A PHASE III STUDY OF BMS-188667 IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS

STUDY PHASE III, MULTICENTRIC, RANDOMIZED, DOUBLE-BLIND, CONTROLLED, CLINICAL USE AGAINST PLACEBO, TO EVALUATE THE SAFETY AND TOLERANCE OF BMS-188667 INTRAVENOUSLY ADMINISTERED IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS (AR), WITH OR WITHOUT CONCOMITANT DISEASES, AND WHO RECEIVE ANTIRREUMATIC DRUGS (DMARDS) THAT MODIFY THE NATURAL HISTORY OF THE DISEASE AND / OR BIOLOGICAL PRODUCTS APPROVED FOR AR.

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

REPEC

Registry ID

PER-086-02

Enrollment

Registered

2002-12-30

Start date

Unknown

Completion date

Unknown

Last updated

2023-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

BMS-188667 Type of group

BMS-188667 will be administered in doses based on body weight: 500 mg in patients weighing

The placebo will be administered IV on days 1,15, 29.

Eligibility

Inclusion 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.

Exclusion criteria

Exclusion criteria: Other auto-immune disease as a main diagnosis (e.g. Systemic Lupus Erythematosus [SLE], Scleroderma) Active tuberculosis (TB) requiring treatment within last 3 years

Design outcomes

Primary

Measure	Time frame
Outcome name:Number of Participants With AEs of Special Interest Measure:Number of Participants With AEs of Special Interest Timepoints:Day 1 to Day 365, and including data up to 56 days post last dose of double-blind medication	—

Secondary

Measure	Time frame
Outcome name:Number of participants with positive anti-abatacept antigen or cytotoxic antigen T-Lymphocytes 4 Measure:Number of Participants With Positive Anti-Abatacept or Anti-Cytotoxic T-Lymphocyte Antigen 4 (CTLA4) Responses by Enzyme-Linked Immunosorbant Assay (ELISA) Timepoints:Days 1, 29, 57, 85, 113, 169, 281, 365	—

Countries

Austria, Canada, South Africa, United States

Outcome results