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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.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00035529
First received: May 3, 2002
Last updated: December 2, 2010
Last verified: December 2010

May 3, 2002
December 2, 2010
November 2001
December 2003   (final data collection date for primary outcome measure)
Preliminary efficacy- Reduction in cumulative nr of new or recurrent Gd-enhancing lesions.
Not Provided
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.
Not Provided
Not Provided
Not Provided
 
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

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Multiple Sclerosis
  • Drug: Placebo
    Solution, i.v infusion, 0 mg, Days 1 & 15 then monthly, 10 months.
  • Drug: BMS 188667 (Abatacept)
    Vial, i.v infusion, 2mg/kg, Days 1 & 15 then monthly, 10 months.
    Other Name: Orencia
  • Drug: BMS 188667 (Abatacept)
    Vial, i.v infusion, 10 mg/kg, Days 1 & 15 then monthly, 10 months.
    Other Name: Orencia
  • 1
    Intervention: Drug: Placebo
  • Active Comparator: 2
    Intervention: Drug: BMS 188667 (Abatacept)
  • Active Comparator: 3
    Intervention: Drug: BMS 188667 (Abatacept)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
Not Provided
December 2003
December 2003   (final data collection date for primary outcome measure)

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
Not Provided
Not Provided
Bristol-Myers Squibb
Not Provided
Not Provided
Bristol-Myers Squibb
December 2010

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