At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 102 enrolled
Drug / intervention
Sarilumabdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open-label, Sequential, Ascending, Repeated Dose-finding Study of Sarilumab, Administered With Subcutaneous (SC) Injection, in Children and Adolescents, Aged 2 to 17 Years, With Polyarticular-course Juvenile Idiopathic Arthritis (pcJIA) Followed by an Extension Phase
In Brief
A Phase 2 clinical trial evaluating Sarilumab for Juvenile Idiopathic Arthritis. Completed, enrolled 102 participants across 30 sites in 15 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsJuvenile Idiopathic Arthritis
CountriesArgentina, Canada, Chile, Czechia, Finland, France, Germany, Italy, Mexico, Netherlands, Poland, Russia, Spain, United Kingdom, United States
CollaboratorsRegeneron Pharmaceuticals
Timeline
Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedMay 2016
Enrollment StartSep 2016
Primary CompletionApr 2022
Study CompletionDec 2023
TodayJul 2026
First PostedMay 18, 2016
Enrollment StartSep 6, 2016
Primary CompletionApr 8, 2022
Study CompletionDec 27, 2023
TodayJul 2, 2026
Enrollment to primary: 5.6 yearsPosted 10.1 years ago
Interventions
Sarilumabdrug
Pharmaceutical form:Solution Route of administration: Subcutaneous