At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 397 enrolled
Drug / intervention
Secukinumab (AIN457) +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase III Randomized, Double-blind, Placebo-controlled Multicenter Study of Subcutaneous Secukinumab in Prefilled Syringes to Demonstrate the Efficacy at 24 Weeks and to Assess the Long Term Efficacy, Safety and Tolerability up to 5 Years in Patients With Active Psoriatic Arthritis
In Brief
A Phase 3 clinical trial evaluating Secukinumab (AIN457) and Placebo for Psoriatic Arthritis. Completed, enrolled 397 participants across 76 sites in 11 countries.
Detailed Summary
This study was to provide 24 - 52 week efficacy, safety and tolerability data to support the registration of the secukinumab (AIN457) prefilled syringe (PFS) for subcutaneous self administration in subjects with active PsA despite current or previous NSAID, DMARD and/or anti-TNFα therapy. An additional 4 years of long-term efficacy and safety data were collected during the post Week 52 period of the study.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPsoriatic Arthritis
CountriesAustralia, Belgium, Canada, Czechia, Germany, Poland, Puerto Rico, Russia, Thailand, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedDec 2012
Enrollment StartApr 2013
Primary CompletionMay 2014
Study CompletionJan 2019
TodayJul 2026
First PostedDec 19, 2012
Enrollment StartApr 14, 2013
Primary CompletionMay 12, 2014
Study CompletionJan 9, 2019
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 13.5 years ago
Interventions
Secukinumab (AIN457)drug
Secukinumab (AIN457)
Placebodrug
Placebo PFS for s.c. administration.