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).
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
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