An Observational Study of Rituximab in Combination With Methotrexate in Participants With Active Rheumatoid Arthritis

Roche

Status: Completed

Conditions: Rheumatoid Arthritis

Study type: Observational

Funder types: Industry

Identifiers

NCT01283399

ML25270

Details and patient eligibility

About

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.

Enrollment: 79 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

79 participants in 1 patient group

Rituximab + Methotrexate

Description:

All participants with active refractory RA who were eligible to receive treatment with methotrexate and rituximab in the Investigators' opinion as per the routine clinical practice following inadequate response to a single cycle of anti-TNF therapy.