A Study of Efficacy of Rituximab [Mabthera/Rituxan] in Patients With Rheumatoid Arthritis Using Magnetic Resonance Imaging of the Hand (RESONAR)

Efficacy of MabThera in Patients With Rheumatoid Arthritis, by Measurement of Disease Parameters Through Magnetic Resonance of the Hand (RESONAR Study)

This randomized, double-blind, placebo controlled, parallel group study will assess the efficacy and safety of rituximab [MabThera/Rituxan] in patients with severe active rheumatoid arthritis refractory to at least one anti-TNF treatment, using magnetic resonance imaging (MRI) of the hand for efficacy measurement. Patients will be randomized to receive 2 intravenous infusions 14 days apart of either 1000mg MabThera (group A) or placebo (group B). All patients will receive methotrexate 10-25mg weekly. Patients in group A demonstrating clinical response at week 24 may receive further cycles of MabThera, patients in group B without clinical response will also be treated with active MabThera. Anticipated time on study treatment is up to 2 years. Target sample size is <50 patients.

Inclusion Criteria:

• adult patients, 18-75 years of age
• active rheumatoid arthritis (DAS28-CRP>3.2)
• refractory to one or more anti-TNF
• on stable treatment for RA for >/=4 weeks
• evidence of erosive disease and/or synovitis in wrist and/or knuckles

Exclusion Criteria:

• active systemic or local infection
• previous or current history of any demyelinization process in central nervous system, pancytopenia or aplasic anaemia
• signs of immunodeficiency, HIV infection or tuberculosis
• contraindications to MRI, such as metal devices, claustrophobia, moderate or severe renal insufficiency, or allergy to contrast agent