U.S. investigators are recruiting 300 people with early relapsing-remitting MS to 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.
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.
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.
Contact: To learn more about the enrollment criteria and to find out if you are eligible to participate, please email firstname.lastname@example.org
. If you do not have access to email, please ask your physician to contact the study. Sites are enrolling in these U.S. cities:
Advance, North Carolina
East Lansing, Michigan
Ft. Collins, Colorado
La Jolla, California
Lake Barrington Illinois
Latham, New York
Long Beach, California
New York, New York
Newport Beach, California
Newport News, Virginia
Overland Park, Kansas
Patchogue, New York
Plainview, New York
Round Rock, Texas
Salt Lake City, Utah
Washington, District of Columbia
Winston-Salem, North Carolina
a brochure that discusses issues to think about when considering enrolling in an MS clinical trial (PDF).
Tysabri is a registered trademark of Biogen Idec and Elan.