A Non-Interventional Study in Rheumatoid Arthritis Patients Treated With Tocilizumab (RoActemra/Actemra)

Study Overview
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Brief Summary
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This multi-center, non-interventional study will evaluate the pattern of usage in clinical practice, efficacy and safety of tocilizumab in patients with rheumatoid arthritis. Patients initiated on treatment with tocilizumab according to the licensed Canadian product monograph recommendations will be followed for 12 months from the start of treatment.

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

Conditions
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Rheumatoid Arthritis

Intervention / Treatment
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* Other: No intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients, >/= 18 years of age Moderate to severe rheumatoid arthritis according to revised (1987) American college of rheumatology (ACR) criteria Initiated on tocilizumab treatment by the treating physician in accordance with the Canadian product monograph Informed consent to data being subject to computerized data processing Participant must fulfill the reimbursement criteria for treatment with tocilizumab under provincial or private health insurance coverage Exclusion Criteria: Received tocilizumab prior to enrolment visit Previously received tocilizumab in a clinical trial or for compassionate use Enrolled in an ongoing clinical trial and/or 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 Participation in another clinical trial or industry sponsored observational study History of autoimmune disease or any joint inflammatory disease other than rheumatoid arthritis, with the exception of concomitant secondary Sjörgen's syndrome

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 |
| --- | --- |
| Rheumatoid Arthritis Cohort<br>The cohort included participants with moderate to severe rheumatoid arthritis (RA) in whom the treating physician made the decision to initiate tocilizumab treatment. | Other: No intervention<br>* No intervention administered in this study<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Tender Joint Count (TJC) | Following an assessment of 68 joints for tenderness, joints were classified as tender or not tender by the investigator. | From baseline to Month 12 | 
| Change From Baseline in Swollen Joint Count (SJC) | Following an assessment of 66 joints for swelling, joints were classified as swollen or not swollen by the investigator. | From baseline to Month 12 | 
| Change From Baseline in Disease Activity Score 28 (DAS28) | The DAS28 scale is a combined index for measuring disease activity in rheumatoid arthritis. Scores range from 0 to 10, with higher scores representing more disease activity. | From baseline to Month 12 | 
| Change From Baseline in Duration of Morning Stiffness (Visual Analog Scale, VAS) | With VAS, participants specify their level of agreement to a statement by indicating a position along a continuous line between two endpoints, with 0 being the lowest level and 100 being the highest level of morning stiffness. | From baseline to Month 12 | 
| Change From Baseline in Patient Global Assessment of Disease Activity (Visual Analog Scale, VAS) | With VAS, participants specify their level of agreement to a statement by indicating a position along a continuous line between two endpoints, with 0 being the lowest level and 100 being the highest level of disease activity. | From baseline to Month 12 | 
| Change From Baseline in Physician Global Assessment of Disease Activity (Visual Analog Scale, VAS) | With VAS, physicians specify their level of agreement to a statement by indicating a position along a continuous line between two endpoints, with 0 being the lowest level and 100 being the highest level of disease activity. | From baseline to Month 12 | 
| Change From Baseline in Patient Assessment of Pain (Visual Analog Scale, VAS) | With VAS, participants specify their level of agreement to a statement by indicating a position along a continuous line between two endpoints, with 0 being the lowest level and 100 being the highest level of pain. | From baseline to Month 12 | 
| Change From Baseline in Patient Assessment of Fatigue (Visual Analog Scale, VAS) | With VAS, participants specify their level of agreement to a statement by indicating a position along a continuous line between two endpoints, with 0 being the lowest level and 100 being the highest level of fatigue. | From baseline to Month 12 | 
| Change From Baseline in C-Reactive Protein (CRP) | The serum concentration of C-reactive protein (CRP) was measured. A reduction in the level of CRP was considered an improvement. | From baseline to Month 12 | 
| Change From Baseline in Erythrocyte Sedimentation Rate (ESR) | The erythrocyte sedimentation rate (ESR) was analyzed at the site using the kit provided by the central laboratory. A reduction in the level of ESR was considered an improvement. | From baseline to Month 12 | 
| Percentage of Participants With Changes in Extra-Articular Manifestations at 12 Months | The extra-articular RA manifestations ascertained were the nodules, Raynaud's phenomenon, secondary Sjogren's syndrome, pulmonary fibrosis, pericarditis, polyneuropathy, scleritis, severe cutaneous vasculitis, weight loss and anemia. Percentages are based on the total number of participants with available data. | At 12 months | 
| Number of Participants With Changes in Severity of Extra-Articular Manifestations at 12 Months | The severity of extra-articular RA manifestations ascertained were the nodules, Raynaud's phenomenon, secondary Sjogren's syndrome, pulmonary fibrosis, pericarditis, polyneuropathy, scleritis, severe cutaneous vasculitis, weight loss and anemia. Percentages are based on the total number of participants who responded YES to changes in extra- articular RA manifestations (new presence or change in severity) since the last visit. NA=Not applicable | At 12 months |