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

Bristol-Myers Squibb (BMS)

Status and phase: Terminated; Phase 2

Conditions: Multiple Sclerosis

Treatments: Drug: Placebo; Drug: BMS 188667 (Abatacept)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00035529

IM101-200

Details and patient eligibility

About

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

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 3 patient groups

1

Other group

Treatment:

Drug: Placebo

2

Active Comparator group

Treatment:

Drug: BMS 188667 (Abatacept)

Drug: BMS 188667 (Abatacept)

3

Active Comparator group

Treatment:

Drug: BMS 188667 (Abatacept)

Drug: BMS 188667 (Abatacept)