A Multi-Center, Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Safety and Clinical Efficacy of Intravenous Infusions of BMS-188667 (10 mg/kg) Given Monthly in Combination With Subcutaneous Injections of Etanercept (25mg)Given Twice Weekly to Subjects With Active Rheumatoid Arthritis

Bristol-Myers Squibb35 sites in 1 country141 target enrollmentStarted: October 2000Last updated: December 6, 2010

Conditions

Drugs

Trial Snapshot

Phase: Phase 2
Status: Completed
Sponsor
Enrollment: 141
Locations: 35
Primary Endpoint: Abatacept combined with etanercept will have greater clinical efficacy compared to subjects receiving etanercept alone

Study Overview Study Design Eligibility Criteria Outcomes Investigators Sites Records & Identifiers Similar Trials

Study Overview

Brief Summary

The Study was designed to look at the safety and efficacy of abatacept in combination with etanercept.

Study Design

Study Type: Interventional
Allocation: Randomized
Intervention Model: Single Group
Primary Purpose: Treatment
Masking: Double

Eligibility Criteria

Ages: 18 Years to — (Adult, Older Adult)
Sex: All
Accepts Healthy Volunteers: No

Inclusion Criteria

•All subjects who had completed the short term portion of IM101-101.

Exclusion Criteria

Not provided

Outcomes

Primary Outcomes

Abatacept combined with etanercept will have greater clinical efficacy compared to subjects receiving etanercept alone

Time Frame: at 6 months

Secondary Outcomes

ACR 50 and 70 will be evaluated(at 6 months)

Investigators

Sponsor

Bristol-Myers Squibb

Sponsor Class

Industry

Study Sites (35)

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