A Cooperative Clinical Study of Abatacept in Multiple Sclerosis
Condition: Multiple Sclerosis, Relapsing-Remitting
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Study type: Interventional
Phase: Phase 2

Summary: 
      The ACCLAIM study is testing whether the medication "abatacept" can be of benefit to patients
      with relapsing-remitting multiple sclerosis (MS). Although abatacept is an investigational
      medication for MS, it is not a new drug. Abatacept has been approved by the FDA to treat
      rheumatoid arthritis.
    

Detailed description: 
      MS is a chronic autoimmune disease in which blood cells that are supposed to protect the body
      from infection mistakenly attack the body's own tissue. In MS, the target of this attack is a
      protein called myelin that coats nerves throughout the body. Damage to this protective layer
      can lead to loss of neurologic function.

      There are a number of treatments available to MS patients. Interferon beta, Copaxone, and
      other drugs can delay the worsening of the disease in some patients. For other patients, more
      aggressive treatment with chemotherapy drugs such as cyclophosphamide or azathioprine are
      needed. These drugs attempt to slow the disease by limiting the activity of the entire immune
      system. Because of this, they can often have serious side effects.

      This study evaluates the efficacy of abatacept in the treatment of relapsing-remitting MS. In
      the first phase of the study, all participants will receive 8 intravenous treatments over a
      period of 24 weeks. Then, if a participant remains eligible, they will enter the second phase
      of the study and will receive another 8 treatments over the following 24 weeks. Two-thirds (2
      out of 3) of participants will receive the study drug abatacept in the first phase, and then
      an inactive form (placebo) of the drug in the second phase. The remaining one-third (1 in 3)
      will get the placebo first, then the study drug in the second phase if they remain eligible.
      Therefore, all participants in the ACCLAIM trial will have the opportunity to receive the
      study drug abatacept if they remain healthy during the study. Participants will be asked to
      return for a follow-up visit 12 weeks after all treatments have been completed.

      Regular appointments scheduled during the trial will be used to monitor participants' health
      and progress in the study. These appointments will include: physical and neurological exams,
      blood tests and motor function assessments. A total of 11 magnetic resonance imaging (MRI)
      procedures are scheduled during the study. The study medication and procedures related to the
      study will be provided at no expense to the participant.
    

Intervention name(s): abatacept; Placebo
Intervention type(s): Biological; Drug
Intervention description(s): In core/extension phase: administered IV at weeks 0/28, 2/30, and 4/32, and then every 4 weeks until week 24/52; Dosing: less than 60 kg, 500 mg; 60-100 kg, 750 mg; or greater than 100 kg, 1 gram; In core/extension phase: administered IV at weeks 0/28, 2/30, and 4/32, and then every 4 weeks until week 24/52
Other intervention name(s): Orencia®; CTLA4-Ig; placebo abatacept
Intervention MeSH terms: Abatacept
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: MS; multiple sclerosis; relapsing-remitting multiple sclerosis; RRMS