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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
190
Administered orally.
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
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
CONTACT
Physicians interested in becoming principal investigators please contact
CONTACT
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Instituto CAICI SRL
Rosario, Argentina
RECRUITINGCentro de Investigaciones Médicas Tucuman
SAN M. de Tucuman, Argentina
RECRUITINGRoyal Children's Hospital
Melbourne, Australia
NOT_YET_RECRUITINGPerth Children's Hospital
Perth, Australia
NOT_YET_RECRUITINGThe Children's Hospital at Westmead
Westmead, Australia
ACTIVE_NOT_RECRUITINGLandeskrankenhaus Bregenz
Bregenz, Austria
COMPLETEDCliniques universitaires Saint-Luc
Brussels, Belgium
COMPLETEDUZ Gent
Ghent, Belgium
RECRUITINGUZ Leuven
Leuven, Belgium
RECRUITINGFaculdade de Medicina da UNESP
Botucatu, Brazil
RECRUITING...and 72 more locations
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