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

Phase 2

Terminated

• Conditions: Multiple Sclerosis
• Interventions: Drug: BMS 188667 (Abatacept); Drug: Placebo

• Registration Number: NCT00035529
• Lead Sponsor: 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

Detailed Description

Not available

Study Timeline

• Study Start: 2001-11
• Study First Submitted: 2002-05-03
• Study First Submitted QC: 2002-05-03
• Study First Posted: 2002-05-06
• Primary Completion: 2003-12
• Study Completion: 2003-12
• Disposition First Submitted: 2010-09-03
• Disposition First Submitted QC: 2010-09-03
• Disposition First Posted: 2010-09-08
• Status Verified: 2010-12
• Last Update Submitted: 2010-12-02
• Last Update Posted: 2010-12-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	BMS 188667 (Abatacept)	-
1	Placebo	-
3	BMS 188667 (Abatacept)	-

Primary Outcome Measures

Name	Time	Method
Preliminary efficacy- Reduction in cumulative nr of new or recurrent Gd-enhancing lesions.

Secondary Outcome Measures

Name	Time	Method
Preliminary efficacy: 1) Decrease in annualized relapse rate and 2) Reduction in cumulative nr of new or enlarging T2-weighted MRI lesions.

Trial Locations

Locations (1)

Local Institution; 🇺🇸 Madison, Wisconsin, United States