NCT01388309
Completed
Not Applicable
DAS Evaluation of RA Activity in Patients Treated With Tocilizumab
ConditionsRheumatoid Arthritis
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Rheumatoid Arthritis
- Sponsor
- Hoffmann-La Roche
- Enrollment
- 64
- Primary Endpoint
- Disease activity score (DAS28)
- Status
- Completed
- Last Updated
- 9 years ago
Overview
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.
Investigators
Eligibility Criteria
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
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
Outcomes
Primary Outcomes
Disease activity score (DAS28)
Time Frame: 12 months
Secondary Outcomes
- DAS 28 (subgroup on monotherapy)(12 months)
- Safety: Incidence of adverse events(12 months)
- DAS 28 (subgroup on 4 mg/kg dose)(12 months)
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