CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 414 enrolled
Drug / intervention
Secukinumab +1 morebiological
Likely dose
Secukinumab 150 mgfrom 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.

Search/NCT01989468
NCT01989468Phase 3Completed

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

Novartis Pharmaceuticals·interventional·Posted Nov 21, 2013·Updated Apr 16, 2019

In Brief

A Phase 3 clinical trial evaluating Secukinumab and Placebo for Psoriatic Arthritis. Completed, enrolled 414 participants across 77 sites in 13 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesAustralia, Bulgaria, Canada, Czechia, Germany, Italy, Netherlands, Puerto Rico, Russia, Spain, Switzerland, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedNov 21, 2013
Enrollment StartApr 10, 2014
Primary CompletionMay 27, 2015
Study CompletionMar 28, 2018
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 12.6 years ago

Interventions

Secukinumabbiological

Secukinumab 150 mg provided in a 1 mL autoinjector (1 autoinjector for 150 mg dose, 2 autoinjectors for 300 mg dose)

Placebobiological

Secukinumab placebo provided in 1 mL autoinjector