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.
Age range
2 Years – 17 Years
Sex
ALL
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Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Maximum Serum Concentration (Cmax) of Sarilumab at Week 12
Timeframe: Pre-dose on Days 1, 3, 5, 8, 12 and Weeks 2, 4, 8 and 12
Area Under the Serum Concentration Versus Time Curve Using the Trapezoidal Method During a Dose Interval (AUC0-t) of Sarilumab at Week 12
Timeframe: Pre-dose on Days 1, 3, 5, 8, 12 and Weeks 2, 4, 8 and 12
Concentration Before Treatment Administration During Repeated Dosing (Ctrough) of Sarilumab at Week 12
Timeframe: Pre-dose on Days 1, 3, 5, 8, 12 and Weeks 2, 4, 8 and 12