NCT01490450

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 165 (actual)
• Sponsor: CSL Behring · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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-inflammatory drugs (NSAIDs) and non-biologic Disease modifying anti-rheumatic drugs (DMARDs).

Conditions

• Arthritis, Psoriatic

Interventions

Type	Name	Description
BIOLOGICAL	Placebo matching BMS-945429	Injection, Subcutaneous, 0 mg, every 4 weeks, Short term:24 weeks, Long term: After 24 Wk, selected dose, open-label
BIOLOGICAL	BMS-945429	Injection, Subcutaneous, 25 mg, every 4 weeks, Short term:24 weeks, Long term: After 24 Wk, selected dose, open-label
BIOLOGICAL	BMS-945429	Injection, Subcutaneous, 100 mg, every 4 weeks, Short term:24 weeks, Long term: After 24 Wk, selected dose, open-label
BIOLOGICAL	BMS-945429	Injection, Subcutaneous, 200 mg, every 4 weeks, Short term:24 weeks, Long term: After 24 Wk, selected dose, open-label

Timeline

• Start date: 2011-12-01
• Primary completion: 2013-06-01
• Completion: 2015-06-01
• First posted: 2011-12-13
• Last updated: 2021-11-05
• Results posted: 2021-11-05

Locations

49 sites across 13 countries: United States, Argentina, Australia, Canada, Czechia, Germany, Hungary, Italy, Mexico, Poland, Russia, South Africa, Spain