Study of Abatacept (BMS-188667) in Subjects With Active Rheumatoid Arthritis on Background Non-Biologic DMARDS (Disease Modifying Antirheumatic Drugs) Who Have an Inadequate Response to Anti-TNF Therapy

Condition(s) targeted: Rheumatoid Arthritis

Intervention: Abatacept (Drug)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: Bristol-Myers Squibb

The purpose of this study is to learn if Abatacept will provide clinical efficacy to subjects who have failed an anti-TNF therapy. The safety of this treatment will also be studied.

Official title: A Phase III, Multi-Center, Open Label Study to Evaluate the Efficacy, Tolerability and Safety of Abatacept (BMS-188667) in Subjects With Active Rheumatoid Arthritis on Background Non-Biologic DMARDs Who Have an Inadequate Response to Anti-TNF Therapy and Have Limited Therapeutic Options

Study design: Interventional, Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study

Primary outcome: Summarize the incidence of adverse events, serious adverse events and discontinuations due to adverse events based on physical exam findings, vital signs, laboratory test results and adverse events reported during the course of the study.

Secondary outcome:

A disease activity score

Percentage of subjects achieving remission

Discontinuation rate in subjects

Minimum age: 18 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

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

- American College of Rheumatology (ACR) functional class I, II, III

- Subjects currently or previously received an anti-TNF therapy at an approved labeled dose for at least 3 months.

Exclusion Criteria:

- Subjects with active vasculitis of a major organ system (except subcutaneous rheumatoid nodules).

- History of cancer within the last 5 years (other than non-melanoma skin cell cancers cured by local resection).

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BMS Clinical Trials Disclosure

For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm

Starting date: April 2005
Last updated: September 26, 2007