Investigators Recruiting for Study of Tysabri in Early Relapsing-Remitting MS

Aug 24, 2012

Summary: U.S. investigators are recruiting 300 people with early relapsing-remitting MSto detect factors that might help better predict which patients do better on natalizumab (Tysabri®, Biogen Idec and Elan) in this population. This is an observational study: The investigators are observing people who have been diagnosed with relapsing-remitting MS within the past three years, and have decided to take Tysabri – no study drug will be provided. The study, also known as the STRIVE study, is sponsored by Biogen Idec.

Rationale: Tysabri is a laboratory-produced monoclonal antibody that is approved for people with relapsing forms of MS to delay the accumulation of physical disability and reduce the frequency of clinical exacerbations. It is designed to hamper movement of potentially damaging immune cells from the bloodstream, across the “blood-brain barrier” into the brain and spinal cord. (Click here to read about Tysabri and its association with PML, a potentially fatal viral infection of the brain.)

Tysabri is generally recommended for patients who have had an inadequate response to, or cannot tolerate, an alternate MS therapy. Its use in the earliest stages of MS has not been systematically studied. The primary purpose of the study is to determine which patient characteristics most reliably predict future favorable disease-free response, to enhance the ability to make benefit-risk decisions for using Tysabri in early-stage relapsing MS.

Eligibility and Details: Participants must be ages 18 to 45. This is an observational study; the investigators are observing people who have been diagnosed with relapsing-remitting MS within the past three years, and have decided to take Tysabri. No study drug will be provided. Individuals who test positive for JC virus antibody (indicating previous exposure to the virus that causes PML) are not eligible to participate.

Participants are being followed for four years. The primary outcome being measured is the proportion of people who are free of disease activity (according to the EDSS scale, MRI scans and relapses) at the end of two years and four years. The investigators are also looking at, secondarily, the factors that might predict disease-free status, as well as other measures including optic nerve fiber damage, cognitive function, capacity for work and quality of life.

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