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Trial record 2 of 2 for:    Abatacept in Adults with Relapsing-remitting Multiple Sclerosis

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.
Information provided by:
Bristol-Myers Squibb Identifier:
First received: May 3, 2002
Last updated: December 2, 2010
Last verified: December 2010
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 Intervention Phase
Multiple Sclerosis
Drug: Placebo
Drug: BMS 188667 (Abatacept)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (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

Resource links provided by NLM:

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Preliminary efficacy- Reduction in cumulative nr of new or recurrent Gd-enhancing lesions.

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

Study Start Date: November 2001
Study Completion Date: December 2003
Primary Completion Date: December 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Orencia
Active Comparator: 3 Drug: BMS 188667 (Abatacept)
Vial, i.v infusion, 10 mg/kg, Days 1 & 15 then monthly, 10 months.
Other Name: Orencia


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


  • relapsing-remitting MS
  • at least 1 exacerbation in preceding 2 years
  • at least 1 MRI lesion
  • stable for 2 months prior to dosing


  • 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
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Please refer to this study by its identifier: NCT00035529

United States, Connecticut
Local Institution
New Haven, Connecticut, United States
United States, Kentucky
Local Institution
Louisville, Kentucky, United States
United States, Massachusetts
Local Institution
Worcester, Massachusetts, United States
United States, New Jersey
Local Institution
Newark, New Jersey, United States
United States, New York
Local Institution
New York, New York, United States
United States, North Carolina
Local Institution
Charlotte, North Carolina, United States
United States, Pennsylvania
Local Institution
Philadelphia, Pennsylvania, United States
United States, Texas
Local Institution
Dallas, Texas, United States
United States, Vermont
Local Institution
Burlington, Vermont, United States
United States, Wisconsin
Local Institution
Madison, Wisconsin, United States
Sponsors and Collaborators
Bristol-Myers Squibb
  More Information

Additional Information: Identifier: NCT00035529     History of Changes
Other Study ID Numbers: IM101-200
Study First Received: May 3, 2002
Last Updated: December 2, 2010

Keywords provided by Bristol-Myers Squibb:

Additional relevant MeSH terms:
Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents processed this record on May 25, 2017