An Observational Study of RoActemra/Actemra (Tocilizumab) in Smoking Versus Non-Smoking Patients With Rheumatoid Arthritis
Completed
- Conditions
- Rheumatoid Arthritis
- Registration Number
- NCT01337388
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
This observational study will assess the efficacy and safety of RoActemra/Actemra (Tocilizumab) in smoking versus non-smoking patients with rheumatoid arthritis. Data from patients treated in routine clinical practice with intravenous RoActemra/Actemra will be collected for 12 months each.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 197
Inclusion Criteria
- Adult patients, > 18 years of age
- Rheumatoid arthritis, defined as fulfilling at least 4 of 7 American College of Rheumatology (ACR) criteria
- Treatment with RoActemra/Actemra
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Exclusion Criteria
- Participation in interventional clinical studies
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Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in disease activity score (DAS 28) 12 months Treatment patterns (frequency/dosage) and demographics of patients treated with RoActemra/Actemra in routine clinical practice 36 months
- Secondary Outcome Measures
Name Time Method Safety: Incidence of adverse events 36 months Clinical response (DAS 28/blood chemistry/QoL) with or without methotrexate 36 months Quality of life: Health assessment questionnaire Disease Index (HAQ-DI), Functional Assessment of Chronic Illness Therapy- Fatigue (FACIT-Fatigue) questionnaire 12 months Rate of patients achieving remission (DAS <2.6) 36 months Change in blood lipids 12 months