NIH Deepens Investment In Combination Study Of MS Drugs

Main Category: Multiple Sclerosis
Article Date: 22 Jul 2009 - 4:00 PDT

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The first large-scale "CombiRX" clinical trial testing the combined use of FDA-approved interferon beta-1a (Avonex®) and glatiramer acetate (Copaxone®) to treat relapsing-remitting MS has just received a $19-million renewal grant from the National Institutes of Health. This is the largest MS trial ever supported by the NIH, with a cumulative investment of more than $44 million. The long-term trial is led by principal investigator Fred Lublin, MD, (Corinne Goldsmith Dickinson Multiple Sclerosis Center at Mount Sinai School of Medicine, New York, NY).

The study is now fully enrolled, with more than 1,000 participants at 67 medical centers across the United States and Canada. Dr. Lublin is a member of the National Board of Directors of the National MS Society and the Society's National Clinical Advisory Board and the New York City Chapter Clinical Advisory Committee.

Combination therapy is being compared to the use of either agent alone for 36 months. All participants are receiving at least one active medication and there is not a placebo-only treatment arm. Each of these treatments is approved by the U.S. Food and Drug Administration for the treatment of relapsing MS. A previous, smaller pilot trial of the combination therapy suggested it was safe and warranted further study.

An important ancillary study to this trial, the NIH-sponsored biomarker project, is examining genetic and other biological markers at baseline and at a minimum of one additional point during the study. The hope is that these biological markers will provide a means for identifying, in the future, those patients with more aggressive disease as well as those who respond or fail to respond to therapy. Such markers would have considerable value in the management of MS.

Read more about this study in its listing on clinicaltrials.gov.

Source
MS Society