A Cooperative Clinical Study of Abatacept in Multiple Sclerosis
Condition: Multiple Sclerosis, Relapsing-Remitting
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Intervention: abatacept; Placebo
Intervention description: 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
Intervention MeSH terms: Abatacept
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 65.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: MS; multiple sclerosis; relapsing-remitting multiple sclerosis; RRMS

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinically definite Relapsing-remitting Multiple Sclerosis (RRMS) meeting McDonald's
             criteria

          -  Expanded Disability Status Scale (EDSS) scores between 0 and 5

          -  Active disease as defined by at least one of the following criteria:

               1. One or more documented clinical exacerbations in the past year prior to visit -2

               2. One or more gadolinium (Gd)-enhanced MRI lesions in the past year

          -  Willingness to forego available MS therapies

          -  Ability and willingness to provide informed consent and comply with study requirements
             and procedures

        Exclusion Criteria:

          -  Normal brain MRI at week -5 scan

          -  Females who are pregnant, intending pregnancy, or lactating, and unwilling to undergo
             pregnancy testing

          -  Females who are unwilling to use approved methods of contraception for the duration of
             the study

          -  Any chronic medical disease, other than MS, that compromises organ function

          -  Active infection

          -  Diagnosis of secondary or primary progressive MS

          -  Previous treatment with cyclophosphamide, mitoxantrone, cladribine, or rituximab at
             any time

          -  Previous treatment with abatacept within the last 52 weeks prior to visit -2

          -  Previous treatment with systemic steroids, interferon, Copaxone, mycophenolate, or
             other immunosuppressive medications within the last 4 weeks prior to visit -2

          -  Previous treatment with Natalizumab within the last 26 weeks prior to visit -2

          -  Previous vaccination with live vaccine, or previous treatment with fingolimod, within
             the last 8 weeks prior to visit-2

          -  Diagnosis of malignancy other than basal cell carcinoma or cervical carcinoma in situ

          -  Claustrophobia or other contraindications to Gd-enhanced MRI

          -  Positive for human immunodeficiency virus (HIV) serology

          -  Positive for hepatitis B surface antigen (HBsAg)

          -  Positive for hepatitis C virus (HCV) serology

          -  Purified protein derivative (PPD)-tuberculin skin test result greater than 5 mm
             induration

          -  Hemoglobin less than 10.5 gm/dL

          -  Platelets less than 100K/µL

          -  Absolute lymphocyte count less than 700 cells/μL

          -  Serum creatinine greater than 1.20 mg/dL

          -  eGFR (estimated glomerular filtration rate) less than 60 mL/min/1.73 m^2

          -  IgG anti-cardiolipin antibody greater than 15 GPL U/mL

          -  Previous participation in another interventional clinical trial within the past 4
             weeks prior to visit -2

          -  Allergy or sensitivity to any component of abatacept

          -  The presence of any medical condition that the investigator deems incompatible with
             participation in the trial