An Observational Study of MabThera/Rituxan (Rituximab) in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Anti-TNF Therapy (REPEAT)

Terminated

• Conditions: Rheumatoid Arthritis

• Registration Number: NCT01196780
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

This observational study will assess the efficacy and safety of MabThera/Rituxan (Rituximab) in patients with active rheumatoid arthritis who have had an inadequate response or are intolerant to anti-TNF therapy. Data will be collected from patients initiated on MabThera/Rituxan therapy according to standard of care in routine clinical practice. For each patient data will be collected for 92 weeks.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-02
• Study First Submitted: 2010-09-06
• Study First Submitted QC: 2010-09-06
• Study First Posted: 2010-09-08
• Primary Completion: 2015-10
• Study Completion: 2015-10
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-01
• Last Update Posted: 2016-11-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1240

Inclusion Criteria

• Adult patients, >/= 18 years of age
• Active Rheumatoid Arthritis
• Inadequate response to anti-TNF
• Eligible for MabThera/Rituxan therapy according to physician's decision

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Exclusion Criteria

• According to Summary of Product Characteristics

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Efficacy: Change in Disease Activity Score - erythrocyte sedimentation rate (DAS28 - ESR)	from baseline to Week 92

Secondary Outcome Measures

Name	Time	Method
Safety: Incidence of adverse events	4 years