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Clinical Trial to Investigate Infliximab Therapy for Prevention of Rheumatoid Arthritis

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www.ProHealth.com • June 18, 2003


An international coalition of leading rheumatologists have announced the launch of the new DINORA trial that will investigate infliximab (Remicade®) in the treatment of pre-clinical rheumatoid arthritis (RA) to determine whether or not it can prevent the development of rheumatoid arthritis. DINORA was launched at the European League Against Rheumatism (EULAR) Annual Meeting and will be partially funded by Schering-Plough Corporation and Centocor, Inc.

“We anticipate very positive results from the ASPIRE trial (Active Controlled Study of Patients Receiving Infliximab for Treatment of Rheumatoid Arthritis of Early Onset) which looked at the combination of infliximab plus methotrexate in patients with early RA", said Peter Lipsky, MD, Scientific Director of the National Institute of Arthritis and Musculoskeletal and Skin Diseases, National Institutes of Health. "DINORA will examine various combinations of infliximab and methotrexate in patients at an even earlier stage of RA -- some of whom are only a few weeks into the disease. We are now exploring the possibility of a cure for RA."




DINORA (Definitive Intervention in New-Onset Rheumatoid Arthritis) is a placebo controlled, double-blind, 12-month study, which will have a four-year follow-up period. The primary endpoint is absolute remission of disease -- the absence of all signs and symptoms of RA, at 12 months and 24 months. The DINORA study will have seven different treatment regimen arms, comparing methotrexate monotherapy, infliximab monotherapy, and infliximab/methotrexate combination therapy and placebo. Patients in DINORA will exhibit the entire spectrum of very early arthritis, as encountered in clinical practice. However, patients will be selected for the trial only if they have been diagnosed with arthritis in the last two to six weeks, and have had symptoms for no longer than six to 16 weeks.

Rheumatoid arthritis is a painful, crippling condition that affects an estimated 9.7 million people worldwide. This inflammatory disease causes swelling of joints, and leads to the deterioration and destruction of joint surfaces, and breakdown of bone. Within two years of disease onset, research shows joint destruction occurs within 50 to70 percent of RA patients and one-third become unable to continue working.



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