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

• Status: Terminated
• Trial end date: 2010-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Methotrexate; Rituximab

Criteria

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