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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

Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Terminated
CT.gov ID
NCT00035529
Collaborator
(none)
10
Locations
3
Arms
25
Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Drug: Placebo
  • Drug: BMS 188667 (Abatacept)
  • Drug: BMS 188667 (Abatacept)
 Phase 2

Study Design

Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
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
Study Start Date :
Nov 1, 2001
Actual Primary Completion Date :
Dec 1, 2003
Actual Study Completion Date :
Dec 1, 2003

Arms and Interventions

Arm Intervention/Treatment
Other: 1

Drug: Placebo
Solution, i.v infusion, 0 mg, Days 1 & 15 then monthly, 10 months.
Active Comparator: 2

Drug: BMS 188667 (Abatacept)
Vial, i.v infusion, 2mg/kg, Days 1 & 15 then monthly, 10 months.
Other Names:
  • Orencia

    		•
    Active Comparator: 3

    Drug: BMS 188667 (Abatacept)
    Vial, i.v infusion, 10 mg/kg, Days 1 & 15 then monthly, 10 months.
    Other Names:
  • Orencia

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Preliminary efficacy- Reduction in cumulative nr of new or recurrent Gd-enhancing lesions. []

    Secondary Outcome Measures

    1. Preliminary efficacy: 1) Decrease in annualized relapse rate and 2) Reduction in cumulative nr of new or enlarging T2-weighted MRI lesions. []

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 55 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Local Institution New Haven Connecticut United States
    2 Local Institution Louisville Kentucky United States
    3 Local Institution Worcester Massachusetts United States
    4 Local Institution Newark New Jersey United States
    5 Local Institution New York New York United States
    6 Local Institution Charlotte North Carolina United States
    7 Local Institution Philadelphia Pennsylvania United States
    8 Local Institution Dallas Texas United States
    9 Local Institution Burlington Vermont United States
    10 Local Institution Madison Wisconsin United States

    Sponsors and Collaborators

    • Bristol-Myers Squibb

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00035529
    Other Study ID Numbers:
    • IM101-200
    First Posted:
    May 6, 2002
    Last Update Posted:
    Dec 6, 2010
    Last Verified:
    Dec 1, 2010
    Keywords provided by , ,
    MS
    Additional relevant MeSH terms:
    Multiple Sclerosis
    Multiple Sclerosis, Relapsing-Remitting
    Sclerosis
    Abatacept

    Study Results

    No Results Posted as of Dec 6, 2010