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

Study Overview
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Brief Summary
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The reason for this study is to see if the study drug baricitinib is safe and effective in the treatment of JIA in participants ages 1 to 17. This study is for participants that have been enrolled in studies I4V-MC-JAHV (NCT03773978) or I4V-MC-JAHU.

Official Title
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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 (JIA)

Conditions
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Juvenile Idiopathic Arthritis

Intervention / Treatment
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* Drug: Baricitinib


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants must have completed a previous study of baricitinib for the treatment of JIA. Exclusion Criteria: Participants must not have had a permanent discontinuation of baricitinib in the prior study. Participants must have not developed an allergy to baricitinib.

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Baricitinib<br>Baricitinib given orally. | Drug: Baricitinib<br>* Administered orally.<br>* Other names: LY3009104;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with One or More Serious Adverse Event(s) (SAEs) | Number of participants with one or more SAEs | Baseline through Week 264 | 
| Number of Participants with Permanent Investigational Product Discontinuations | Number of participants with permanent investigational product discontinuations | Baseline through Week 264 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Participants Achieving Pediatric American College of Rheumatology 30 Responder Index (PedACR30) | Proportion of participants achieving PedACR30 | Week 264 | 
| Proportion of Participants who have Disease Flare | Proportion of participants who have disease flare | Baseline through Week 264 | 
| Proportion of Participants with Inactive Disease | Proportion of participants with inactive disease | Week 264 | 
| Proportion of Participants with Minimal Disease Activity | Proportion of participants with minimal disease activity | Week 264 | 
| Proportion of Participants in Remission | Proportion of participants in remission | Week 264 | 
| Change from Baseline in Juvenile Arthritis Disease Activity Score-27 (JADAS27) | Change from baseline of originating study in JADAS27 | Baseline, Week 264 | 
| Change from Baseline in Arthritis-Related Pain Severity as Measured by the Childhood Health Assessment Questionnaire (CHAQ) Pain Visual Analog Scale (VAS) Item | Change from baseline in arthritis-related pain severity as measured by the CHAQ pain VAS item | Baseline, Week 264 | 
| Change from Baseline in Psoriasis Area and Severity Index (PASI) | Change from baseline in PASI | Baseline, Week 264 | 
| Change from Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index | Change from baseline in SPARCC enthesitis index | Baseline, Week 264 | 
| Change from Baseline in Juvenile Spondyloarthritis Disease Activity Index (JSpADA) | Change from baseline in JSpADA | Baseline, Week 264 | 
| Change from Baseline in Immunoglobulin Levels | Change from baseline in immunoglobulin levels | Baseline, Week 264 | 
| Change from Baseline in Immunophenotyping (T Cells) | Change from baseline in immunophenotyping (T Cells) | Baseline, Week 264 | 
| Change of Immunoglobulin G (IgG) Titers | Change of IgG titers | Pre-Vaccination to 12 Weeks Post-Vaccination | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Polyarticular JIA, Oligoarthritis, Juvenile psoriatic arthritis (JPsA), Enthesitis-related juvenile idiopathic arthritis (ERA), Systemic JIA with and without systemic features