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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

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ClinicalTrials.gov Identifier: NCT00035529
Recruitment Status : Terminated
First Posted : May 6, 2002
Last Update Posted : December 6, 2010
Sponsor:
Information provided by:
Bristol-Myers Squibb

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
Multiple Sclerosis Drug: Placebo Drug: BMS 188667 (Abatacept) Phase 2

Study Type : Interventional  (Clinical Trial)
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 : November 2001
Actual Primary Completion Date : December 2003
Actual Study Completion Date : December 2003

Resource links provided by the National Library of Medicine

Drug Information available for: Abatacept

Arm Intervention/treatment
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




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.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
ClinicalTrials.gov Identifier: NCT00035529     History of Changes
Other Study ID Numbers: IM101-200
First Posted: May 6, 2002    Key Record Dates
Last Update Posted: December 6, 2010
Last Verified: December 2010

Keywords provided by Bristol-Myers Squibb:
MS

Additional relevant MeSH terms:
Sclerosis
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
Abatacept
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents