An Open-label, Ascending, Repeated Dose-finding Study of Sarilumab in Children and Adolescents With Polyarticular-course Juvenile Idiopathic Arthritis (pcJIA)

Summary

Primary Objective: To describe the pharmacokinetic (PK) profile of sarilumab in participants aged 2-17 years with Polyarticular-course Juvenile Idiopathic Arthritis (pcJIA) in order to identify the dose and regimen for adequate treatment of this population Secondary Objective: To describe the pharmacodynamic (PD) profile, the efficacy and the long-term safety of sarilumab in participants with pcJIA.

Timeline

Start

2016-09-06

Primary completion

2022-04-08

Completion

2023-12-27

Publications

• De Benedetti F, Penades IC, Nikishina I, Foeldvari I, Spindler AJ, Kozlova A, Rubio-Perez N, Quartier P, Zuber Z, Barria R, Clemente D, Cornejo GV, Marzan K, Liu N, Xu C, DiMartino S, Giannelou A, Cao-Ghoul F, Akinlade B, Baret-Cormel L. Sarilumab in Polyarticular-Course Juvenile Idiopathic Arthritis: Dose-Finding and 1-Year Analysis of a Phase 2b, Open-Label, Multicenter Study. Arthritis Care Res (Hoboken). 2026 Jun;78(6):749-760. doi: 10.1002/acr.25692. Epub 2026 Mar 24.

Drugs

Indications