A Study of Baricitinib (LY3009104) in Participants From 1 Year to Less Than 18 Years Old With Systemic Juvenile Idiopathic Arthritis (sJIA)
- Conditions
- Systemic Juvenile Idiopathic Arthritis
- Registration Number
- NCT04088396
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria:<br><br> - Participants must have a diagnosis of systemic Juvenile Idiopathic Arthritis (sJIA)<br> as defined by International League of Associations for Rheumatology (ILAR) criteria<br> with onset before the age of 16 years<br><br> - Participants must have at least 2 active joints at screening and baseline<br><br> - Cohort 1 (IL-6 inhibitor therapy naive): Participants who are at least 1 year and<br> less than 18 years of age, except in countries that restrict use of tocilizumab in<br> participants less than 2 years of age<br><br> - Cohort 2 (open-label baricitinib): Participants who are at least 1 year and less<br> than 18 years of age<br><br>Exclusion Criteria:<br><br> - Participants must not have polyarticular JIA (positive or negative for rheumatoid<br> factor), extended oligoarticular JIA, enthesitis-related JIA, or juvenile psoriatic<br> arthritis<br><br> - Participants must not have persistent oligoarticular arthritis as defined by the<br> ILAR criteria<br><br> - Participants must not have a history or presence of any autoimmune inflammatory<br> condition other than JIA<br><br> - Participants must not have active anterior uveitis or are receiving concurrent<br> treatment for anterior uveitis<br><br> - Participants must not have active fibromyalgia or other chronic pain conditions<br> that, in the investigator's opinion, would make it difficult to appropriately assess<br> disease activity for the purposes of this study<br><br> - Participants must not have biologic features of Macrophage Activation Syndrome (MAS)<br> over the past 12 weeks<br><br> - Participants must not have a current or recent (<4 weeks prior to baseline)<br> clinically serious infection<br><br> - Participants must not have a positive test for hepatitis B virus<br><br> - Participants must not have evidence of active tuberculosis (TB) or untreated latent<br> TB
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage of Participants Achieving Adapted Pediatric American College of Rheumatology 30 Responder Index (PediACR30) Response Criteria at Week 12
- Secondary Outcome Measures
Name Time Method Percentage of Participants Achieving Adapted PediACR30 Response Criteria at Week 24;Percentage of Participants with Inactive Disease;Percentage of Participants with Minimal Disease Activity;Change from Baseline in Juvenile Arthritis Disease Activity Score (JADAS)-27;Change from Baseline in Arthritis-Related Pain Severity as Measured by the Childhood Health Assessment Questionnaire (CHAQ) Pain Visual Analog Scale (VAS) Item;Pharmacokinetics (PK): Maximum Plasma Baricitinib Concentration at Steady-State (Cmax, ss);PK: Area Under the Baricitinib Concentration-Time Curve at Steady-State (AUC, ss)