A Study of Baricitinib in Participants From 1 Year to Less Than 18 Years Old With Juvenile Idiopathic Arthritis (JUVE-X)

May 11, 2026 updated by: Eli Lilly and Company

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)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

190

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
  • Phone Number: 1-317-615-4559
  • Email: LillyTrials@Lilly.com

Study Contact Backup

Study Locations

  • Argentina
      • Rosario, Argentina, S2000
        • Recruiting
        • Instituto CAICI SRL
        • Contact:
          • Phone Number: 543414248045
        • Principal Investigator:
          • Diego Viola
      • SAN M. de Tucuman, Argentina, T4000AXL
        • Recruiting
        • Centro de Investigaciones Medicas Tucuman
        • Contact:
          • Phone Number: +54-381-4200180
        • Principal Investigator:
          • Alberto Spindler
  • Australia
      • Melbourne, Australia, 3052
        • Not yet recruiting
        • Royal Children's Hospital
        • Principal Investigator:
          • Jonathan Akikusa
      • Perth, Australia, 6009
        • Not yet recruiting
        • Perth Children's Hospital
        • Contact:
          • Phone Number: 61264564348
        • Principal Investigator:
          • Kevin Murray
      • Westmead, Australia, 2145
        • Active, not recruiting
        • The Children's Hospital at Westmead
  • Austria
      • Bregenz, Austria, 6900
        • Completed
        • Landeskrankenhaus Bregenz
  • Belgium
      • Brussels, Belgium, 1200
        • Completed
        • Cliniques Universitaires Saint-luc
      • Ghent, Belgium, 9000
        • Recruiting
        • UZ Gent
        • Principal Investigator:
          • Joke Dehoorne
      • Leuven, Belgium, 3000
        • Recruiting
        • UZ Leuven
        • Contact:
          • Phone Number: 3216343801
        • Principal Investigator:
          • Lien De Somer
  • Brazil
      • Botucatu, Brazil, 18618-686
        • Recruiting
        • Faculdade de Medicina da UNESP
        • Principal Investigator:
          • Claudia Magalhaes
        • Contact:
          • Phone Number: +551438801476
      • São Paulo, Brazil, 04024-002
        • Recruiting
        • Universidade Federal de Sao Paulo
        • Principal Investigator:
          • Maria Teresa Terreri
        • Contact:
          • Phone Number: 5511 55792581
      • São Paulo, Brazil, 05403-000
        • Recruiting
        • Instituto da Crianca do Hospital das Clinicas da FMUSP
        • Principal Investigator:
          • Clovis Silva
        • Contact:
          • Phone Number: 551126618840
  • China
      • Beijing, China, 100045
        • Active, not recruiting
        • Beijing Children's Hospital, Capital Medical University
      • Chongqing, China, 400065
        • Active, not recruiting
        • The Children's Hospital of Chongqing Medical University
      • Nanjing, China, 210008
        • Recruiting
        • Childrens Hospital of Nanjing Medical University
        • Principal Investigator:
          • Haiguo Yu
      • Suzhou, China, 215025
        • Recruiting
        • Children's Hospital of Soochow University
        • Principal Investigator:
          • Qihua Feng
  • Czechia
      • Brno, Czechia, 613 00
        • Recruiting
        • Detska nemocnice FN Brno
        • Contact:
          • Phone Number: 420532234482
        • Principal Investigator:
          • Marcel Schuller
      • Prague, Czechia, 150 06
        • Recruiting
        • Fakultni nemocnice Motol
        • Principal Investigator:
          • Rudolf Horvath
        • Contact:
          • Phone Number: 420727812317
      • Prague, Czechia, 12808
        • Recruiting
        • Vseobecna fakultni nemocnice v Praze
        • Principal Investigator:
          • Pavla Dolezalova
  • Denmark
      • Aarhus, Denmark, 8200
        • Recruiting
        • Aarhus Universitetshospital, Skejby
        • Principal Investigator:
          • Mia Glerup
        • Contact:
          • Phone Number: +45 61333138
  • France
      • Bron, France, 69500
        • Recruiting
        • Hospices Civils de Lyon - Hopital Femme Mère Enfant
        • Principal Investigator:
          • Alexandre BELOT
      • Le Kremlin-Bicêtre, France, 94270
        • Recruiting
        • Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre
        • Principal Investigator:
          • isabelle Kone-Paut
      • Nîmes, France, 30029
        • Recruiting
        • Centre Hospitalier Universitaire de Nîmes - Hôpital Universitaire Carémeau
        • Principal Investigator:
          • Tu-Anh TRAN
      • Paris, France, 75015
        • Recruiting
        • Hôpital Universitaire Necker Enfants Malades
        • Principal Investigator:
          • Pierre Quartier Dit Maire
        • Contact:
          • Phone Number: +33144494828
      • Poitiers, France, 86021
        • Recruiting
        • Centre Hospitalier Universitaire de Poitiers
        • Principal Investigator:
          • Elisabeth Gervais
  • Germany
      • Berlin, Germany, 13125
        • Active, not recruiting
        • Helios Klinikum Berlin-Buch
      • Berlin, Germany, 13353
        • Completed
        • Charité Campus Virchow-Klinikum
      • Hamburg, Germany, 22081
        • Active, not recruiting
        • Praxis Kinder- und Jugendrheumatologie Dr. Ivan Foeldvari
      • Heidelberg, Germany, 69115
        • Completed
        • UniversitatsKlinikum Heidelberg
      • Sankt Augustin, Germany, 53757
        • Active, not recruiting
        • Asklepios Klinik Sankt Augustin
      • Tübingen, Germany, 72076
        • Active, not recruiting
        • Universitaetsklinikum Tuebingen
  • India
      • Chennai, India, 600116
        • Completed
        • Sri Ramachandra MedicaL College & Research Institute
      • New Delhi, India, 110060
        • Recruiting
        • Sir Ganga Ram Hospital
        • Principal Investigator:
          • Sujata Sawhney
      • Vellore, India, 632004
        • Recruiting
        • Christian Medical College Vellore
        • Principal Investigator:
          • Sathish Kumar
  • Israel
      • Haifa, Israel, 3109601
        • Recruiting
        • Rambam Health Care Campus
        • Principal Investigator:
          • Yonatan Butbul
        • Contact:
          • Phone Number: 9727774513
      • Kfar Saba, Israel, 4428164
        • Recruiting
        • Meir Medical Center
        • Principal Investigator:
          • Ruby Haviv
      • Petah Tikva, Israel, 49202
        • Recruiting
        • Schneider Children's Medical Center
        • Principal Investigator:
          • Gil Amarilyo
      • Ramat Gan, Israel, 5262100
        • Recruiting
        • Sheba Medical Center
        • Principal Investigator:
          • Irit Tirosh
  • Italy
      • Brescia, Italy, 25123
        • Recruiting
        • Azienda Ospedaliera Spedali Civili di Brescia
        • Principal Investigator:
          • Marco Cattalini
      • Chieti, Italy, 66100
        • Completed
        • Azienda Sanitaria Locale n. 2 - Lanciano Vasto Chieti
      • Genova, Italy, 16147
        • Recruiting
        • IRCCS Istituto Giannina Gaslini
        • Principal Investigator:
          • Roberta Caorsi
      • Milan, Italy, 20122
        • Not yet recruiting
        • Centro Specialistico Ortopedico Traumatologico Gaetano Pini - CTO
        • Principal Investigator:
          • Achille Marino
      • Milan, Italy, 20122
        • Completed
        • Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
      • Naples, Italy, 80131
        • Recruiting
        • University of Naples Federico II
        • Principal Investigator:
          • Maria Alessio
      • Palermo, Italy, 90127
        • Not yet recruiting
        • Azienda di Rilievo Nazionale e Alta Specializzazione Civico Di Cristina Benfratelli
        • Principal Investigator:
          • Maria Cristina Maggio
        • Contact:
          • Phone Number: 39 091 0916666250
      • Trieste, Italy, 34137
        • Recruiting
        • Ospedale Infantile Burlo Garofolo
        • Principal Investigator:
          • Alberto Tommasini
  • Japan
      • Bunkyō, Japan, 113-8519
        • Recruiting
        • Institute of Science Tokyo Hospital
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Masaki Shimizu
      • Chiba, Japan, 266-0007
        • Recruiting
        • Chiba Children's Hospital
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Minako Tomiita
      • Kagoshima, Japan, 890-8520
        • Recruiting
        • Kagoshima University Hospital
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Yuichi Yamasaki
      • Kanazawa, Japan, 920-8641
        • Recruiting
        • Kanazawa University Hospital
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Tadafumi Yokoyama
      • Niigata, Japan, 951-8520
        • Recruiting
        • Niigata University Medical & Dental Hospital
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Utako Kaneko
      • Saitama-shi, Japan, 330 8777
        • Recruiting
        • Saitama Children's Medical Center
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Satoshi Sato
      • Sendai, Japan, 989-3126
        • Recruiting
        • Miyagi Children's Hospital
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Hiroaki Umebayashi
      • Shinjuku-ku, Japan, 162-8666
        • Recruiting
        • Tokyo Women's Medical University Hospital
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Takako Miyamae
      • Takatsuki, Japan, 569-8686
        • Recruiting
        • Osaka Medical and Pharmaceutical University Hospital
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Yuko Sugita
      • Yokohama, Japan, 236-0004
        • Recruiting
        • Yokohama City University Hospital
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Shuichi Ito
      • Yokohama, Japan, 232-8555
        • Recruiting
        • Kanagawa Children's Medical Center
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Tomoyuki Imagawa
  • Mexico
      • Chihuahua City, Mexico, 31000
        • Recruiting
        • Investigacion y Biomedicina de Chihuahua
        • Contact:
          • Phone Number: 526144373003
        • Principal Investigator:
          • Cesar Pacheco-Tena
      • Durango, Mexico, 34000
        • Recruiting
        • Instituto de Investigaciones Clínicas para la Salud
        • Principal Investigator:
          • Edgar Hernandez
        • Contact:
          • Phone Number: +52 1 618 812 5351
      • Guadalajara, Mexico, 44600
        • Recruiting
        • Crea de Guadalajara
        • Principal Investigator:
          • Gabriel Vega Cornejo
      • Monterrey, Mexico, 66460
        • Recruiting
        • Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
        • Principal Investigator:
          • Nadina Rubio Perez
        • Contact:
          • Phone Number: 8183338623
      • México, Mexico, 6700
        • Recruiting
        • Clinstile, S.A. de C.V.
        • Contact:
          • Phone Number: 525552561496
        • Principal Investigator:
          • Favio Edmundo Enriquez Sosa
  • Poland
      • Krakow, Poland, 31-503
        • Recruiting
        • Wojewódzki Specjalistyczny Szpital Dzieciecy im. Sw. Ludwika w Krakowie
        • Principal Investigator:
          • Zbigniew Zuber
        • Contact:
          • Phone Number: +48 126198630
      • Lodz, Poland, 91-738
        • Recruiting
        • Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi
        • Principal Investigator:
          • Elzbieta Smolewska
        • Contact:
          • Phone Number: +48426177700
      • Warsaw, Poland, 02-637
        • Recruiting
        • Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji
        • Principal Investigator:
          • Piotr Gietka
  • Russia
      • Moscow, Russia, 115522
        • Completed
        • Federal State Budgetary Scientific Institution Research Institute Rheumatology named after V.A.Nasonova
      • Moscow, Russia, 119991
        • Completed
        • Scientific Center of Children's Health
  • Spain
      • Esplugues de Llobregat, Spain, 8950
        • Recruiting
        • Hospital Sant Joan de Déu
        • Principal Investigator:
          • Jordi Anton
        • Contact:
          • Phone Number: (34)936009733
      • Madrid, Spain, 28034
        • Recruiting
        • Hospital Universitario Ramon y Cajal
        • Principal Investigator:
          • Alina Lucica Boteanu
      • Madrid, Spain, 28046
        • Recruiting
        • Hospital Universitario La Paz
        • Principal Investigator:
          • Rosa Alcobendas
      • Madrid, Spain, 28009
        • Recruiting
        • Hospital Infantil Universitario Niño Jesús
        • Principal Investigator:
          • DANIEL CLEMENTE
        • Contact:
          • Phone Number: 34 915035900-280
      • Seville, Spain, 41013
        • Not yet recruiting
        • Hospital Universitario Virgen del Rocio
        • Principal Investigator:
          • Marisol Camacho Lovillo
      • Valencia, Spain, 46026
        • Recruiting
        • Hospital Universitari i Politecnic La Fe
        • Contact:
          • Phone Number: +34961244792
        • Principal Investigator:
          • LUCIA LACRUZ PEREZ
  • Turkey (Türkiye)
      • Istanbul, Turkey (Türkiye), 34098
        • Recruiting
        • Istanbul University-Cerrahpasa, Cerrahpasa Faculty of Medicine
        • Principal Investigator:
          • Ozgur Kasapcopur
      • Izmir, Turkey (Türkiye), 35340
        • Recruiting
        • 9 Eylul University Hospital
        • Principal Investigator:
          • Erbil Unsal
  • United Kingdom
      • Bristol, United Kingdom, BS2 8BJ
        • Recruiting
        • Bristol Royal Hospital for Children
        • Principal Investigator:
          • Athimalaipet Ramanan
      • Liverpool, United Kingdom, L14 5AB
        • Recruiting
        • Alder Hey Children's Hospital
        • Principal Investigator:
          • Beverley Almeida
      • London, United Kingdom, WC1N 3JH
        • Recruiting
        • Great Ormond Street Hospital for Children NHS Foundation Trust
        • Principal Investigator:
          • Muthana Al Obaidi
      • Oxford, United Kingdom, OX3 7LD
        • Recruiting
        • Oxford University Hospitals - Nuffield Orthopaedic Centre
        • Principal Investigator:
          • Inga Turtsevich
      • Sheffield, United Kingdom, S10 2TH
        • Recruiting
        • Sheffield Children's Hospital
        • Principal Investigator:
          • Daniel Hawley

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Baricitinib
Baricitinib given orally.
Drug: Baricitinib
Administered orally.
Other Names:
  • LY3009104

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline through Week 264
Number of Participants with Permanent Investigational Product Discontinuations
Time Frame: Baseline through Week 264
Number of participants with permanent investigational product discontinuations
Baseline through Week 264

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of Participants Achieving Pediatric American College of Rheumatology 30 Responder Index (PedACR30)
Time Frame: Week 264
Proportion of participants achieving PedACR30
Week 264
Proportion of Participants who have Disease Flare
Time Frame: Baseline through Week 264
Proportion of participants who have disease flare
Baseline through Week 264
Proportion of Participants with Inactive Disease
Time Frame: Week 264
Proportion of participants with inactive disease
Week 264
Proportion of Participants with Minimal Disease Activity
Time Frame: Week 264
Proportion of participants with minimal disease activity
Week 264
Proportion of Participants in Remission
Time Frame: Week 264
Proportion of participants in remission
Week 264
Change from Baseline in Juvenile Arthritis Disease Activity Score-27 (JADAS27)
Time Frame: Baseline, Week 264
Change from baseline of originating study in 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
Time Frame: Baseline, Week 264
Change from baseline in arthritis-related pain severity as measured by the CHAQ pain VAS item
Baseline, Week 264
Change from Baseline in Psoriasis Area and Severity Index (PASI)
Time Frame: Baseline, Week 264
Change from baseline in PASI
Baseline, Week 264
Change from Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index
Time Frame: Baseline, Week 264
Change from baseline in SPARCC enthesitis index
Baseline, Week 264
Change from Baseline in Juvenile Spondyloarthritis Disease Activity Index (JSpADA)
Time Frame: Baseline, Week 264
Change from baseline in JSpADA
Baseline, Week 264
Change from Baseline in Immunoglobulin Levels
Time Frame: Baseline, Week 264
Change from baseline in immunoglobulin levels
Baseline, Week 264
Change from Baseline in Immunophenotyping (T Cells)
Time Frame: Baseline, Week 264
Change from baseline in immunophenotyping (T Cells)
Baseline, Week 264
Change of Immunoglobulin G (IgG) Titers
Time Frame: Pre-Vaccination to 12 Weeks Post-Vaccination
Change of IgG titers
Pre-Vaccination to 12 Weeks Post-Vaccination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eli Lilly and Company

Investigators

  • Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST, Eli Lilly and Company

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 5, 2019

Primary Completion (Estimated)

July 1, 2031

Study Completion (Estimated)

July 1, 2031

Study Registration Dates

First Submitted

December 11, 2018

First Submitted That Met QC Criteria

December 11, 2018

First Posted (Actual)

December 12, 2018

Study Record Updates

Last Update Posted (Actual)

May 12, 2026

Last Update Submitted That Met QC Criteria

May 11, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16278
  • I4V-MC-JAHX (Other Identifier: Eli Lilly and Company)
  • 2017-004471-31 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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 Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Juvenile Idiopathic Arthritis

Clinical Trials on Baricitinib

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Zimbabwe

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe