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

Phase 2TerminatedNCT00035529

Bristol-Myers Squibb

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Conditions

Multiple Sclerosis

Interventions

PlaceboDRUG

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

BMS 188667 (Abatacept)DRUG

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

BMS 188667 (Abatacept)DRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 Years

Medical Language ↔ Plain English

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

Locations (10)

Local Institution

New Haven, Connecticut, United States

Local Institution

Louisville, Kentucky, United States

Local Institution

Worcester, Massachusetts, United States

Local Institution

Newark, New Jersey, United States

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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