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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.
First Received: May 3, 2002   Last Updated: July 24, 2008   History of Changes
Sponsor: Bristol-Myers Squibb
Information provided by: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00035529
  Purpose

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 II

Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
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.

Arms Assigned Interventions
1 Drug: Placebo
Solution, i.v infusion, 0 mg, Days 1 & 15 then monthly, 10 months.
2: Active Comparator Drug: BMS 188667 (Abatacept)
Vial, i.v infusion, 2mg/kg, Days 1 & 15 then monthly, 10 months.
3: Active Comparator Drug: BMS 188667 (Abatacept)
Vial, i.v infusion, 10 mg/kg, Days 1 & 15 then monthly, 10 months.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00035529

Locations
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:
No publications provided

Study ID Numbers: IM101-200
Study First Received: May 3, 2002
Last Updated: July 24, 2008
ClinicalTrials.gov Identifier: NCT00035529     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by Bristol-Myers Squibb:
MS

Additional relevant MeSH terms:
Autoimmune Diseases
Immunologic Factors
Demyelinating Diseases
Immune System Diseases
Physiological Effects of Drugs
Nervous System Diseases
Sclerosis
Immunosuppressive Agents
Multiple Sclerosis, Relapsing-Remitting
Pharmacologic Actions
Multiple Sclerosis
Pathologic Processes
Abatacept
Therapeutic Uses
Demyelinating Autoimmune Diseases, CNS
Antirheumatic Agents
Autoimmune Diseases of the Nervous System

ClinicalTrials.gov processed this record on November 09, 2009