drugset / Trial / NCT01392326

Efficacy at 24 Weeks and Long Term Safety, Tolerability and Efficacy up to 2 Years of Secukinumab (AIN457) in Patients With Active Psoriatic Arthritis (PsA)

NCT01392326 ↗

Phase 3 Completed 606 enrolled Novartis Pharmaceuticals
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This study will assess the efficacy and safety of secukinumab in patients with active psoriatic arthritis who are intolerant to or have had an inadequate response to NSAIDs, DMARDs and / or TNFα inhibitor therapy.

Timeline

Start
2011-09
Primary completion
2014-10
Completion
2014-10

Outcome

Met primary endpoint

paper ACR20 response rates at week 24 were significantly higher in the group receiving secukinumab at doses of 150 mg (50.0%) and 75 mg (50.5%) than in those receiving placebo (17.3%) (P<0.001 for both comparisons with placebo). PMID 26422723 ↗

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject Secukinumab Monoclonal antibody 75 mg Intravenous
Subject Secukinumab Monoclonal antibody 150 mg Intravenous

Indications