A Phase 3 Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients From 1 Year to 18 Years of Age With Juvenile Idiopathic Arthritis

What this Trial Is About

Researchers are evaluating the long-term safety and effectiveness of the drug baricitinib for treating Juvenile Idiopathic Arthritis JIA in children and adolescents aged 1 to less than 18 years. This Phase 3 study focuses on participants who have previously taken part in baricitinib studies for JIA. The goal is to understand how well baricitinib works and monitor any serious side effects over an extended period. Participants will receive baricitinib orally as part of the study treatment. The study tracks outcomes such as the frequency of serious adverse events, permanent discontinuations of the drug, and various measures of disease activity and symptoms including pain, disease flare, inactive disease, and remission. Assessments will collect data on arthritis activity, skin symptoms, and immune system markers during the study. During the study, participants will be monitored regularly through clinical evaluations and questionnaires to assess their arthritis symptoms, disease activity, and overall health. Researchers will measure outcomes from the start of the study through week 264, focusing on safety and how well the disease is controlled. The study is designed to ensure participants health is closely observed while collecting important information on long-term treatment effects.

A Study of Baricitinib in Participants From 1 Year to Less Than 18 Years Old With Juvenile Idiopathic Arthritis