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news.Mount Sinai School of Medicine has begun enrolling patients in the first study to assess the effectiveness of combining two FDA-approved medications as initial treatment for people with relapsing remitting multiple sclerosis.
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Approximately 130,000 multiple sclerosis (MS) patients are receiving either FDA-approved interferon beta-1a weekly (Biogen Idec’s Avonex) or glatiramer acetate daily (Teva’s Copaxone) to treat relapsing forms of MS. However, because these agents provide only a partial amelioration of the risk for additional attacks and development of disability, there is a major and continuing need for better therapies.
The US National Institutes of Health-sponsored study, known as CombiRx, will determine if the combined use of each treatment reduces relapse rate when compared to either agent alone. Enrollment is currently underway at clinics across the US and Canada.
This trial is unique among placebo-controlled studies, in that none of the participants will receive placebo alone. All participants will receive at least one active, FDA-approved treatment. Specifically, 50% will receive the combined investigational therapy, 25% will receive interferon beta 1-a weekly plus a daily placebo, and 25% will receive glatiramer acetate daily plus a weekly placebo.
In addition to CombiRx, participants will be offered the opportunity to volunteer for another study known as Biomarkers in MS. This study is designed to determine if there are specific genes and proteins that can predict the course and progression of MS. More importantly, this study may allow identification of markers that may be useful in distinguishing which MS patients may respond to specific treatments.