Phase IIB Rheumatoid Arthritis Dose Ranging Study for BMS-945429 in Subjects Who Are Not Responding to Methotrexate

Status:	Completed
Conditions:	Arthritis, Rheumatoid Arthritis
Therapuetic Areas:	Rheumatology
Healthy:	No
Age Range:	18 - Any
Updated:	4/21/2016
Start Date:	June 2011
End Date:	June 2015

A Phase IIB , Randomized, Multi-Center, Double-Blind, Dose-Ranging, Placebo/Active Controlled Study to Evaluate the Efficacy and Safety of BMS-945429 Subcutaneous Injection With or Without Methotrexate in Subjects With Moderate to Severe Rheumatoid Arthritis With Inadequate Response to Methotrexate.

The purpose of this study is to determine the effective dose of BMS-945429 in subjects with
inadequate response to Methotrexate in the treatment of moderate to severe Rheumatoid
Arthritis.

Inclusion Criteria:

- Inadequate response to Methotrexate

- Must have been taking Methotrexate for at least 3 months at a minimal weekly dose of
at least 15 mg and stable dose for 4 weeks prior to randomization

- American College of Rheumatology (ACR) global function status class 1-3

- Minimum of 6 swollen and 6 tender joints with evidence of synovitis in at least 1
hand or wrist

- High sensitivity C-reactive protein (hsCRP) ≥ 0.8 mg/dL

Exclusion Criteria:

- Previously received or currently receiving concomitant biologic therapy

We found this trial at

sites

Altoona Center for Clinical Research

Duncansville, Pennsylvania 16635

244

from 43215

Duncansville, PA