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:
Bristol-Myers Squibb
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00035529
First received: May 3, 2002
Last updated: December 2, 2010
Last verified: December 2010
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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 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, 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:
Genetics Home Reference related topics:
multiple sclerosis
MedlinePlus related topics:
Multiple Sclerosis
Drug Information available for:
Abatacept
U.S. FDA Resources
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
|
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
| ClinicalTrials.gov Identifier: | NCT00035529 History of Changes |
| Other Study ID Numbers: | IM101-200 |
| Study First Received: | May 3, 2002 |
| Last Updated: | December 2, 2010 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Bristol-Myers Squibb:
|
MS |
Additional relevant MeSH terms:
|
Multiple Sclerosis Sclerosis Multiple Sclerosis, Relapsing-Remitting Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System Nervous System Diseases Demyelinating Diseases Autoimmune Diseases Immune System Diseases |
Pathologic Processes Abatacept Antirheumatic Agents Therapeutic Uses Pharmacologic Actions Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 23, 2013