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

N/ATerminatedNCT01196780

Hoffmann-La Roche1,240 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

1,240

Conditions

Rheumatoid Arthritis

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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 Exclusion Criteria: * According to Summary of Product Characteristics

Locations (1)

Unnamed facility

Bucharest, Romania

Outcomes

Primary Outcomes

Efficacy: Change in Disease Activity Score - erythrocyte sedimentation rate (DAS28 - ESR)

Time frame: from baseline to Week 92

Secondary Outcomes

Safety: Incidence of adverse events

Time frame: 4 years

Data from ClinicalTrials.gov

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