drugset / Trial / NCT01116427
A Cooperative Clinical Study of Abatacept in Multiple Sclerosis
Phase 2
Completed
65 enrolled
National Institute of Allergy and Infectious Diseases (NIAID)
Immune Tolerance Network (ITN) · collab
RandomizedCrossoverTriple-blindTreatment
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.
Timeline
- Start
- 2010-09
- Primary completion
- 2014-06
- Completion
- 2015-02
Outcome
Missed primary endpoint
registry analysis (superiority or other test); Abatacept First, Then Placebo vs Placebo First, Then Abatacept; p = 0.87; Wilcoxon (Mann-Whitney); NCT01116427 ↗
paper No statistically significant differences were observed in mean number of new Gd+ MRI lesions between the abatacept and placebo groups. PMID 27481207 ↗
Publications
- Background 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.
- Results Khoury 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Abatacept | Other / unclassified | 500 mg | Intravenous |
| Subject | Abatacept | Other / unclassified | 750 mg | Intravenous |
| Subject | Abatacept | Other / unclassified | 1 g | Intravenous |