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

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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
9
sites
Denver, Colorado 80230
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Denver, CO
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Bethlehem, Pennsylvania 18015
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Bethlehem, PA
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Capital Federal, Buenos Aires
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Capital Federal,
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Charlotte, North Carolina 00000
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Charlotte, NC
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Jackson, Mississippi 39202
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Jackson, MS
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Oklahoma City, Oklahoma 73103
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Oklahoma City, OK
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San Diego, California 92108
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San Diego, CA
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Sarasota, Florida 34239
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Sarasota, FL
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Trumbull, Connecticut 06611
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Trumbull, CT
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