Research Study Summary
A Cooperative Clinical Study of Abatacept in Multiple Sclerosis (ACCLAIM)
ACCLAIM trial is a Phase II clinical research trial of the safety and efficacy of abatacept in adults with relapsing-remitting multiple sclerosis (RRMS). Abatacept is approved by the Federal Drug Administration (FDA) for the treatment of moderate to severe Rheumatoid Arthritis; however, for this trial abatacept is considered an investigational therapy.
If you meet the following criteria, you may be eligible to participate in the ACCLAIM trial:
- Are between the ages of 18-65;
- Have been diagnosed with Relapsing-Remitting MS; and
- Have had one or more relapses or new MRI lesions in the past year.
Regular appointments scheduled during the trial will be used to monitor participants' health and progress in the trial. These appointments will include: physical and neurological exams, blood tests and motor function assessments. In the first period of the trial, all participants will receive 8 intravenous treatments over a period of 24 weeks. If a participant remains eligible, he/she will enter the second period of the trial and will receive another 8 treatments over the following 24 weeks.
Two-thirds (2 out of 3) of participants will receive the investigational drug abatacept in the first period of the trial, and then a placebo in the second period. The remaining one-third (1 in 3) will get the placebo first, then the investigational drug in the second period if they remain eligible. All participants in the ACCLAIM trial will have the opportunity to receive the investigational drug abatacept if they remain stable during the trial. Participants will be asked to return for a follow-up visit 12 weeks after all treatments have been completed. A total of 11 MRI procedures are scheduled during the trial. The trial medication and procedures related to the trial will be provided at no expense to the participant.
This clinical research trial is conducted by the Immune Tolerance Network and sponsored by the National Institute of Allergy and Infectious Disease (NIH funded). For more information: http://www.acclaimstudy.org/
If you would like to learn more about participating in this trial, please send an e-mail message using the form below.
Investigator: Vernon Rowe III, MD
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