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

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

Official Title
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Multinational, Multicenter, Non Interventional Study, in Patients With Rheumatoid Arthritis (RA) 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 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 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 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 |  | approximately 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rates of dose modifications/interruptions |  | approximately 2 years | 
| Clinical/demographic patient characteristics at initiation of RoActemra/Actemra treatment |  | approximately 2 years | 
| Proportion of patients on RoActemra/Actemra monotherapy at study entry and at Month 6 |  | approximately 2 years | 
| Efficacy: Response according to total joint count evaluation by DAS28/EULAR/SDAI/CDAI/ACR |  | approximately 2 years | 
| Safety: Incidence of adverse events |  | approximately 2 years | 
| Health Assessment Questionnaire Disability Index |  | approximately 2 years | 
| Visual Analogue Scale - Fatigue |  | approximately 2 years | 
| Visual Analogue Scale - severity of pain |  | approximately 2 years | 
| Visual Analogue Scale - morning stiffness |  | aproximately 2 years | 
| Patient Global Assessment of disease activity |  | approximately 2 years |