A Study of Baricitinib in Participants From 1 Year to Less Than 18 Years Old With Juvenile Idiopathic Arthritis
- Registration Number
- NCT03773965
- Lead Sponsor
- Eli Lilly and Company
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 190
- Participants must have completed a previous study of baricitinib for the treatment of JIA.
- Participants must not have had a permanent discontinuation of baricitinib in the prior study.
- Participants must have not developed an allergy to baricitinib.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Baricitinib Baricitinib Baricitinib given orally.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
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
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
Trial Locations
- Locations (85)
Instituto CAICI SRL
🇦🇷Rosario, Argentina
Centro de Investigaciones Médicas Tucuman
🇦🇷SAN M. DE Tucuman, Argentina
Royal Children's Hospital
🇦🇺Melbourne, Australia
Perth Children's Hospital
🇦🇺Perth, Australia
The Children's Hospital at Westmead
🇦🇺Westmead, Australia
Landeskrankenhaus Bregenz
🇦🇹Bregenz, Austria
Cliniques universitaires Saint-Luc
🇧🇪Brussels, Belgium
UZ Gent
🇧🇪Gent, Belgium
UZ Leuven
🇧🇪Leuven, Belgium
Faculdade de Medicina da UNESP
🇧🇷Botucatu, Brazil
Scroll for more (75 remaining)Instituto CAICI SRL🇦🇷Rosario, ArgentinaDiego ViolaPrincipal Investigator