A Pilot Study of MabThera (Rituximab) Evaluated by MRI in Patients With Rheumatoid Arthritis.
Status:
Completed
Trial end date:
2010-07-23
Target enrollment:
Participant gender:
Summary
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.