A multicenter, randomized open-label study to assess the efficacy, safety, and pharmacokinetics of upadacitinib with a tocilizumab reference arm in subjects from 1 year to less than 18 years old with active systemic juvenile idiopathic arthritis.

juvenile idiopathic arthritis

The primary endpoint only applies to Cohort 1. The primary endpoint is achievement of adapted sJIA ACR 30 response at Week 12 (defined as absence of fever [> 38°C] in the previous 1 week preceding evaluation and improvement of ≥ 30% in ≥ 3 of the 6 variables of the JIA core set [defined in Section 3.3], with no more than 1 variable worsening by > 30%).

The secondary endpoints only apply to Cohort 1. Secondary Endpoint(s) 1. Achievement of adapted sJIA ACR 50/70/90/100 response at Week 12 2. Change from Baseline in each core adapted sJIA ACR component at Week 12 · Number of joints with active arthritis · Number of joints with limitation of motion · Childhood Health Assessment Questionnaire-Disability Index (CHAQ-DI) · Patient/Parent Global Assessment (Pt/ParentGA) · Physician's global assessment of disease activity (PhGA) · High-sensitivity CRP

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Austria, Belgium, Germany, Hungary, Italy, Netherlands, Spain, Sweden