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

December 2, 2010 updated by: Bristol-Myers Squibb

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

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 Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States
        • Local Institution
    • Kentucky
      • Louisville, Kentucky, United States
        • Local Institution
    • Massachusetts
      • Worcester, Massachusetts, United States
        • Local Institution
    • New Jersey
      • Newark, New Jersey, United States
        • Local Institution
    • New York
      • New York, New York, United States
        • Local Institution
    • North Carolina
      • Charlotte, North Carolina, United States
        • Local Institution
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States
        • Local Institution
    • Texas
      • Dallas, Texas, United States
        • Local Institution
    • Vermont
      • Burlington, Vermont, United States
        • Local Institution
    • Wisconsin
      • Madison, Wisconsin, United States
        • Local Institution

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 2
Drug: BMS 188667 (Abatacept)
Vial, i.v infusion, 2mg/kg, Days 1 & 15 then monthly, 10 months.
Other Names:
  • Orencia
Drug: BMS 188667 (Abatacept)
Vial, i.v infusion, 10 mg/kg, Days 1 & 15 then monthly, 10 months.
Other Names:
  • Orencia
Other: 1
Drug: Placebo
Solution, i.v infusion, 0 mg, Days 1 & 15 then monthly, 10 months.
Active Comparator: 3
Drug: BMS 188667 (Abatacept)
Vial, i.v infusion, 2mg/kg, Days 1 & 15 then monthly, 10 months.
Other Names:
  • Orencia
Drug: BMS 188667 (Abatacept)
Vial, i.v infusion, 10 mg/kg, Days 1 & 15 then monthly, 10 months.
Other Names:
  • Orencia

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2001

Primary Completion (Actual)

December 1, 2003

Study Completion (Actual)

December 1, 2003

Study Registration Dates

First Submitted

May 3, 2002

First Submitted That Met QC Criteria

May 3, 2002

First Posted (Estimate)

May 6, 2002

Study Record Updates

Last Update Posted (Estimate)

December 6, 2010

Last Update Submitted That Met QC Criteria

December 2, 2010

Last Verified

December 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IM101-200

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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