Study Evaluating Safety and Effectiveness of Oral Upadacitinib and Tocilizumab in Children and Adolescents Aged 1 to Under 18 with Active Systemic Juvenile Idiopathic Arthritis

What this Trial Is About

Juvenile Idiopathic Arthritis JIA is a common chronic arthritis in children, with systemic JIA sJIA being a rare, severe type that affects joints and other organs like the liver, lungs, and heart. This trial evaluates how safe and effective the drug upadacitinib is in treating children and adolescents aged 1 to under 18 years with active sJIA. The study also includes a tocilizumab treatment group for comparison, assessing adverse events and changes in disease activity. Participants are assigned to one of two groups Cohort 1 receives either upadacitinib or tocilizumab, while Cohort 2 receives upadacitinib only. Upadacitinib is given daily as oral tablets or oral solution, and tocilizumab is administered via subcutaneous injection or intravenous infusion according to local guidelines. Treatment lasts for 52 weeks, followed by about 30 days of monitoring after treatment ends. During the study, participants will attend regular hospital or clinic visits or calls for medical assessments, side effect monitoring, and questionnaires. Researchers will measure disease activity changes, adverse events, and how the drugs move through the body. The main outcomes include the percentage of participants achieving specific responses in sJIA disease activity by week 12 and reporting adverse events up to week 52.

Study of Oral Upadacitinib and Subcutaneous/Intravenous Tocilizumab to Evaluate Change in Disease Activity, Adverse Events and How Drug Moves Through the Body of Pediatric and Adolescent Participants With Active Systemic Juvenile Idiopathic Arthritis.