A Study to Evaluate the Preliminary Efficacy Pharmacokinetics and Immunogenicity of BMS-188667 Administered to Subjects With Relapsing-remitting Multiple Sclerosis

Multiple Sclerosis Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00035529
• Other study ID #: IM101-200
• Status: Terminated
• Phase: Phase 2
• First received: May 3, 2002
• Last updated: December 2, 2010
• Start date: November 2001
• Est. completion date: December 2003

Study information

• Verified date: December 2010
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 0
• Est. completion date: December 2003
• Est. primary completion date: December 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Relapsing-Remitting
• Sclerosis

Intervention

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

Locations

Country	Name	City	State
United States	Local Institution	Burlington	Vermont
United States	Local Institution	Charlotte	North Carolina
United States	Local Institution	Dallas	Texas
United States	Local Institution	Louisville	Kentucky
United States	Local Institution	Madison	Wisconsin
United States	Local Institution	New Haven	Connecticut
United States	Local Institution	New York	New York
United States	Local Institution	Newark	New Jersey
United States	Local Institution	Philadelphia	Pennsylvania
United States	Local Institution	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Preliminary efficacy- Reduction in cumulative nr of new or recurrent Gd-enhancing lesions.
Secondary	Preliminary efficacy: 1) Decrease in annualized relapse rate and 2) Reduction in cumulative nr of new or enlarging T2-weighted MRI lesions.

External Links

•   BMS Clinical Trials Disclosure
•   For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm