A Cooperative Clinical Study of Abatacept in Multiple Sclerosis

Completed · Phase 2 · Has a placebo group

Conditions studied: Multiple Sclerosis, Relapsing-Remitting

In brief

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.

Key facts

Study ID

NCT01116427

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

65

Starts

2010-09-01

Expected to finish

2015-02-01

Last updated by the study team

2016-09-15

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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:
• One or more documented clinical exacerbations in the past year prior to visit -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

You may not qualify if…

• 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

Where it is running

• St. Josephs Hospital and Medical Center - Barrow Neurology — Phonix, Arizona, United States
• Jordan Research and Education Institute (REDI): Alta Bates Summit Medical Center — Berkeley, California, United States
• University of Southern California - Keck School of Medicine — Los Angeles, California, United States
• Newport Beach Clinical Research Associates, Inc. — Newport Beach, California, United States
• University of California, Davis — Sacramento, California, United States
• University of Miami — Miami, Florida, United States
• South Suburban Neurology — Flossmoor, Illinois, United States
• Norton Neuroscience Institute - Norton Neurology Services MS Center — Louisville, Kentucky, United States
• Louisiana State University — Shreveport, Louisiana, United States
• University of Maryland — Baltimore, Maryland, United States
• Brigham & Women's Hospital — Boston, Massachusetts, United States
• University of Minnesota — Minneapolis, Minnesota, United States
• Judith Jaffe Multiple Sclerosis Center: Weill Cornell Medical College — New York, New York, United States
• University of North Carolina — Chapel Hill, North Carolina, United States
• Neurology Specialists, Inc. — Dayton, Ohio, United States
• Providence St. Vincent Medical Center — Portland, Oregon, United States
• University of Pennsylvania — Philadelphia, Pennsylvania, United States
• The Neurology Foundation, Inc. — Providence, Rhode Island, United States
• Advanced Neurosciences Institute — Franklin, Tennessee, United States
• Benaroya Research Institute at Virginia Mason — Seattle, Washington, United States
• Ottawa Hospital Research Institute — Ottawa, Ontario, Canada

Full record on ClinicalTrials.gov

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