Study of Oral medicine in Patients from 1 Years to Less Than 18 Years Old.

Phase 3

Recruiting

• Conditions: Other autoinflammatory syndromes,

• Registration Number: CTRI/2021/04/032948
• Lead Sponsor: Eli Lilly and Company India Pvt Ltd

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-04-23
• Last Update Posted: 2024-06-28

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 410

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.

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)	Baseline through Week 264

Secondary Outcome Measures

Name	Time	Method
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
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
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

Trial Locations

Locations (4)

Christian Medical College; 🇮🇳 Vellore, TAMIL NADU, India

Sanjay Gandhi Post Graduate Institute of Medical Sciences (SGPGI); 🇮🇳 Bareli, UTTAR PRADESH, India

Sir Ganga Ram Hospital; 🇮🇳 Delhi, DELHI, India

Sri Ramachandra medical college & Research Institute; 🇮🇳 Chennai, TAMIL NADU, India

Christian Medical College

🇮🇳Vellore, TAMIL NADU, India

Dr Sathish Kumar

Principal investigator

9488469989

sathishkumar@cmcvellore.ac.in