An Observational Study of MabThera/Rituxan (Rituximab) in Patients With Rheumatoid Arthritis and an Inadequate Response or Intolerance to One Anti-Tumor Necrosis Factor (Anti-TNF) Agent

• Status: Completed
• Trial end date: 2015-01-01
• Target enrollment: 0
• Participant gender: All

Summary

This observational, prospective, multicenter study will evaluate the efficacy and safety of MabThera/Rituxan in participants with active rheumatoid arthritis and an inadequate response or intolerance to one anti-TNF therapy. Participants who receive MabThera/Rituxan according to the current standard and in line with the summary of product characteristics at a dose of 1000 milligram (mg) intravenously on Days 1 and 15 will be followed for 20 weeks.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Rituximab

Criteria

Inclusion Criteria:

• Adult participants, >/= 18 years of age

• Participants with rheumatoid arthritis, eligible for treatment with MabThera/Rituxan in accordance with summary of product characteristics (SPC)

• Inadequate response to a single TNF inhibitor defined as change in disease activity score-28 erythrocyte sedimentation rate (DAS28-ESR) <1.2 or DAS28-ESR >3.5 at 5 months after first course of anti-TNF therapy

• Participants with a clinical and biological evaluation performed within 12 weeks prior to enrollment may be included

Exclusion Criteria:

• More than one previous anti-TNF therapies

• Any other biological therapy apart from the one anti-TNF therapy

• Hypersensitivity to rituximab or any of the excipients or to murine proteins

• Active severe infections

• Participants in a severely immunocompromised state

• Severe heart failure [New York Heart Association (NYHA) Class IV] or severe, uncontrolled cardiac disease

• Women of childbearing potential not willing to use contraception

• Pregnant or breastfeeding women

• Participation in another trial