A Study of Baricitinib in Participants From 1 Year to Less Than 18 Years Old With Juvenile Idiopathic Arthritis (JUVE-X)

Lilly

Status and phase: Enrolling; Phase 3

Conditions: Juvenile Idiopathic Arthritis

Treatments: Drug: Baricitinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT03773965

16278

I4V-MC-JAHX (Other Identifier)

2017-004471-31 (EudraCT Number)

Details and patient eligibility

About

The reason for this study is to see if the study drug baricitinib is safe and effective in the treatment of JIA in participants ages 1 to 17. This study is for participants that have been enrolled in studies I4V-MC-JAHV (NCT03773978) or I4V-MC-JAHU.

Enrollment: 190 estimated patients

Sex: All

Ages: 1 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participants must have completed a previous study of baricitinib for the treatment of JIA.

Exclusion criteria

• Participants must not have had a permanent discontinuation of baricitinib in the prior study.
• Participants must have not developed an allergy to baricitinib.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

190 participants in 1 patient group

Baricitinib

Experimental group

Description:

Baricitinib given orally.

Treatment:

Drug: Baricitinib