A Study of Baricitinib in Participants From 1 Year to Less Than 18 Years Old With Juvenile Idiopathic Arthritis

Phase 3

Recruiting

Conditions: Juvenile Idiopathic Arthritis

Registration Number: NCT03773965

Lead Sponsor: Eli Lilly and Company

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

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.

Exclusion Criteria

Not provided

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of Participants with One or More Serious Adverse Event(s) (SAEs);Number of Participants with Permanent Investigational Product Discontinuations

Secondary Outcome Measures

Name	Time	Method
Proportion of Participants Achieving Pediatric American College of Rheumatology 30 Responder Index (PedACR30);Proportion of Participants who have Disease Flare;Proportion of Participants with Inactive Disease;Proportion of Participants with Minimal Disease Activity;Proportion of Participants in Remission;Change from Baseline in Juvenile Arthritis Disease Activity Score-27 (JADAS27);Change from Baseline in Arthritis-Related Pain Severity as Measured by the Childhood Health Assessment Questionnaire (CHAQ) Pain Visual Analog Scale (VAS) Item;Change from Baseline in Psoriasis Area and Severity Index (PASI);Change from Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index;Change from Baseline in Juvenile Spondyloarthritis Disease Activity Index (JSpADA);Change from Baseline in Immunoglobulin Levels;Change from Baseline in Immunophenotyping (T Cells);Change of Immunoglobulin G (IgG) Titers