An Observational Study of Tocilizumab (Actemra) in Participants With Moderate to Severe Rheumatoid Arthritis

Study Overview
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Brief Summary
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This observational study evaluates the use and efficacy of intravenous (IV) tocilizumab in routine clinical practice in participants with moderate to severe rheumatoid arthritis. Eligible participants initiated on tocilizumab treatment in accordance with the local label were followed for 6 months.

Official Title
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A Multi-National, Multi-Center Non-Interventional Study in Rheumatoid Arthritis (RA) Patients Treated With Tocilizumab

Conditions
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Rheumatoid Arthritis

Intervention / Treatment
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* Biological: Tocilizumab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults, >/= 18 years of age Moderate to severe rheumatoid arthritis according to the revised (1987) American College of Rheumatology (ACR) criteria Participants in whom the treating physician has made the decision to commence tocilizumab treatment (in accordance with the local label); this can include participants who have received tocilizumab treatment within 8 weeks prior to the enrollment visit Exclusion Criteria: Participants who have received tocilizumab more than 8 weeks prior to the enrollment visit Participants who have received treatment with any investigational agent within 4 weeks (or 5 half-lives of the investigational agent, whichever is longer) before starting treatment with tocilizumab History of autoimmune disease or any joint inflammatory disease other than rheumatoid arthritis

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Tocilizumab<br>Participants with moderate to severe rheumatoid arthritis (RA), according to the American College of Rheumatology (ACR) criteria and the Disease Activity Score Based on 28 Joints (DAS28), in whom the attending physician has decided to start treatment with tocilizumab (according to the local label). | Biological: Tocilizumab<br>* Tocilizumab was administered according to the local label.<br>* Other names: Actemra;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants on Tocilizumab at 6 Months After Treatment Initiation |  | At 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Systemic Manifestations of Rheumatoid Arthritis | Systemic manifestation measured by C-reactive protein levels > 3 | At baseline | 
| Percentage of Participants Starting Tocilizumab After Prior and Baseline Disease-Modifying Anti-rheumatic Drugs (DMARDs) Exposure | DMARDs exposure was evaluated for all participants. Prior DMARDs treatment includes participants, who were treated with DMARDs 6 months before being included in the study. DMARDs treatment at baseline includes participants, who were receiving DMARDs when they were included in the study and continued with this concomitant medication to tocilizumab. | At baseline | 
| Number of Participants Starting Tocilizumab After Failing Other Biologic Agents | Other biologic agents include anti-Tumor Necrosis Factor (TNF) antibody. | At baseline | 
| Median Dose at 6 Months |  | At 6 months | 
| Number of Participants With Dose Modifications at 6 Months |  | At 6 months | 
| Median Duration of Treatment |  | Approximately 16 months | 
| Percentage of Participants Discontinued From Tocilizumab for Safety | Safety variable measuring number of patients that discontinued tocilizumab due to adverse reactions to tocilizumab. | Approximately 16 months | 
| Percentage of Participants Discontinued From Tocilizumab for Lack of Efficacy | Efficacy variable that measures the rate of participants discontinued from tocilizumab due to lack of efficacy according to criteria of treating physician. | Approximately 16 months | 
| Number of Participants Discontinued From Tocilizumab for Other Reasons | This variable measures the number of events not related to safety or efficacy leading to discontinuation of tocilizumab treatment. | Approximately 16 months | 
| Time to Restoration of Initial Dosing Regimen |  | Approximately 16 months | 
| Non-adherence Rate of Physician to the Recommended Dosing Regimen |  | Approximately 16 months | 
| Percentage of Participants on Tocilizumab Monotherapy at Study Entry |  | At baseline | 
| Total Tender Joint Count (TJC) |  | At Visit 1 (Baseline), Observation 1: up to 4 weeks, Observation 2: up to 8 weeks; Observation 3: up to 12 weeks; Observation 4: up to 16 weeks and Observation 5: up to 20 weeks | 
| Total Swollen Joint Count (SJC) |  | At Visit 1 (Baseline), Observation 1: up to 4 weeks, Observation 2: up to 8 weeks; Observation 3: up to 12 weeks; Observation 4: up to 16 weeks and Observation 5: up to 20 weeks | 
| Disease Activity Score Based on 28 Joints (DAS28) | The DAS28 is a measure of disease activity in rheumatoid arthritis (RA) and the number 28 refers to the 28 joints that are examined in this assessment. To calculate the DAS28 the following assessments are done: 1) count the number of swollen joints (out of the 28 [sw28]), 2) count the number of tender joints (out of the 28 [t28]), 3) measure Erythrocyte Sedimentation Rate (ESR), and 4) ask the participant to make a 'global assessment of health' (GH) indicated by marking a 10 cm line between very good and very bad. The Score is developed under the follow formula: DAS28(4) = 0.56*sqrt(t28) + 0.28*sqrt(sw28) + 0.70*Ln(ESR) + 0.014*GH Where, t=tender joints; sw=swollen joints; ESR= Erythrocyte Sedimentation Rate; GH=Global assessment of health score. This score may range from 0 to 9.3, where a DAS28 of greater than 5.1 implies active disease, less than 3.2 low disease activity, and less than 2.6 remission. | At Visit 1 (Baseline), Observation 1: up to 4 weeks, Observation 2: up to 8 weeks; Observation 3: up to 12 weeks; Observation 4: up to 16 weeks and Observation 5: up to 20 weeks |