A Study of Baricitinib (LY3009104) in Participants From 1 Year to Less Than 18 Years Old With Systemic Juvenile Idiopathic Arthritis (sJIA)

Launched by ELI LILLY AND COMPANY · Sep 11, 2019

Keywords

ClinConnect Summary

This clinical trial is looking at a medication called baricitinib to see if it is safe and effective for children and teens between 1 and 17 years old who have systemic juvenile idiopathic arthritis (sJIA). This is a type of arthritis that can cause inflammation in the joints and affect other parts of the body. Participants in the study will either receive baricitinib or another treatment called tocilizumab, depending on which group they are assigned to. The trial is currently recruiting participants who have been diagnosed with sJIA and have at least two active joints showing symptoms.

To join the study, participants must be between 1 and 17 years old and have sJIA that started before they turned 16. They should have active joint symptoms and cannot have certain other types of juvenile arthritis or conditions that could interfere with the study. Throughout the trial, participants will be monitored closely by healthcare professionals to assess how well the medication works and to ensure their safety. This trial is an important step in finding new treatments for children with sJIA.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Participants must have a diagnosis of systemic Juvenile Idiopathic Arthritis (sJIA) as defined by International League of Associations for Rheumatology (ILAR) criteria with onset before the age of 16 years
• • Participants must have at least 2 active joints at screening and baseline
• • Cohort 1 (IL-6 inhibitor therapy naive): Participants who are at least 1 year and less than 18 years of age, except in countries that restrict use of tocilizumab in participants less than 2 years of age
• • Cohort 2 (open-label baricitinib): Participants who are at least 1 year and less than 18 years of age
• Exclusion Criteria:
• • Participants must not have polyarticular JIA (positive or negative for rheumatoid factor), extended oligoarticular JIA, enthesitis-related JIA, or juvenile psoriatic arthritis
• • Participants must not have persistent oligoarticular arthritis as defined by the ILAR criteria
• • Participants must not have a history or presence of any autoimmune inflammatory condition other than JIA
• • Participants must not have active anterior uveitis or are receiving concurrent treatment for anterior uveitis
• • Participants must not have active fibromyalgia or other chronic pain conditions that, in the investigator's opinion, would make it difficult to appropriately assess disease activity for the purposes of this study
• • Participants must not have biologic features of Macrophage Activation Syndrome (MAS) over the past 12 weeks
• • Participants must not have a current or recent (\<4 weeks prior to baseline) clinically serious infection
• • Participants must not have a positive test for hepatitis B virus
• • Participants must not have evidence of active tuberculosis (TB) or untreated latent TB