    <description>The PGH was measured using a 100 mm VAS, where the responses were on a continuous range from 0 mm = managing very well and 100 mm = managing very poorly.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline to Month 6 in PhGH</measure>
    <time_frame>Baseline and Month 6</time_frame>
    <description>The PhGH was evaluated using a 100 mm VAS where 0 mm = no arthritis activity and 100 mm = extremely active arthritis. Higher scores indicated increased level of disease.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline to Month 6 in Patient's Assessment of Pain</measure>
    <time_frame>Baseline and Month 6</time_frame>
    <description>Participants measured the pain intensity due to RA using a 100 mm VAS, where the responses were on a continuous range from 0 mm = no pain to 100 mm = unbearable pain.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline to Month 6 in HAQ-DI Score</measure>
    <time_frame>Baseline and Month 6</time_frame>
    <description>The HAQ-DI is a questionnaire that measures functional status (disability) and health-related QoL. It measures the participant's ability to perform everyday tasks. The index consists of 20 questions regarding the function of the upper and lower extremities. These questions are summarized in 8 categories: dressing and grooming, arising, eating, walking, hygiene, reach, grip and common activities over past week. Each question was evaluated according to the degree of severity on a 4-point scale ranging from 0 = without any difficulty to 3 = unable to do.Total score for HAQ-DI is the average of all the questions, which ranges from 0 to 3, where higher scores represent higher disease activity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline to Month 6 in Participant Assessment of Fatigue</measure>
    <time_frame>Baseline and Month 6</time_frame>
    <description>Participants measured the level of fatigue due to RA using a 100 mm VAS, where the responses were on a continuous range from 0 mm = no fatigue to 100 mm = extreme fatigue.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline to Month 6 in Participant Assessment of Morning Stiffness</measure>
    <time_frame>Baseline and Month 6</time_frame>
    <description>The participant assessment of morning stiffness was measured using a ruler on a 100 mm VAS, where the responses were on a continuous range from 0 mm = no stiffness and 100 mm = maximum stiffness.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Clinically Meaningful Improvement in HAQ-DI</measure>
    <time_frame>Month 3 and Month 6</time_frame>
    <description>The HAQ-DI is a questionnaire that measures functional status (disability) and health-related QoL. It measures the participant's ability to perform everyday tasks. The index consists of 20 questions regarding the function of the upper and lower extremities. These questions are summarized in 8 categories: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and common activities over past week. Each question was evaluated according to the degree of severity on a 4-point scale ranging from 0 = without any difficulty to 3 = unable to do. Total score for HAQ-DI is the average of all the questions, which ranges from 0 to 3, where higher scores represent higher disease activity. HAQ-DI clinically meaningful improvement is defined as decrease in HAQ total score from baseline of greater or equal to 0.22 points.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Achieving Good/Moderate/No European League Against Rheumatism (EULAR) Response at Month 3 and Month 6</measure>
    <time_frame>Month 3 and Month 6</time_frame>
    <description>Clinical response was assessed according to EULAR criteria that classified the participant according to individual changes in DAS28 score as good, moderate, or no response. DAS28 score is a measurement of RA activity on 0 to 10 scale and calculated as DAS28= 0.56 x √TJC28 + 0.28 x √SJC28 + 0.36 x ln(CRP + 1) + 0.014 x PGH + 0.96, where TJC28= tender joint count on 28 units, SJC28= swollen joint count on 28 units, CRP= serum concentration of C-reactive protein (after converting units to mg/dL), PGH= patient's global assessment of disease activity measured on a 100 mm VAS, where 0 mm= managing very well and 100 mm= managing very poorly. Good responders experienced change (chg) from baseline (BL) of &gt;1.2 with DAS28 score ≤ 3.2, moderate responders experienced chg from BL &gt;1.2 with DAS28 score &gt; 3.2 to ≤ 5.1 or a chg from BL &gt; 0.6 to ≤ 1.2 with DAS28 score of ≤ 5.1. No responders experienced chg from BL &lt; 0.6 regardless initial DAS28 score or &gt; 0.6 to ≤ 1.2 with DAS28 score of &gt; 5.1.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to DMARD Dose Reduction</measure>
    <time_frame>Baseline up to Month 6</time_frame>
    <description>DMARDs that met the criteria for &quot;concomitant medications&quot; were selected. The time to DMARD dose reduction was calculated as the difference between date of dose reduction and the date of first TCZ infusion. For participants presenting more than 1 DMARD dose reduction, only the first dose reduction was considered.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to DMARD Dose Withdrawal</measure>
    <time_frame>Baseline up to Month 6</time_frame>
    <description>DMARDs that met the criteria for &quot;concomitant medications&quot; were selected. The time to DMARD withdrawal was calculated as the difference between date of withdrawal and the date of first TCZ infusion.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants by Reason for DMARD Withdrawal During the Study</measure>
    <time_frame>Baseline up to Month 6</time_frame>
    <description>DMARDs that met the criteria for &quot;concomitant medications&quot; were selected. All treatments with DMARDs interrupted after the first TCZ infusion were selected.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Steroid Dose Reduction</measure>
    <time_frame>Baseline up to Month 6</time_frame>
    <description>Steroids that met the criteria for &quot;concomitant medications&quot; were selected. The time to steroid dose reduction was calculated as the difference between date of dose reduction and the date of first TCZ infusion. For participants presenting more than one steroid dose reduction, only the first dose reduction was considered.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Steroid Dose Withdrawal</measure>
    <time_frame>Baseline up to Month 6</time_frame>
    <description>Steroids that met the criteria for &quot;concomitant medications&quot; were selected. The time to steroid dose withdrawal was calculated as the difference between date of withdrawal and the date of first TCZ infusion.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in CRP at Month 3 and Month 6</measure>
    <time_frame>Baseline, Month 3, and Month 6</time_frame>
    <description>The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement. Change from baseline = CRP level at Month X - CRP level at baseline. Here X = 3 and 6 for Change at Months 3 and 6, respectively.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in ESR at Month 3 and Month 6</measure>
    <time_frame>Baseline, Month 3, and Month 6</time_frame>
    <description>ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 mm/hr. A decrease in the level indicates reduction in inflammation and therefore improvement. Change from baseline = ESR level at Month X - ESR level at baseline. Here X = 3 and 6 for Change at Months 3 and 6, respectively.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CRP at the Start of TCZ Treatment by Remission Status Using DAS28-CRP, SDAI, and CDAI at Month 6</measure>
    <time_frame>Baseline</time_frame>
    <description>The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement. DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity. DAS28 is calculated as follows: DAS28 = 0.56 x √TJC28 + 0.28 x √SJC28 + 0.36 x ln(CRP + 1) + 0.014 x PGH + 0.96, A score of &lt; 2.6 represents clinical remission. SDAI is a combined index for measuring disease activity in RA and calculated as SDAI = TJC28 + SJC28 + PGH (in cm) + PhGH (in cm) + CRP (in mg/dL). A SDAI score of ≤ 3.3 represents clinical remission. CDAI is a combined index for measuring disease activity in RA and calculated as CDAI = TJC28 + SJC28 + PGH (in cm) + PhGH (in cm). A CDAI score of ≤ 2.8 represents clinical remission.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body Mass Index (BMI) at the Start of TCZ Treatment by Remission Status Using DAS-28 CRP, SDAI, and CDAI at Month 6</measure>
    <time_frame>Baseline</time_frame>
    <description>DAS28 scale ranges from 0 to 10, and calculated as DAS28 = 0.56 x √TJC28 + 0.28 x √SJC28 + 0.36 x ln(CRP + 1) + 0.014 x PGH + 0.96, where TJC28 and SJC28 = tender joint and swollen joint count on 28 units, PGH = patient's global assessment of disease activity, assessed on a 100 mm VAS, where 0 mm = managing very well and 100 mm = managing very poorly, CRP = serum concentration of C-reactive protein. A score of &lt; 2.6 represents clinical remission. SDAI is a combined index for measuring disease activity in RA and calculated as SDAI = TJC28 + SJC28 + PGH (in cm) + PhGH (in cm) + CRP (in mg/dL), where PhGH = physician global assessment of disease activity, assessed on a 100 mm VAS, where 0 mm = no arthritis activity and 100mm = extremely active arthritis. A SDAI score of ≤ 3.3 represents clinical remission. CDAI is a combined index for measuring disease activity in RA and calculated as CDAI = TJC28 + SJC28 + PGH (in cm) + PhGH (in cm). A CDAI score of ≤ 2.8 represents clinical remission.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With and Without Morning Stiffness</measure>
    <time_frame>Month 3 and Month 6</time_frame>
    <description>Morning stiffness was defined by the time elapsed between the time of usual awakening (even if not in the morning) and the time the participant was able to resume normal activities without stiffness. The participant assessed morning stiffness based on the following criteria:&#xD;
Presence of participant's joints stiff when woke up that day, measured as yes (stiffness present) or no (stiffness not present);&#xD;
Duration of morning stiffness, measured by ticking 1 of the six categories: &lt; 30 minutes, 30 - 60 minutes, 60 - 120 minutes, 120 - 240 minutes, &gt; 240 minutes, and the whole day;&#xD;
Severity of morning stiffness measured using a ruler on a 100 mm VAS where the responses were on a continuous range from 0 mm = no stiffness to 100 mm = maximum stiffness.&#xD;
'Not estimable' represented that the participants were not able to quantify it. 'Not done' represented that the assessment was not performed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants by Duration of Morning Stiffness</measure>
    <time_frame>Month 3 and Month 6</time_frame>
    <description>Duration of morning stiffness was defined as the time elapsed between the time of usual awakening (even if not in the morning) and the time the participant was able to resume normal activities without stiffness. The participant reported the duration of morning stiffness in the case report form by ticking 1 of the following categories: no morning stiffness, &lt; 30 minutes, 30 - 60 minutes, 60 - 120 minutes, 120 - 240 minutes, &gt; 240 minutes, and the whole day. 'Not estimable' represented that the participants were not able to quantify it. 'Not done' represented that the assessment was not performed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CRP at the Start of TCZ Treatment by Morning Stiffness at Month 6</measure>
    <time_frame>Baseline</time_frame>
    <description>The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement. The participant reported the duration of morning stiffness in the case report form by ticking the categories: ≤ 30 minutes and &gt; 30 minutes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>BMI at the Start of TCZ Treatment by Morning Stiffness at Month 6</measure>
    <time_frame>Baseline</time_frame>
    <description>Morning stiffness was defined as the time elapsed between the time of usual awakening (even if not in the morning) and the time the participant was able to resume normal activities without stiffness. The participant reported the duration of morning stiffness in the case report form by ticking the categories: ≤ 30 minutes and &gt; 30 minutes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation Coefficient Between CRP (mg/dL) at the Start of TCZ Treatment and HAQ-DI (0-3) at Month 6</measure>
    <time_frame>Baseline and Month 6</time_frame>
    <description>The test for CRP is laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in level of CRP indicates reduction in inflammation and therefore improvement. HAQ-DI is a questionnaire that measures functional status (disability) and health-related QoL. It measures the participant's ability to perform everyday tasks. The index consists of 20 questions regarding the function of the upper and lower extremities. These questions are summarized in 8 categories: dressing and grooming, arising, eating, walking, hygiene, reach, grip and common activities over past week. Each question was evaluated according to the degree of severity on a 4-point scale ranging from 0 = without any difficulty to 3 = unable to do. Total score is average of all questions, which ranges from 0 to 3, where higher scores represent higher disease activity. The Pearson and Spearman correlation coefficients can range in value from -1 to +1.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation Coefficient Between Change From Baseline in CRP (mg/dL) and HAQ-DI (0-3) at Month 6</measure>
    <time_frame>Baseline and Month 6</time_frame>
    <description>CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in level of CRP indicates reduction in inflammation and therefore improvement. HAQ-DI is a questionnaire that measures functional status (disability) and health-related QoL. It measures the participant's ability to perform everyday tasks. The index consists of 20 questions regarding the function of the upper and lower extremities. These questions are summarized in 8 categories: dressing and grooming, arising, eating, walking, hygiene, reach, grip and common activities over past week. Each question was evaluated according to the degree of severity on a 4-point scale ranging from 0= without any difficulty to 3= unable to do. Total score is the average of all questions, which ranges from 0 to 3, where higher scores represent higher disease activity. The Pearson and Spearman correlation coefficients can range in value from -1 to +1.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation Coefficient Between CRP (mg/dL) at the Start of TCZ Treatment and VAS Fatigue at Month 6</measure>
    <time_frame>Baseline and Month 6</time_frame>
    <description>The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement. Participants measured the level of fatigue due to RA using a 100 mm VAS, where the responses were on a continuous range from 0 mm = no fatigue to 100 mm = extreme fatigue. The Pearson and Spearman correlation coefficients can range in value from -1 to +1.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation Coefficient Between Change From Baseline in CRP (mg/dL) at the Start of TCZ Treatment and Change From Baseline in VAS Fatigue at Month 6</measure>
    <time_frame>Baseline and Month 6</time_frame>
    <description>The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement. Participants measured the level of fatigue due to RA using a 100 mm VAS, where the responses were on a continuous range from 0 mm = no fatigue to 100 mm = extreme fatigue. The Pearson and Spearman correlation coefficients can range in value from -1 to +1.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation Coefficient Between BMI at the Start of TCZ Treatment and HAQ-DI (0-3) at Month 6</measure>
    <time_frame>Baseline and Month 6</time_frame>
    <description>The HAQ-DI is a questionnaire that measures functional status (disability) and health-related QoL. It measures the participant's ability to perform everyday tasks. The index consists of 20 questions regarding the function of the upper and lower extremities. These questions are summarized in 8 categories: dressing and grooming, arising, eating, walking, hygiene,reach, grip and common activities over past week. Each question was evaluated according to the degree of severity on a 4-point scale ranging from 0 = without any difficulty to 3 = unable to do. Total score is the average of all questions, which ranges from 0 to 3, where higher scores represent higher disease activity. The Pearson and Spearman correlation coefficients can range in value from -1 to +1.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation Coefficient Between Change From Baseline in CRP (mg/dL) and Change From Baseline in Morning Stiffness According to VAS at Month 6</measure>
    <time_frame>Baseline and Month 6</time_frame>
    <description>The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement. Morning stiffness was defined as the time elapsed between the time of usual awakening (even if not in the morning) and the time the participant was able to resume normal activities without stiffness. The participant reported the duration of morning stiffness in the case report form by ticking 1 of the following categories: no morning stiffness, &lt; 30 minutes, 30 - 60 minutes, 60 - 120 minutes, 120 - 240 minutes, &gt; 240 minutes, and the whole day. The Pearson and Spearman correlation coefficients can range in value from -1 to +1.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation Coefficient Between BMI at the Start of TCZ Treatment and VAS Fatigue at Month 6</measure>
    <time_frame>Baseline and Month 6</time_frame>
    <description>Participants measured the level of fatigue due to RA using a 100 mm VAS, where the responses were on a continuous range from 0 mm = no fatigue to 100 mm = extreme fatigue. The Pearson and Spearman correlation coefficients can range in value from -1 to +1.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">151</enrollment>
  <condition>Rheumatoid Arthritis</condition>
  <arm_group>
    <arm_group_label>RA Participants</arm_group_label>
    <description>Participants with moderate or severe RA who are under tocilizumab treatment in routine clinical practice (in accordance with the local label) will be observed for 6 months from the start of treatment.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tocilizumab</intervention_name>
    <description>Tocilizumab will be administered in routine clinical practice in accordance with local label. Study protocol does not specify/enforce any treatment regimen.</description>
    <arm_group_label>RA Participants</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Participants with moderate to severe RA who are being treated or begin treatment with&#xD;
        tocilizumab according to routine clinical practice.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of moderate to severe RA according to revised American College of&#xD;
             Rheumatology criteria&#xD;
&#xD;
          -  Participants have started tocilizumab treatment according to routine clinical practice&#xD;
             within 3 months prior to site opening and still in treatment, as well as participants&#xD;
             who began treatment at enrollment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participants who have started tocilizumab treatment more than 3 months prior to site&#xD;
             opening&#xD;
&#xD;
          -  Participants who have previously received tocilizumab in a clinical trial setting or&#xD;
             for compassionate use&#xD;
&#xD;
          -  Participants who have been enrolled in an ongoing clinical trial and/or have received&#xD;
             treatment with any investigational drug within 4 weeks prior to study start&#xD;
&#xD;
          -  Participants with a history of autoimmune disease or joint inflammatory disease other&#xD;
             than RA&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Clinical Trials</last_name>
    <role>Study Director</role>
    <affiliation>Hoffmann-La Roche</affiliation>
  </overall_official>
  <location>
    <facility>
      <address>
        <city>Coppito</city>
        <state>Abruzzo</state>
        <zip>67100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Reggio Calabria</city>
        <state>Calabria</state>
        <zip>89133</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Benevento</city>
        <state>Campania</state>
        <zip>82100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Telese Terme</city>
        <state>Campania</state>
        <zip>82037</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Bologna</city>
        <state>Emilia-Romagna</state>
        <zip>40138</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Roma</city>
        <state>Lazio</state>
        <zip>00128</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Bergamo</city>
        <state>Lombardia</state>
        <zip>24127</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Castel Goffredo</city>
        <state>Lombardia</state>
        <zip>46042</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Gavardo</city>
        <state>Lombardia</state>
        <zip>25085</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Milano</city>
        <state>Lombardia</state>
        <zip>20122</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Monza</city>
        <state>Lombardia</state>
        <zip>20052</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Pavia</city>
        <state>Lombardia</state>
        <zip>27100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Novara</city>
        <state>Piemonte</state>
        <zip>28100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Barletta</city>
        <state>Puglia</state>
        <zip>76121</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Casarano (LE)</city>
        <state>Puglia</state>
        <zip>73042</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Foggia</city>
        <state>Puglia</state>
        <zip>71100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Catania</city>
        <state>Sicilia</state>
        <zip>95124</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Catania</city>
        <state>Sicilia</state>
        <zip>95126</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Palermo</city>
        <state>Sicilia</state>
        <zip>90146</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Firenze</city>
        <state>Toscana</state>
        <zip>50139</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Pisa</city>
        <state>Toscana</state>
        <zip>56100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Cona (Ferrara)</city>
        <state>Veneto</state>
        <zip>44124</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Verona</city>
        <state>Veneto</state>
        <zip>37126</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Verona</city>
        <state>Veneto</state>
        <zip>37134</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>April 2017</verification_date>
  <study_first_submitted>August 7, 2012</study_first_submitted>
  <study_first_submitted_qc>August 10, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 14, 2012</study_first_posted>
  <results_first_submitted>January 26, 2017</results_first_submitted>
  <results_first_submitted_qc>April 14, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">July 13, 2017</results_first_posted>
  <last_update_submitted>April 14, 2017</last_update_submitted>
  <last_update_submitted_qc>April 14, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">July 13, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Arthritis</mesh_term>
    <mesh_term>Arthritis, Rheumatoid</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>A total of 151 participants were enrolled in the study; of which,136 participants met the eligibility criteria. The results are reported only for those participants who met the eligibility criteria.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Rheumatoid Arthritis (RA) Participants</title>
          <description>Participants with moderate or severe RA who were under tocilizumab (TCZ) treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="136"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="120"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="16"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lack of Efficacy</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Unknown: Reason Unrelated to TCZ</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>All enrolled participants evaluable for primary objective: All enrolled participants except participants who withdrew from study for reasons not related to TCZ and had not interrupted TCZ treatment at withdrawal; lost to follow-up participants in treatment with TCZ at withdrawal; or premature termination occurring until 5 months from start of TCZ.</population>
      <group_list>
        <group group_id="B1">
          <title>RA Participants</title>
          <description>Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="133"/>
          </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="56.5" spread="11.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="114"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants on TCZ Treatment at Month 6</title>
        <description>Percentage of participants on TCZ treatment at Month 6 was calculated as: [(participants on TCZ treatment at Month 6) divided by (participants evaluable for primary objective)] multiplied by 100. Confidence interval was computed based on the Clopper-Pearson method.</description>
        <time_frame>Month 6</time_frame>
        <population>All enrolled participants evaluable for primary objective.</population>
        <group_list>
          <group group_id="O1">
            <title>RA Participants</title>
            <description>Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants on TCZ Treatment at Month 6</title>
          <description>Percentage of participants on TCZ treatment at Month 6 was calculated as: [(participants on TCZ treatment at Month 6) divided by (participants evaluable for primary objective)] multiplied by 100. Confidence interval was computed based on the Clopper-Pearson method.</description>
          <population>All enrolled participants evaluable for primary objective.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="133"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="86.5" lower_limit="79.46" upper_limit="91.78"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants by TCZ Dose at Month 6</title>
        <description>TCZ dose at Month 6 was calculated over the total number of participants evaluable for the primary objective and who did not interrupt TCZ. Percentage of participants on TCZ dose at Month 6 was calculated as the [(participants with specified TCZ dose at 6 months) divided by (participants who did not interrupt TCZ at Month 6)] multiplied by 100.</description>
        <time_frame>Month 6</time_frame>
        <population>All enrolled participants evaluable for primary objective and who did not interrupt TCZ at Month 6.</population>
        <group_list>
          <group group_id="O1">
            <title>RA Participants</title>
            <description>Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants by TCZ Dose at Month 6</title>
          <description>TCZ dose at Month 6 was calculated over the total number of participants evaluable for the primary objective and who did not interrupt TCZ. Percentage of participants on TCZ dose at Month 6 was calculated as the [(participants with specified TCZ dose at 6 months) divided by (participants who did not interrupt TCZ at Month 6)] multiplied by 100.</description>
          <population>All enrolled participants evaluable for primary objective and who did not interrupt TCZ at Month 6.</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="115"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>8 milligrams per kilogram (mg/kg)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="93.91"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>4 mg/kg</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.74"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6.35 mg/kg</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.87"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>7.1 mg/kg</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.87"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>7.6 mg/kg</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.87"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6.4 mg/kg</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.87"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Not available</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.87"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Starting TCZ After Inadequate Response (IR) to a Biologic Treatment or After Intolerance or IR to Disease-Modifying Anti-Rheumatic Drugs (DMARDs)</title>
        <description>Participants with at least 1 treatment with biologic agent not equal missing and which is not ongoing or with a stop date lower or equal to first TCZ administration had IR to biologic treatment. Participants with at least 1 treatment with DMARDs with a stop date lower or equal to first TCZ administration had IR to DMARDs. Participants with a biologic and DMARDs interruption or with a biologic interruption and ongoing treatment with DMARDs were classified in &quot;IR to biologic group&quot;. Participants with DMARDs interruption or ongoing DMARDs and adding TCZ without a biologic interruption were classified in the &quot;DMARDs intolerance and/or IR&quot; group.</description>
        <time_frame>Baseline</time_frame>
        <population>All enrolled participants evaluable for primary objective.</population>
        <group_list>
          <group group_id="O1">
            <title>RA Participants</title>
            <description>Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Starting TCZ After Inadequate Response (IR) to a Biologic Treatment or After Intolerance or IR to Disease-Modifying Anti-Rheumatic Drugs (DMARDs)</title>
          <description>Participants with at least 1 treatment with biologic agent not equal missing and which is not ongoing or with a stop date lower or equal to first TCZ administration had IR to biologic treatment. Participants with at least 1 treatment with DMARDs with a stop date lower or equal to first TCZ administration had IR to DMARDs. Participants with a biologic and DMARDs interruption or with a biologic interruption and ongoing treatment with DMARDs were classified in &quot;IR to biologic group&quot;. Participants with DMARDs interruption or ongoing DMARDs and adding TCZ without a biologic interruption were classified in the &quot;DMARDs intolerance and/or IR&quot; group.</description>
          <population>All enrolled participants evaluable for primary objective.</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="133"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>IR to biologic treatment</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="62.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Intolerance or IR to DMARDs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="37.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time Elapsed From Diagnosis of RA</title>
        <description>Time elapsed from diagnosis of RA in years was calculated as the (difference between the date of enrollment visit and the date of first diagnosis of RA) divided by 365.25.</description>
        <time_frame>Baseline (assessed retrospectively)</time_frame>
        <population>All enrolled participants evaluable for primary objective with available data for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>RA Participants</title>
            <description>Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.</description>
          </group>
        </group_list>
        <measure>
          <title>Time Elapsed From Diagnosis of RA</title>
          <description>Time elapsed from diagnosis of RA in years was calculated as the (difference between the date of enrollment visit and the date of first diagnosis of RA) divided by 365.25.</description>
          <population>All enrolled participants evaluable for primary objective with available data for this outcome measure.</population>
          <units>years</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="131"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.5" lower_limit="0.3" upper_limit="49.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Patient Assessment of Pain Using Visual Analog Scale (VAS) at Baseline</title>
        <description>Participants measured the pain intensity due to RA on a 100 millimeter (mm) VAS, where the responses were on a continuous range from 0 mm = no pain to 100 mm = unbearable pain.</description>
        <time_frame>Baseline</time_frame>
        <population>All enrolled participants evaluable for primary objective with available data for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>RA Participants</title>
            <description>Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.</description>
          </group>
        </group_list>
        <measure>
          <title>Patient Assessment of Pain Using Visual Analog Scale (VAS) at Baseline</title>
          <description>Participants measured the pain intensity due to RA on a 100 millimeter (mm) VAS, where the responses were on a continuous range from 0 mm = no pain to 100 mm = unbearable pain.</description>
          <population>All enrolled participants evaluable for primary objective with available data for this outcome measure.</population>
          <units>mm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="125"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="61.3" spread="28.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Patient Global Assessment of Disease Activity (PGH) Using VAS at Baseline</title>
        <description>The PGH was measured using a 100 mm VAS, where the responses were on a continuous range from 0 mm = managing very well to 100 mm = managing very poorly.</description>
        <time_frame>Baseline</time_frame>
        <population>All enrolled participants evaluable for primary objective with available data for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>RA Participants</title>
            <description>Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.</description>
          </group>
        </group_list>
        <measure>
          <title>Patient Global Assessment of Disease Activity (PGH) Using VAS at Baseline</title>
          <description>The PGH was measured using a 100 mm VAS, where the responses were on a continuous range from 0 mm = managing very well to 100 mm = managing very poorly.</description>
          <population>All enrolled participants evaluable for primary objective with available data for this outcome measure.</population>
          <units>mm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="117"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="61.0" spread="28.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Physician Global Assessment of Disease Activity (PhGH) Using VAS at Baseline</title>
        <description>The PhGH was measured on a 100 mm VAS, where 0 mm = no arthritis activity to 100 mm = extremely active arthritis.</description>
        <time_frame>Baseline</time_frame>
        <population>All enrolled participants evaluable for primary objective with available data for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>RA Participants</title>
            <description>Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.</description>
          </group>
        </group_list>
        <measure>
          <title>Physician Global Assessment of Disease Activity (PhGH) Using VAS at Baseline</title>
          <description>The PhGH was measured on a 100 mm VAS, where 0 mm = no arthritis activity to 100 mm = extremely active arthritis.</description>
          <population>All enrolled participants evaluable for primary objective with available data for this outcome measure.</population>
          <units>mm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="114"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="53.4" spread="24.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Participant Assessment of Morning Stiffness Using VAS at Baseline</title>
        <description>The participant assessment of morning stiffness was measured using a ruler on a 100 mm VAS, where the responses were on a continuous range from 0 mm = no stiffness and 100 mm = maximum stiffness.</description>
        <time_frame>Baseline</time_frame>
        <population>All enrolled participants evaluable for primary objective with available data for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>RA Participants</title>
            <description>Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.</description>
          </group>
        </group_list>
        <measure>
          <title>Participant Assessment of Morning Stiffness Using VAS at Baseline</title>
          <description>The participant assessment of morning stiffness was measured using a ruler on a 100 mm VAS, where the responses were on a continuous range from 0 mm = no stiffness and 100 mm = maximum stiffness.</description>
          <population>All enrolled participants evaluable for primary objective with available data for this outcome measure.</population>
          <units>mm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="50"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="47.0" spread="32.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Participant Assessment of Fatigue Using VAS at Baseline</title>
        <description>Participants measured the level of fatigue due to RA using a 100 mm VAS, where the responses were on a continuous range from 0 mm = no fatigue to 100 mm = extreme fatigue.</description>
        <time_frame>Baseline</time_frame>
        <population>All enrolled participants evaluable for primary objective with available data for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>RA Participants</title>
            <description>Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.</description>
          </group>
        </group_list>
        <measure>
          <title>Participant Assessment of Fatigue Using VAS at Baseline</title>
          <description>Participants measured the level of fatigue due to RA using a 100 mm VAS, where the responses were on a continuous range from 0 mm = no fatigue to 100 mm = extreme fatigue.</description>
          <population>All enrolled participants evaluable for primary objective with available data for this outcome measure.</population>
          <units>mm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="91"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="57.1" spread="29.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Health Assessment Questionnaire Disability Index (HAQ-DI) Score at Baseline</title>
        <description>The HAQ-DI is a questionnaire that measures functional status (disability) and health-related quality of life (QoL). It measures the participant's ability to perform everyday tasks. The index consists of 20 questions regarding the function of the upper and lower extremities. These questions are summarized in 8 categories: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and common activities over past week. Each question was evaluated according to the degree of severity on a 4-point scale ranging from 0 = without any difficulty to 3 = unable to do. Total score for HAQ-DI is the average of all questions and ranges from 0 to 3, where higher scores represent higher disease activity.</description>
        <time_frame>Baseline</time_frame>
        <population>All enrolled participants evaluable for primary objective with available data for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>RA Participants</title>
            <description>Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.</description>
          </group>
        </group_list>
        <measure>
          <title>Health Assessment Questionnaire Disability Index (HAQ-DI) Score at Baseline</title>
          <description>The HAQ-DI is a questionnaire that measures functional status (disability) and health-related quality of life (QoL). It measures the participant's ability to perform everyday tasks. The index consists of 20 questions regarding the function of the upper and lower extremities. These questions are summarized in 8 categories: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and common activities over past week. Each question was evaluated according to the degree of severity on a 4-point scale ranging from 0 = without any difficulty to 3 = unable to do. Total score for HAQ-DI is the average of all questions and ranges from 0 to 3, where higher scores represent higher disease activity.</description>
          <population>All enrolled participants evaluable for primary objective with available data for this outcome measure.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="111"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.4" spread="0.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Tender Joint Count (TJC) at Baseline</title>
        <description>TJC was determined by examining 28 joints and identifying the joints that were painful under pressure or to passive motion. Tenderness was recorded on the joint assessment form at baseline; no tenderness = 0 and tenderness = 1.</description>
        <time_frame>Baseline</time_frame>
        <population>All enrolled participants evaluable for primary objective with available data for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>RA Participants</title>
            <description>Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.</description>
          </group>
        </group_list>
        <measure>
          <title>Tender Joint Count (TJC) at Baseline</title>
          <description>TJC was determined by examining 28 joints and identifying the joints that were painful under pressure or to passive motion. Tenderness was recorded on the joint assessment form at baseline; no tenderness = 0 and tenderness = 1.</description>
          <population>All enrolled participants evaluable for primary objective with available data for this outcome measure.</population>
          <units>tender joints</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="130"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.5" spread="7.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Swollen Joint Count (SJC) at Baseline</title>
        <description>SJC was determined by examining 28 joints and identifying when swelling was present. Swelling was recorded on the joint assessment form at baseline; no swelling = 0 and swelling = 1.</description>
        <time_frame>Baseline</time_frame>
        <population>All enrolled participants evaluable for primary objective with available data for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>RA Participants</title>
            <description>Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.</description>
          </group>
        </group_list>
        <measure>
          <title>Swollen Joint Count (SJC) at Baseline</title>
          <description>SJC was determined by examining 28 joints and identifying when swelling was present. Swelling was recorded on the joint assessment form at baseline; no swelling = 0 and swelling = 1.</description>
          <population>All enrolled participants evaluable for primary objective with available data for this outcome measure.</population>
          <units>swollen joints</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="130"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.7" spread="5.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Erythrocyte Sedimentation Rate (ESR) at Baseline</title>
        <description>ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 millimeter per hour (mm/hour). A decrease in the level indicates reduction in inflammation and therefore improvement.</description>
        <time_frame>Baseline</time_frame>
        <population>All enrolled participants evaluable for primary objective with available data for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>RA Participants</title>
            <description>Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.</description>
          </group>
        </group_list>
        <measure>
          <title>Erythrocyte Sedimentation Rate (ESR) at Baseline</title>
          <description>ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 millimeter per hour (mm/hour). A decrease in the level indicates reduction in inflammation and therefore improvement.</description>
          <population>All enrolled participants evaluable for primary objective with available data for this outcome measure.</population>
          <units>mm/hour</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="131"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="33.0" spread="25.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>C-Reactive Protein (CRP) at Baseline</title>
        <description>The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.</description>
        <time_frame>Baseline</time_frame>
        <population>All enrolled participants evaluable for primary objective with available data for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>RA Participants</title>
            <description>Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.</description>
          </group>
        </group_list>
        <measure>
          <title>C-Reactive Protein (CRP) at Baseline</title>
          <description>The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.</description>
          <population>All enrolled participants evaluable for primary objective with available data for this outcome measure.</population>
          <units>milligrams per deciliter (mg/dL)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="126"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.7" spread="7.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Presence of Extra-Articular Systemic Features of RA at Baseline</title>
        <description>Extra-articular systemic features referred to anemia, fatigue as well as a wide range of co-morbidities such as osteoporosis and other iatrogenic complications. Percentage of participants with any of the extra-articular systemic feature are reported.</description>
        <time_frame>Baseline</time_frame>
        <population>All enrolled participants evaluable for primary objective with available data for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>RA Participants</title>
            <description>Participants with moderate or severe RA were prescribed with tocilizumab, in accordance with routine clinic practice, and following the local label were observed for 6 months with maximum study duration of 18 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Presence of Extra-Articular Systemic Features of RA at Baseline</title>
          <description>Extra-articular systemic features referred to anemia, fatigue as well as a wide range of co-morbidities such as osteoporosis and other iatrogenic complications. Percentage of participants with any of the extra-articular systemic feature are reported.</description>
          <population>All enrolled participants evaluable for primary objective with available data for this outcome measure.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="128"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Evidence of Structural Joint Damage at Baseline</title>
        <time_frame>Baseline</time_frame>
        <population>All enrolled participants evaluable for primary objective with available data for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>RA Participants</title>
            <description>Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Evidence of Structural Joint Damage at Baseline</title>
          <population>All enrolled participants evaluable for primary objective with available data for this outcome measure.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="114"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="71.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Previous RA-Related Surgical Procedures at Baseline</title>
        <time_frame>Baseline</time_frame>
        <population>All enrolled participants evaluable for primary objective with available data for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>RA Participants</title>
            <description>Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Previous RA-Related Surgical Procedures at Baseline</title>
          <population>All enrolled participants evaluable for primary objective with available data for this outcome measure.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="124"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Positive Rheumatoid Factor (RF) at Baseline</title>
        <description>RF is the auto antibody directed against immunoglobulin G and its concentration is observed in human serum or plasma. RF value higher than 20 units per milliliter is considered positive.</description>
        <time_frame>Baseline</time_frame>
        <population>All enrolled participants evaluable for primary objective with available data for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>RA Participants</title>
            <description>Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Positive Rheumatoid Factor (RF) at Baseline</title>
          <description>RF is the auto antibody directed against immunoglobulin G and its concentration is observed in human serum or plasma. RF value higher than 20 units per milliliter is considered positive.</description>
          <population>All enrolled participants evaluable for primary objective with available data for this outcome measure.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="116"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="59.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Anti-Citrullinated Cyclic Peptide at Baseline</title>
        <time_frame>Baseline</time_frame>
        <population>All enrolled participants evaluable for primary objective with available data for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>RA Participants</title>
            <description>Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Anti-Citrullinated Cyclic Peptide at Baseline</title>
          <population>All enrolled participants evaluable for primary objective with available data for this outcome measure.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="103"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="58.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants by Duration of Morning Stiffness at Baseline</title>
        <description>Duration of morning stiffness was defined as the time elapsed between the time of usual awakening (even if not in the morning) and the time the participant was able to resume normal activities without stiffness. The participant reported the duration of morning stiffness in the case report form by ticking 1 of the following categories: no morning stiffness, less than (&lt;) 30 minutes, 30 - 60 minutes, 60 - 120 minutes, 120 - 240 minutes, greater than (&gt;) 240 minutes, and the whole day. 'Not estimable' represented that the participants were not able to quantify it.</description>
        <time_frame>Baseline</time_frame>
        <population>All enrolled participants evaluable for primary objective.</population>
        <group_list>
          <group group_id="O1">
            <title>RA Participants</title>
            <description>Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants by Duration of Morning Stiffness at Baseline</title>
          <description>Duration of morning stiffness was defined as the time elapsed between the time of usual awakening (even if not in the morning) and the time the participant was able to resume normal activities without stiffness. The participant reported the duration of morning stiffness in the case report form by ticking 1 of the following categories: no morning stiffness, less than (&lt;) 30 minutes, 30 - 60 minutes, 60 - 120 minutes, 120 - 240 minutes, greater than (&gt;) 240 minutes, and the whole day. 'Not estimable' represented that the participants were not able to quantify it.</description>
          <population>All enrolled participants evaluable for primary objective.</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="133"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>No morning stiffness</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>&lt; 30 minutes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Between 30 - 60 minutes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Between 60 - 120 minutes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Between 120 - 240 minutes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>&gt; 240 minutes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>The whole day</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Not estimable</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With TCZ Dose Change According to the Reason for Change</title>
        <description>Number of participants with TCZ dose change (increase or decrease with respect to starting dose) was reported by reason for change.</description>
        <time_frame>Baseline up to Month 6</time_frame>
        <population>All enrolled participants evaluable for the primary objective and had TCZ dose modification.</population>
        <group_list>
          <group group_id="O1">
            <title>RA Participants</title>
            <description>Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With TCZ Dose Change According to the Reason for Change</title>
          <description>Number of participants with TCZ dose change (increase or decrease with respect to starting dose) was reported by reason for change.</description>
          <population>All enrolled participants evaluable for the primary objective and had TCZ dose modification.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Adverse event</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Physician decision</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Weight variation</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants by Number of TCZ Dose Modifications Per Participant</title>
        <description>The number of TCZ dose modifications per participant was calculated as the number of times that the participant changed the prescribed dose with respect to the dose planned at enrollment/previous administration. If the participant did not change the prescribed dose, the values were set at missing.</description>
        <time_frame>Baseline up to Month 6</time_frame>
        <population>All enrolled participants evaluable for primary objective.</population>
        <group_list>
          <group group_id="O1">
            <title>RA Participants</title>
            <description>Participants with moderate or severe RA who were prescribed with tocilizumab, in accordance with routine clinic practice, and following the local label were observed for 6 months with maximum study duration of 18 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants by Number of TCZ Dose Modifications Per Participant</title>
          <description>The number of TCZ dose modifications per participant was calculated as the number of times that the participant changed the prescribed dose with respect to the dose planned at enrollment/previous administration. If the participant did not change the prescribed dose, the values were set at missing.</description>
          <population>All enrolled participants evaluable for primary objective.</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="133"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>0 dose modification</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="95.49"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 dose modification</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2 dose modifications</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.01"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time in Days Elapsed Between TCZ Infusions</title>
        <description>The time elapsed in days between TCZ infusions was calculated as the difference between the date of TCZ infusion and the date of the previous administration.</description>
        <time_frame>Baseline up to Month 6 (assessed retrospectively and prospectively at each administration [approximately 1 month apart] up to administration 8</time_frame>
        <population>All enrolled participants evaluable for primary objective. Here, Number of participants analyzed = participants evaluable for the outcome measure and number analyzed = participants with available data for specified category.</population>
        <group_list>
          <group group_id="O1">
            <title>RA Participants</title>
            <description>Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.</description>
          </group>
        </group_list>
        <measure>
          <title>Time in Days Elapsed Between TCZ Infusions</title>
          <description>The time elapsed in days between TCZ infusions was calculated as the difference between the date of TCZ infusion and the date of the previous administration.</description>
          <population>All enrolled participants evaluable for primary objective. Here, Number of participants analyzed = participants evaluable for the outcome measure and number analyzed = participants with available data for specified category.</population>
          <units>days</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="130"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Infusion 1 and Infusion 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="130"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31" lower_limit="28" upper_limit="35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Infusion 2 and Infusion 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="124"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31.5" lower_limit="28.5" upper_limit="34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Infusion 3 and Infusion 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="121"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31" lower_limit="28" upper_limit="35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Infusion 4 and Infusion 5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="115"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30" lower_limit="28" upper_limit="35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Infusion 5 and Infusion 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="107"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31" lower_limit="28" upper_limit="35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Infusion 6 and Infusion 7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="79"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29" lower_limit="28" upper_limit="33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Infusion 7 and Infusion 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28" lower_limit="28" upper_limit="31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With TCZ Infusion Interruption</title>
        <description>The percentage of participants with at least one infusion interruption was reported as &quot;Yes&quot;. Participants with unknown infusion interruption were set to &quot;No&quot;.</description>
        <time_frame>Baseline up to Month 6</time_frame>
        <population>All enrolled participants evaluable for primary objective.</population>
        <group_list>
          <group group_id="O1">
            <title>RA Participants</title>
            <description>Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With TCZ Infusion Interruption</title>
          <description>The percentage of participants with at least one infusion interruption was reported as &quot;Yes&quot;. Participants with unknown infusion interruption were set to &quot;No&quot;.</description>
          <population>All enrolled participants evaluable for primary objective.</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="133"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Yes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.01"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="96.99"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Who Discontinued TCZ by Reason for Discontinuation</title>
        <time_frame>Baseline up to Month 6</time_frame>
        <population>All enrolled participants evaluable for primary objective who discontinued TCZ.</population>
        <group_list>
          <group group_id="O1">
            <title>RA Participants</title>
            <description>Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Discontinued TCZ by Reason for Discontinuation</title>
          <population>All enrolled participants evaluable for primary objective who discontinued TCZ.</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="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Adverse event</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="50.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lack of or insufficient efficacy</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="33.33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Unspecified</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With TCZ Reintroduction</title>
        <description>The percentage of participants with at least one TCZ reintroduction was reported as &quot;Yes&quot;. Participants with unknown TCZ reintroduction were set to &quot;No&quot;.</description>
        <time_frame>Baseline up to Month 6</time_frame>
        <population>All enrolled participants evaluable for primary objective.</population>
        <group_list>
          <group group_id="O1">
            <title>RA Participants</title>
            <description>Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With TCZ Reintroduction</title>
          <description>The percentage of participants with at least one TCZ reintroduction was reported as &quot;Yes&quot;. Participants with unknown TCZ reintroduction were set to &quot;No&quot;.</description>
          <population>All enrolled participants evaluable for primary objective.</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="133"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Yes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="98.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants by Reason for Choice of TCZ Monotherapy at Baseline</title>
        <time_frame>Baseline</time_frame>
        <population>All enrolled participants evaluable for primary objective with available data for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>RA Participants</title>
            <description>Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants by Reason for Choice of TCZ Monotherapy at Baseline</title>
          <population>All enrolled participants evaluable for primary objective with available data for this outcome measure.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="40"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Lack of DMARD efficacy</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>DMARD intolerability</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="85"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Both lack of efficacy and intolerability to DMARDs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Disease Activity Score Based on 28 Joint Count (DAS28) Score at Month 3 and Month 6</title>
        <description>DAS28 score is a measurement of RA activity on a 0 to 10 scale, with higher scores representing higher disease activity, and calculated as DAS28 = 0.56 x √TJC28 + 0.28 x √SJC28 + 0.36 x natural logarithm (ln) (CRP + 1) + 0.014 x PGH + 0.96, where TJC28 = tender joint count on 28 units, SJC28 = swollen joint count on 28 units, CRP = serum concentration of c-reactive protein (after converting units to mg/dL), PGH = patient global assessment of disease activity, which was measured on a 100 mm VAS, where 0 mm = managing very well and 100 mm = managing very poorly (√ = square root). A score of &lt; 2.6 represents clinical remission, a score of greater than or equal to (≥) 2.6 and less than or equal to (≤) 3.2 represents low disease activity, a score of &gt; 3.2 and ≤ 5.1 represents moderate disease activity and a score of &gt; 5.1 represents high (or severe) disease activity. Change from baseline = DAS28 at Month X - DAS28 at baseline. Here X = 3 and 6 for Change at Months 3 and 6, respectively.</description>
        <time_frame>Baseline, Month 3, and Month 6</time_frame>
        <population>All enrolled participants evaluable for primary objective with available data for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>RA Participants</title>
            <description>Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Disease Activity Score Based on 28 Joint Count (DAS28) Score at Month 3 and Month 6</title>
          <description>DAS28 score is a measurement of RA activity on a 0 to 10 scale, with higher scores representing higher disease activity, and calculated as DAS28 = 0.56 x √TJC28 + 0.28 x √SJC28 + 0.36 x natural logarithm (ln) (CRP + 1) + 0.014 x PGH + 0.96, where TJC28 = tender joint count on 28 units, SJC28 = swollen joint count on 28 units, CRP = serum concentration of c-reactive protein (after converting units to mg/dL), PGH = patient global assessment of disease activity, which was measured on a 100 mm VAS, where 0 mm = managing very well and 100 mm = managing very poorly (√ = square root). A score of &lt; 2.6 represents clinical remission, a score of greater than or equal to (≥) 2.6 and less than or equal to (≤) 3.2 represents low disease activity, a score of &gt; 3.2 and ≤ 5.1 represents moderate disease activity and a score of &gt; 5.1 represents high (or severe) disease activity. Change from baseline = DAS28 at Month X - DAS28 at baseline. Here X = 3 and 6 for Change at Months 3 and 6, respectively.</description>
          <population>All enrolled participants evaluable for primary objective with available data for this outcome measure.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="37"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.16" spread="1.06"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Month 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.99" spread="1.04"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Month 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.15" spread="1.26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>P-value was calculated between baseline versus change at Month 3.</p_value_desc>
            <method>Wilcoxon test</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>P-value was calculated between baseline versus change at Month 6.</p_value_desc>
            <method>Wilcoxon test</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Simplified Disease Activity Index (SDAI) Score at Month 3 and Month 6</title>
        <description>SDAI is a combined index for measuring disease activity in RA and calculated as SDAI = TJC28 + SJC28 + PGH (in cm) + PhGH (in cm) + CRP (in mg/dL), where TJC28 = tender joint count on 28 units, SJC28 = swollen joint count on 28 units, PGH = patient's global assessment of disease activity, assessed on a 100 mm VAS, where 0 = managing very well and 100 = managing very poorly, PhGH = physician global assessment of disease activity, assessed on a 100 mm VAS, where 0 mm = no arthritis activity and 100 mm = extremely active arthritis, CRP = serum concentration of C-reactive protein. SDAI total score ranged from 0-86. Higher scores represent greater disease activity. SDAI scores of ≤ 3.3 represents clinical remission, ≤ 11.0 represents low disease activity , ≤ 26.0 represents moderate disease activity, and &gt; 26.0 represents high (or severe) disease activity. Change from baseline = SDAI score at Month X - SDAI score at baseline. Here X = 3 and 6 for Change at Months 3 and 6, respectively.</description>
        <time_frame>Baseline, Month 3, and Month 6</time_frame>
        <population>All enrolled participants evaluable for primary objective with available data for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>RA Participants</title>
            <description>Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Simplified Disease Activity Index (SDAI) Score at Month 3 and Month 6</title>
          <description>SDAI is a combined index for measuring disease activity in RA and calculated as SDAI = TJC28 + SJC28 + PGH (in cm) + PhGH (in cm) + CRP (in mg/dL), where TJC28 = tender joint count on 28 units, SJC28 = swollen joint count on 28 units, PGH = patient's global assessment of disease activity, assessed on a 100 mm VAS, where 0 = managing very well and 100 = managing very poorly, PhGH = physician global assessment of disease activity, assessed on a 100 mm VAS, where 0 mm = no arthritis activity and 100 mm = extremely active arthritis, CRP = serum concentration of C-reactive protein. SDAI total score ranged from 0-86. Higher scores represent greater disease activity. SDAI scores of ≤ 3.3 represents clinical remission, ≤ 11.0 represents low disease activity , ≤ 26.0 represents moderate disease activity, and &gt; 26.0 represents high (or severe) disease activity. Change from baseline = SDAI score at Month X - SDAI score at baseline. Here X = 3 and 6 for Change at Months 3 and 6, respectively.</description>
          <population>All enrolled participants evaluable for primary objective with available data for this outcome measure.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="61"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35.12" spread="20.50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Month 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19.37" spread="17.08"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Month 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.35" spread="22.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>P-value was calculated between baseline versus change at Month 3.</p_value_desc>
            <method>Wilcoxon test</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>Wilcoxon test</method>
            <method_desc>P-value was calculated between baseline versus change at Month 6.</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Clinical Disease Activity Index (CDAI) Score at Month 3 and Month 6</title>
        <description>The CDAI is a combined index for measuring disease activity in RA and calculated as CDAI = TJC28 + SJC28 + PGH (in cm) + PhGH (in cm), where TJC28 = tender joint count on 28 units, SJC28 = swollen joint count on 28 units, PGH = patient's global assessment of disease activity, assessed on a 100 mm VAS, where 0 = managing very well and 100 = managing very poorly, and PhGH = physician global assessment of disease activity, assessed on a 100 mm VAS, where 0 mm = no arthritis activity and 100 mm = extremely active arthritis. CDAI total score ranged from 0-76. Higher scores indicate greater disease activity. CDAI score of ≤ 2.8 represents clinical remission, score of ≤ 10.0 represents low disease activity, score of ≤ 22.0 represents moderate disease activity, and score of &gt; 22.0 represents high (or severe) disease activity. Change from baseline = CDAI score at Month X - CDAI score at baseline. Here X = 3 and 6 for Change at Months 3 and 6, respectively.</description>
        <time_frame>Baseline, Month 3, and Month 6</time_frame>
        <population>All enrolled participants evaluable for primary objective with available data for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>RA Participants</title>
            <description>Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Clinical Disease Activity Index (CDAI) Score at Month 3 and Month 6</title>
          <description>The CDAI is a combined index for measuring disease activity in RA and calculated as CDAI = TJC28 + SJC28 + PGH (in cm) + PhGH (in cm), where TJC28 = tender joint count on 28 units, SJC28 = swollen joint count on 28 units, PGH = patient's global assessment of disease activity, assessed on a 100 mm VAS, where 0 = managing very well and 100 = managing very poorly, and PhGH = physician global assessment of disease activity, assessed on a 100 mm VAS, where 0 mm = no arthritis activity and 100 mm = extremely active arthritis. CDAI total score ranged from 0-76. Higher scores indicate greater disease activity. CDAI score of ≤ 2.8 represents clinical remission, score of ≤ 10.0 represents low disease activity, score of ≤ 22.0 represents moderate disease activity, and score of &gt; 22.0 represents high (or severe) disease activity. Change from baseline = CDAI score at Month X - CDAI score at baseline. Here X = 3 and 6 for Change at Months 3 and 6, respectively.</description>
          <population>All enrolled participants evaluable for primary objective with available data for this outcome measure.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="80"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30.48" spread="13.62"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Month 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.06" spread="13.56"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Month 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.96" spread="15.73"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>Wilcoxon test</method>
            <method_desc>P-value was calculated between baseline versus change at Month 3.</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>Wilcoxon test</method>
            <method_desc>P-value was calculated between baseline versus change at Month 6.</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants by DAS28 Class at the Start of TCZ Treatment and After Month 3 and Month 6</title>
        <description>DAS28 score is a measurement of RA activity on a 0 to 10 scale and calculated as DAS28 = 0.56 x √TJC28 + 0.28 x √SJC28 + 0.36 x ln(CRP + 1) + 0.014 x PGH + 0.96, where TJC28 = tender joint count on 28 units, SJC28 = swollen joint count on 28 units, CRP = serum concentration of c-reactive protein (after converting units to mg/dL), PGH = patient's global assessment of disease activity, which was measured on a 100 mm VAS, where 0 mm = managing very well and 100 mm = managing very poorly. Higher scores represent greater disease activity. A score of &lt; 2.6 represents clinical remission, a score of ≥ 2.6 and ≤ 3.2 represents low disease activity, a score of &gt;3.2 and ≤ 5.1 represents moderate disease activity, and a score of &gt; 5.1 represents high (or severe) disease activity.</description>
        <time_frame>Baseline, Month 3, and Month 6</time_frame>
        <population>All enrolled participants evaluable for primary objective. Here, Number of participants analyzed= participants evaluable for this outcome and number analyzed = participants with available data for specified category.</population>
        <group_list>
          <group group_id="O1">
            <title>RA Participants</title>
            <description>Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants by DAS28 Class at the Start of TCZ Treatment and After Month 3 and Month 6</title>
          <description>DAS28 score is a measurement of RA activity on a 0 to 10 scale and calculated as DAS28 = 0.56 x √TJC28 + 0.28 x √SJC28 + 0.36 x ln(CRP + 1) + 0.014 x PGH + 0.96, where TJC28 = tender joint count on 28 units, SJC28 = swollen joint count on 28 units, CRP = serum concentration of c-reactive protein (after converting units to mg/dL), PGH = patient's global assessment of disease activity, which was measured on a 100 mm VAS, where 0 mm = managing very well and 100 mm = managing very poorly. Higher scores represent greater disease activity. A score of &lt; 2.6 represents clinical remission, a score of ≥ 2.6 and ≤ 3.2 represents low disease activity, a score of &gt;3.2 and ≤ 5.1 represents moderate disease activity, and a score of &gt; 5.1 represents high (or severe) disease activity.</description>
          <population>All enrolled participants evaluable for primary objective. Here, Number of participants analyzed= participants evaluable for this outcome and number analyzed = participants with available data for specified category.</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="92"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline: DAS28 &lt; 2.6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="57"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline: DAS28 ≥ 2.6 to ≤ 3.2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="57"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline: DAS28 &gt; 3.2 to ≤ 5.1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="57"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="43.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline: DAS28 &gt; 5.1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="57"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="50.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 3: DAS28 &lt; 2.6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="92"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 3: DAS28 ≥ 2.6 to ≤ 3.2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="92"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 3: DAS28 &gt;3.2 to ≤ 5.1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="92"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="50.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 3: DAS28 &gt; 5.1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="92"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6: DAS28 &lt; 2.6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="86"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="33.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6: DAS28 ≥ 2.6 to ≤ 3.2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="86"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6: DAS28 &gt;3.2 to ≤ 5.1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="86"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="43.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6: DAS28 &gt; 5.1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="86"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants by SDAI Class at the Start of TCZ Treatment and After Month 3 and Month 6</title>
        <description>SDAI is a combined index for measuring disease activity in RA and calculated as SDAI = TJC28 + SJC28 + PGH (in cm) + PhGH (in cm) + CRP (in mg/dL), where TJC28 = tender joint count on 28 units, SJC28 = swollen joint count on 28 units, PGH = patient's global assessment of disease activity, assessed on a 100 mm VAS, where 0 mm = managing very well and 100 mm = managing very poorly, PhGH = physician global assessment of disease activity, assessed on a 100 mm VAS, where 0 = no arthritis activity and 100 = extremely active arthritis, CRP = serum concentration of C-reactive protein. SDAI total score ranged from 0-86. Higher scores represent greater disease activity. SDAI scores of ≤ 3.3 represents clinical remission, ≤ 11.0 represents low disease activity, ≤ 26.0 represents moderate disease activity, and &gt; 26.0 represents high (or severe) disease activity.</description>
        <time_frame>Baseline, Month 3, and Month 6</time_frame>
        <population>All enrolled participants evaluable for primary objective. Here, Number of participants analyzed = participants evaluable for the outcome measure and number analyzed = participants with available data for specified category.</population>
        <group_list>
          <group group_id="O1">
            <title>RA Participants</title>
            <description>Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants by SDAI Class at the Start of TCZ Treatment and After Month 3 and Month 6</title>
          <description>SDAI is a combined index for measuring disease activity in RA and calculated as SDAI = TJC28 + SJC28 + PGH (in cm) + PhGH (in cm) + CRP (in mg/dL), where TJC28 = tender joint count on 28 units, SJC28 = swollen joint count on 28 units, PGH = patient's global assessment of disease activity, assessed on a 100 mm VAS, where 0 mm = managing very well and 100 mm = managing very poorly, PhGH = physician global assessment of disease activity, assessed on a 100 mm VAS, where 0 = no arthritis activity and 100 = extremely active arthritis, CRP = serum concentration of C-reactive protein. SDAI total score ranged from 0-86. Higher scores represent greater disease activity. SDAI scores of ≤ 3.3 represents clinical remission, ≤ 11.0 represents low disease activity, ≤ 26.0 represents moderate disease activity, and &gt; 26.0 represents high (or severe) disease activity.</description>
          <population>All enrolled participants evaluable for primary objective. Here, Number of participants analyzed = participants evaluable for the outcome measure and number analyzed = participants with available data for specified category.</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="93"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline: SDAI ≤ 3.3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="93"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline: SDAI ≤ 11.0</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="93"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline: SDAI ≤ 26.0</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="93"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="36.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline: SDAI &gt; 26.0</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="93"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="63.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 3: SDAI ≤ 3.3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="83"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 3: SDAI ≤ 11.0</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="83"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="34.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 3: SDAI ≤ 26.0</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="83"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="80.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 3: SDAI &gt; 26.0</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="83"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6: SDAI ≤ 3.3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="80"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6: SDAI ≤ 11.0</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="80"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="47.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6: SDAI ≤ 26.0</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="80"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="82.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6: SDAI &gt; 26.0</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="80"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants by CDAI Class at the Start of TCZ Treatment and After Month 3 and Month 6</title>
        <description>CDAI is a combined index for measuring disease activity in RA and calculated as CDAI = TJC28 + SJC28 + PGH (in cm) + PhGH (in cm), where TJC28 = tender joint count on 28 units, SJC28 = swollen joint count on 28 units, PGH = patient's global assessment of disease activity, assessed on a 100 mm VAS, where 0 mm = managing very well and 100 mm = managing very poorly, and PhGH = physician global assessment of disease activity, assessed on a 100 mm VAS, where 0 mm = no arthritis activity and 100 mm = extremely active arthritis. CDAI total score ranged from 0-76. Higher scores indicate greater disease activity. CDAI score of ≤ 2.8 represents clinical remission, score of ≤ 10.0 represents low disease activity, score of ≤ 22.0 represents moderate disease activity, and score of &gt; 22.0 represents high (or severe) disease activity.</description>
        <time_frame>Baseline, Month 3, and Month 6</time_frame>
        <population>All enrolled participants evaluable for primary objective. Here, Number of participants analyzed= participants evaluable for the outcome measure and number analyzed = participants with available data for specified category.</population>
        <group_list>
          <group group_id="O1">
            <title>RA Participants</title>
            <description>Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants by CDAI Class at the Start of TCZ Treatment and After Month 3 and Month 6</title>
          <description>CDAI is a combined index for measuring disease activity in RA and calculated as CDAI = TJC28 + SJC28 + PGH (in cm) + PhGH (in cm), where TJC28 = tender joint count on 28 units, SJC28 = swollen joint count on 28 units, PGH = patient's global assessment of disease activity, assessed on a 100 mm VAS, where 0 mm = managing very well and 100 mm = managing very poorly, and PhGH = physician global assessment of disease activity, assessed on a 100 mm VAS, where 0 mm = no arthritis activity and 100 mm = extremely active arthritis. CDAI total score ranged from 0-76. Higher scores indicate greater disease activity. CDAI score of ≤ 2.8 represents clinical remission, score of ≤ 10.0 represents low disease activity, score of ≤ 22.0 represents moderate disease activity, and score of &gt; 22.0 represents high (or severe) disease activity.</description>
          <population>All enrolled participants evaluable for primary objective. Here, Number of participants analyzed= participants evaluable for the outcome measure and number analyzed = participants with available data for specified category.</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="97"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline: CDAI ≤ 2.8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="97"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline: CDAI ≤ 10.0</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="97"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline: CDAI ≤ 22.0</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="97"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline: CDAI &gt; 22.0</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="97"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="75.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 3: CDAI ≤ 2.8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="94"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 3: CDAI ≤ 10.0</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="94"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="36.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 3: CDAI ≤ 22.0</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="94"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="77.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 3: CDAI &gt; 22.0</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="94"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6: CDAI ≤ 2.8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="94"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6: CDAI ≤ 10.0</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="94"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6: CDAI ≤ 22.0</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="94"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="78.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6: CDAI &gt; 22.0</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="94"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With an American College of Rheumatology (ACR) 20%, 50%, 70%, or 90% (ACR20/50/70/90) Response After Month 3 and Month 6 From the Start of TCZ Treatment</title>
        <description>ACR20, 50, 70 or 90 response = an improvement of ≥20%, ≥50%, ≥70% or ≥90% respectively, as compared to baseline in TJC28 and SJC28, and 20/50/70/90%, improvement in at least 3 of 5 following measures: Patient's Assessment of Pain over previous 24 hours, PGH, PhGH, HAQ, and acute phase reactant (either CRP or ESR). TJC and SJC, based on 28-joint assessments. Number of tender joints and swollen joints were recorded on joint assessment form at baseline; no tenderness = 0 and tenderness = 28, no swelling = 0 and swelling = 28, respectively. HAQ measures functional status (disability) and health-related QoL with 20 questions, summarized in 8 categories: dressing and grooming, arising, eating, walking, hygiene, reach, grip and common activities over past week, 0= without difficulty to 3= unable to do. Patient's assessment of pain assessed using VAS; 0 mm = no pain, 100 mm = unbearable pain; PGH and PhGH, assessed using VAS; 0 mm = no disease activity, 100 mm = maximum disease activity.</description>
        <time_frame>Month 3 and Month 6</time_frame>
        <population>All enrolled participants evaluable for primary objective with available data for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>RA Participants</title>
            <description>Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With an American College of Rheumatology (ACR) 20%, 50%, 70%, or 90% (ACR20/50/70/90) Response After Month 3 and Month 6 From the Start of TCZ Treatment</title>
          <description>ACR20, 50, 70 or 90 response = an improvement of ≥20%, ≥50%, ≥70% or ≥90% respectively, as compared to baseline in TJC28 and SJC28, and 20/50/70/90%, improvement in at least 3 of 5 following measures: Patient's Assessment of Pain over previous 24 hours, PGH, PhGH, HAQ, and acute phase reactant (either CRP or ESR). TJC and SJC, based on 28-joint assessments. Number of tender joints and swollen joints were recorded on joint assessment form at baseline; no tenderness = 0 and tenderness = 28, no swelling = 0 and swelling = 28, respectively. HAQ measures functional status (disability) and health-related QoL with 20 questions, summarized in 8 categories: dressing and grooming, arising, eating, walking, hygiene, reach, grip and common activities over past week, 0= without difficulty to 3= unable to do. Patient's assessment of pain assessed using VAS; 0 mm = no pain, 100 mm = unbearable pain; PGH and PhGH, assessed using VAS; 0 mm = no disease activity, 100 mm = maximum disease activity.</description>
          <population>All enrolled participants evaluable for primary objective with available data for this outcome measure.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="120"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Month 3: ACR 20 achieved</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 3: ACR 20 not achieved</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="38.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 3: ACR 20 at least 1 missing data</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 3: ACR 50 achieved</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 3: ACR 50 not achieved</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="62.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 3: ACR 50 at least 1 missing data</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 3: ACR 70 achieved</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 3: ACR 70 not achieved</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="79.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 3: ACR 70 at least 1 missing data</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 3: ACR 90 achieved</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 3: ACR 90 not achieved</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="90.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 3: ACR 90 at least 1 missing data</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6: ACR 20 achieved</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="51.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6: ACR 20 not achieved</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6: ACR 20 at least 1 missing data</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6: ACR 50 achieved</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6: ACR 50 not achieved</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="57.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6: ACR 50 at least 1 missing data</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6: ACR 70 achieved</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6: ACR 70 not achieved</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="73.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6: ACR 70 at least 1 missing data</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6: ACR 90 achieved</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6: ACR 90 not achieved</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="89.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6: ACR 90 at least 1 missing data</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline to Month 6 in TJC</title>
        <description>TJC 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 baseline and at Month 6. No tenderness = 0 and tenderness = 1.</description>
        <time_frame>Baseline and Month 6</time_frame>
        <population>All enrolled participants evaluable for primary objective with available data for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>RA Participants</title>
            <description>Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to Month 6 in TJC</title>
          <description>TJC 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 baseline and at Month 6. No tenderness = 0 and tenderness = 1.</description>
          <population>All enrolled participants evaluable for primary objective with available data for this outcome measure.</population>
          <units>tender joints</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="114"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.0" spread="7.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline to Month 6 in SJC</title>
        <description>SJC 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 baseline and at Month 6. No swelling = 0 and swelling = 1.</description>
        <time_frame>Baseline and Month 6</time_frame>
        <population>All enrolled participants evaluable for primary objective with available data for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>RA Participants</title>
            <description>Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to Month 6 in SJC</title>
          <description>SJC 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 baseline and at Month 6. No swelling = 0 and swelling = 1.</description>
          <population>All enrolled participants evaluable for primary objective with available data for this outcome measure.</population>
          <units>swollen joints</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="114"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.2" spread="6.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline to Month 6 in PGH</title>
        <description>The PGH was measured using a 100 mm VAS, where the responses were on a continuous range from 0 mm = managing very well and 100 mm = managing very poorly.</description>
        <time_frame>Baseline and Month 6</time_frame>
        <population>All enrolled participants evaluable for the primary objective with available data for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>RA Participants</title>
            <description>Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to Month 6 in PGH</title>
          <description>The PGH was measured using a 100 mm VAS, where the responses were on a continuous range from 0 mm = managing very well and 100 mm = managing very poorly.</description>
          <population>All enrolled participants evaluable for the primary objective with available data for this outcome measure.</population>
          <units>mm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="96"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.4" spread="26.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline to Month 6 in PhGH</title>
        <description>The PhGH was evaluated using a 100 mm VAS where 0 mm = no arthritis activity and 100 mm = extremely active arthritis. Higher scores indicated increased level of disease.</description>
        <time_frame>Baseline and Month 6</time_frame>
        <population>All enrolled participants evaluable for the primary objective with available data for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>RA Participants</title>
            <description>Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to Month 6 in PhGH</title>
          <description>The PhGH was evaluated using a 100 mm VAS where 0 mm = no arthritis activity and 100 mm = extremely active arthritis. Higher scores indicated increased level of disease.</description>
          <population>All enrolled participants evaluable for the primary objective with available data for this outcome measure.</population>
          <units>mm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="93"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23.9" spread="26.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline to Month 6 in Patient's Assessment of Pain</title>
        <description>Participants measured the pain intensity due to RA using a 100 mm VAS, where the responses were on a continuous range from 0 mm = no pain to 100 mm = unbearable pain.</description>
        <time_frame>Baseline and Month 6</time_frame>
        <population>All enrolled participants evaluable for primary objective with available data for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>RA Participants</title>
            <description>Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to Month 6 in Patient's Assessment of Pain</title>
          <description>Participants measured the pain intensity due to RA using a 100 mm VAS, where the responses were on a continuous range from 0 mm = no pain to 100 mm = unbearable pain.</description>
          <population>All enrolled participants evaluable for primary objective with available data for this outcome measure.</population>
          <units>mm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="107"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22.5" spread="26.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline to Month 6 in HAQ-DI Score</title>
        <description>The HAQ-DI is a questionnaire that measures functional status (disability) and health-related QoL. It measures the participant's ability to perform everyday tasks. The index consists of 20 questions regarding the function of the upper and lower extremities. These questions are summarized in 8 categories: dressing and grooming, arising, eating, walking, hygiene, reach, grip and common activities over past week. Each question was evaluated according to the degree of severity on a 4-point scale ranging from 0 = without any difficulty to 3 = unable to do.Total score for HAQ-DI is the average of all the questions, which ranges from 0 to 3, where higher scores represent higher disease activity.</description>
        <time_frame>Baseline and Month 6</time_frame>
        <population>All enrolled participants evaluable for the primary objective with available data for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>RA Participants</title>
            <description>Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to Month 6 in HAQ-DI Score</title>
          <description>The HAQ-DI is a questionnaire that measures functional status (disability) and health-related QoL. It measures the participant's ability to perform everyday tasks. The index consists of 20 questions regarding the function of the upper and lower extremities. These questions are summarized in 8 categories: dressing and grooming, arising, eating, walking, hygiene, reach, grip and common activities over past week. Each question was evaluated according to the degree of severity on a 4-point scale ranging from 0 = without any difficulty to 3 = unable to do.Total score for HAQ-DI is the average of all the questions, which ranges from 0 to 3, where higher scores represent higher disease activity.</description>
          <population>All enrolled participants evaluable for the primary objective with available data for this outcome measure.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="89"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.4" spread="0.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline to Month 6 in Participant Assessment of Fatigue</title>
        <description>Participants measured the level of fatigue due to RA using a 100 mm VAS, where the responses were on a continuous range from 0 mm = no fatigue to 100 mm = extreme fatigue.</description>
        <time_frame>Baseline and Month 6</time_frame>
        <population>All enrolled participants evaluable for the primary objective with available data for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>RA Participants</title>
            <description>Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to Month 6 in Participant Assessment of Fatigue</title>
          <description>Participants measured the level of fatigue due to RA using a 100 mm VAS, where the responses were on a continuous range from 0 mm = no fatigue to 100 mm = extreme fatigue.</description>
          <population>All enrolled participants evaluable for the primary objective with available data for this outcome measure.</population>
          <units>mm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="68"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.9" spread="23.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline to Month 6 in Participant Assessment of Morning Stiffness</title>
        <description>The participant assessment of morning stiffness was measured using a ruler on a 100 mm VAS, where the responses were on a continuous range from 0 mm = no stiffness and 100 mm = maximum stiffness.</description>
        <time_frame>Baseline and Month 6</time_frame>
        <population>All enrolled participants evaluable for primary objective with available data for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>RA Participants</title>
            <description>Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to Month 6 in Participant Assessment of Morning Stiffness</title>
          <description>The participant assessment of morning stiffness was measured using a ruler on a 100 mm VAS, where the responses were on a continuous range from 0 mm = no stiffness and 100 mm = maximum stiffness.</description>
          <population>All enrolled participants evaluable for primary objective with available data for this outcome measure.</population>
          <units>mm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="35"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.8" spread="31.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Clinically Meaningful Improvement in HAQ-DI</title>
        <description>The HAQ-DI is a questionnaire that measures functional status (disability) and health-related QoL. It measures the participant's ability to perform everyday tasks. The index consists of 20 questions regarding the function of the upper and lower extremities. These questions are summarized in 8 categories: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and common activities over past week. Each question was evaluated according to the degree of severity on a 4-point scale ranging from 0 = without any difficulty to 3 = unable to do. Total score for HAQ-DI is the average of all the questions, which ranges from 0 to 3, where higher scores represent higher disease activity. HAQ-DI clinically meaningful improvement is defined as decrease in HAQ total score from baseline of greater or equal to 0.22 points.</description>
        <time_frame>Month 3 and Month 6</time_frame>
        <population>All enrolled participants evaluable for primary objective with available data for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>RA Participants</title>
            <description>Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Clinically Meaningful Improvement in HAQ-DI</title>
          <description>The HAQ-DI is a questionnaire that measures functional status (disability) and health-related QoL. It measures the participant's ability to perform everyday tasks. The index consists of 20 questions regarding the function of the upper and lower extremities. These questions are summarized in 8 categories: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and common activities over past week. Each question was evaluated according to the degree of severity on a 4-point scale ranging from 0 = without any difficulty to 3 = unable to do. Total score for HAQ-DI is the average of all the questions, which ranges from 0 to 3, where higher scores represent higher disease activity. HAQ-DI clinically meaningful improvement is defined as decrease in HAQ total score from baseline of greater or equal to 0.22 points.</description>
          <population>All enrolled participants evaluable for primary objective with available data for this outcome measure.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="120"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Month 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="36.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="45.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Achieving Good/Moderate/No European League Against Rheumatism (EULAR) Response at Month 3 and Month 6</title>
        <description>Clinical response was assessed according to EULAR criteria that classified the participant according to individual changes in DAS28 score as good, moderate, or no response. DAS28 score is a measurement of RA activity on 0 to 10 scale and calculated as DAS28= 0.56 x √TJC28 + 0.28 x √SJC28 + 0.36 x ln(CRP + 1) + 0.014 x PGH + 0.96, where TJC28= tender joint count on 28 units, SJC28= swollen joint count on 28 units, CRP= serum concentration of C-reactive protein (after converting units to mg/dL), PGH= patient's global assessment of disease activity measured on a 100 mm VAS, where 0 mm= managing very well and 100 mm= managing very poorly. Good responders experienced change (chg) from baseline (BL) of &gt;1.2 with DAS28 score ≤ 3.2, moderate responders experienced chg from BL &gt;1.2 with DAS28 score &gt; 3.2 to ≤ 5.1 or a chg from BL &gt; 0.6 to ≤ 1.2 with DAS28 score of ≤ 5.1. No responders experienced chg from BL &lt; 0.6 regardless initial DAS28 score or &gt; 0.6 to ≤ 1.2 with DAS28 score of &gt; 5.1.</description>
        <time_frame>Month 3 and Month 6</time_frame>
        <population>All enrolled participants evaluable for primary objective. Here, Number of participants analyzed= participants evaluable for the outcome measure and number analyzed = participants with available data for specified category.</population>
        <group_list>
          <group group_id="O1">
            <title>RA Participants</title>
            <description>Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving Good/Moderate/No European League Against Rheumatism (EULAR) Response at Month 3 and Month 6</title>
          <description>Clinical response was assessed according to EULAR criteria that classified the participant according to individual changes in DAS28 score as good, moderate, or no response. DAS28 score is a measurement of RA activity on 0 to 10 scale and calculated as DAS28= 0.56 x √TJC28 + 0.28 x √SJC28 + 0.36 x ln(CRP + 1) + 0.014 x PGH + 0.96, where TJC28= tender joint count on 28 units, SJC28= swollen joint count on 28 units, CRP= serum concentration of C-reactive protein (after converting units to mg/dL), PGH= patient's global assessment of disease activity measured on a 100 mm VAS, where 0 mm= managing very well and 100 mm= managing very poorly. Good responders experienced change (chg) from baseline (BL) of &gt;1.2 with DAS28 score ≤ 3.2, moderate responders experienced chg from BL &gt;1.2 with DAS28 score &gt; 3.2 to ≤ 5.1 or a chg from BL &gt; 0.6 to ≤ 1.2 with DAS28 score of ≤ 5.1. No responders experienced chg from BL &lt; 0.6 regardless initial DAS28 score or &gt; 0.6 to ≤ 1.2 with DAS28 score of &gt; 5.1.</description>
          <population>All enrolled participants evaluable for primary objective. Here, Number of participants analyzed= participants evaluable for the outcome measure and number analyzed = participants with available data for specified category.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="46"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Month 3: Good response</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="46"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="41.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 3: Moderate response</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="46"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="47.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 3: No response</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="46"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6: Good response</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="44"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="45.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6: Moderate response</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="44"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6: No response</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="44"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to DMARD Dose Reduction</title>
        <description>DMARDs that met the criteria for &quot;concomitant medications&quot; were selected. The time to DMARD dose reduction was calculated as the difference between date of dose reduction and the date of first TCZ infusion. For participants presenting more than 1 DMARD dose reduction, only the first dose reduction was considered.</description>
        <time_frame>Baseline up to Month 6</time_frame>
        <population>All enrolled participants evaluable for primary objective with available data for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>RA Participants</title>
            <description>Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.</description>
          </group>
        </group_list>
        <measure>
          <title>Time to DMARD Dose Reduction</title>
          <description>DMARDs that met the criteria for &quot;concomitant medications&quot; were selected. The time to DMARD dose reduction was calculated as the difference between date of dose reduction and the date of first TCZ infusion. For participants presenting more than 1 DMARD dose reduction, only the first dose reduction was considered.</description>
          <population>All enrolled participants evaluable for primary objective with available data for this outcome measure.</population>
          <units>months</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.2" lower_limit="1.0" upper_limit="4.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to DMARD Dose Withdrawal</title>
        <description>DMARDs that met the criteria for &quot;concomitant medications&quot; were selected. The time to DMARD withdrawal was calculated as the difference between date of withdrawal and the date of first TCZ infusion.</description>
        <time_frame>Baseline up to Month 6</time_frame>
        <population>All enrolled participants evaluable for primary objective with available data for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>RA Participants</title>
            <description>Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.</description>
          </group>
        </group_list>
        <measure>
          <title>Time to DMARD Dose Withdrawal</title>
          <description>DMARDs that met the criteria for &quot;concomitant medications&quot; were selected. The time to DMARD withdrawal was calculated as the difference between date of withdrawal and the date of first TCZ infusion.</description>
          <population>All enrolled participants evaluable for primary objective with available data for this outcome measure.</population>
          <units>months</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.1" lower_limit="2.9" upper_limit="5.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants by Reason for DMARD Withdrawal During the Study</title>
        <description>DMARDs that met the criteria for &quot;concomitant medications&quot; were selected. All treatments with DMARDs interrupted after the first TCZ infusion were selected.</description>
        <time_frame>Baseline up to Month 6</time_frame>
        <population>All enrolled participants evaluable for primary objective with available data for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>RA Participants</title>
            <description>Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants by Reason for DMARD Withdrawal During the Study</title>
          <description>DMARDs that met the criteria for &quot;concomitant medications&quot; were selected. All treatments with DMARDs interrupted after the first TCZ infusion were selected.</description>
          <population>All enrolled participants evaluable for primary objective with available data for this outcome measure.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Lack of efficacy</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Subjective intolerance</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.09"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Objective intolerance</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="36.36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Unspecified</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="36.36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Steroid Dose Reduction</title>
        <description>Steroids that met the criteria for &quot;concomitant medications&quot; were selected. The time to steroid dose reduction was calculated as the difference between date of dose reduction and the date of first TCZ infusion. For participants presenting more than one steroid dose reduction, only the first dose reduction was considered.</description>
        <time_frame>Baseline up to Month 6</time_frame>
        <population>All enrolled participants evaluable for primary objective with available data for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>RA Participants</title>
            <description>Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Steroid Dose Reduction</title>
          <description>Steroids that met the criteria for &quot;concomitant medications&quot; were selected. The time to steroid dose reduction was calculated as the difference between date of dose reduction and the date of first TCZ infusion. For participants presenting more than one steroid dose reduction, only the first dose reduction was considered.</description>
          <population>All enrolled participants evaluable for primary objective with available data for this outcome measure.</population>
          <units>months</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.3" lower_limit="1.7" upper_limit="4.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Steroid Dose Withdrawal</title>
        <description>Steroids that met the criteria for &quot;concomitant medications&quot; were selected. The time to steroid dose withdrawal was calculated as the difference between date of withdrawal and the date of first TCZ infusion.</description>
        <time_frame>Baseline up to Month 6</time_frame>
        <population>All enrolled participants evaluable for primary objective with available data for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>RA Participants</title>
            <description>Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Steroid Dose Withdrawal</title>
          <description>Steroids that met the criteria for &quot;concomitant medications&quot; were selected. The time to steroid dose withdrawal was calculated as the difference between date of withdrawal and the date of first TCZ infusion.</description>
          <population>All enrolled participants evaluable for primary objective with available data for this outcome measure.</population>
          <units>months</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.8" lower_limit="1.1" upper_limit="3.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in CRP at Month 3 and Month 6</title>
        <description>The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement. Change from baseline = CRP level at Month X - CRP level at baseline. Here X = 3 and 6 for Change at Months 3 and 6, respectively.</description>
        <time_frame>Baseline, Month 3, and Month 6</time_frame>
        <population>All enrolled participants evaluable for primary objective with available data for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>RA Participants</title>
            <description>Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in CRP at Month 3 and Month 6</title>
          <description>The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement. Change from baseline = CRP level at Month X - CRP level at baseline. Here X = 3 and 6 for Change at Months 3 and 6, respectively.</description>
          <population>All enrolled participants evaluable for primary objective with available data for this outcome measure.</population>
          <units>mg/dL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <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>Change at Month 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.28" spread="8.61"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Month 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.98" spread="8.87"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>P-value was calculated between baseline versus change at Month 3.</p_value_desc>
            <method>Wilcoxon test</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>P-value was calculated between baseline versus change at Month 6.</p_value_desc>
            <method>Wilcoxon test</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in ESR at Month 3 and Month 6</title>
        <description>ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 mm/hr. A decrease in the level indicates reduction in inflammation and therefore improvement. Change from baseline = ESR level at Month X - ESR level at baseline. Here X = 3 and 6 for Change at Months 3 and 6, respectively.</description>
        <time_frame>Baseline, Month 3, and Month 6</time_frame>
        <population>All enrolled participants evaluable for primary objective with available data for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>RA Participants</title>
            <description>Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in ESR at Month 3 and Month 6</title>
          <description>ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 mm/hr. A decrease in the level indicates reduction in inflammation and therefore improvement. Change from baseline = ESR level at Month X - ESR level at baseline. Here X = 3 and 6 for Change at Months 3 and 6, respectively.</description>
          <population>All enrolled participants evaluable for primary objective with available data for this outcome measure.</population>
          <units>mm/hr</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="100"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Change at Month 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23.15" spread="21.72"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Month 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.42" spread="23.21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>P-value was calculated between baseline versus change at Month 3.</p_value_desc>
            <method>Wilcoxon test</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>P-value was calculated between baseline versus change at Month 6.</p_value_desc>
            <method>Wilcoxon test</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>CRP at the Start of TCZ Treatment by Remission Status Using DAS28-CRP, SDAI, and CDAI at Month 6</title>
        <description>The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement. DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity. DAS28 is calculated as follows: DAS28 = 0.56 x √TJC28 + 0.28 x √SJC28 + 0.36 x ln(CRP + 1) + 0.014 x PGH + 0.96, A score of &lt; 2.6 represents clinical remission. SDAI is a combined index for measuring disease activity in RA and calculated as SDAI = TJC28 + SJC28 + PGH (in cm) + PhGH (in cm) + CRP (in mg/dL). A SDAI score of ≤ 3.3 represents clinical remission. CDAI is a combined index for measuring disease activity in RA and calculated as CDAI = TJC28 + SJC28 + PGH (in cm) + PhGH (in cm). A CDAI score of ≤ 2.8 represents clinical remission.</description>
        <time_frame>Baseline</time_frame>
        <population>All enrolled participants evaluable for primary objective. Here, Number of participants analyzed = participants evaluable for this outcome measure and number analyzed = participants with available data for specified category.</population>
        <group_list>
          <group group_id="O1">
            <title>RA Participants</title>
            <description>Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.</description>
          </group>
        </group_list>
        <measure>
          <title>CRP at the Start of TCZ Treatment by Remission Status Using DAS28-CRP, SDAI, and CDAI at Month 6</title>
          <description>The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement. DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity. DAS28 is calculated as follows: DAS28 = 0.56 x √TJC28 + 0.28 x √SJC28 + 0.36 x ln(CRP + 1) + 0.014 x PGH + 0.96, A score of &lt; 2.6 represents clinical remission. SDAI is a combined index for measuring disease activity in RA and calculated as SDAI = TJC28 + SJC28 + PGH (in cm) + PhGH (in cm) + CRP (in mg/dL). A SDAI score of ≤ 3.3 represents clinical remission. CDAI is a combined index for measuring disease activity in RA and calculated as CDAI = TJC28 + SJC28 + PGH (in cm) + PhGH (in cm). A CDAI score of ≤ 2.8 represents clinical remission.</description>
          <population>All enrolled participants evaluable for primary objective. Here, Number of participants analyzed = participants evaluable for this outcome measure and number analyzed = participants with available data for specified category.</population>
          <units>mg/dL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <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>With DAS28-CRP clinical remission</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="27"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.2" spread="6.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Without DAS28-CRP clinical remission</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="54"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.1" spread="10.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>With SDAI clinical remission</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.6" spread="10.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Without SDAI clinical remission</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="66"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.8" spread="9.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>With CDAI clinical remission</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.2" spread="10.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Without CDAI clinical remission</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="79"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.7" spread="8.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.6904</p_value>
            <method>t-test</method>
            <method_desc>P-value signifies CRP at the start of TCZ treatment by remission status using DAS28-CRP (remission versus no remission).</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.6032</p_value>
            <method>t-test</method>
            <method_desc>P-value signifies the CRP at the start of TCZ treatment by remission status using SDAI (remission versus no remission).</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.6146</p_value>
            <method>t-test</method>
            <method_desc>P-value signifies the CRP at the start of TCZ treatment by remission status using CDAI (remission versus no remission).</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Body Mass Index (BMI) at the Start of TCZ Treatment by Remission Status Using DAS-28 CRP, SDAI, and CDAI at Month 6</title>
        <description>DAS28 scale ranges from 0 to 10, and calculated as DAS28 = 0.56 x √TJC28 + 0.28 x √SJC28 + 0.36 x ln(CRP + 1) + 0.014 x PGH + 0.96, where TJC28 and SJC28 = tender joint and swollen joint count on 28 units, PGH = patient's global assessment of disease activity, assessed on a 100 mm VAS, where 0 mm = managing very well and 100 mm = managing very poorly, CRP = serum concentration of C-reactive protein. A score of &lt; 2.6 represents clinical remission. SDAI is a combined index for measuring disease activity in RA and calculated as SDAI = TJC28 + SJC28 + PGH (in cm) + PhGH (in cm) + CRP (in mg/dL), where PhGH = physician global assessment of disease activity, assessed on a 100 mm VAS, where 0 mm = no arthritis activity and 100mm = extremely active arthritis. A SDAI score of ≤ 3.3 represents clinical remission. CDAI is a combined index for measuring disease activity in RA and calculated as CDAI = TJC28 + SJC28 + PGH (in cm) + PhGH (in cm). A CDAI score of ≤ 2.8 represents clinical remission.</description>
        <time_frame>Baseline</time_frame>
        <population>All enrolled participants evaluable for primary objective. Here, Number of participants analyzed = participants evaluable for this outcome measure and number analyzed = participants with available data for specified category.</population>
        <group_list>
          <group group_id="O1">
            <title>RA Participants</title>
            <description>Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.</description>
          </group>
        </group_list>
        <measure>
          <title>Body Mass Index (BMI) at the Start of TCZ Treatment by Remission Status Using DAS-28 CRP, SDAI, and CDAI at Month 6</title>
          <description>DAS28 scale ranges from 0 to 10, and calculated as DAS28 = 0.56 x √TJC28 + 0.28 x √SJC28 + 0.36 x ln(CRP + 1) + 0.014 x PGH + 0.96, where TJC28 and SJC28 = tender joint and swollen joint count on 28 units, PGH = patient's global assessment of disease activity, assessed on a 100 mm VAS, where 0 mm = managing very well and 100 mm = managing very poorly, CRP = serum concentration of C-reactive protein. A score of &lt; 2.6 represents clinical remission. SDAI is a combined index for measuring disease activity in RA and calculated as SDAI = TJC28 + SJC28 + PGH (in cm) + PhGH (in cm) + CRP (in mg/dL), where PhGH = physician global assessment of disease activity, assessed on a 100 mm VAS, where 0 mm = no arthritis activity and 100mm = extremely active arthritis. A SDAI score of ≤ 3.3 represents clinical remission. CDAI is a combined index for measuring disease activity in RA and calculated as CDAI = TJC28 + SJC28 + PGH (in cm) + PhGH (in cm). A CDAI score of ≤ 2.8 represents clinical remission.</description>
          <population>All enrolled participants evaluable for primary objective. Here, Number of participants analyzed = participants evaluable for this outcome measure and number analyzed = participants with available data for specified category.</population>
          <units>kilogram per meter square (Kg/m^2)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="91"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>With DAS-28 CRP clinical remission</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="26"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23.3" spread="3.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Without DAS-28 CRP clinical remission</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="57"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26.7" spread="5.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>With SDAI clinical remission</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23.7" spread="3.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Without SDAI clinical remission</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="68"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26.0" spread="5.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>With CDAI clinical remission</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23.8" spread="3.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Without CDAI clinical remission</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="81"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26.6" spread="5.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.0018</p_value>
            <method>t-test</method>
            <method_desc>P-value signifies the BMI at the start of TCZ treatment by remission status using DAS28-CRP (remission versus no remission).</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.1617</p_value>
            <method>t-test</method>
            <method_desc>P-value signifies the BMI at the start of TCZ treatment by remission status using SDAI (remission versus no remission).</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.1296</p_value>
            <method>t-test</method>
            <method_desc>P-value signifies the BMI at the start of TCZ treatment by remission status using CDAI (remission versus no remission).</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With and Without Morning Stiffness</title>
        <description>Morning stiffness was defined by the time elapsed between the time of usual awakening (even if not in the morning) and the time the participant was able to resume normal activities without stiffness. The participant assessed morning stiffness based on the following criteria:&#xD;
Presence of participant's joints stiff when woke up that day, measured as yes (stiffness present) or no (stiffness not present);&#xD;
Duration of morning stiffness, measured by ticking 1 of the six categories: &lt; 30 minutes, 30 - 60 minutes, 60 - 120 minutes, 120 - 240 minutes, &gt; 240 minutes, and the whole day;&#xD;
Severity of morning stiffness measured using a ruler on a 100 mm VAS where the responses were on a continuous range from 0 mm = no stiffness to 100 mm = maximum stiffness.&#xD;
'Not estimable' represented that the participants were not able to quantify it. 'Not done' represented that the assessment was not performed.</description>
        <time_frame>Month 3 and Month 6</time_frame>
        <population>All enrolled participants evaluable for primary objective with available data for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>RA Participants</title>
            <description>Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With and Without Morning Stiffness</title>
          <description>Morning stiffness was defined by the time elapsed between the time of usual awakening (even if not in the morning) and the time the participant was able to resume normal activities without stiffness. The participant assessed morning stiffness based on the following criteria:&#xD;
Presence of participant's joints stiff when woke up that day, measured as yes (stiffness present) or no (stiffness not present);&#xD;
Duration of morning stiffness, measured by ticking 1 of the six categories: &lt; 30 minutes, 30 - 60 minutes, 60 - 120 minutes, 120 - 240 minutes, &gt; 240 minutes, and the whole day;&#xD;
Severity of morning stiffness measured using a ruler on a 100 mm VAS where the responses were on a continuous range from 0 mm = no stiffness to 100 mm = maximum stiffness.&#xD;
'Not estimable' represented that the participants were not able to quantify it. 'Not done' represented that the assessment was not performed.</description>
          <population>All enrolled participants evaluable for primary objective with available data for this outcome measure.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="120"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Month 3 (with morning stiffness)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="70.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 3 (without morning stiffness)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 3 (morning stiffness not estimable)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 3 (morning stiffness not done)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6 (with morning stiffness)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="65.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6 (without morning stiffness)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6 (morning stiffness not estimable)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants by Duration of Morning Stiffness</title>
        <description>Duration of morning stiffness was defined as the time elapsed between the time of usual awakening (even if not in the morning) and the time the participant was able to resume normal activities without stiffness. The participant reported the duration of morning stiffness in the case report form by ticking 1 of the following categories: no morning stiffness, &lt; 30 minutes, 30 - 60 minutes, 60 - 120 minutes, 120 - 240 minutes, &gt; 240 minutes, and the whole day. 'Not estimable' represented that the participants were not able to quantify it. 'Not done' represented that the assessment was not performed.</description>
        <time_frame>Month 3 and Month 6</time_frame>
        <population>All enrolled participants evaluable for primary objective with available data for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>RA Participants</title>
            <description>Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants by Duration of Morning Stiffness</title>
          <description>Duration of morning stiffness was defined as the time elapsed between the time of usual awakening (even if not in the morning) and the time the participant was able to resume normal activities without stiffness. The participant reported the duration of morning stiffness in the case report form by ticking 1 of the following categories: no morning stiffness, &lt; 30 minutes, 30 - 60 minutes, 60 - 120 minutes, 120 - 240 minutes, &gt; 240 minutes, and the whole day. 'Not estimable' represented that the participants were not able to quantify it. 'Not done' represented that the assessment was not performed.</description>
          <population>All enrolled participants evaluable for primary objective with available data for this outcome measure.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="120"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Month 3 (no morning stiffness)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6 (no morning stiffness)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 3 (&lt; 30 minutes)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6 (&lt; 30 minutes)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 3 (between 30 - 60 minutes )</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6 (between 30 - 60 minutes)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 3 (Between 60 - 240 minutes)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6 (Between 60 - 240 minutes)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 3 (&gt; 240 minutes)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6 (&gt; 240 minutes)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 3 (whole day)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6 (whole day)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 3 (not estimable)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6 (not estimable)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 3 (not done)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>CRP at the Start of TCZ Treatment by Morning Stiffness at Month 6</title>
        <description>The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement. The participant reported the duration of morning stiffness in the case report form by ticking the categories: ≤ 30 minutes and &gt; 30 minutes.</description>
        <time_frame>Baseline</time_frame>
        <population>All enrolled participants evaluable for primary objective. Here, Number of participants analyzed = participants evaluable for this outcome measure and number analyzed = participants with available data for specified category.</population>
        <group_list>
          <group group_id="O1">
            <title>RA Participants</title>
            <description>Participants with moderate or severe RA were prescribed with tocilizumab, in accordance with routine clinic practice, and following the local label were observed for 6 months with maximum study duration of 18 months.</description>
          </group>
        </group_list>
        <measure>
          <title>CRP at the Start of TCZ Treatment by Morning Stiffness at Month 6</title>
          <description>The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement. The participant reported the duration of morning stiffness in the case report form by ticking the categories: ≤ 30 minutes and &gt; 30 minutes.</description>
          <population>All enrolled participants evaluable for primary objective. Here, Number of participants analyzed = participants evaluable for this outcome measure and number analyzed = participants with available data for specified category.</population>
          <units>mg/dL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="40"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Morning stiffness (≤ 30 minutes)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="40"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.3" spread="12.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Morning stiffness (&gt; 30 minutes)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="39"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.1" spread="2.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.5332</p_value>
            <method>t-test</method>
            <method_desc>P-value signifies the CRP at the start of TCZ treatment using the morning stiffness ( ≤ 30 minutes versus &gt; 30 minutes).</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>BMI at the Start of TCZ Treatment by Morning Stiffness at Month 6</title>
        <description>Morning stiffness was defined as the time elapsed between the time of usual awakening (even if not in the morning) and the time the participant was able to resume normal activities without stiffness. The participant reported the duration of morning stiffness in the case report form by ticking the categories: ≤ 30 minutes and &gt; 30 minutes.</description>
        <time_frame>Baseline</time_frame>
        <population>All enrolled participants evaluable for primary objective. Here, Number of participants analyzed = participants evaluable for the outcome measure and number analyzed = participants with available data for specified category.</population>
        <group_list>
          <group group_id="O1">
            <title>RA Participants</title>
            <description>Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.</description>
          </group>
        </group_list>
        <measure>
          <title>BMI at the Start of TCZ Treatment by Morning Stiffness at Month 6</title>
          <description>Morning stiffness was defined as the time elapsed between the time of usual awakening (even if not in the morning) and the time the participant was able to resume normal activities without stiffness. The participant reported the duration of morning stiffness in the case report form by ticking the categories: ≤ 30 minutes and &gt; 30 minutes.</description>
          <population>All enrolled participants evaluable for primary objective. Here, Number of participants analyzed = participants evaluable for the outcome measure and number analyzed = participants with available data for specified category.</population>
          <units>Kg/m^2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="39"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Morning stiffness (≤ 30 minutes)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="39"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26.1" spread="4.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Morning stiffness (&gt; 30 minutes)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="37"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26.6" spread="5.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.6159</p_value>
            <method>t-test</method>
            <method_desc>P-value signifies the BMI at the start of TCZ treatment using the morning stiffness ( ≤ 30 minutes versus &gt; 30 minutes).</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Correlation Coefficient Between CRP (mg/dL) at the Start of TCZ Treatment and HAQ-DI (0-3) at Month 6</title>
        <description>The test for CRP is laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in level of CRP indicates reduction in inflammation and therefore improvement. HAQ-DI is a questionnaire that measures functional status (disability) and health-related QoL. It measures the participant's ability to perform everyday tasks. The index consists of 20 questions regarding the function of the upper and lower extremities. These questions are summarized in 8 categories: dressing and grooming, arising, eating, walking, hygiene, reach, grip and common activities over past week. Each question was evaluated according to the degree of severity on a 4-point scale ranging from 0 = without any difficulty to 3 = unable to do. Total score is average of all questions, which ranges from 0 to 3, where higher scores represent higher disease activity. The Pearson and Spearman correlation coefficients can range in value from -1 to +1.</description>
        <time_frame>Baseline and Month 6</time_frame>
        <population>All enrolled participants evaluable for primary objective with available data for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>RA Participants</title>
            <description>Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.</description>
          </group>
        </group_list>
        <measure>
          <title>Correlation Coefficient Between CRP (mg/dL) at the Start of TCZ Treatment and HAQ-DI (0-3) at Month 6</title>
          <description>The test for CRP is laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in level of CRP indicates reduction in inflammation and therefore improvement. HAQ-DI is a questionnaire that measures functional status (disability) and health-related QoL. It measures the participant's ability to perform everyday tasks. The index consists of 20 questions regarding the function of the upper and lower extremities. These questions are summarized in 8 categories: dressing and grooming, arising, eating, walking, hygiene, reach, grip and common activities over past week. Each question was evaluated according to the degree of severity on a 4-point scale ranging from 0 = without any difficulty to 3 = unable to do. Total score is average of all questions, which ranges from 0 to 3, where higher scores represent higher disease activity. The Pearson and Spearman correlation coefficients can range in value from -1 to +1.</description>
          <population>All enrolled participants evaluable for primary objective with available data for this outcome measure.</population>
          <units>correlation coefficient</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>Pearson correlation</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.12663"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Spearman correlation</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.02678"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.2370</p_value>
            <method>Pearson correlation</method>
            <method_desc>P-value was calculated from Pearson correlation coefficient between CRP at the start of TCZ treatment versus HAQ-DI (0-3) at Month 6.</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.8033</p_value>
            <method>Spearman Correlation</method>
            <method_desc>P-value was calculated from Spearman correlation coefficient between CRP at the start of TCZ treatment versus HAQ-D1 (0-3) at Month 6.</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Correlation Coefficient Between Change From Baseline in CRP (mg/dL) and HAQ-DI (0-3) at Month 6</title>
        <description>CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in level of CRP indicates reduction in inflammation and therefore improvement. HAQ-DI is a questionnaire that measures functional status (disability) and health-related QoL. It measures the participant's ability to perform everyday tasks. The index consists of 20 questions regarding the function of the upper and lower extremities. These questions are summarized in 8 categories: dressing and grooming, arising, eating, walking, hygiene, reach, grip and common activities over past week. Each question was evaluated according to the degree of severity on a 4-point scale ranging from 0= without any difficulty to 3= unable to do. Total score is the average of all questions, which ranges from 0 to 3, where higher scores represent higher disease activity. The Pearson and Spearman correlation coefficients can range in value from -1 to +1.</description>
        <time_frame>Baseline and Month 6</time_frame>
        <population>All enrolled participants evaluable for primary objective with available data for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>RA Participants</title>
            <description>Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.</description>
          </group>
        </group_list>
        <measure>
          <title>Correlation Coefficient Between Change From Baseline in CRP (mg/dL) and HAQ-DI (0-3) at Month 6</title>
          <description>CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in level of CRP indicates reduction in inflammation and therefore improvement. HAQ-DI is a questionnaire that measures functional status (disability) and health-related QoL. It measures the participant's ability to perform everyday tasks. The index consists of 20 questions regarding the function of the upper and lower extremities. These questions are summarized in 8 categories: dressing and grooming, arising, eating, walking, hygiene, reach, grip and common activities over past week. Each question was evaluated according to the degree of severity on a 4-point scale ranging from 0= without any difficulty to 3= unable to do. Total score is the average of all questions, which ranges from 0 to 3, where higher scores represent higher disease activity. The Pearson and Spearman correlation coefficients can range in value from -1 to +1.</description>
          <population>All enrolled participants evaluable for primary objective with available data for this outcome measure.</population>
          <units>correlation coefficient</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="72"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Pearson correlation</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.25513"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Spearman correlation</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.21125"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.0306</p_value>
            <method>Pearson correlation</method>
            <method_desc>P-value was calculated from Pearson correlation coefficient for change from baseline in CRP versus change from baseline in HAQ-DI (0-3) at Month 6.</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.0749</p_value>
            <method>Spearman Correlation</method>
            <method_desc>P-value was calculated from Spearman correlation coefficient for change from baseline in CRP versus change from baseline in HAQ-DI (0-3) at Month 6.</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Correlation Coefficient Between CRP (mg/dL) at the Start of TCZ Treatment and VAS Fatigue at Month 6</title>
        <description>The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement. Participants measured the level of fatigue due to RA using a 100 mm VAS, where the responses were on a continuous range from 0 mm = no fatigue to 100 mm = extreme fatigue. The Pearson and Spearman correlation coefficients can range in value from -1 to +1.</description>
        <time_frame>Baseline and Month 6</time_frame>
        <population>All enrolled participants evaluable for primary objective with available data for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>RA Participants</title>
            <description>Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.</description>
          </group>
        </group_list>
        <measure>
          <title>Correlation Coefficient Between CRP (mg/dL) at the Start of TCZ Treatment and VAS Fatigue at Month 6</title>
          <description>The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement. Participants measured the level of fatigue due to RA using a 100 mm VAS, where the responses were on a continuous range from 0 mm = no fatigue to 100 mm = extreme fatigue. The Pearson and Spearman correlation coefficients can range in value from -1 to +1.</description>
          <population>All enrolled participants evaluable for primary objective with available data for this outcome measure.</population>
          <units>correlation coefficient</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="75"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Pearson correlation</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.08180"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Spearman correlation</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.11521"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.4854</p_value>
            <method>Pearson correlation</method>
            <method_desc>P-value was calculated from Pearson correlation coefficient between CRP at the start of TCZ treatment versus VAS fatigue at Month 6.</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.3250</p_value>
            <method>S</method>
            <method_desc>P-value was calculated from Spearman correlation coefficient between CRP at the start of TCZ treatment versus VAS fatigue at Month 6.</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Correlation Coefficient Between Change From Baseline in CRP (mg/dL) at the Start of TCZ Treatment and Change From Baseline in VAS Fatigue at Month 6</title>
        <description>The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement. Participants measured the level of fatigue due to RA using a 100 mm VAS, where the responses were on a continuous range from 0 mm = no fatigue to 100 mm = extreme fatigue. The Pearson and Spearman correlation coefficients can range in value from -1 to +1.</description>
        <time_frame>Baseline and Month 6</time_frame>
        <population>All enrolled participants evaluable for primary objective with available data for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>RA Participants</title>
            <description>Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.</description>
          </group>
        </group_list>
        <measure>
          <title>Correlation Coefficient Between Change From Baseline in CRP (mg/dL) at the Start of TCZ Treatment and Change From Baseline in VAS Fatigue at Month 6</title>
          <description>The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement. Participants measured the level of fatigue due to RA using a 100 mm VAS, where the responses were on a continuous range from 0 mm = no fatigue to 100 mm = extreme fatigue. The Pearson and Spearman correlation coefficients can range in value from -1 to +1.</description>
          <population>All enrolled participants evaluable for primary objective with available data for this outcome measure.</population>
          <units>correlation coefficient</units>
          <param>Number</param>
          <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>Pearson correlation</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.41350"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Spearman correlation</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.40842"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.0011</p_value>
            <method>Pearson correlation</method>
            <method_desc>P-value was calculated from Pearson correlation coefficient between change from baseline in CRP versus change from baseline in VAS fatigue at Month 6.</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.0013</p_value>
            <method>Spearman Correlation</method>
            <method_desc>P-value calculated from Spearman correlation coefficient between change from baseline in CRP versus change from baseline in VAS fatigue at Month 6.</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Correlation Coefficient Between BMI at the Start of TCZ Treatment and HAQ-DI (0-3) at Month 6</title>
        <description>The HAQ-DI is a questionnaire that measures functional status (disability) and health-related QoL. It measures the participant's ability to perform everyday tasks. The index consists of 20 questions regarding the function of the upper and lower extremities. These questions are summarized in 8 categories: dressing and grooming, arising, eating, walking, hygiene,reach, grip and common activities over past week. Each question was evaluated according to the degree of severity on a 4-point scale ranging from 0 = without any difficulty to 3 = unable to do. Total score is the average of all questions, which ranges from 0 to 3, where higher scores represent higher disease activity. The Pearson and Spearman correlation coefficients can range in value from -1 to +1.</description>
        <time_frame>Baseline and Month 6</time_frame>
        <population>All enrolled participants evaluable for primary objective with available data for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>RA Participants</title>
            <description>Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.</description>
          </group>
        </group_list>
        <measure>
          <title>Correlation Coefficient Between BMI at the Start of TCZ Treatment and HAQ-DI (0-3) at Month 6</title>
          <description>The HAQ-DI is a questionnaire that measures functional status (disability) and health-related QoL. It measures the participant's ability to perform everyday tasks. The index consists of 20 questions regarding the function of the upper and lower extremities. These questions are summarized in 8 categories: dressing and grooming, arising, eating, walking, hygiene,reach, grip and common activities over past week. Each question was evaluated according to the degree of severity on a 4-point scale ranging from 0 = without any difficulty to 3 = unable to do. Total score is the average of all questions, which ranges from 0 to 3, where higher scores represent higher disease activity. The Pearson and Spearman correlation coefficients can range in value from -1 to +1.</description>
          <population>All enrolled participants evaluable for primary objective with available data for this outcome measure.</population>
          <units>correlation coefficient</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="48"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Pearson correlation</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.08505"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Spearman correlation</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.12488"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.5655</p_value>
            <method>Pearson correlation</method>
            <method_desc>P-value was calculated from Pearson correlation coefficient between BMI at the start of TCZ treatment versus HAQ-DI (0-3) at Month 6.</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.3977</p_value>
            <method>Spearman Correlation</method>
            <method_desc>P-value was calculated from Spearman correlation coefficient between BMI at the start of TCZ treatment versus HAQ-DI (0-3) at Month 6.</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Correlation Coefficient Between Change From Baseline in CRP (mg/dL) and Change From Baseline in Morning Stiffness According to VAS at Month 6</title>
        <description>The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement. Morning stiffness was defined as the time elapsed between the time of usual awakening (even if not in the morning) and the time the participant was able to resume normal activities without stiffness. The participant reported the duration of morning stiffness in the case report form by ticking 1 of the following categories: no morning stiffness, &lt; 30 minutes, 30 - 60 minutes, 60 - 120 minutes, 120 - 240 minutes, &gt; 240 minutes, and the whole day. The Pearson and Spearman correlation coefficients can range in value from -1 to +1.</description>
        <time_frame>Baseline and Month 6</time_frame>
        <population>All enrolled participants evaluable for primary objective with available data for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>RA Participants</title>
            <description>Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.</description>
          </group>
        </group_list>
        <measure>
          <title>Correlation Coefficient Between Change From Baseline in CRP (mg/dL) and Change From Baseline in Morning Stiffness According to VAS at Month 6</title>
          <description>The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement. Morning stiffness was defined as the time elapsed between the time of usual awakening (even if not in the morning) and the time the participant was able to resume normal activities without stiffness. The participant reported the duration of morning stiffness in the case report form by ticking 1 of the following categories: no morning stiffness, &lt; 30 minutes, 30 - 60 minutes, 60 - 120 minutes, 120 - 240 minutes, &gt; 240 minutes, and the whole day. The Pearson and Spearman correlation coefficients can range in value from -1 to +1.</description>
          <population>All enrolled participants evaluable for primary objective with available data for this outcome measure.</population>
          <units>correlation coefficient</units>
          <param>Number</param>
          <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>Pearson correlation</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.41875"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Spearman correlation</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.40754"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.0123</p_value>
            <method>Pearson correlation</method>
            <method_desc>P-value obtained from Pearson correlation coefficient between change from baseline in CRP versus change from baseline in morning stiffness at Month 6.</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.0151</p_value>
            <method>Spearman Correlation</method>
            <method_desc>P-value obtained from Spearman correlation coefficient between change from baseline in CRP versus change from baseline in morning stiffness at Month 6</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Correlation Coefficient Between BMI at the Start of TCZ Treatment and VAS Fatigue at Month 6</title>
        <description>Participants measured the level of fatigue due to RA using a 100 mm VAS, where the responses were on a continuous range from 0 mm = no fatigue to 100 mm = extreme fatigue. The Pearson and Spearman correlation coefficients can range in value from -1 to +1.</description>
        <time_frame>Baseline and Month 6</time_frame>
        <population>All enrolled participants evaluable for primary objective with available data for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>RA Participants</title>
            <description>Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.</description>
          </group>
        </group_list>
        <measure>
          <title>Correlation Coefficient Between BMI at the Start of TCZ Treatment and VAS Fatigue at Month 6</title>
          <description>Participants measured the level of fatigue due to RA using a 100 mm VAS, where the responses were on a continuous range from 0 mm = no fatigue to 100 mm = extreme fatigue. The Pearson and Spearman correlation coefficients can range in value from -1 to +1.</description>
          <population>All enrolled participants evaluable for primary objective with available data for this outcome measure.</population>
          <units>correlation coefficient</units>
          <param>Number</param>
          <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>Pearson correlation</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.00181"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Spearman correlation</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.07250"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.9909</p_value>
            <method>Pearson correlation</method>
            <method_desc>P-value was calculated from Pearson correlation coefficient between BMI at the start of TCZ treatment versus VAS fatigue at Month 6.</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.6482</p_value>
            <method>Spearman Correlation</method>
            <method_desc>P-value was calculated from Spearman correlation coefficient between BMI at the start of TCZ treatment versus VAS fatigue at Month 6.</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse events (AEs) were recorded from enrollment up to 6 months (final visit).</time_frame>
      <desc>Safety Analysis Set: Participants evaluable at enrollment.</desc>
      <group_list>
        <group group_id="E1">
          <title>RA Participants</title>
          <description>Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA (17.0)</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="136"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Amyotrophic Lateral Sclerosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="136"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Respiratory Failure</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="136"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA (17.0)</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="8" subjects_at_risk="136"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="136"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

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


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01664104
org study id: ML28336
nct id: NCT01664104
lead sponsor: 
This observational, multi-center study will evaluate the treatment regimen, treatment
      responses and safety of tocilizumab therapy in a routine clinical practice in participants
      with moderate to severe rheumatoid arthritis (RA). Data will be collected for 6 months with a
      maximum study duration of 18 months.
observational model: Cohort
time perspective: Prospective
measure: Percentage of Participants on TCZ Treatment at Month 6
time frame: Month 6
description: Percentage of participants on TCZ treatment at Month 6 was calculated as: [(participants on TCZ treatment at Month 6) divided by (participants evaluable for primary objective)] multiplied by 100. Confidence interval was computed based on the Clopper-Pearson method.
measure: Percentage of Participants by TCZ Dose at Month 6
time frame: Month 6
description: TCZ dose at Month 6 was calculated over the total number of participants evaluable for the primary objective and who did not interrupt TCZ. Percentage of participants on TCZ dose at Month 6 was calculated as the [(participants with specified TCZ dose at 6 months) divided by (participants who did not interrupt TCZ at Month 6)] multiplied by 100.
measure: Percentage of Participants Starting TCZ After Inadequate Response (IR) to a Biologic Treatment or After Intolerance or IR to Disease-Modifying Anti-Rheumatic Drugs (DMARDs)
time frame: Baseline
description: Participants with at least 1 treatment with biologic agent not equal missing and which is not ongoing or with a stop date lower or equal to first TCZ administration had IR to biologic treatment. Participants with at least 1 treatment with DMARDs with a stop date lower or equal to first TCZ administration had IR to DMARDs. Participants with a biologic and DMARDs interruption or with a biologic interruption and ongoing treatment with DMARDs were classified in "IR to biologic group". Participants with DMARDs interruption or ongoing DMARDs and adding TCZ without a biologic interruption were classified in the "DMARDs intolerance and/or IR" group.
measure: Time Elapsed From Diagnosis of RA
time frame: Baseline (assessed retrospectively)
description: Time elapsed from diagnosis of RA in years was calculated as the (difference between the date of enrollment visit and the date of first diagnosis of RA) divided by 365.25.
measure: Patient Assessment of Pain Using Visual Analog Scale (VAS) at Baseline
time frame: Baseline
description: Participants measured the pain intensity due to RA on a 100 millimeter (mm) VAS, where the responses were on a continuous range from 0 mm = no pain to 100 mm = unbearable pain.
measure: Patient Global Assessment of Disease Activity (PGH) Using VAS at Baseline
time frame: Baseline
description: The PGH was measured using a 100 mm VAS, where the responses were on a continuous range from 0 mm = managing very well to 100 mm = managing very poorly.
measure: Physician Global Assessment of Disease Activity (PhGH) Using VAS at Baseline
time frame: Baseline
description: The PhGH was measured on a 100 mm VAS, where 0 mm = no arthritis activity to 100 mm = extremely active arthritis.
measure: Participant Assessment of Morning Stiffness Using VAS at Baseline
time frame: Baseline
description: The participant assessment of morning stiffness was measured using a ruler on a 100 mm VAS, where the responses were on a continuous range from 0 mm = no stiffness and 100 mm = maximum stiffness.
measure: Participant Assessment of Fatigue Using VAS at Baseline
time frame: Baseline
description: Participants measured the level of fatigue due to RA using a 100 mm VAS, where the responses were on a continuous range from 0 mm = no fatigue to 100 mm = extreme fatigue.
measure: Health Assessment Questionnaire Disability Index (HAQ-DI) Score at Baseline
time frame: Baseline
description: The HAQ-DI is a questionnaire that measures functional status (disability) and health-related quality of life (QoL). It measures the participant's ability to perform everyday tasks. The index consists of 20 questions regarding the function of the upper and lower extremities. These questions are summarized in 8 categories: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and common activities over past week. Each question was evaluated according to the degree of severity on a 4-point scale ranging from 0 = without any difficulty to 3 = unable to do. Total score for HAQ-DI is the average of all questions and ranges from 0 to 3, where higher scores represent higher disease activity.
measure: Tender Joint Count (TJC) at Baseline
time frame: Baseline
description: TJC was determined by examining 28 joints and identifying the joints that were painful under pressure or to passive motion. Tenderness was recorded on the joint assessment form at baseline; no tenderness = 0 and tenderness = 1.
measure: Swollen Joint Count (SJC) at Baseline
time frame: Baseline
description: SJC was determined by examining 28 joints and identifying when swelling was present. Swelling was recorded on the joint assessment form at baseline; no swelling = 0 and swelling = 1.
measure: Erythrocyte Sedimentation Rate (ESR) at Baseline
time frame: Baseline
description: ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 millimeter per hour (mm/hour). A decrease in the level indicates reduction in inflammation and therefore improvement.
measure: C-Reactive Protein (CRP) at Baseline
time frame: Baseline
description: The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.
measure: Percentage of Participants With Presence of Extra-Articular Systemic Features of RA at Baseline
time frame: Baseline
description: Extra-articular systemic features referred to anemia, fatigue as well as a wide range of co-morbidities such as osteoporosis and other iatrogenic complications. Percentage of participants with any of the extra-articular systemic feature are reported.
measure: Percentage of Participants With Evidence of Structural Joint Damage at Baseline
time frame: Baseline
measure: Percentage of Participants With Previous RA-Related Surgical Procedures at Baseline
time frame: Baseline
measure: Percentage of Participants With Positive Rheumatoid Factor (RF) at Baseline
time frame: Baseline
description: RF is the auto antibody directed against immunoglobulin G and its concentration is observed in human serum or plasma. RF value higher than 20 units per milliliter is considered positive.
measure: Percentage of Participants With Anti-Citrullinated Cyclic Peptide at Baseline
time frame: Baseline
measure: Percentage of Participants by Duration of Morning Stiffness at Baseline
time frame: Baseline
description: Duration of morning stiffness was defined as the time elapsed between the time of usual awakening (even if not in the morning) and the time the participant was able to resume normal activities without stiffness. The participant reported the duration of morning stiffness in the case report form by ticking 1 of the following categories: no morning stiffness, less than (<) 30 minutes, 30 - 60 minutes, 60 - 120 minutes, 120 - 240 minutes, greater than (>) 240 minutes, and the whole day. 'Not estimable' represented that the participants were not able to quantify it.
measure: Number of Participants With TCZ Dose Change According to the Reason for Change
time frame: Baseline up to Month 6
description: Number of participants with TCZ dose change (increase or decrease with respect to starting dose) was reported by reason for change.
measure: Percentage of Participants by Number of TCZ Dose Modifications Per Participant
time frame: Baseline up to Month 6
description: The number of TCZ dose modifications per participant was calculated as the number of times that the participant changed the prescribed dose with respect to the dose planned at enrollment/previous administration. If the participant did not change the prescribed dose, the values were set at missing.
measure: Time in Days Elapsed Between TCZ Infusions
time frame: Baseline up to Month 6 (assessed retrospectively and prospectively at each administration [approximately 1 month apart] up to administration 8
description: The time elapsed in days between TCZ infusions was calculated as the difference between the date of TCZ infusion and the date of the previous administration.
measure: Percentage of Participants With TCZ Infusion Interruption
time frame: Baseline up to Month 6
description: The percentage of participants with at least one infusion interruption was reported as "Yes". Participants with unknown infusion interruption were set to "No".
measure: Percentage of Participants Who Discontinued TCZ by Reason for Discontinuation
time frame: Baseline up to Month 6
measure: Percentage of Participants With TCZ Reintroduction
time frame: Baseline up to Month 6
description: The percentage of participants with at least one TCZ reintroduction was reported as "Yes". Participants with unknown TCZ reintroduction were set to "No".
measure: Percentage of Participants by Reason for Choice of TCZ Monotherapy at Baseline
time frame: Baseline
measure: Change From Baseline in Disease Activity Score Based on 28 Joint Count (DAS28) Score at Month 3 and Month 6
time frame: Baseline, Month 3, and Month 6
description: DAS28 score is a measurement of RA activity on a 0 to 10 scale, with higher scores representing higher disease activity, and calculated as DAS28 = 0.56 x √TJC28 + 0.28 x √SJC28 + 0.36 x natural logarithm (ln) (CRP + 1) + 0.014 x PGH + 0.96, where TJC28 = tender joint count on 28 units, SJC28 = swollen joint count on 28 units, CRP = serum concentration of c-reactive protein (after converting units to mg/dL), PGH = patient global assessment of disease activity, which was measured on a 100 mm VAS, where 0 mm = managing very well and 100 mm = managing very poorly (√ = square root). A score of < 2.6 represents clinical remission, a score of greater than or equal to (≥) 2.6 and less than or equal to (≤) 3.2 represents low disease activity, a score of > 3.2 and ≤ 5.1 represents moderate disease activity and a score of > 5.1 represents high (or severe) disease activity. Change from baseline = DAS28 at Month X - DAS28 at baseline. Here X = 3 and 6 for Change at Months 3 and 6, respectively.
measure: Change From Baseline in Simplified Disease Activity Index (SDAI) Score at Month 3 and Month 6
time frame: Baseline, Month 3, and Month 6
description: SDAI is a combined index for measuring disease activity in RA and calculated as SDAI = TJC28 + SJC28 + PGH (in cm) + PhGH (in cm) + CRP (in mg/dL), where TJC28 = tender joint count on 28 units, SJC28 = swollen joint count on 28 units, PGH = patient's global assessment of disease activity, assessed on a 100 mm VAS, where 0 = managing very well and 100 = managing very poorly, PhGH = physician global assessment of disease activity, assessed on a 100 mm VAS, where 0 mm = no arthritis activity and 100 mm = extremely active arthritis, CRP = serum concentration of C-reactive protein. SDAI total score ranged from 0-86. Higher scores represent greater disease activity. SDAI scores of ≤ 3.3 represents clinical remission, ≤ 11.0 represents low disease activity , ≤ 26.0 represents moderate disease activity, and > 26.0 represents high (or severe) disease activity. Change from baseline = SDAI score at Month X - SDAI score at baseline. Here X = 3 and 6 for Change at Months 3 and 6, respectively.
measure: Change From Baseline in Clinical Disease Activity Index (CDAI) Score at Month 3 and Month 6
time frame: Baseline, Month 3, and Month 6
description: The CDAI is a combined index for measuring disease activity in RA and calculated as CDAI = TJC28 + SJC28 + PGH (in cm) + PhGH (in cm), where TJC28 = tender joint count on 28 units, SJC28 = swollen joint count on 28 units, PGH = patient's global assessment of disease activity, assessed on a 100 mm VAS, where 0 = managing very well and 100 = managing very poorly, and PhGH = physician global assessment of disease activity, assessed on a 100 mm VAS, where 0 mm = no arthritis activity and 100 mm = extremely active arthritis. CDAI total score ranged from 0-76. Higher scores indicate greater disease activity. CDAI score of ≤ 2.8 represents clinical remission, score of ≤ 10.0 represents low disease activity, score of ≤ 22.0 represents moderate disease activity, and score of > 22.0 represents high (or severe) disease activity. Change from baseline = CDAI score at Month X - CDAI score at baseline. Here X = 3 and 6 for Change at Months 3 and 6, respectively.
measure: Percentage of Participants by DAS28 Class at the Start of TCZ Treatment and After Month 3 and Month 6
time frame: Baseline, Month 3, and Month 6
description: DAS28 score is a measurement of RA activity on a 0 to 10 scale and calculated as DAS28 = 0.56 x √TJC28 + 0.28 x √SJC28 + 0.36 x ln(CRP + 1) + 0.014 x PGH + 0.96, where TJC28 = tender joint count on 28 units, SJC28 = swollen joint count on 28 units, CRP = serum concentration of c-reactive protein (after converting units to mg/dL), PGH = patient's global assessment of disease activity, which was measured on a 100 mm VAS, where 0 mm = managing very well and 100 mm = managing very poorly. Higher scores represent greater disease activity. A score of < 2.6 represents clinical remission, a score of ≥ 2.6 and ≤ 3.2 represents low disease activity, a score of >3.2 and ≤ 5.1 represents moderate disease activity, and a score of > 5.1 represents high (or severe) disease activity.
measure: Percentage of Participants by SDAI Class at the Start of TCZ Treatment and After Month 3 and Month 6
time frame: Baseline, Month 3, and Month 6
description: SDAI is a combined index for measuring disease activity in RA and calculated as SDAI = TJC28 + SJC28 + PGH (in cm) + PhGH (in cm) + CRP (in mg/dL), where TJC28 = tender joint count on 28 units, SJC28 = swollen joint count on 28 units, PGH = patient's global assessment of disease activity, assessed on a 100 mm VAS, where 0 mm = managing very well and 100 mm = managing very poorly, PhGH = physician global assessment of disease activity, assessed on a 100 mm VAS, where 0 = no arthritis activity and 100 = extremely active arthritis, CRP = serum concentration of C-reactive protein. SDAI total score ranged from 0-86. Higher scores represent greater disease activity. SDAI scores of ≤ 3.3 represents clinical remission, ≤ 11.0 represents low disease activity, ≤ 26.0 represents moderate disease activity, and > 26.0 represents high (or severe) disease activity.
measure: Percentage of Participants by CDAI Class at the Start of TCZ Treatment and After Month 3 and Month 6
time frame: Baseline, Month 3, and Month 6
description: CDAI is a combined index for measuring disease activity in RA and calculated as CDAI = TJC28 + SJC28 + PGH (in cm) + PhGH (in cm), where TJC28 = tender joint count on 28 units, SJC28 = swollen joint count on 28 units, PGH = patient's global assessment of disease activity, assessed on a 100 mm VAS, where 0 mm = managing very well and 100 mm = managing very poorly, and PhGH = physician global assessment of disease activity, assessed on a 100 mm VAS, where 0 mm = no arthritis activity and 100 mm = extremely active arthritis. CDAI total score ranged from 0-76. Higher scores indicate greater disease activity. CDAI score of ≤ 2.8 represents clinical remission, score of ≤ 10.0 represents low disease activity, score of ≤ 22.0 represents moderate disease activity, and score of > 22.0 represents high (or severe) disease activity.
measure: Percentage of Participants With an American College of Rheumatology (ACR) 20%, 50%, 70%, or 90% (ACR20/50/70/90) Response After Month 3 and Month 6 From the Start of TCZ Treatment
time frame: Month 3 and Month 6
description: ACR20, 50, 70 or 90 response = an improvement of ≥20%, ≥50%, ≥70% or ≥90% respectively, as compared to baseline in TJC28 and SJC28, and 20/50/70/90%, improvement in at least 3 of 5 following measures: Patient's Assessment of Pain over previous 24 hours, PGH, PhGH, HAQ, and acute phase reactant (either CRP or ESR). TJC and SJC, based on 28-joint assessments. Number of tender joints and swollen joints were recorded on joint assessment form at baseline; no tenderness = 0 and tenderness = 28, no swelling = 0 and swelling = 28, respectively. HAQ measures functional status (disability) and health-related QoL with 20 questions, summarized in 8 categories: dressing and grooming, arising, eating, walking, hygiene, reach, grip and common activities over past week, 0= without difficulty to 3= unable to do. Patient's assessment of pain assessed using VAS; 0 mm = no pain, 100 mm = unbearable pain; PGH and PhGH, assessed using VAS; 0 mm = no disease activity, 100 mm = maximum disease activity.
measure: Change From Baseline to Month 6 in TJC
time frame: Baseline and Month 6
description: TJC 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 baseline and at Month 6. No tenderness = 0 and tenderness = 1.
measure: Change From Baseline to Month 6 in SJC
time frame: Baseline and Month 6
description: SJC 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 baseline and at Month 6. No swelling = 0 and swelling = 1.
measure: Change From Baseline to Month 6 in PGH
time frame: Baseline and Month 6
description: The PGH was measured using a 100 mm VAS, where the responses were on a continuous range from 0 mm = managing very well and 100 mm = managing very poorly.
measure: Change From Baseline to Month 6 in PhGH
time frame: Baseline and Month 6
description: The PhGH was evaluated using a 100 mm VAS where 0 mm = no arthritis activity and 100 mm = extremely active arthritis. Higher scores indicated increased level of disease.
measure: Change From Baseline to Month 6 in Patient's Assessment of Pain
time frame: Baseline and Month 6
description: Participants measured the pain intensity due to RA using a 100 mm VAS, where the responses were on a continuous range from 0 mm = no pain to 100 mm = unbearable pain.
measure: Change From Baseline to Month 6 in HAQ-DI Score
time frame: Baseline and Month 6
description: The HAQ-DI is a questionnaire that measures functional status (disability) and health-related QoL. It measures the participant's ability to perform everyday tasks. The index consists of 20 questions regarding the function of the upper and lower extremities. These questions are summarized in 8 categories: dressing and grooming, arising, eating, walking, hygiene, reach, grip and common activities over past week. Each question was evaluated according to the degree of severity on a 4-point scale ranging from 0 = without any difficulty to 3 = unable to do.Total score for HAQ-DI is the average of all the questions, which ranges from 0 to 3, where higher scores represent higher disease activity.
measure: Change From Baseline to Month 6 in Participant Assessment of Fatigue
time frame: Baseline and Month 6
description: Participants measured the level of fatigue due to RA using a 100 mm VAS, where the responses were on a continuous range from 0 mm = no fatigue to 100 mm = extreme fatigue.
measure: Change From Baseline to Month 6 in Participant Assessment of Morning Stiffness
time frame: Baseline and Month 6
description: The participant assessment of morning stiffness was measured using a ruler on a 100 mm VAS, where the responses were on a continuous range from 0 mm = no stiffness and 100 mm = maximum stiffness.
measure: Percentage of Participants With Clinically Meaningful Improvement in HAQ-DI
time frame: Month 3 and Month 6
description: The HAQ-DI is a questionnaire that measures functional status (disability) and health-related QoL. It measures the participant's ability to perform everyday tasks. The index consists of 20 questions regarding the function of the upper and lower extremities. These questions are summarized in 8 categories: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and common activities over past week. Each question was evaluated according to the degree of severity on a 4-point scale ranging from 0 = without any difficulty to 3 = unable to do. Total score for HAQ-DI is the average of all the questions, which ranges from 0 to 3, where higher scores represent higher disease activity. HAQ-DI clinically meaningful improvement is defined as decrease in HAQ total score from baseline of greater or equal to 0.22 points.
measure: Percentage of Participants Achieving Good/Moderate/No European League Against Rheumatism (EULAR) Response at Month 3 and Month 6
time frame: Month 3 and Month 6
description: Clinical response was assessed according to EULAR criteria that classified the participant according to individual changes in DAS28 score as good, moderate, or no response. DAS28 score is a measurement of RA activity on 0 to 10 scale and calculated as DAS28= 0.56 x √TJC28 + 0.28 x √SJC28 + 0.36 x ln(CRP + 1) + 0.014 x PGH + 0.96, where TJC28= tender joint count on 28 units, SJC28= swollen joint count on 28 units, CRP= serum concentration of C-reactive protein (after converting units to mg/dL), PGH= patient's global assessment of disease activity measured on a 100 mm VAS, where 0 mm= managing very well and 100 mm= managing very poorly. Good responders experienced change (chg) from baseline (BL) of >1.2 with DAS28 score ≤ 3.2, moderate responders experienced chg from BL >1.2 with DAS28 score > 3.2 to ≤ 5.1 or a chg from BL > 0.6 to ≤ 1.2 with DAS28 score of ≤ 5.1. No responders experienced chg from BL < 0.6 regardless initial DAS28 score or > 0.6 to ≤ 1.2 with DAS28 score of > 5.1.
measure: Time to DMARD Dose Reduction
time frame: Baseline up to Month 6
description: DMARDs that met the criteria for "concomitant medications" were selected. The time to DMARD dose reduction was calculated as the difference between date of dose reduction and the date of first TCZ infusion. For participants presenting more than 1 DMARD dose reduction, only the first dose reduction was considered.
measure: Time to DMARD Dose Withdrawal
time frame: Baseline up to Month 6
description: DMARDs that met the criteria for "concomitant medications" were selected. The time to DMARD withdrawal was calculated as the difference between date of withdrawal and the date of first TCZ infusion.
measure: Percentage of Participants by Reason for DMARD Withdrawal During the Study
time frame: Baseline up to Month 6
description: DMARDs that met the criteria for "concomitant medications" were selected. All treatments with DMARDs interrupted after the first TCZ infusion were selected.
measure: Time to Steroid Dose Reduction
time frame: Baseline up to Month 6
description: Steroids that met the criteria for "concomitant medications" were selected. The time to steroid dose reduction was calculated as the difference between date of dose reduction and the date of first TCZ infusion. For participants presenting more than one steroid dose reduction, only the first dose reduction was considered.
measure: Time to Steroid Dose Withdrawal
time frame: Baseline up to Month 6
description: Steroids that met the criteria for "concomitant medications" were selected. The time to steroid dose withdrawal was calculated as the difference between date of withdrawal and the date of first TCZ infusion.
measure: Change From Baseline in CRP at Month 3 and Month 6
time frame: Baseline, Month 3, and Month 6
description: The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement. Change from baseline = CRP level at Month X - CRP level at baseline. Here X = 3 and 6 for Change at Months 3 and 6, respectively.
measure: Change From Baseline in ESR at Month 3 and Month 6
time frame: Baseline, Month 3, and Month 6
description: ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 mm/hr. A decrease in the level indicates reduction in inflammation and therefore improvement. Change from baseline = ESR level at Month X - ESR level at baseline. Here X = 3 and 6 for Change at Months 3 and 6, respectively.
measure: CRP at the Start of TCZ Treatment by Remission Status Using DAS28-CRP, SDAI, and CDAI at Month 6
time frame: Baseline
description: The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement. DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity. DAS28 is calculated as follows: DAS28 = 0.56 x √TJC28 + 0.28 x √SJC28 + 0.36 x ln(CRP + 1) + 0.014 x PGH + 0.96, A score of < 2.6 represents clinical remission. SDAI is a combined index for measuring disease activity in RA and calculated as SDAI = TJC28 + SJC28 + PGH (in cm) + PhGH (in cm) + CRP (in mg/dL). A SDAI score of ≤ 3.3 represents clinical remission. CDAI is a combined index for measuring disease activity in RA and calculated as CDAI = TJC28 + SJC28 + PGH (in cm) + PhGH (in cm). A CDAI score of ≤ 2.8 represents clinical remission.
measure: Body Mass Index (BMI) at the Start of TCZ Treatment by Remission Status Using DAS-28 CRP, SDAI, and CDAI at Month 6
time frame: Baseline
description: DAS28 scale ranges from 0 to 10, and calculated as DAS28 = 0.56 x √TJC28 + 0.28 x √SJC28 + 0.36 x ln(CRP + 1) + 0.014 x PGH + 0.96, where TJC28 and SJC28 = tender joint and swollen joint count on 28 units, PGH = patient's global assessment of disease activity, assessed on a 100 mm VAS, where 0 mm = managing very well and 100 mm = managing very poorly, CRP = serum concentration of C-reactive protein. A score of < 2.6 represents clinical remission. SDAI is a combined index for measuring disease activity in RA and calculated as SDAI = TJC28 + SJC28 + PGH (in cm) + PhGH (in cm) + CRP (in mg/dL), where PhGH = physician global assessment of disease activity, assessed on a 100 mm VAS, where 0 mm = no arthritis activity and 100mm = extremely active arthritis. A SDAI score of ≤ 3.3 represents clinical remission. CDAI is a combined index for measuring disease activity in RA and calculated as CDAI = TJC28 + SJC28 + PGH (in cm) + PhGH (in cm). A CDAI score of ≤ 2.8 represents clinical remission.
measure: Percentage of Participants With and Without Morning Stiffness
time frame: Month 3 and Month 6
description: Morning stiffness was defined by the time elapsed between the time of usual awakening (even if not in the morning) and the time the participant was able to resume normal activities without stiffness. The participant assessed morning stiffness based on the following criteria:
Presence of participant's joints stiff when woke up that day, measured as yes (stiffness present) or no (stiffness not present);
Duration of morning stiffness, measured by ticking 1 of the six categories: < 30 minutes, 30 - 60 minutes, 60 - 120 minutes, 120 - 240 minutes, > 240 minutes, and the whole day;
Severity of morning stiffness measured using a ruler on a 100 mm VAS where the responses were on a continuous range from 0 mm = no stiffness to 100 mm = maximum stiffness.
'Not estimable' represented that the participants were not able to quantify it. 'Not done' represented that the assessment was not performed.
measure: Percentage of Participants by Duration of Morning Stiffness
time frame: Month 3 and Month 6
description: Duration of morning stiffness was defined as the time elapsed between the time of usual awakening (even if not in the morning) and the time the participant was able to resume normal activities without stiffness. The participant reported the duration of morning stiffness in the case report form by ticking 1 of the following categories: no morning stiffness, < 30 minutes, 30 - 60 minutes, 60 - 120 minutes, 120 - 240 minutes, > 240 minutes, and the whole day. 'Not estimable' represented that the participants were not able to quantify it. 'Not done' represented that the assessment was not performed.
measure: CRP at the Start of TCZ Treatment by Morning Stiffness at Month 6
time frame: Baseline
description: The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement. The participant reported the duration of morning stiffness in the case report form by ticking the categories: ≤ 30 minutes and > 30 minutes.
measure: BMI at the Start of TCZ Treatment by Morning Stiffness at Month 6
time frame: Baseline
description: Morning stiffness was defined as the time elapsed between the time of usual awakening (even if not in the morning) and the time the participant was able to resume normal activities without stiffness. The participant reported the duration of morning stiffness in the case report form by ticking the categories: ≤ 30 minutes and > 30 minutes.
measure: Correlation Coefficient Between CRP (mg/dL) at the Start of TCZ Treatment and HAQ-DI (0-3) at Month 6
time frame: Baseline and Month 6
description: The test for CRP is laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in level of CRP indicates reduction in inflammation and therefore improvement. HAQ-DI is a questionnaire that measures functional status (disability) and health-related QoL. It measures the participant's ability to perform everyday tasks. The index consists of 20 questions regarding the function of the upper and lower extremities. These questions are summarized in 8 categories: dressing and grooming, arising, eating, walking, hygiene, reach, grip and common activities over past week. Each question was evaluated according to the degree of severity on a 4-point scale ranging from 0 = without any difficulty to 3 = unable to do. Total score is average of all questions, which ranges from 0 to 3, where higher scores represent higher disease activity. The Pearson and Spearman correlation coefficients can range in value from -1 to +1.
measure: Correlation Coefficient Between Change From Baseline in CRP (mg/dL) and HAQ-DI (0-3) at Month 6
time frame: Baseline and Month 6
description: CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in level of CRP indicates reduction in inflammation and therefore improvement. HAQ-DI is a questionnaire that measures functional status (disability) and health-related QoL. It measures the participant's ability to perform everyday tasks. The index consists of 20 questions regarding the function of the upper and lower extremities. These questions are summarized in 8 categories: dressing and grooming, arising, eating, walking, hygiene, reach, grip and common activities over past week. Each question was evaluated according to the degree of severity on a 4-point scale ranging from 0= without any difficulty to 3= unable to do. Total score is the average of all questions, which ranges from 0 to 3, where higher scores represent higher disease activity. The Pearson and Spearman correlation coefficients can range in value from -1 to +1.
measure: Correlation Coefficient Between CRP (mg/dL) at the Start of TCZ Treatment and VAS Fatigue at Month 6
time frame: Baseline and Month 6
description: The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement. Participants measured the level of fatigue due to RA using a 100 mm VAS, where the responses were on a continuous range from 0 mm = no fatigue to 100 mm = extreme fatigue. The Pearson and Spearman correlation coefficients can range in value from -1 to +1.
measure: Correlation Coefficient Between Change From Baseline in CRP (mg/dL) at the Start of TCZ Treatment and Change From Baseline in VAS Fatigue at Month 6
time frame: Baseline and Month 6
description: The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement. Participants measured the level of fatigue due to RA using a 100 mm VAS, where the responses were on a continuous range from 0 mm = no fatigue to 100 mm = extreme fatigue. The Pearson and Spearman correlation coefficients can range in value from -1 to +1.
measure: Correlation Coefficient Between BMI at the Start of TCZ Treatment and HAQ-DI (0-3) at Month 6
time frame: Baseline and Month 6
description: The HAQ-DI is a questionnaire that measures functional status (disability) and health-related QoL. It measures the participant's ability to perform everyday tasks. The index consists of 20 questions regarding the function of the upper and lower extremities. These questions are summarized in 8 categories: dressing and grooming, arising, eating, walking, hygiene,reach, grip and common activities over past week. Each question was evaluated according to the degree of severity on a 4-point scale ranging from 0 = without any difficulty to 3 = unable to do. Total score is the average of all questions, which ranges from 0 to 3, where higher scores represent higher disease activity. The Pearson and Spearman correlation coefficients can range in value from -1 to +1.
measure: Correlation Coefficient Between Change From Baseline in CRP (mg/dL) and Change From Baseline in Morning Stiffness According to VAS at Month 6
time frame: Baseline and Month 6
description: The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement. Morning stiffness was defined as the time elapsed between the time of usual awakening (even if not in the morning) and the time the participant was able to resume normal activities without stiffness. The participant reported the duration of morning stiffness in the case report form by ticking 1 of the following categories: no morning stiffness, < 30 minutes, 30 - 60 minutes, 60 - 120 minutes, 120 - 240 minutes, > 240 minutes, and the whole day. The Pearson and Spearman correlation coefficients can range in value from -1 to +1.
measure: Correlation Coefficient Between BMI at the Start of TCZ Treatment and VAS Fatigue at Month 6
time frame: Baseline and Month 6
description: Participants measured the level of fatigue due to RA using a 100 mm VAS, where the responses were on a continuous range from 0 mm = no fatigue to 100 mm = extreme fatigue. The Pearson and Spearman correlation coefficients can range in value from -1 to +1.
arm group label: RA Participants
description: Participants with moderate or severe RA who are under tocilizumab treatment in routine clinical practice (in accordance with the local label) will be observed for 6 months from the start of treatment.
intervention type: Drug
intervention name: Tocilizumab
description: Tocilizumab will be administered in routine clinical practice in accordance with local label. Study protocol does not specify/enforce any treatment regimen.
arm group label: RA Participants
study pop: 
sampling method: Non-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: Italy
responsible party type: Sponsor
mesh term: Arthritis
mesh term: Arthritis, Rheumatoid
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