Status:
COMPLETED
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
Lead Sponsor:
CSL Behring
Conditions:
Arthritis, Psoriatic
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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-inflammato...
Eligibility Criteria
Inclusion
- 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
- Previously received or currently receiving concomitant biologic therapy
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2015
Estimated Enrollment :
165 Patients enrolled
Trial Details
Trial ID
NCT01490450
Start Date
December 1 2011
End Date
June 1 2015
Last Update
November 5 2021
Active Locations (49)
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1
San Diego Arthritis Medical Clinic
San Diego, California, United States, 92108
2
Denver Arthritis Clinic
Denver, Colorado, United States, 80230
3
New England Research Associates, Llc
Trumbull, Connecticut, United States, 06611
4
Sarasota Arthritis Research Center
Sarasota, Florida, United States, 34239