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

Roche

Status: Completed

Conditions: Rheumatoid Arthritis

Treatments: Drug: Rituximab

Study type: Observational

Funder types: Industry

Identifiers

NCT01641952

ML27953

Details and patient eligibility

About

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.

Enrollment: 505 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

505 participants in 1 patient group

Rituximab

Description:

Participants who had an inadequate response or intolerance to one anti- tumor necrosis factor (anti-TNF) agent received rituximab (Mabthera) at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics.

Treatment:

Drug: Rituximab