Rituximab for the Treatment of Early Rheumatoid Arthritis (RA)

Summary

Rheumatoid arthritis (RA) is a chronic inflammatory disease characterized by joint swelling, pain, stiffness, damage, and ultimately loss of joint function. Scientists estimate that about 1.3 million people (0.6 percent) of the U.S. adult population have RA. Current therapies target the immune system early in the disease process before joint damage occurs, and include drugs such as methotrexate (MTX) and tumor necrosis factor (TNF)-blocking agents. Rituximab is a disease-modifying antirheumatic drug (DMARD) recently approved by the FDA for use in combination with MTX for treatment of moderately to severely active RA in patients who have had an inadequate response to TNF-blocking agents, in an effort to try to slow the course of the disease. This study will examine the effects of rituximab on the immune response and disease activity in participants with early RA who have not been treated with any disease-modifying agent. In addition, the safety and tolerability of rituximab in this population will be examined.

Timeline

Start

2006-11

Primary completion

2009-07

Completion

2009-07

Outcome

Outcome not reported

Stopped: “The perceived risk-benefit ratio for individuals with early active RA”

Publications

• Background De Vita S, Quartuccio L. Treatment of rheumatoid arthritis with rituximab: an update and possible indications. Autoimmun Rev. 2006 Aug;5(7):443-8. doi: 10.1016/j.autrev.2006.02.007. Epub 2006 Mar 15.
• Background Eisenberg R, Albert D. B-cell targeted therapies in rheumatoid arthritis and systemic lupus erythematosus. Nat Clin Pract Rheumatol. 2006 Jan;2(1):20-7. doi: 10.1038/ncprheum0042.
• Background Isenberg DA. B cell targeted therapies in autoimmune diseases. J Rheumatol Suppl. 2006 May;77:24-8.
• Background Looney RJ. B cell-targeted therapy for rheumatoid arthritis: an update on the evidence. Drugs. 2006;66(5):625-39. doi: 10.2165/00003495-200666050-00004.

Drugs

Indications