A Non-Comparative Study to Assess the Safety of MabThera (Rituximab) in Patients With Rheumatoid Arthritis.

Roche

Status and phase: Completed; Phase 3

Conditions: Rheumatoid Arthritis

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00502996

ML19385

Details and patient eligibility

About

This single arm study will assess the safety of MabThera plus methotrexate in patients with rheumatoid arthritis who have had a lack of response to 1-5 DMARDs or biological agents. Patients will receive MabThera (1g i.v.) on days 1 and 15, concomitantly with methotrexate >=15mg p.o./week. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Enrollment: 246 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• adult patients, >=18 years of age;
• rheumatoid arthritis >=6 months;
• lack of response to 1-5 DMARDs or biological agents;
• rheumatoid factor positive.

Exclusion criteria

• other chronic inflammatory articular disease or systemic rheumatic disease;
• joint or bone surgery during 8 weeks prior to randomization;
• previous treatment with any cell-depleting therapy.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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246 participants in 1 patient group

Rituximab

Experimental group

Description:

Eligible participants receiving Rituximab (MabThera/Rituxan) 1 gram/dose (g/dose) intravenously (IV) on Day 1 and Day 15 followed by previous pre-medication (methylprednisolone 100 mg IV, antihistamine and antipyretic) and concomitant treatment of Methotrexate at least 15 mg per oris (PO) weekly were observed during the study period of 24 weeks. After treatment completion, participants were followed-up for safety up to 24 weeks.

Treatment:

Drug: rituximab [MabThera/Rituxan]

Drug: Methotrexate