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

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.

Sponsored by:	Bristol-Myers Squibb
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00035529

Purpose

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

Condition	Intervention	Phase
Multiple Sclerosis	Drug: Placebo Drug: BMS 188667 (Abatacept)	Phase II

MedlinePlus related topics:

Multiple Sclerosis

ChemIDplus related topics:

Abatacept

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study

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

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

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

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00035529

Locations


United States, Connecticut
	Local Institution
	New Haven, Connecticut, United States

United States, Kentucky
	Local Institution
	Louisville, Kentucky, United States

United States, Massachusetts
	Local Institution
	Worcester, Massachusetts, United States

United States, New Jersey
	Local Institution
	Newark, New Jersey, United States

United States, New York
	Local Institution
	New York, New York, United States

United States, North Carolina
	Local Institution
	Charlotte, North Carolina, United States

United States, Pennsylvania
	Local Institution
	Philadelphia, Pennsylvania, United States

United States, Texas
	Local Institution
	Dallas, Texas, United States

United States, Vermont
	Local Institution
	Burlington, Vermont, United States

United States, Wisconsin
	Local Institution
	Madison, Wisconsin, United States

Sponsors and Collaborators

Bristol-Myers Squibb

More Information

BMS Clinical Trials Disclosure This link exits the ClinicalTrials.gov site

For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm This link exits the ClinicalTrials.gov site

Study ID Numbers:	IM101-200
First Received:	May 3, 2002
Last Updated:	July 24, 2008
ClinicalTrials.gov Identifier:	NCT00035529
Health Authority:	United States: Food and Drug Administration

Keywords provided by Bristol-Myers Squibb:

Study placed in the following topic categories:

Abatacept

Autoimmune Diseases

Multiple Sclerosis

Demyelinating Diseases

Demyelinating Autoimmune Diseases, CNS

Demyelinating diseases

Sclerosis

Multiple Sclerosis, Relapsing-Remitting

Autoimmune Diseases of the Nervous System

Additional relevant MeSH terms:

Pathologic Processes

Immunologic Factors

Immune System Diseases

Therapeutic Uses

Physiological Effects of Drugs

Nervous System Diseases

Antirheumatic Agents

Immunosuppressive Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on August 29, 2008