A Study to Evaluate the Preliminary Efficacy Pharmacokinetics and Immunogenicity of BMS-188667 Administered to Subjects With Relapsing-remitting Multiple Sclerosis
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
1 other identifier
interventional
N/A
1 country
10
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Nov 2001
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2001
CompletedFirst Submitted
Initial submission to the registry
May 3, 2002
CompletedFirst Posted
Study publicly available on registry
May 6, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2003
CompletedDecember 6, 2010
December 1, 2010
2.1 years
May 3, 2002
December 2, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Preliminary efficacy- Reduction in cumulative nr of new or recurrent Gd-enhancing lesions.
Secondary Outcomes (1)
Preliminary efficacy: 1) Decrease in annualized relapse rate and 2) Reduction in cumulative nr of new or enlarging T2-weighted MRI lesions.
Study Arms (3)
1
OTHER2
ACTIVE COMPARATOR3
ACTIVE COMPARATORInterventions
Vial, i.v infusion, 2mg/kg, Days 1 \& 15 then monthly, 10 months.
Eligibility Criteria
You may qualify if:
- relapsing-remitting MS
- at least 1 exacerbation in preceding 2 years
- at least 1 MRI lesion
- stable for 2 months prior to dosing
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
Local Institution
New Haven, Connecticut, United States
Local Institution
Louisville, Kentucky, United States
Local Institution
Worcester, Massachusetts, United States
Local Institution
Newark, New Jersey, United States
Local Institution
New York, New York, United States
Local Institution
Charlotte, North Carolina, United States
Local Institution
Philadelphia, Pennsylvania, United States
Local Institution
Dallas, Texas, United States
Local Institution
Burlington, Vermont, United States
Local Institution
Madison, Wisconsin, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
May 3, 2002
First Posted
May 6, 2002
Study Start
November 1, 2001
Primary Completion
December 1, 2003
Study Completion
December 1, 2003
Last Updated
December 6, 2010
Record last verified: 2010-12