An Observational Study of Rituximab in Combination With Methotrexate in Participants With Active Rheumatoid Arthritis
Completed
- Conditions
- Rheumatoid Arthritis
- Registration Number
- NCT01283399
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
This observational study will assess the efficacy and safety of combination of rituximab (MabThera) and methotrexate in participants with active refractory rheumatoid arthritis (RA) who have failed to respond to a single course of anti-tumor necrosis factor (TNF) therapy in routine clinical practice. Data will be collected from participants for 12 months after the first dose of rituximab or a minimum of 6 months following a rituximab re-treatment course.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 79
Inclusion Criteria
- Active rheumatoid arthritis
- Inadequate response to a single TNF inhibitor
- Participants receiving rituximab therapy in accordance with the prescribing information
- Signed data release form within 6 weeks (42 days) of initiating rituximab therapy
- Women of childbearing potential must use effective form of contraception
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Exclusion Criteria
- Contra-indication to receive rituximab according to the local labelling
- Previous treatment with rituximab
- Treatment with any investigational drug within 30 days prior to enrolment
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Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Disease Activity Score Based on 28-joints Count (DAS28) Up to 5 years
- Secondary Outcome Measures
Name Time Method Reasons for Re-treatment With Rituximab Within 6 Months of the First Treatment Up to 5 years Disease Activity Score Based on 28-joints Count (DAS28) 6 Months After the Re-treatment With Rituximab 6 Months After the Re-treatment With Rituximab (up to 5 years) Demographics of Participants Eligible to Receive Rituximab Baseline Number of Participants With Adverse Events 5 years