An Observational Study of RoActemra/Actemra (Tocilizumab) in Patients With Rheumatoid Arthritis
Terminated
- Conditions
- Rheumatoid Arthritis
- Registration Number
- NCT01277328
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
This observational, prospective, open-label, multi-center study will evaluate the effectiveness in disease reduction and the safety of RoActemra/Actemra (tocilizumab) in patients with rheumatoid arthritis. Data will be collected for 11 months.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 95
Inclusion Criteria
- Adult patients >/=18 years of age
- Patients with rheumatoid arthritis eligible for RoActemra
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Exclusion Criteria
- Hypersensitivity to RoActemra
- Active, severe infections
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Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Mean change in Disease Activity Score 28 (DAS28) 11 months
- Secondary Outcome Measures
Name Time Method Incidence of adverse events 11 months Proportion of patients with a change in Disease Activity Score 28 (DAS28) 5 months European League Against Rheumatism (EULAR) response rates 20 weeks Proportion of patients with disease remission 20 weeks Proportion of patients with low disease activity 20 weeks