A Pilot Study of MabThera (Rituximab) Evaluated by MRI in Patients With Rheumatoid Arthritis.

Roche

Status and phase: Completed; Phase 4

Conditions: Rheumatoid Arthritis

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00502853

ML21081

Details and patient eligibility

About

This single arm study will measure the effect of MabThera in combination with methotrexate on the progression of synovitis, the extent of bone marrow edema, and the number of erosions in the wrist and hand of patients with rheumatoid arthritis, using a new MRI technique. Patients will receive MabThera 1000mg i.v. on days 1 and 15, in combination with a stable dosage of 10-25mg/week methotrexate throughout the duration of the study. Further courses of MabThera will be provided to eligible patients. MRI will be performed 1-2 weeks before treatment initiation, and repeated 1 and 6 months after the first MabThera infusion. The anticipated time on study treatment is 1-2 years, and the target sample size is <100 individuals.

Enrollment: 10 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• adult patients, 18-75 years of age;
• rheumatoid arthritis for >=3 months and <=10 years;
• inadequate response to methotrexate (12.5-25mg/week) for >=3 months;
• evidence of erosive disease and/or clinical synovitis in a signal joint.

Exclusion criteria

• autoimmune rheumatic diseases other than RA;
• surgical operations on bones/joints in 12 weeks prior to baseline visit;
• concomitant treatment with biologic agents;
• previous treatment with more than one biologic agent approved for RA, or with cell-depleting therapies.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

1

Experimental group

Treatment:

Drug: Methotrexate

Drug: rituximab [MabThera/Rituxan]