I4V-MC-JAHU: 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

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-507883-38-00

Acronym

I4V-MC-JAHU

Enrollment

Registered

2024-02-20

Start date

2019-11-18

Completion date

Unknown

Last updated

2026-01-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Systemic Juvenile Idiopathic Arthritis

Brief summary

Percentage of Participants Achieving Adapted Pediatric American College of Rheumatology 30 (PediACR30) Response Criteria at Week 12

Interventions

DRUGPlacebo to match 4 mg tablet

DRUGBARICITINIB

DRUGPlacebo to match 2 mg/mL oral suspension

DRUGPlacebo to match 2 mg tablet

DRUGPlacebo to match 1 mg tablet

DRUGBaricitinib

DRUGJAK1/JAK2 inhibitor

DRUGTocilizumab

DRUGTOCILIZUMAB

Eligibility

Sex/Gender

All

Age

0 Years to 17 Years

Design outcomes

Primary

Measure	Time frame
Percentage of Participants Achieving Adapted Pediatric American College of Rheumatology 30 (PediACR30) Response Criteria at Week 12	—

Countries

Austria, Belgium, Czechia, France, Italy, Poland, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026