A Study of Baricitinib in Participants From 1 Year to Less Than 18 Years Old With Juvenile Idiopathic Arthritis (JUVE-X)
Primary Purpose
Juvenile Idiopathic Arthritis
Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Baricitinib
Sponsored by
About this trial
This is an interventional treatment trial for Juvenile Idiopathic Arthritis focused on measuring Polyarticular JIA, Oligoarthritis, Juvenile psoriatic arthritis (JPsA), Enthesitis-related juvenile idiopathic arthritis (ERA), Systemic JIA with and without systemic features
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.
Sites / Locations
- Instituto CAICI SRLRecruiting
- Centro de Investigaciones Médicas TucumanRecruiting
- Hospital General de Niños Dr. Pedro de ElizaldeRecruiting
- Perth Children's HospitalRecruiting
- Landeskrankenhaus Bregenz
- CMIP - Centro Mineiro de PesquisaRecruiting
- Faculdade de Medicina da UNESPRecruiting
- Instituto da Crianca do Hospital das Clinicas da FMUSP
- IPITEC
- Universidade Federal de Sao PauloRecruiting
- Children's Hospital Capital Institute of PediatricsRecruiting
- Beijing Children's hospital, Capital Medical University
- The Second Affiliated Hospital Chongqing Medical University
- The Children's Hospital of Chongqing Medical University
- Childrens Hospital of Nanjing Medical UniversityRecruiting
- Children's Hospital of Soochow UniversityRecruiting
- Aarhus Universitetshospital, SkejbyRecruiting
- Universitätsklinikum Heidelberg
- Universitaetsklinikum TuebingenRecruiting
- Praxis Kinder- und Jugendrheumatologie Dr. Ivan FoeldvariRecruiting
- Sri Ramachandra MedicaL College & Research Institute
- Christian Medical College VelloreRecruiting
- Kanazawa University HospitalRecruiting
- Miyagi Children's HospitalRecruiting
- Osaka Medical and Pharmaceutical University HospitalRecruiting
- Saitama Children's Medical CenterRecruiting
- Tokyo Medical And Dental University Medical HospitalRecruiting
- Tokyo Women's Medical University HospitalRecruiting
- Kagoshima University HospitalRecruiting
- St. Luke's International HospitalRecruiting
- Clinstile, S.A. de C.V.Recruiting
- Crea de GuadalajaraRecruiting
- Investigacion y Biomedicina de ChihuahuaRecruiting
- Instituto de Investigaciones Clínicas para la SaludRecruiting
- Scientific Center of Children's HealthRecruiting
- University College Hospital - LondonRecruiting
- Great Ormond Street Hospital For Children NHS Foundation TrustRecruiting
- Oxford University Hospitals - Nuffield Orthopaedic CentreRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Baricitinib
Arm Description
Baricitinib given orally.
Outcomes
Primary Outcome Measures
Number of Participants with One or More Serious Adverse Event(s) (SAEs)
Number of participants with one or more SAEs
Number of Participants with Permanent Investigational Product Discontinuations
Number of participants with permanent investigational product discontinuations
Secondary Outcome Measures
Proportion of Participants Achieving Pediatric American College of Rheumatology 30 Responder Index (PedACR30)
Proportion of participants achieving PedACR30
Proportion of Participants who have Disease Flare
Proportion of participants who have disease flare
Proportion of Participants with Inactive Disease
Proportion of participants with inactive disease
Proportion of Participants with Minimal Disease Activity
Proportion of participants with minimal disease activity
Proportion of Participants in Remission
Proportion of participants in remission
Change from Baseline in Juvenile Arthritis Disease Activity Score-27 (JADAS27)
Change from baseline of originating study in 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 arthritis-related pain severity as measured by the CHAQ pain VAS item
Change from Baseline in Psoriasis Area and Severity Index (PASI)
Change from baseline in PASI
Change from Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index
Change from baseline in SPARCC enthesitis index
Change from Baseline in Juvenile Spondyloarthritis Disease Activity Index (JSpADA)
Change from baseline in JSpADA
Change from Baseline in Immunoglobulin Levels
Change from baseline in immunoglobulin levels
Change from Baseline in Immunophenotyping (T Cells)
Change from baseline in immunophenotyping (T Cells)
Change of Immunoglobulin G (IgG) Titers
Change of IgG titers
Full Information
NCT ID
NCT03773965
First Posted
December 11, 2018
Last Updated
October 9, 2023
Sponsor
Eli Lilly and Company
1. Study Identification
Unique Protocol Identification Number
NCT03773965
Brief Title
A Study of Baricitinib in Participants From 1 Year to Less Than 18 Years Old With Juvenile Idiopathic Arthritis
Acronym
JUVE-X
Official Title
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)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 5, 2019 (Actual)
Primary Completion Date
December 18, 2030 (Anticipated)
Study Completion Date
December 18, 2030 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eli Lilly and Company
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Juvenile Idiopathic Arthritis
Keywords
Polyarticular JIA, Oligoarthritis, Juvenile psoriatic arthritis (JPsA), Enthesitis-related juvenile idiopathic arthritis (ERA), Systemic JIA with and without systemic features
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
190 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Baricitinib
Arm Type
Experimental
Arm Description
Baricitinib given orally.
Intervention Type
Drug
Intervention Name(s)
Baricitinib
Other Intervention Name(s)
LY3009104
Intervention Description
Administered orally.
Primary Outcome Measure Information:
Title
Number of Participants with One or More Serious Adverse Event(s) (SAEs)
Description
Number of participants with one or more SAEs
Time Frame
Baseline through Week 264
Title
Number of Participants with Permanent Investigational Product Discontinuations
Description
Number of participants with permanent investigational product discontinuations
Time Frame
Baseline through Week 264
Secondary Outcome Measure Information:
Title
Proportion of Participants Achieving Pediatric American College of Rheumatology 30 Responder Index (PedACR30)
Description
Proportion of participants achieving PedACR30
Time Frame
Week 264
Title
Proportion of Participants who have Disease Flare
Description
Proportion of participants who have disease flare
Time Frame
Baseline through Week 264
Title
Proportion of Participants with Inactive Disease
Description
Proportion of participants with inactive disease
Time Frame
Week 264
Title
Proportion of Participants with Minimal Disease Activity
Description
Proportion of participants with minimal disease activity
Time Frame
Week 264
Title
Proportion of Participants in Remission
Description
Proportion of participants in remission
Time Frame
Week 264
Title
Change from Baseline in Juvenile Arthritis Disease Activity Score-27 (JADAS27)
Description
Change from baseline of originating study in JADAS27
Time Frame
Baseline, Week 264
Title
Change from Baseline in Arthritis-Related Pain Severity as Measured by the Childhood Health Assessment Questionnaire (CHAQ) Pain Visual Analog Scale (VAS) Item
Description
Change from baseline in arthritis-related pain severity as measured by the CHAQ pain VAS item
Time Frame
Baseline, Week 264
Title
Change from Baseline in Psoriasis Area and Severity Index (PASI)
Description
Change from baseline in PASI
Time Frame
Baseline, Week 264
Title
Change from Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index
Description
Change from baseline in SPARCC enthesitis index
Time Frame
Baseline, Week 264
Title
Change from Baseline in Juvenile Spondyloarthritis Disease Activity Index (JSpADA)
Description
Change from baseline in JSpADA
Time Frame
Baseline, Week 264
Title
Change from Baseline in Immunoglobulin Levels
Description
Change from baseline in immunoglobulin levels
Time Frame
Baseline, Week 264
Title
Change from Baseline in Immunophenotyping (T Cells)
Description
Change from baseline in immunophenotyping (T Cells)
Time Frame
Baseline, Week 264
Title
Change of Immunoglobulin G (IgG) Titers
Description
Change of IgG titers
Time Frame
Pre-Vaccination to 12 Weeks Post-Vaccination
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
Phone
1-317-615-4559
Email
ClinicalTrials.gov@lilly.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
Instituto CAICI SRL
City
Rosario
State/Province
Santa Fe
ZIP/Postal Code
S2000
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Diego Oscar Viola
Facility Name
Centro de Investigaciones Médicas Tucuman
City
SAN M. DE Tucuman
State/Province
Tucumán
ZIP/Postal Code
T4000AXL
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alberto Jorge Spindler
Facility Name
Hospital General de Niños Dr. Pedro de Elizalde
City
Buenos Aires
ZIP/Postal Code
1270
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ruben José Cuttica
Facility Name
Perth Children's Hospital
City
Perth
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
Phone
61264564348
First Name & Middle Initial & Last Name & Degree
Kevin Murray
Facility Name
Landeskrankenhaus Bregenz
City
Bregenz
State/Province
Vorarlberg
ZIP/Postal Code
6900
Country
Austria
Individual Site Status
Completed
Facility Name
CMIP - Centro Mineiro de Pesquisa
City
Juiz de Fora
State/Province
Minas Gerais
ZIP/Postal Code
36010-570
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
Phone
553233128920
First Name & Middle Initial & Last Name & Degree
Vania Shinzel
Facility Name
Faculdade de Medicina da UNESP
City
Botucatu
State/Province
São Paulo
ZIP/Postal Code
18618-686
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Claudia Saad Magalhaes
Facility Name
Instituto da Crianca do Hospital das Clinicas da FMUSP
City
Sao Paulo
State/Province
São Paulo
ZIP/Postal Code
05403-000
Country
Brazil
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clovis Silva
Facility Name
IPITEC
City
São Paulo
ZIP/Postal Code
01223-001
Country
Brazil
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria Carolina dos Santos
Facility Name
Universidade Federal de Sao Paulo
City
São Paulo
ZIP/Postal Code
04024-002
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria Teresa Terreri
Facility Name
Children's Hospital Capital Institute of Pediatrics
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100020
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhixuan Zhou
Facility Name
Beijing Children's hospital, Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100045
Country
China
Individual Site Status
Active, not recruiting
Facility Name
The Second Affiliated Hospital Chongqing Medical University
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400010
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lin Tang
Facility Name
The Children's Hospital of Chongqing Medical University
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400065
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Childrens Hospital of Nanjing Medical University
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210008
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Haiguo Yu
Facility Name
Children's Hospital of Soochow University
City
Suzhou
State/Province
Jiangsu
ZIP/Postal Code
215025
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qihua Feng
Facility Name
Aarhus Universitetshospital, Skejby
City
Aarhus
State/Province
Midtjylland
ZIP/Postal Code
8200
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mia Glerup
Facility Name
Universitätsklinikum Heidelberg
City
Heidelberg
State/Province
Baden-Württemberg
ZIP/Postal Code
69120
Country
Germany
Individual Site Status
Completed
Facility Name
Universitaetsklinikum Tuebingen
City
Tuebingen
State/Province
Baden-Württemberg
ZIP/Postal Code
72076
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jasmin Kuemmerle-Deschner
Facility Name
Praxis Kinder- und Jugendrheumatologie Dr. Ivan Foeldvari
City
Hamburg
ZIP/Postal Code
22081
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ivan Foeldvari
Facility Name
Sri Ramachandra MedicaL College & Research Institute
City
Chennai
State/Province
Tamil Nadu
ZIP/Postal Code
600116
Country
India
Individual Site Status
Completed
Facility Name
Christian Medical College Vellore
City
Vellore
State/Province
Tamil Nadu
ZIP/Postal Code
632 004
Country
India
Individual Site Status
Recruiting
Facility Contact:
Phone
9488469989
First Name & Middle Initial & Last Name & Degree
Sathish Sathish Kumar
Facility Name
Kanazawa University Hospital
City
Kanazawa
State/Province
Ishikawa
ZIP/Postal Code
920-8641
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
Phone
81120023812
First Name & Middle Initial & Last Name & Degree
Tadafumi Yokoyama
Facility Name
Miyagi Children's Hospital
City
Sendai
State/Province
Miyagi
ZIP/Postal Code
989-3126
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hiroaki Umebayashi
Facility Name
Osaka Medical and Pharmaceutical University Hospital
City
Takatsuki
State/Province
Osaka
ZIP/Postal Code
569-8686
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuko Sugita
Facility Name
Saitama Children's Medical Center
City
Saitama-shi
State/Province
Saitama
ZIP/Postal Code
330 8777
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
Phone
81120023812
First Name & Middle Initial & Last Name & Degree
Satoshi Sato
Facility Name
Tokyo Medical And Dental University Medical Hospital
City
Bunkyō
State/Province
Tokyo
ZIP/Postal Code
113-8519
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Masaki Shimizu
Facility Name
Tokyo Women's Medical University Hospital
City
Shinjuku-ku
State/Province
Tokyo
ZIP/Postal Code
162-8666
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
Phone
81120023812
First Name & Middle Initial & Last Name & Degree
Takako Miyamae
Facility Name
Kagoshima University Hospital
City
Kagoshima
ZIP/Postal Code
890-8520
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuichi Yamasaki
Facility Name
St. Luke's International Hospital
City
Tokyo
ZIP/Postal Code
104-8560
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
Phone
81120023812
First Name & Middle Initial & Last Name & Degree
Kenichi Yamaguchi
Facility Name
Clinstile, S.A. de C.V.
City
Mexico
State/Province
Distrito Federal
ZIP/Postal Code
6700
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Favio Edmundo Enriquez Sosa
Facility Name
Crea de Guadalajara
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44600
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gabriel Vega Cornejo
Facility Name
Investigacion y Biomedicina de Chihuahua
City
Chihuahua
ZIP/Postal Code
31000
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cesar Francisco Pacheco-Tena
Facility Name
Instituto de Investigaciones Clínicas para la Salud
City
Durango
ZIP/Postal Code
34000
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Edgar Hernandez
Facility Name
Scientific Center of Children's Health
City
Moscow
State/Province
Moskva
ZIP/Postal Code
119991
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
Phone
84959671420
First Name & Middle Initial & Last Name & Degree
Ekaterina Alexeeva
Facility Name
University College Hospital - London
City
London
State/Province
Greater London
ZIP/Postal Code
W1T 7HA
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
Phone
2034567890
First Name & Middle Initial & Last Name & Degree
Corinne Fisher
Facility Name
Great Ormond Street Hospital For Children NHS Foundation Trust
City
London
State/Province
London, City Of
ZIP/Postal Code
WC1N 3JH
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sandrine Lacassagne
Facility Name
Oxford University Hospitals - Nuffield Orthopaedic Centre
City
Oxford
State/Province
Oxfordshire
ZIP/Postal Code
OX3 7LD
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Akhila Murthy Kavirayani
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
IPD Sharing Time Frame
Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
IPD Sharing Access Criteria
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
IPD Sharing URL
http://www.clinicalstudydatarequest.com
Links:
URL
https://trials.lillytrialguide.com/en-US/trial/1jKB0Gb6daw6sUu4gseGga
Description
A Study of Baricitinib in Participants From 1 Year to Less Than 18 Years Old With Juvenile Idiopathic Arthritis
Learn more about this trial
A Study of Baricitinib in Participants From 1 Year to Less Than 18 Years Old With Juvenile Idiopathic Arthritis
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