Overview

A Phase III Study of Abatacept (BMS-188667) in Patients With Active Rheumatoid Arthritis and Inadequate Response to Methotrexate

Status:
Completed

Trial end date:
2009-10-01

Target enrollment:
0

Participant gender:
All

Summary

Short Term: The purpose of this clinical research study is to learn if abatacept (BMS-188667) in combination with methotrexate is better than methotrexate alone in participants that have active rheumatoid arthritis and are not responding to methotrexate. The safety of this treatment will also be studied. Long Term Extension: The purpose of this amendment is to provide participants who have completed the initial 12-month double-blind treatment period the opportunity to receive open label treatment with active drug treatment until abatacept is approved in the local country or until clinical development has been discontinued.

Phase:

Phase 3

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Bristol-Myers Squibb

Treatments:

Abatacept
Methotrexate

Criteria

- Rheumatoid Arthritis (RA) for greater than 1 year from the time of initial diagnosis
of RA.

- Participants must have been taking methotrexate for at least 3 months with at least a
weekly dose of 15 mg.