Posted Monday, March 28, 2011
Summary: Investigators in 18 states are conducting a trial to test the safety and effectiveness of abatacept, an experimental drug administered intravenously, in 123 people with relapsing-remitting MS, versus inactive placebo. The trial also is known as the ACCLAIM trial, and is being conducted by the Immune Tolerance Network and sponsored by the National Institute for Allergy and Infectious Disease.
Rationale: Multiple sclerosis involves an immune system attack that results in damage to the brain and spinal cord. Abatacept has been shown to suppress the MS-like disease EAE in mice by blocking a vital immune system interaction early in the development of the disease. The hypothesis is that treatment with abatacept may arrest the disease if administered early in the course of relapsing-remitting MS. In a phase I study, the drug was well tolerated. (Neurology 2008;71:917-24) Abatacept has been approved by the U.S. Food and Drug Administration to treat rheumatoid arthritis, an autoimmune disease. Because it has not been tested in MS, it is considered investigational for MS.
Eligibility and Details: Participants should be between the ages of 18 and 65, and have been diagnosed with relapsing-remitting MS. Participants will be informed of all available approved MS treatments, and have expressed willingness to forego them for the duration of the trial.
At the beginning of the trial, participants will undergo a number of screening and baseline procedures, including a physical exam, blood and urine collection, questionnaires, and MRI scans. Participants who remain eligible will receive eight infusions of abatacept followed by eight infusions of inactive placebo, or eight infusions of inactive placebo followed by eight infusions of abatacept over a 16-month period. Participants who remain eligible will receive up to 11 MRI scans as well as continuing physical exams, blood and urine collections, and questionnaires. The investigators will consider participants who are not patients in their treatment centers. All trial-related care and treatments are provided at no cost.
Contact: To learn more about the enrollment criteria for this trial, and to find out if you are eligible to participate, please contact the trial site nearest you (see the study listing on the National MS Society Web site, or visit www.acclaimstudy.org.
Sites are to be enrolling in the following cities:
Ann Arbor, MI
Chapel Hill, NC
Los Angeles, CA
New York, NY