An Observational Study of RoActemra/Actemra (Tocilizumab) in Patients With Rheumatoid Arthritis Who Have an Inadequate Response to DMARDs
Completed
- Conditions
- Rheumatoid Arthritis
- Registration Number
- NCT01388309
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
This observational study will evaluate in clinical practice the change in Disease Activity Score (DAS28) in patients with rheumatoid arthritis and an inadequate response to DMARDs who are initiated on treatment with RoActemra/Actemra (tocilizumab). Data will be collected from eligible patients (on 8 mg/kg or 4 mg/kg intravenously every 4 weeks, with or without methotrexate) for 12 months.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 64
Inclusion Criteria
- Adult patients, >/= 18 years of age
- Moderate to severe active rheumatoid arthritis
- Inadequate response or intolerance to previous therapy with one or more traditional DMARDs
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Exclusion Criteria
- Pregnant or lactating women
- Active infection
- Positive for hepatitis B, hepatitis C or HIV infection
- Concomitant anti-TNF drugs
- Contraindications to treatment with RoActemra/Actemra
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Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Disease activity score (DAS28) 12 months
- Secondary Outcome Measures
Name Time Method Safety: Incidence of adverse events 12 months DAS 28 (subgroup on 4 mg/kg dose) 12 months DAS 28 (subgroup on monotherapy) 12 months