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

This study has been terminated.

Sponsor:

Information provided by:

Bristol-Myers Squibb

ClinicalTrials.gov Identifier:

NCT00035529

First received: May 3, 2002

Last updated: December 2, 2010

Last verified: December 2010

History of Changes

Tracking Information
First Received Date ^ICMJE	May 3, 2002
Last Updated Date	December 2, 2010
Start Date ^ICMJE	November 2001
Primary Completion Date	December 2003 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: July 24, 2008)	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 (submitted: July 24, 2008)	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 Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, 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 Arm (s)	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
Completion Date	December 2003
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
Gender	Both
Ages	18 Years to 55 Years (Adult)
Accepts Healthy Volunteers	No
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
Plan to Share Data	Not Provided
IPD Description	Not Provided
Responsible Party	Not Provided
Study Sponsor ^ICMJE	Bristol-Myers Squibb
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	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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