A Cooperative Clinical Study of Abatacept in Multiple Sclerosis

• Status: Completed
• Trial end date: 2015-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Collaborator: Immune Tolerance Network (ITN)
• Treatments: Abatacept

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