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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ClinicalTrials.gov Identifier: NCT00035529

Recruitment Status : Terminated

First Posted : May 6, 2002

Last Update Posted : December 6, 2010

Sponsor:

Information provided by:

Bristol-Myers Squibb

Tracking Information

First Submitted Date ^ICMJE

May 3, 2002

First Posted Date ^ICMJE

May 6, 2002

Last Update Posted Date

December 6, 2010

Study Start Date ^ICMJE

November 2001

Actual Primary Completion Date

December 2003 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00035529 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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 Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Multiple Sclerosis

Intervention ^ICMJE

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

Other Name: Orencia
Drug: BMS 188667 (Abatacept)
Vial, i.v infusion, 10 mg/kg, Days 1 & 15 then monthly, 10 months.

Other Name: Orencia

Study Arms

1
Intervention: Drug: Placebo
Active Comparator: 2
Intervention: Drug: BMS 188667 (Abatacept)
Active Comparator: 3
Intervention: Drug: BMS 188667 (Abatacept)

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

Not Provided

Original Enrollment ^ICMJE

Not Provided

Actual Study Completion Date

December 2003

Actual Primary Completion Date

December 2003 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years to 55 Years (Adult)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

United States

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT00035529

Other Study ID Numbers ^ICMJE

IM101-200

Has Data Monitoring Committee

Not Provided

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Bristol-Myers Squibb

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Not Provided

PRS Account

Bristol-Myers Squibb

Verification Date

December 2010

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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