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

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.

Timeline

Start

2010-04

Primary completion

2010-06

Completion

2010-06

Outcome

Outcome not reported

Stopped (Enrollment): “This study was prematurely terminated as 2 patients were recruited and both of them withdrawn from the study before reaching the primary end point.”

Drugs

Indications