At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Parallel-group, Double-blind, Placebo-controlled, Multicenter Phase III Trial to Evaluate Efficacy and Safety of Secukinumab Administered Subcutaneously Versus Placebo, in Combination With a Glucocorticoid Taper Regimen, in Patients With Polymyalgia Rheumatica (PMR)
In Brief
A Phase 3 clinical trial evaluating Secukinumab 300 mg, Secukinumab 150 mg, and 1 other intervention for Polymyalgia Rheumatica. Completed, enrolled 381 participants across 132 sites in 26 countries.
Signals
Detailed Summary
The purpose of this study is to demonstrate the efficacy and safety of secukinumab 300 milligram (mg) and 150 mg administered subcutaneously (s.c.) for 52 weeks in combination with prednisone tapered over 24 weeks in adult participants with PMR who have recently relapsed.
Study Details
Timeline
Arms & Interventions
randomized in 1:1:1 ratio every 4 weeks
randomized in 1:1:1 ratio every 4 weeks
randomized in 1:1:1 ratio every 4 weeks
Interventions
Taken subcutaneously every 4 weeks until Week 48 in combination with a 24-week prednisone taper regimen
Taken subcutaneously every 4 weeks until Week 48 in combination with a 24-week prednisone taper regimen
Taken subcutaneously every 4 weeks until Week 48 in combination with a 24-week prednisone taper regimen