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A Study to Evaluate the Preliminary Efficacy Pharmacokinetics and Immunogenicity of BMS-188667 Administered to Subjects With Relapsing-Remitting Multiple Sclerosis
This study has been terminated.
Study NCT00035529   Information provided by Bristol-Myers Squibb
First Received: May 3, 2002   Last Updated: July 24, 2008   History of Changes

May 3, 2002
July 24, 2008
 
 
Preliminary efficacy- Reduction in cumulative nr of new or recurrent Gd-enhancing lesions.
Same as current
Complete list of historical versions of study NCT00035529 on ClinicalTrials.gov Archive Site
Preliminary efficacy: 1) Decrease in annualized relapse rate and 2) Reduction in cumulative nr of new or enlarging T2-weighted MRI lesions.
Same as current
 
A Study to Evaluate the Preliminary Efficacy Pharmacokinetics and Immunogenicity of BMS-188667 Administered to Subjects With Relapsing-Remitting Multiple Sclerosis
A Phase II,Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Preliminary Efficacy, Pharmacokinetics and Immunogenicity of BMS-188667 Administered to Subjects With Relapsing-Remitting Multiple Sclerosis

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

 
Phase II
Interventional
Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Multiple Sclerosis
  • Drug: Placebo
  • Drug: BMS 188667 (Abatacept)
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Terminated
 
 
 

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
Both
18 Years to 55 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00035529
 
IM101-200
Bristol-Myers Squibb
 
 
Bristol-Myers Squibb
July 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP