A Cooperative Clinical Study of Abatacept in Multiple Sclerosis
ACCLAIM
A Phase II, Randomized, Double-blind, Parallel-group, Placebo-controlled, Multicenter Study to Evaluate the Safety and Efficacy of Abatacept in Adults With Relapsing-remitting Multiple Sclerosis
1 other identifier
interventional
65
2 countries
21
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Sep 2010
Typical duration for phase_2
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 3, 2010
CompletedFirst Posted
Study publicly available on registry
May 5, 2010
CompletedStudy Start
First participant enrolled
September 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2015
CompletedResults Posted
Study results publicly available
April 8, 2016
CompletedSeptember 15, 2016
August 1, 2016
3.8 years
May 3, 2010
December 15, 2015
August 3, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mean Number of New Inflammatory MRI Lesions Per Monthly Scans
The mean number of new inflammatory MRI lesions obtained on scans every 4 weeks from Week 8 to Week 24, adjusted for differences between subjects before treatment by subtracting the number of new inflammatory lesions observed from the week -1 MRI scan . An inflammatory lesion is defined as a gadolinium (Gd)-enhancing lesion that shows hyperintensity on postcontrast but no hyperintensity on noncontrast T1 images. A new inflammatory lesion is one that was not present on the previously scheduled MRI scan. If the previously scheduled MRI scan was missing, the scan was compared to the last available MRI.
Weeks 8-24
Secondary Outcomes (13)
Absolute Number of New Inflammatory MRI Lesions on Monthly Scans
Weeks 4-24
Lesion Volume Accumulation on T2-weighted MRI Scans Over 24 Weeks
Week -1 to Week 24
Percent Brain Volume Change
Week -1 to Week 24
Mean Number of New Inflammatory Lesions in 8-week Intervals
Week 8 to Week 24
Number of Participants Progressing on the EDSS Scale by at Least 1 Point
Week -1 to Week 24
- +8 more secondary outcomes
Study Arms (2)
Abatacept
EXPERIMENTALReceives abatacept during first course of treatment, switching to placebo during extension phase.
Placebo, followed by abatacept
PLACEBO COMPARATORReceives a placebo for first course of treatment, switching to abatacept in the extension phase.
Interventions
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
Eligibility Criteria
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)
- +11 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (21)
St. Josephs Hospital and Medical Center - Barrow Neurology
Phonix, Arizona, 85013, United States
Jordan Research and Education Institute (REDI): Alta Bates Summit Medical Center
Berkeley, California, 94705, United States
University of Southern California - Keck School of Medicine
Los Angeles, California, 90033, United States
Newport Beach Clinical Research Associates, Inc.
Newport Beach, California, 92663, United States
University of California, Davis
Sacramento, California, 95817, United States
University of Miami
Miami, Florida, 33136, United States
South Suburban Neurology
Flossmoor, Illinois, 60422, United States
Norton Neuroscience Institute - Norton Neurology Services MS Center
Louisville, Kentucky, 40207, United States
Louisiana State University
Shreveport, Louisiana, 71130, United States
University of Maryland
Baltimore, Maryland, 21201, United States
Brigham & Women's Hospital
Boston, Massachusetts, 02115, United States
University of Minnesota
Minneapolis, Minnesota, 55414, United States
Judith Jaffe Multiple Sclerosis Center: Weill Cornell Medical College
New York, New York, 10065, United States
University of North Carolina
Chapel Hill, North Carolina, 27514, United States
Neurology Specialists, Inc.
Dayton, Ohio, 45417, United States
Providence St. Vincent Medical Center
Portland, Oregon, 97225, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
The Neurology Foundation, Inc.
Providence, Rhode Island, 02905, United States
Advanced Neurosciences Institute
Franklin, Tennessee, 37064, United States
Benaroya Research Institute at Virginia Mason
Seattle, Washington, 98101, United States
Ottawa Hospital Research Institute
Ottawa, Ontario, K1H 8L6, Canada
Related Publications (2)
Viglietta V, Bourcier K, Buckle GJ, Healy B, Weiner HL, Hafler DA, Egorova S, Guttmann CR, Rusche JR, Khoury SJ. CTLA4Ig treatment in patients with multiple sclerosis: an open-label, phase 1 clinical trial. Neurology. 2008 Sep 16;71(12):917-24. doi: 10.1212/01.wnl.0000325915.00112.61.
PMID: 18794494BACKGROUNDKhoury SJ, Rochon J, Ding L, Byron M, Ryker K, Tosta P, Gao W, Freedman MS, Arnold DL, Sayre PH, Smilek DE; ACCLAIM Study Group. ACCLAIM: A randomized trial of abatacept (CTLA4-Ig) for relapsing-remitting multiple sclerosis. Mult Scler. 2017 Apr;23(5):686-695. doi: 10.1177/1352458516662727. Epub 2016 Aug 5.
PMID: 27481207RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Director, Clinical Research Operations Program
- Organization
- DAIT/NIAID
Study Officials
- PRINCIPAL INVESTIGATOR
Samia Khoury, MD
Brigham and Women's Hospital
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 3, 2010
First Posted
May 5, 2010
Study Start
September 1, 2010
Primary Completion
June 1, 2014
Study Completion
February 1, 2015
Last Updated
September 15, 2016
Results First Posted
April 8, 2016
Record last verified: 2016-08
Data Sharing
- IPD Sharing
- Will share
The plan is to share data in: 1.)ImmPort, a long-term archive of clinical and mechanistic data from DAIT-funded grants and contracts that also provides data analysis tools that are available to researchers who register online and subsequently receive DAIT approval; and 2.)TrialShare, a clinical trials research portal developed by the Immune Tolerance Network that makes data from the consortium's clinical trials publicly available without charge.