A Study of Retreatment With MabThera (Rituximab) in Combination With Methotrexate in Patients With Rheumatoid Arthritis (RA)

Summary

This study will evaluate the efficacy and safety of various treatment and retreatment regimens of MabThera. All patients will receive concomitant methotrexate, 10-25mg once weekly either orally or parenterally. The anticipated time on study treatment is 2+ years, and the target sample size is 100-500 individuals.

Timeline

Start

2006-02

Primary completion

2013-03

Completion

2013-03

Outcome

Missed primary endpoint

paper At Week 48, ACR20 responses were not statistically significantly different between the dose regimens. PMID 20463186 ↗

registry analysis (superiority or other test); Rituximab Low Dose + Methotrexate vs Rituximab High Dose + Methotrexate; p = 0.2419; Weighted Difference 0.07 (95% CI -0.05 to 0.19); Cochran-Mantel-Haenszel NCT00422383 ↗

Publications

• Rubbert-Roth A, Tak PP, Zerbini C, Tremblay JL, Carreno L, Armstrong G, Collinson N, Shaw TM; MIRROR Trial Investigators. Efficacy and safety of various repeat treatment dosing regimens of rituximab in patients with active rheumatoid arthritis: results of a Phase III randomized study (MIRROR). Rheumatology (Oxford). 2010 Sep;49(9):1683-93. doi: 10.1093/rheumatology/keq116. Epub 2010 May 12.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Rituximab	Monoclonal antibody	500 mg	Intravenous
Subject	Rituximab	Monoclonal antibody	1000 mg	Intravenous

Indications