Psoriatic Arthritis Dose Ranging Study for BMS-945429 in Subjects Who Are Not Responding to NSAIDs or Non-biologic Disease Modifying Anti-rheumatic Drugs (DMARDs) Therapy

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

A Phase 2b, Randomized, Double-Blind, Placebo-Controlled, Dose Ranging, Multi-Center Study to Evaluate the Efficacy and Safety of BMS-945429 Subcutaneous Injection in Adults With Active Psoriatic Arthritis

The purpose of this study is to characterize the safety, efficacy and dose response of
BMS-945429 in subjects with active Psoriatic Arthritis and an inadequate response to
Nonsteroidal anti-inflammatory drugs (NSAIDs) and non-biologic Disease modifying
anti-rheumatic drugs (DMARDs).

Inclusion Criteria:

- Must be on a stable background Methotrexate (MTX) therapy prior to
Day1/Randomization. Subjects must have taken MTX for at least 3 months at a dose ≥ 15
mg/week to a maximum weekly dose of ≤ 25 mg/week, and be at a stable dose for 4 weeks
prior to randomization (Day 1). Methotrexate dose ≥ 15 mg/week that was not
efficacious and that was decreased due to toxicity as low as 10 mg/week is allowed

- Inadequate response to NSAID and/or non-biologic DMARD

- Minimum of 3 swollen and 3 tender joints

- Active psoriatic skin lesions over minimum 3% body surface area

- high sensitivity C-reactive protein (hsCRP) ≥ 0.3 mg/dL

Exclusion Criteria:

- Previously received or currently receiving concomitant biologic therapy

We found this trial at

sites

East Penn Rheumatology Associates, P.C.

Bethlehem, Pennsylvania 18015

from

Bethlehem, PA