A Phase 3 Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients From 1 Year to <18 Years of Age With Juvenile Idiopathic Arthritis (JIA)

Eli Lilly and Company98 sites in 17 countries190 target enrollmentApril 5, 2019

ConditionsJuvenile Idiopathic Arthritis

InterventionsBaricitinib

DrugsBaricitinib

Overview

Phase: Phase 3
Intervention: Baricitinib
Conditions: Juvenile Idiopathic Arthritis
Sponsor: Eli Lilly and Company
Enrollment: 190
Locations: 98
Primary Endpoint: Number of Participants with One or More Serious Adverse Event(s) (SAEs)
Status: Recruiting
Last Updated: 2 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

April 5, 2019

End Date

July 1, 2031

Last Updated

2 months ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Eli Lilly and Company

Responsible Party

Sponsor

Eligibility 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.

Arms & Interventions

Baricitinib

Baricitinib given orally.

Intervention: Baricitinib

Outcomes

Primary Outcomes

Number of Participants with One or More Serious Adverse Event(s) (SAEs)

Time Frame: Baseline through Week 264

Number of participants with one or more SAEs

Number of Participants with Permanent Investigational Product Discontinuations

Time Frame: Baseline through Week 264

Number of participants with permanent investigational product discontinuations

Secondary Outcomes

Change from Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index(Baseline, Week 264)
Change from Baseline in Juvenile Spondyloarthritis Disease Activity Index (JSpADA)(Baseline, Week 264)
Change from Baseline in Immunoglobulin Levels(Baseline, Week 264)
Change from Baseline in Immunophenotyping (T Cells)(Baseline, Week 264)
Change of Immunoglobulin G (IgG) Titers(Pre-Vaccination to 12 Weeks Post-Vaccination)
Proportion of Participants with Inactive Disease(Week 264)
Proportion of Participants with Minimal Disease Activity(Week 264)
Proportion of Participants in Remission(Week 264)
Change from Baseline in Juvenile Arthritis Disease Activity Score-27 (JADAS27)(Baseline, Week 264)
Change from Baseline in Arthritis-Related Pain Severity as Measured by the Childhood Health Assessment Questionnaire (CHAQ) Pain Visual Analog Scale (VAS) Item(Baseline, Week 264)
Change from Baseline in Psoriasis Area and Severity Index (PASI)(Baseline, Week 264)
Proportion of Participants Achieving Pediatric American College of Rheumatology 30 Responder Index (PedACR30)(Week 264)
Proportion of Participants who have Disease Flare(Baseline through Week 264)