The reason for this study is to see if the study drug baricitinib is safe and effective in participants from 1 year to less than 18 years old with systemic juvenile idiopathic arthritis (sJIA). Participants are assigned to 1 of 2 cohorts. In cohort 1, participants will receive baricitinib or tocilizumab reference. In cohort 2, participants will receive baricitinib.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
58
Administered orally
Administered SC
Percentage of Participants Achieving Adapted Pediatric American College of Rheumatology 30 Responder Index (PediACR30) Response Criteria at Week 12
Percentage of Participants Achieving Adapted PediACR30 Response Criteria
Time frame: Week 12
Percentage of Participants Achieving Adapted PediACR30 Response Criteria at Week 24
Percentage of Participants Achieving Adapted PediACR30 Response Criteria
Time frame: Week 24
Percentage of Participants with Inactive Disease
Percentage of Participants with Inactive Disease
Time frame: Week 12
Percentage of Participants with Minimal Disease Activity
Percentage of Participants with Minimal Disease Activity
Time frame: Week 12
Change from Baseline in Juvenile Arthritis Disease Activity Score (JADAS)-27
Change from Baseline in JADAS-27
Time frame: Baseline, Week 24
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 24
Pharmacokinetics (PK): Maximum Plasma Baricitinib Concentration at Steady-State (Cmax, ss)
PK: Cmax, ss of Baricitinib
Time frame: Baseline through Week 24
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
CONTACT
Physicians interested in becoming principal investigators please contact
CONTACT
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Instituto CAICI SRL
Rosario, Argentina
RECRUITINGCentro Medico Privado de Reumatologia
SAN M. de Tucuman, Argentina
RECRUITINGUZ Gent
Ghent, Belgium
RECRUITINGFaculdade de Medicina da UNESP
Botucatu, Brazil
RECRUITINGHospital de Clinicas de Porto Alegre
Porto Alegre, Brazil
RECRUITINGIPITEC
São Paulo, Brazil
NOT_YET_RECRUITINGUniversidade Federal de Sao Paulo
São Paulo, Brazil
RECRUITINGInstituto da Crianca do Hospital das Clinicas da FMUSP
São Paulo, Brazil
RECRUITINGDetska nemocnice FN Brno
Brno, Czechia
RECRUITINGVseobecna fakultni nemocnice v Praze
Prague, Czechia
RECRUITING...and 45 more locations
PK: Area Under the Baricitinib Concentration-Time Curve at Steady-State (AUC, ss)
PK: AUC, ss of Baricitinib
Time frame: Baseline through Week 24