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

Completed · Phase 2 · Has a placebo group

Conditions studied: Arthritis, Psoriatic

In brief

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).

Key facts

Study ID

NCT01490450

Run by

CSL Behring

People needed

165

Starts

2011-12-01

Expected to finish

2015-06-01

Last updated by the study team

2021-11-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Previously received or currently receiving concomitant biologic therapy

Where it is running

• San Diego Arthritis Medical Clinic — San Diego, California, United States
• Denver Arthritis Clinic — Denver, Colorado, United States
• New England Research Associates, Llc — Trumbull, Connecticut, United States
• Sarasota Arthritis Research Center — Sarasota, Florida, United States
• Arthritis Associates Of Mississippi — Jackson, Mississippi, United States
• Box Arthritis And Rheumatology Of The Carolinas, Pllc — Charlotte, North Carolina, United States
• Health Research Of Oklahoma — Oklahoma City, Oklahoma, United States
• East Penn Rheumatology Associates, P.C. — Bethlehem, Pennsylvania, United States
• Local Institution — Capital Federal, Buenos Aires, Argentina
• Local Institution — Capital Federal, Buenos Aires, Argentina
• Local Institution — Capital Federal, Buenos Aires, Argentina
• Local Institution — San Miguel de Tucumán, Argentina
• Local Institution — Cairns, Queensland, Australia
• Local Institution — Maroochydore, Queensland, Australia
• Local Institution — Woodville, South Australia, Australia
• Local Institution — Shenton Park, Western Australia, Australia
• Manitoba Clinic — Winnipeg, Manitoba, Canada
• Local Institution — Montreal, Quebec, Canada
• Centre De Rhumatologie De L Est Du Quebec — Rimouski, Quebec, Canada
• Centre De Recherche Musculo-Squelettique — Trois-Rivières, Quebec, Canada
• Local Institution — Pardubice, Czechia
• Local Institution — Prague, Czechia
• Local Institution — Bad Nauheim, Germany
• Local Institution — Erlangen, Germany
• Local Institution — Planegg, Germany

Full record on ClinicalTrials.gov

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