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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

NCT ID: NCT00035529

Last Updated: 2010-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2001-11-30

Study Completion Date

2003-12-31

Brief Summary

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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

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Conditions

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Multiple Sclerosis

Keywords

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MS

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

Group Type OTHER

Placebo

Intervention Type DRUG

Solution, i.v infusion, 0 mg, Days 1 \& 15 then monthly, 10 months.

2

Group Type ACTIVE_COMPARATOR

BMS 188667 (Abatacept)

Intervention Type DRUG

Vial, i.v infusion, 2mg/kg, Days 1 \& 15 then monthly, 10 months.

3

Group Type ACTIVE_COMPARATOR

BMS 188667 (Abatacept)

Intervention Type DRUG

Vial, i.v infusion, 10 mg/kg, Days 1 \& 15 then monthly, 10 months.

Interventions

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Placebo

Solution, i.v infusion, 0 mg, Days 1 \& 15 then monthly, 10 months.

Intervention Type DRUG

BMS 188667 (Abatacept)

Vial, i.v infusion, 2mg/kg, Days 1 \& 15 then monthly, 10 months.

Intervention Type DRUG

BMS 188667 (Abatacept)

Vial, i.v infusion, 10 mg/kg, Days 1 \& 15 then monthly, 10 months.

Intervention Type DRUG

Other Intervention Names

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Orencia Orencia

Eligibility Criteria

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Inclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Locations

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Local Institution

New Haven, Connecticut, United States

Site Status

Local Institution

Louisville, Kentucky, United States

Site Status

Local Institution

Worcester, Massachusetts, United States

Site Status

Local Institution

Newark, New Jersey, United States

Site Status

Local Institution

New York, New York, United States

Site Status

Local Institution

Charlotte, North Carolina, United States

Site Status

Local Institution

Philadelphia, Pennsylvania, United States

Site Status

Local Institution

Dallas, Texas, United States

Site Status

Local Institution

Burlington, Vermont, United States

Site Status

Local Institution

Madison, Wisconsin, United States

Site Status

Countries

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United States

Other Identifiers

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IM101-200

Identifier Type: -

Identifier Source: org_study_id