Back to resultsA Study to Evaluate the Preliminary Efficacy Pharmacokinetics and Immunogenicity of BMS-188667 Administered to Subjects With Relapsing-remitting Multiple Sclerosis
Primary Purpose
Multiple Sclerosis
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Placebo
BMS 188667 (Abatacept)
BMS 188667 (Abatacept)
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Sclerosis focused on measuring MS
Eligibility 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
Sites / Locations
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Other
Active Comparator
Active Comparator
Arm Label
1
2
3
Arm Description
Outcomes
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00035529
Brief Title
A Study to Evaluate the Preliminary Efficacy Pharmacokinetics and Immunogenicity of BMS-188667 Administered to Subjects With Relapsing-remitting Multiple Sclerosis
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 Type
Interventional
2. Study Status
Record Verification Date
December 2010
Overall Recruitment Status
Terminated
Study Start Date
November 2001 (undefined)
Primary Completion Date
December 2003 (Actual)
Study Completion Date
December 2003 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Bristol-Myers Squibb
4. Oversight
5. 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
MS
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Other
Arm Title
2
Arm Type
Active Comparator
Arm Title
3
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Solution, i.v infusion, 0 mg, Days 1 & 15 then monthly, 10 months.
Intervention Type
Drug
Intervention Name(s)
BMS 188667 (Abatacept)
Other Intervention Name(s)
Orencia
Intervention Description
Vial, i.v infusion, 2mg/kg, Days 1 & 15 then monthly, 10 months.
Intervention Type
Drug
Intervention Name(s)
BMS 188667 (Abatacept)
Other Intervention Name(s)
Orencia
Intervention Description
Vial, i.v infusion, 10 mg/kg, Days 1 & 15 then monthly, 10 months.
Primary Outcome Measure Information:
Title
Preliminary efficacy- Reduction in cumulative nr of new or recurrent Gd-enhancing lesions.
Secondary Outcome Measure Information:
Title
Preliminary efficacy: 1) Decrease in annualized relapse rate and 2) Reduction in cumulative nr of new or enlarging T2-weighted MRI lesions.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Local Institution
City
New Haven
State/Province
Connecticut
Country
United States
Facility Name
Local Institution
City
Louisville
State/Province
Kentucky
Country
United States
Facility Name
Local Institution
City
Worcester
State/Province
Massachusetts
Country
United States
Facility Name
Local Institution
City
Newark
State/Province
New Jersey
Country
United States
Facility Name
Local Institution
City
New York
State/Province
New York
Country
United States
Facility Name
Local Institution
City
Charlotte
State/Province
North Carolina
Country
United States
Facility Name
Local Institution
City
Philadelphia
State/Province
Pennsylvania
Country
United States
Facility Name
Local Institution
City
Dallas
State/Province
Texas
Country
United States
Facility Name
Local Institution
City
Burlington
State/Province
Vermont
Country
United States
Facility Name
Local Institution
City
Madison
State/Province
Wisconsin
Country
United States
12. IPD Sharing Statement
Learn more about this trial
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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