NCT01989468

24 Week Efficacy and 3-year Safety and Efficacy of Secukinumab in Active Psoriatic Arthritis

A Phase III, Randomized, Double-blind, Placebo-controlled Multicenter Study of Subcutaneous Secukinumab in Autoinjectors, to Demonstrate Efficacy at 24 Weeks and to Assess the Long Term Safety, Tolerability and Efficacy up to 3 Years in Subjects With Active Psoriatic Arthritis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 414 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to provide 24 - 52 week efficacy, safety and tolerability data, and up to 3-year efficacy, safety and tolerability data in subjects with active Psoriatic Arthritis despite current or previous nonsteroidal anti-inflammatory drug (NSAID), disease-modifying antirheumatic drug (DMARD) therapy and/or previous anti-tumor necrosis factor alpha (TNFα) therapy.

Conditions

• Psoriatic Arthritis

Interventions

Type	Name	Description
BIOLOGICAL	Secukinumab	Secukinumab 150 mg provided in a 1 mL autoinjector (1 autoinjector for 150 mg dose, 2 autoinjectors for 300 mg dose)
BIOLOGICAL	Placebo	Secukinumab placebo provided in 1 mL autoinjector

Timeline

• Start date: 2014-04-10
• Primary completion: 2015-05-27
• Completion: 2018-03-28
• First posted: 2013-11-21
• Last updated: 2019-04-16
• Results posted: 2019-04-16

Locations

77 sites across 13 countries: United States, Australia, Bulgaria, Canada, Czechia, Germany, Italy, Netherlands, Puerto Rico, Russia, Spain, Switzerland, United Kingdom