NCT04088396Active, not recruitingPhase 3
Open-Label, Randomized Study With a Tocilizumab Reference Arm to Evaluate Safety, Efficacy and Pharmacokinetics of Baricitinib in Children From 1 to Less Than 18 Years of Age With Systemic Juvenile Idiopathic Arthritis.
Eli Lilly and Company105 sites in 14 countries58 target enrollmentStarted: February 12, 2020Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Active, not recruiting
- Sponsor
- Eli Lilly and Company
- Enrollment
- 58
- Locations
- 105
- Primary Endpoint
- Percentage of Participants Achieving Adapted Pediatric American College of Rheumatology 30 Responder Index (PediACR30) Response Criteria at Week 12
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 1 Year to 17 Years (Child)
- Sex
- All
- Accepts 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
Arms & Interventions
Cohort 1 Baricitinib
Experimental
Baricitinib given orally.
Intervention: Baricitinib (Drug)
Cohort 1 Tocilizumab
Active Comparator
Tocilizumab given Subcutaneously (SC).
Intervention: Tocilizumab (Drug)
Cohort 2 Baricitinib
Experimental
Baricitinib given orally.
Intervention: Baricitinib (Drug)
Outcomes
Primary Outcomes
Percentage of Participants Achieving Adapted Pediatric American College of Rheumatology 30 Responder Index (PediACR30) Response Criteria at Week 12
Time Frame: Week 12
Percentage of Participants Achieving Adapted PediACR30 Response Criteria
Secondary Outcomes
- Percentage of Participants Achieving Adapted PediACR30 Response Criteria at Week 24(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(Baseline, Week 24)
- Pharmacokinetics (PK): Maximum Plasma Baricitinib Concentration at Steady-State (Cmax, ss)(Baseline through Week 24)
- PK: Area Under the Baricitinib Concentration-Time Curve at Steady-State (AUC, ss)(Baseline through Week 24)
- Percentage of Participants with Inactive Disease(Week 12)
- Percentage of Participants with Minimal Disease Activity(Week 12)
- Change from Baseline in Juvenile Arthritis Disease Activity Score (JADAS)-27(Baseline, Week 24)
Investigators
Study Sites (105)
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