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

Study Timeline

• Study Start: 2010-08
• Study First Submitted: 2011-01-24
• Study First Submitted QC: 2011-01-25
• Study First Posted: 2011-01-26
• Primary Completion: 2014-04
• Study Completion: 2014-04
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-01
• Last Update Posted: 2016-11-02

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

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

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