Mount Sinai School of Medicine is the Clinical Coordinating Center for the first study to assess the effectiveness of combining two FDA approved medications as initial treatment for people with Relapsing Remitting Multiple Sclerosis.
Sponsored by the National Institutes of Health - National Institute of Neurological Disorders and Stroke (NIH-NINDS), the 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 United States and Canada.
According to study chairman, Fred D. Lublin, M.D., Saunders Family Professor of Neurology at Mount Sinai School of Medicine-Corinne Goldsmith Dickinson Center for Multiple Sclerosis, "This is a very important trial because, if effective, combination therapy will allow us to take advantage of these agents that have different and complementary mechanisms of action to slow or halt progression of MS."
An estimated 400,000 Americans suffer from MS, a chronic neurological disease that affects the central nervous system. MS is most commonly diagnosed in young adults. Relapsing-remitting MS, the most common form of new cases of the disease, is characterized by episodes of attacks of neurologic dysfunction, which occur over many years.
Approximately 130,000 MS patients are receiving either FDA-approved interferon beta-1a weekly (Avonex.) or glatiramer acetate daily (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. As yet, there is no cure for MS.
CombiRx will determine whether the combination of these treatments is more effective than either treatment alone. 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. According to Dr. Henry McFarland, Clinical Director, NINDS, "As with the data from the CombiRx Trial, the implications of the Biomarkers in MS Study could be enormous, both for the individual patient as well as for the costs associated with MS treatment and hence the health care providers and the general public."
One thousand patients are being recruited for these studies at approximately 80 sites across the US and Canada.
Men and women between 18 and 60 years of age who have been diagnosed with relapsing-remitting MS and who have not previously taken interferon beta-1a weekly (Avonex.) or glatiramer acetate daily (Copaxone.) may be eligible to participate in both studies. Participants will be randomly assigned to one of the three study groups and will receive treatment over 36 months. Clinic visits will be scheduled every three months throughout the treatment period to assess the impact of treatment.