Juvenile Idiopathic Arthritis
Conditions
Keywords
Polyarticular JIA, Oligoarthritis, Juvenile psoriatic arthritis (JPsA), Enthesitis-related juvenile idiopathic arthritis (ERA), Systemic JIA with and without systemic features
Brief summary
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.
Interventions
DRUGBaricitinib
Administered orally.
Sponsors
Eli Lilly and Company
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Years to 18 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with One or More Serious Adverse Event(s) (SAEs) | Baseline through Week 264 | Number of participants with one or more SAEs |
| Number of Participants with Permanent Investigational Product Discontinuations | Baseline through Week 264 | Number of participants with permanent investigational product discontinuations |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Participants Achieving Pediatric American College of Rheumatology 30 Responder Index (PedACR30) | Week 264 | Proportion of participants achieving PedACR30 |
| Proportion of Participants who have Disease Flare | Baseline through Week 264 | Proportion of participants who have disease flare |
| Proportion of Participants with Inactive Disease | Week 264 | Proportion of participants with inactive disease |
| Proportion of Participants with Minimal Disease Activity | Week 264 | Proportion of participants with minimal disease activity |
| Proportion of Participants in Remission | Week 264 | Proportion of participants in remission |
| Change from Baseline in Juvenile Arthritis Disease Activity Score-27 (JADAS27) | Baseline, Week 264 | Change from baseline of originating study in JADAS27 |
| Change from Baseline in Arthritis-Related Pain Severity as Measured by the Childhood Health Assessment Questionnaire (CHAQ) Pain Visual Analog Scale (VAS) Item | Baseline, Week 264 | Change from baseline in arthritis-related pain severity as measured by the CHAQ pain VAS item |
| Change from Baseline in Psoriasis Area and Severity Index (PASI) | Baseline, Week 264 | Change from baseline in PASI |
| Change from Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index | Baseline, Week 264 | Change from baseline in SPARCC enthesitis index |
| Change from Baseline in Juvenile Spondyloarthritis Disease Activity Index (JSpADA) | Baseline, Week 264 | Change from baseline in JSpADA |
| Change from Baseline in Immunoglobulin Levels | Baseline, Week 264 | Change from baseline in immunoglobulin levels |
| Change from Baseline in Immunophenotyping (T Cells) | Baseline, Week 264 | Change from baseline in immunophenotyping (T Cells) |
| Change of Immunoglobulin G (IgG) Titers | Pre-Vaccination to 12 Weeks Post-Vaccination | Change of IgG titers |
Countries
Argentina, Australia, Austria, Belgium, Brazil, China, Czechia, Denmark, France, Germany, India, Israel, Italy, Japan, Mexico, Poland, Russia, Spain, Turkey (Türkiye), United Kingdom
Contacts
CONTACTTrial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
CONTACTPhysicians interested in becoming principal investigators please contact
STUDY_DIRECTORCall 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST
Eli Lilly and Company
Outcome results
None listed