Phase 3
N=220
A Study of Baricitinib in Participants From 2 Years to Less Than 18 Years Old With Juvenile Idiopathic Arthritis
Juvenile Idiopathic Arthritis
Bottom Line
View on ClinicalTrials.gov: NCT03773978 ↗Enrolled (actual)
220
Serious AEs
3.4%
Results posted
Oct 2022
Primary outcome: Primary: Time to Disease Flare — NA; 27.14 Weeks — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Baricitinib (Drug); Placebo (Drug)
- Age
- Pediatric · 2+ yrs
- Sex
- All
- Sponsor
- Eli Lilly and Company
- Primary completion
- Jan 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Disease Flare |
NA; 27.14 | <0.001 sig |
| SECONDARY Percentage of Participants Achieving PedACR30 Responder Index |
92.7; 81.5; 87.8; 64.2; 85.4; 55.6 | 0.052 |
| SECONDARY Percentage of Participants Achieving PedACR50 Responder Index |
79.3; 75.3; 81.7; 58; 81.7; 49.4 | 0.568 |
| SECONDARY Percentage of Participants Achieving PedACR70 Responder Index |
54.9; 54.3; 68.3; 45.7; 59.8; 37.0 | 0.972 |
| SECONDARY Percentage of Participants Achieving PedACR90 Responder Index |
29.3; 23.5; 42.7; 24.7; 37.8; 21 | 0.409 |
| SECONDARY Percentage of Participants Achieving PedACR100 Responder Index |
14.6; 17.3; 24.4; 19.8; 18.3; 16 | 0.620 |
| SECONDARY Percentage of Participants With Inactive Disease |
12.2; 11.1; 13.4; 17.3; 17.1; 17.3 | 0.853 |
| SECONDARY Percentage of Participants With Minimal Disease Activity |
36.6; 40.7; 46.3; 33.3; 43.9; 34.6 | 0.511 |
| SECONDARY Percentage of Participants in Remission |
0; 0; 0; 1.2; 1.2; 4.9 | — |
| SECONDARY Change From Baseline in Juvenile Arthritis Disease Activity Score-27 (JADAS-27) Score |
-14.24; -9.91 | 0.001 sig |
| SECONDARY Change From Baseline in Arthritis-Related Pain Severity as Measured by the Childhood Health Assessment Questionnaire (CHAQ) Pain Visual Analog Scale (VAS) Item |
-29.65; -16.68 | 0.003 sig |
| SECONDARY Change From Baseline in Psoriasis Area and Severity Index (PASI) Score |
-1.14; -0.79 | 0.574 |
| SECONDARY Change From Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Index |
-1.51; -1.95 | 0.208 |
| SECONDARY Change From Baseline in Juvenile Spondyloarthritis Disease Activity (JSpADA) Index |
-2.56; -1.47 | 0.019 sig |
| SECONDARY Pharmacokinetics (PK): Maximum Plasma Baricitinib Concentration at Steady-State (Cmax, ss) |
57.7; 79; 56.8; 87.4 | — |
| SECONDARY PK: Area Under the Baricitinib Concentration-Time Curve During a Dosing Interval at Steady-State (AUCτ,ss) |
386; 500; 254; 410 | — |
| SECONDARY Change From Baseline in Immunoglobulin Levels |
-15.98; -81.46; -9.86 | — |
| SECONDARY Number of Participants With Change of Immunoglobulin G (IgG) Titers |
2; 2; 2; 1; 2; 2 | — |
| SECONDARY Number of Participants With Product Acceptability and Palatability Assessment |
2; 6; 8; 2; 3; 1 | — |
Summary
The reason for this study is to see if the study drug baricitinib given orally is safe and effective in participants with JIA from 2 years to less than 18 years old.
Eligibility Criteria
Inclusion Criteria
- Participants must have had a diagnosis of active JIA (polyarticular, extended oligoarticular, or enthesitis-related juvenile idiopathic arthritis [ERA] including JPsA).
- Participants must have had an inadequate response to at least one conventional or biologic disease-modifying antirheumatic drug (DMARD).
Exclusion Criteria
- Participants must not have systemic JIA, with or without active systemic features.
- Participants must not have persistent oligoarticular arthritis.
- Participants must not have been previously treated with a Janus kinase (JAK) inhibitor.
Data sourced from ClinicalTrials.gov (NCT03773978). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.