At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Double-blind, Placebo-controlled, Parallel Group, Phase III Multicenter Study of Intravenous Secukinumab to Compare Efficacy at 16 Weeks With Placebo and to Assess Safety and Tolerability up to 52 Weeks in Subjects With Active Psoriatic Arthritis
In Brief
A Phase 3 clinical trial evaluating AIN457 6 mg/kg i.v., Placebo, and 1 other intervention for Psoriatic Arthritis. Completed, enrolled 381 participants across 80 sites in 15 countries.
Detailed Summary
The purpose of this study was to provide up to 52 weeks of efficacy, safety and tolerability data to support registration of intravenous (i.v.) secukinumab (Initial dose of 6 mg/kg at Baseline (BSL) followed thereafter with 3 mg/kg administered every four weeks) in patients with active psoriatic arthritis (PsA) despite current or previous Non-steroidal anti-inflammatory drugs (NSAIDs), Disease-modifying antirheumatic drugs (DMARDs) and/or anti-tumor necrosis factor (TNF) therapy.
Study Details
Timeline
Interventions
AIN457 6 mg/kg delivered by i.v. infusion
Matching placebo to AIN457 i.v. infusion
AIN457 3 mg/kg delivered by i.v. infusion