Systemic Juvenile Idiopathic Arthritis
Conditions
Keywords
Systemic, Fever, Flare, sJIA, JIA
Brief summary
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.
Interventions
DRUGBaricitinib
Administered orally
DRUGTocilizumab
Administered SC
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* Participants must have a diagnosis of systemic Juvenile Idiopathic Arthritis (sJIA) as defined by International League of Associations for Rheumatology (ILAR) criteria with onset before the age of 16 years * Participants must have at least 2 active joints at screening and baseline * Cohort 1 (IL-6 inhibitor therapy naive): Participants who are at least 1 year and less than 18 years of age, except in countries that restrict use of tocilizumab in participants less than 2 years of age * Cohort 2 (open-label baricitinib): Participants who are at least 1 year and less than 18 years of age
Exclusion criteria
* Participants must not have polyarticular JIA (positive or negative for rheumatoid factor), extended oligoarticular JIA, enthesitis-related JIA, or juvenile psoriatic arthritis * Participants must not have persistent oligoarticular arthritis as defined by the ILAR criteria * Participants must not have a history or presence of any autoimmune inflammatory condition other than JIA * Participants must not have active anterior uveitis or are receiving concurrent treatment for anterior uveitis * Participants must not have active fibromyalgia or other chronic pain conditions that, in the investigator's opinion, would make it difficult to appropriately assess disease activity for the purposes of this study * Participants must not have biologic features of Macrophage Activation Syndrome (MAS) over the past 12 weeks * Participants must not have a current or recent (\<4 weeks prior to baseline) clinically serious infection * Participants must not have a positive test for hepatitis B virus * Participants must not have evidence of active tuberculosis (TB) or untreated latent TB
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving Adapted Pediatric American College of Rheumatology 30 Responder Index (PediACR30) Response Criteria at Week 12 | Week 12 | Percentage of Participants Achieving Adapted PediACR30 Response Criteria |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving Adapted PediACR30 Response Criteria at Week 24 | Week 24 | Percentage of Participants Achieving Adapted PediACR30 Response Criteria |
| Percentage of Participants with Inactive Disease | Week 12 | Percentage of Participants with Inactive Disease |
| Percentage of Participants with Minimal Disease Activity | Week 12 | Percentage of Participants with Minimal Disease Activity |
| Change from Baseline in Juvenile Arthritis Disease Activity Score (JADAS)-27 | Baseline, Week 24 | Change from Baseline in JADAS-27 |
| 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 24 | Change from Baseline in Arthritis-Related Pain Severity as Measured by the CHAQ Pain VAS Item |
| Pharmacokinetics (PK): Maximum Plasma Baricitinib Concentration at Steady-State (Cmax, ss) | Baseline through Week 24 | PK: Cmax, ss of Baricitinib |
| PK: Area Under the Baricitinib Concentration-Time Curve at Steady-State (AUC, ss) | Baseline through Week 24 | PK: AUC, ss of Baricitinib |
Countries
Argentina, Belgium, Brazil, Czechia, France, India, Israel, Italy, Japan, Mexico, Poland, Spain, Turkey (Türkiye), United Kingdom
Contacts
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