A Study to Evaluate the Preliminary Efficacy Pharmacokinetics and Immunogenicity of BMS-188667 Administered to Subjects With Relapsing-remitting Multiple Sclerosis
What it found
The trial ended early for another reason (see below).
mean number of new gadolinium-enhancing (Gd+) lesions obtained on magnetic resonance imaging (MRI) scans performed every 4 weeks · 24 weeks
Total participants: 65
Read by software from the paper's abstract
What was tested
Treatment tested
- Abatacept
T-lymphocyte activation antigen CD80 inhibitor|T-lymphocyte activation antigen CD86 inhibitor
Placebo or sham
- Placebo
What it measured
Main measures
Preliminary efficacy- Reduction in cumulative nr of new or recurrent Gd-enhancing lesions.
MRI lesions
Other measures (1)
Preliminary efficacy: 1) Decrease in annualized relapse rate and 2) Reduction in cumulative nr of new or enlarging T2-weighted MRI lesions.
RelapsesMRI lesions
Who could take part
Relapsing and progressive · 18 to 55
Inclusion * relapsing-remitting MS * at least 1 exacerbation in preceding 2 years * at least 1 MRI lesion * stable for 2 months prior to dosing Exclusion * progressive MS * currently treated with an immunomodulatory therapy * previously treated with an approved MS drug where treatment was discontinued for lack of efficacy * active bacterial or viral infections
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
The purpose of this study is to determine whether BMS-188667 will decrease multiple sclerosis disease activity on MRI examinations, as well as decrease the rate of clinical MS exacerbations, compared to placebo
Papers
Results
ACCLAIM: A randomized trial of abatacept (CTLA4-Ig) for relapsing-remitting multiple sclerosis.Mult Scler · 2017
No statistically significant differences were observed in mean number of new Gd+ MRI lesions between the abatacept and placebo groups.
Read by software from the paper's abstract
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History
Started
Nov 2001
Main results due
Dec 2003
Finished
Dec 2003
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