drugset / Trial / NCT03773978
A Study of Baricitinib in Participants From 2 Years to Less Than 18 Years Old With Juvenile Idiopathic Arthritis
RandomizedParallel-groupTriple-blindTreatment
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.
Timeline
- Start
- 2018-12-17
- Primary completion
- 2022-01-26
- Completion
- 2022-01-26
Outcome
Met primary endpoint
registry analysis (superiority test); Baricitinib vs Placebo; p <0.001; Hazard Ratio (HR) 0.241 (95% CI 0.128 to 0.453); Log Rank NCT03773978 ↗
paper Time to disease flare was significantly shorter with placebo versus baricitinib (hazard ratio 0·241 [95% CI 0·128-0·453], p<0·0001). PMID 37423231 ↗
Publications
- Krishnan V, Keller SY, Chew C, Sims JT, Chang CY, Dow ER, Benschop RJ, Wang R, Ramanan AV. Serum biomarkers associated with baricitinib response in patients with juvenile idiopathic arthritis: a post-hoc analysis of the phase 3 JUVE-BASIS trial. Lancet Rheumatol. 2025 Nov;7(11):e799-e807. doi: 10.1016/S2665-9913(25)00153-5. Epub 2025 Sep 4.
- Ramanan AV, Quartier P, Okamoto N, Foeldvari I, Spindler A, Fingerhutova S, Anton J, Wang Z, Meszaros G, Araujo J, Liao R, Keller S, Brunner HI, Ruperto N; JUVE-BASIS investigators; Paediatric Rheumatology International Trials Organisation. Baricitinib in juvenile idiopathic arthritis: an international, phase 3, randomised, double-blind, placebo-controlled, withdrawal, efficacy, and safety trial. Lancet. 2023 Aug 12;402(10401):555-570. doi: 10.1016/S0140-6736(23)00921-2. Epub 2023 Jul 6.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Baricitinib | Small molecule | 0.5 mg | Oral |
| Subject | Baricitinib | Small molecule | 1 mg | Oral |
| Subject | Baricitinib | Small molecule | 2 mg | Oral |
| Subject | Baricitinib | Small molecule | 4 mg | Oral |