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.

First Received on May 3, 2002. Last Updated on December 2, 2010 History of Changes

Sponsor:	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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Multiple Sclerosis

Drug Information available for: Abatacept

U.S. FDA Resources

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.

Study Start Date:	November 2001
Study Completion Date:	December 2003
Primary Completion Date:	December 2003 (Final data collection date for primary outcome measure)

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

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

Additional 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

No publications provided

ClinicalTrials.gov Identifier:	NCT00035529 History of Changes
Other Study ID Numbers:	IM101-200
Study First Received:	May 3, 2002
Last Updated:	December 2, 2010
Health Authority:	United States: Food and Drug Administration

Keywords provided by Bristol-Myers Squibb:

Additional relevant MeSH terms:

Multiple Sclerosis
Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases

Pathologic Processes
Abatacept
Antirheumatic Agents
Therapeutic Uses
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on February 12, 2012