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

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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.
Information provided by Bristol-Myers Squibb

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields
Brief Title ^†	A Study to Evaluate the Preliminary Efficacy Pharmacokinetics and Immunogenicity of BMS-188667 Administered to Subjects With Relapsing-Remitting Multiple Sclerosis
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
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
Study Phase	Phase II
Study Type ^†	Interventional
Study Design ^†	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Primary Outcome Measure ^†	Preliminary efficacy- Reduction in cumulative nr of new or recurrent Gd-enhancing lesions.
Secondary Outcome Measure ^†	Preliminary efficacy: 1) Decrease in annualized relapse rate and 2) Reduction in cumulative nr of new or enlarging T2-weighted MRI lesions.
Condition ^†	Multiple Sclerosis
Intervention ^†	Drug: Placebo Drug: BMS 188667 (Abatacept)
MEDLINE PMIDs
Links	BMS Clinical Trials Disclosure For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm

Recruitment Information Fields
Recruitment Status ^†	Terminated
Enrollment ^†
Start Date ^†
Completion Date
Eligibility Criteria ^†	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
Accepts Healthy Volunteers	No
Contacts ^††
Location Countries ^†	United States

Administrative Information Fields
NCT ID ^†	NCT00035529
Organization ID	IM101-200
Secondary IDs ^††
Study Sponsor ^†	Bristol-Myers Squibb
Collaborators ^††
Investigators ^†
Information Provided By	Bristol-Myers Squibb
Verification Date	July 2008
First Received Date ^†	May 3, 2002
Last Updated Date	July 24, 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.