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CTRI Number  CTRI/2021/04/032948 [Registered on: 20/04/2021] Trial Registered Prospectively
Last Modified On: 28/06/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Study of Oral medicine in Patients from 1 Years to Less Than 18 Years Old.  
Scientific Title of Study   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) 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
I4V-MC-JAHX protocol dated 16-04-2019  DCGI 
NCT03773965  ClinicalTrials.gov 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)  
Name  Dr Manish Mistry 
Designation  Medical Director 
Affiliation  Eli Lilly and Company (India) Pvt. Ltd. 
Address  Plot No - 92, Sec - 32, Institutional Area, Gurgaon HARYANA-122001 India

Gurgaon
HARYANA
122001
India 
Phone  09820234897  
Fax    
Email  manish.mistry@lilly.com  
 
Details of Contact Person
Scientific Query
Modification(s)  
Name  Dr Manish Mistry 
Designation  Medical Director 
Affiliation  Eli Lilly and Company (India) Pvt. Ltd. 
Address  Plot No - 92, Sec - 32, Institutional Area, Gurgaon - 122001 India

Gurgaon
HARYANA
122001
India 
Phone  09820234897  
Fax    
Email  manish.mistry@lilly.com  
 
Details of Contact Person
Public Query  
Name  Dr Rajeev Sharan Shrivastava 
Designation  Associate Director 
Affiliation  Eli Lilly and Company (India) Pvt. Ltd. 
Address  Plot No - 92, Sec - 32, Institutional Area, Gurgaon - 122001 India

Gurgaon
HARYANA
122001
India 
Phone  09810308697  
Fax    
Email  shrivastava_rajeev_sharan@lilly.com  
 
Source of Monetary or Material Support  
Eli Lilly and Company (India) PVT LTD, Plot No. 92, Sector-32, Gurgaon, Haryana - 122001  
 
Primary Sponsor  
Name  Eli Lilly and Company India Pvt Ltd  
Address  Eli Lilly and Company (India) PVT LTD, Plot No. 92, Sector-32, Gurgaon, Haryana - 122001  
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     Argentina
Australia
Austria
Belgium
Brazil
China
Czech Republic
Denmark
France
Germany
India
Israel
Italy
Japan
Mexico
Poland
Russian Federation
Spain
Turkey
United Kingdom  
Sites of Study  
No of Sites = 4  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sathish Kumar  Christian Medical College  Ida Scudder Road, Vellore – 632004
Vellore
TAMIL NADU 		 9488469989

sathishkumar@cmcvellore.ac.in 
Dr Amita Agarwal  Sanjay Gandhi Post Graduate Institute of Medical Sciences (SGPGI)  Rae Bareli Road, Lucknow –226014, UP, India
Rae Bareli
UTTAR PRADESH 		 915222494315

aa.amita@gmail.com 
Dr Sujata Sawhney  Sir Ganga Ram Hospital  Old Rajinder Nagar, New Delhi- 110060
New Delhi
DELHI 		 9811444116

drsujatasawhney@gmail.com 
Dr Mahesh Janarthanan  Sri Ramachandra medical college & Research Institute  1, Ramachandra Nagar, Porur
Chennai
TAMIL NADU 		 9952552330

maheshjanarthanan@hotmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 4  
Name of Committee  Approval Status 
Institutional Ethics Committee, Sanjay Gandhi Post Graduate Institute of Medical Sciences (SGPGI)  Approved 
Institutional Ethics Committee, Sri Ramachandra Institute of Higher Education and Research  Approved 
Institutional Review Board, Christian Medical College  Approved 
Sir Ganga Ram Hospital Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M048||Other autoinflammatory syndromes,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Baricitinib  Baricitinib given orally. Initial High Dose for 12 to 18 years Low dose for 1 to 6 years Time frame for Week 264 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  1.00 Year(s)
Age To  18.00 Year(s)
Gender  Both 
Details  Participants must have completed a previous study of baricitinib for the treatment of JIA. 
 
ExclusionCriteria 
Details  Participants must not have had a permanent discontinuation of baricitinib in the prior study.
Participants must have not developed an allergy to baricitinib. 
 
Method of Generating Random Sequence   Stratified randomization 
Method of Concealment   Centralized 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Number of Participants with One or More Serious Adverse Event(s) (SAEs)  Baseline through Week 264 
 
Secondary Outcome  
Outcome  TimePoints 
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 
 
Target Sample Size   Total Sample Size="410"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   23/04/2021 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  05/04/2019 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="9"
Days="7" 
Recruitment Status of Trial (Global)
Modification(s)  		 Open to Recruitment 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response (Others) -  www.vivli.org

  6. For how long will this data be available start date provided 27-04-2021 and end date provided 31-10-2021?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
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. 
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