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

Study Overview
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Brief Summary
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This observational study will evaluate the use and efficacy of RoActemra/Actemra (tocilizumab) in monotherapy in routine clinical practice in patients with rheumatoid arthritis. Eligible patients initiated on RoActemra/Actemra treatment according to the approved label will be followed for 6 months.

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

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 the revised (1987) ACR criteria Patients in whom the treating physician has made the decision to commence RoActemra/Actemra treatment in accordance with the local label; this can include patients who have received RoActemra/Actemra treatment within 8 weeks prior to the enrolment visit Patients who for any reason do not take methotrexate and the treating physician has made a decision to prescribe RoActemra/Actemra as monotherapy Patients who were previously on a TNF inhibitor as monotherapy, and the treating physician has made a decision to prescribe RoActemra/Actemra as monotherapy Concomitant treatment with corticosteroids (orally and intra-articularly) and/or NSAIDs is allowed Exclusion Criteria: Patients who have received RoActemra/Actemra more than 8 weeks prior to the enrolment visit Patients who have previously received RoActemra/Actemra in a clinical trial or for compassionate use Patients receiving concomitant DMARD treatment for rheumatoid arthritis (e.g. hydroxychloroquine, sulfasalazine, methotrexate, leflunomide, gold compounds, cyclosporine) Patients who have received treatment with an investigational agent within 4 weeks (or 5 half-lives of the investigational agent, whichever is longer) before starting treatment with RoActemra/Actemra Patients with a 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 |
| --- | --- |
| Cohort<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients on RoActemra/Actemra at 6 months after treatment initiation |  | Month 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical/demographic patient characteristics at initiation of RoActemra/Actemra treatment |  | approximately 6 months | 
| Rates of dose modifications/interruptions |  | approximately 6 months | 
| Efficacy: Response according to total joint count evaluation by DAS28/EULAR/SDAI/CDAI/ACR |  | approximately 6 months | 
| Physician's Global Assessment of Disease Activity |  | approximately 6 months | 
| Safety: Incidence of adverse events |  | approximately 6 months | 
| Patient reported outcomes (Patient Global Assessment of disease activity, HAQ-DI, VAS-Fatigue, severity of pain and morning stiffness) |  | approximately 6 months |