A Phase III Study of BMS-188667 in Subjects With Active Rheumatoid Arthritis

Recruiting in Palo Alto (17 mi)

+43 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Bristol-Myers Squibb

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?

The purpose of this clinical research study is to learn if abatacept is safe when co-administered with other approved rheumatoid arthritis medications.

Eligibility Criteria

Inclusion Criteria

Meet criteria of American Rheumatism Association for the diagnosis of rheumatoid arthritis and the American College of Rheumatology functional classes I, II III or IV

Participants must be taking 1 or more DMARDs and/or biologic approved for rheumatoid arthritis (RA) for at least 3 months and be on a stable dose for 28 days prior to Day 1.

Other auto-immune disease as a main diagnosis (e.g. Systemic Lupus Erythematosus [SLE], Scleroderma)

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Treatment Details

Interventions

Abatacept (Immunomodulator)

Participant Groups

3Treatment groups

Active Control

Placebo Group

Group I: Double-blind abataceptActive Control1 Intervention

Participants received a fixed dose of abatacept approximating 10 mg/kg (500 mg for participants \< 60 kg, 750 mg for participants 60 to 100 kg and 1 g for participants \> 100 kg). Abatacept was administered intravenously (IV) on Days 1, 15, 29, and every 28 days thereafter, for a total of 14 doses. Participants also received background therapy(ies) for rheumatoid arthritis (RA) (non-biologic or biologic disease-modifying drugs \[DMARDs\], or combination) throughout the double-blind treatment period

Group II: Open-label AbataceptActive Control1 Intervention

Participants received abatacept (weight-tiered 10 mg/kg dose) IV every 28 days during the open-label period.

Group III: Double-blind PlaceboPlacebo Group1 Intervention

Participants received Placebo (dextrose 5% water \[D5W\] for injection U.S.P or normal saline \[NS\]) for IV infusion administered on Days 1, 15, 29, and every 28 days thereafter, for a total of 14 doses. Participants also received background therapy(ies) for rheumatoid arthritis (RA) (non-biologic or biologic disease-modifying drugs \[DMARDs\], or combination) throughout the double-blind treatment period.

Abatacept is already approved in European Union, United States, Canada, Japan for the following indications:

🇪🇺 Approved in European Union as Orencia for: