A Phase 3 interventional study of Baricitinib in Juvenile Idiopathic Arthritis, sponsored by Eli Lilly and Company. Recruiting at 77 sites in 20 countries. Open to participants aged 1 Year to 18 Years. Per ClinicalTrials.gov, last updated 2026-11-04.
Sponsored by Eli Lilly and Company · Phase 3, Interventional, and Treatment
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.
365 studies on the registry are indexed under Arthritis, Juvenile; 101 are open to participants now.
This study's planned enrollment of 190 is above the median of 52 across 230 interventional studies indexed under Arthritis, Juvenile.
Browse Arthritis, Juvenile studies →Eli Lilly and Company is the lead sponsor of 2,106 studies on the registry; 152 are open to participants now.
Of its 536 completed or terminated interventional studies of FDA-regulated products, 357 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Baricitinib given orally.
Drug: Baricitinib
Administered orally.
Also known as: LY3009104
Number of Participants with One or More Serious Adverse Event(s) (SAEs)
Number of participants with one or more SAEs
Time frame: Baseline through Week 264
Number of Participants with Permanent Investigational Product Discontinuations
Number of participants with permanent investigational product discontinuations
Time frame: Baseline through Week 264
Proportion of Participants Achieving Pediatric American College of Rheumatology 30 Responder Index (PedACR30)
Proportion of participants achieving PedACR30
Time frame: Week 264
Proportion of Participants who have Disease Flare
Proportion of participants who have disease flare
Time frame: Baseline through Week 264
Proportion of Participants with Inactive Disease
Proportion of participants with inactive disease
Time frame: Week 264
Proportion of Participants with Minimal Disease Activity
Proportion of participants with minimal disease activity
Time frame: Week 264
Proportion of Participants in Remission
Proportion of participants in remission
Time frame: Week 264
Change from Baseline in Juvenile Arthritis Disease Activity Score-27 (JADAS27)
Change from baseline of originating study in JADAS27
Time frame: 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
Time frame: Baseline, Week 264
Change from Baseline in Psoriasis Area and Severity Index (PASI)
Change from baseline in PASI
Time frame: Baseline, Week 264
Change from Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index
Change from baseline in SPARCC enthesitis index
Time frame: Baseline, Week 264
Change from Baseline in Juvenile Spondyloarthritis Disease Activity Index (JSpADA)
Change from baseline in JSpADA
Time frame: Baseline, Week 264
Change from Baseline in Immunoglobulin Levels
Change from baseline in immunoglobulin levels
Time frame: Baseline, Week 264
Change from Baseline in Immunophenotyping (T Cells)
Change from baseline in immunophenotyping (T Cells)
Time frame: Baseline, Week 264
Change of Immunoglobulin G (IgG) Titers
Change of IgG titers
Time frame: Pre-Vaccination to 12 Weeks Post-Vaccination
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Plan to share: Yes — Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Supporting information: Study protocol, Statistical analysis plan, Clinical study report
Time frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
Access criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Data sharing details ↗ · www.clinicalstudydatarequest.com
Started Apr 2019 (actual). Primary completion is estimated for Jul 2031, 147 months after the start.
Of 36 phase 3 interventional studies under Arthritis, Juvenile, half reached primary completion within 42 months of starting (the median), counting those still running; a quarter within 30 and three quarters within 70. This study's planned 147 months is above that.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Studies of the drug tested here: Baricitinib