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

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

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00035529

Enrollment

Unknown

Registered

2002-05-06

Start date

2001-11-30

Completion date

2003-12-31

Last updated

2010-12-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis

Keywords

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

Interventions

DRUGPlacebo

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

DRUGBMS 188667 (Abatacept)

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Inclusion 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

Design outcomes

Primary

Measure	Time frame
Preliminary efficacy- Reduction in cumulative nr of new or recurrent Gd-enhancing lesions.	—

Secondary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026