A Study of MabThera (Rituximab) in Combination With Methotrexate in Patients With Rheumatoid Arthritis Who Have Had an Inadequate Response to Anti-TNF Agents.

Roche

Status and phase: Completed; Phase 4

Conditions: Rheumatoid Arthritis

Treatments: Drug: Methotrexate; Drug: rituximab [MabThera/Rituxan]

Study type: Interventional

Funder types: Industry

Identifiers

NCT00504777

ML20798

Details and patient eligibility

About

This single arm study will assess the safety and efficacy of MabThera in combination with methotrexate in patients with rheumatoid arthritis who have had an inadequate response or intolerance to one or more anti-TNF agents. Patients will receive MabThera 1000mg i.v. on days 1 and 15, and methotrexate (10-25mg/week p.o. or parenteral), together with methylprednisolone 100mg i.v. prior to infusion of MabThera. The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals.

Enrollment: 36 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• adult patients, >=18 years of age;
• active rheumatoid arthritis;
• receiving outpatient treatment;
• an inadequate response, or intolerance, to >=1 anti-TNF agent.

Exclusion criteria

• other rheumatic autoimmune disease or inflammatory joint disease;
• concurrent treatment with any anti-TNF-alpha therapy;
• joint or osseous surgery during 8 weeks prior to recruitment.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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36 participants in 1 patient group

1

Experimental group

Treatment:

Drug: Methotrexate

Drug: rituximab [MabThera/Rituxan]