Secukinumab Safety and Efficacy in Juvenile Psoriatic Arthritis (JPsA) and Enthesitis-related Arthritis (ERA)

Summary

This was a double-blind, placebo-controlled, event-driven randomized withdrawal study to investigate the efficacy and safety of secukinumab treatment in the Juvenile Idiopathic Arthritis (JIA) categories of Juvenile Psoriatic Arthritis (JPsA) and Enthesitis-related Arthritis (ERA). The study was divided into 3 parts (plus a post-treatment follow-up period) consisting of open-label, single-arm active treatment in Treatment Periods 1 and 3 and a randomized, double-blind, placebo controlled, event-driven withdrawal design in Treatment Period 2

Timeline

Start

2017-05-23

Primary completion

2020-10-07

Completion

2020-11-09

Publications

• Weiss PF, Ruperto N, Quebe-Fehling E, Shew A, Pricop L, Pieterse CC, Brunner HI; Paediatric Rheumatology International Trials Organisation (PRINTO) and Pediatric Rheumatology Collaborative Study Group (PRCSG) Investigative Sites. Juvenile Spondyloarthritis Disease Activity Index Validation in Enthesitis-Related Arthritis and Juvenile Psoriatic Arthritis in a Prospective Clinical Trial Setting. J Rheumatol. 2026 Jan 1;53(1):85-94. doi: 10.3899/jrheum.2025-0294.
• Brunner HI, Foeldvari I, Alexeeva E, Ayaz NA, Calvo Penades I, Kasapcopur O, Chasnyk VG, Hufnagel M, Zuber Z, Schulert G, Ozen S, Rakhimyanova A, Ramanan A, Scott C, Sozeri B, Zholobova E, Martin R, Zhu X, Whelan S, Pricop L, Martini A, Lovell D, Ruperto N; Paediatric Rheumatology INternational Trials Organization (PRINTO) and Pediatric Rheumatology Collaborative Study Group (PRCSG). Secukinumab in enthesitis-related arthritis and juvenile psoriatic arthritis: a randomised, double-blind, placebo-controlled, treatment withdrawal, phase 3 trial. Ann Rheum Dis. 2023 Jan;82(1):154-160. doi: 10.1136/ard-2022-222849. Epub 2022 Aug 12.

Drugs

Indications