Juvenile Idiopathic ArthritisPhase 3JUVE-XNCT03773965
A Study of Baricitinib in Participants From 1 Year to Less Than 18 Years Old With Juvenile Idiopathic Arthritis
A Phase 3 study testing Baricitinib in people with Juvenile Idiopathic Arthritis, run by Eli Lilly and Company at 78 sites in 20 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Juvenile Idiopathic Arthritis
- What is being tested?
- Baricitinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 190 participants
- Where
- 78 sitesin 20 countries
- Study dates
- 5 Apr 2019to Jul 2031
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Participants must have completed a previous study of baricitinib for the treatment of JIA.
Who cannot join
- Participants must not have had a permanent discontinuation of baricitinib in the prior study.
- Participants must have not developed an allergy to baricitinib.
Trial locations and contacts
78 sites in 20 countries. Contact the study team or a site near you to ask about taking part.
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or contact
Physicians interested in becoming principal investigators please contact contact
78 sites in 20 countries
Japan11 sites, 11 recruiting
- Recruiting
Institute of Science Tokyo Hospital
Bunkyō, 113-8519
81120023812
Masaki Shimizu
- Recruiting
Chiba Children's Hospital
Chiba, 266-0007
81120023812
Minako Tomiita
- Recruiting
Kagoshima University Hospital
Kagoshima, 890-8520
81120023812
Yuichi Yamasaki
- Recruiting
Kanazawa University Hospital
Kanazawa, 920-8641
81120023812
Tadafumi Yokoyama
- Recruiting
Niigata University Medical & Dental Hospital
Niigata, 951-8520
81120023812
Utako Kaneko
- Recruiting
Saitama Children's Medical Center
Saitama-shi, 330 8777
81120023812
Satoshi Sato
- Recruiting
Miyagi Children's Hospital
Sendai, 989-3126
81120023812
Hiroaki Umebayashi
- Recruiting
Tokyo Women's Medical University Hospital
Shinjuku-ku, 162-8666
81120023812
Takako Miyamae
- Recruiting
Osaka Medical and Pharmaceutical University Hospital
Takatsuki, 569-8686
81120023812
Yuko Sugita
- Recruiting
Kanagawa Children's Medical Center
Yokohama, 232-8555
81120023812
Tomoyuki Imagawa
- Recruiting
Yokohama City University Hospital
Yokohama, 236-0004
81120023812
Shuichi Ito
Italy8 sites, 2 recruiting
- Active, not recruiting
Azienda Ospedaliera Spedali Civili di Brescia
Brescia, 25123
- Completed
Azienda Sanitaria Locale n. 2 - Lanciano Vasto Chieti
Chieti, 66100
- Active, not recruiting
IRCCS Istituto Giannina Gaslini
Genova, 16147
- Not yet recruiting
Centro Specialistico Ortopedico Traumatologico Gaetano Pini - CTO
Milan, 20122
Achille Marino
- Completed
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
Milan, 20122
- Active, not recruiting
University of Naples Federico II
Naples, 80131
- Not yet recruiting
Azienda di Rilievo Nazionale e Alta Specializzazione Civico Di Cristina Benfratelli
Palermo, 90127
39 091 0916666250
Maria Cristina Maggio
- Completed
Ospedale Infantile Burlo Garofolo
Trieste, 34137
Germany6 sites
- Active, not recruiting
Helios Klinikum Berlin-Buch
Berlin, 13125
- Completed
Charité Campus Virchow-Klinikum
Berlin, 13353
- Active, not recruiting
Praxis Kinder- und Jugendrheumatologie Dr. Ivan Foeldvari
Hamburg, 22081
- Completed
Universitätsklinikum Heidelberg
Heidelberg, 69115
- Active, not recruiting
Asklepios Klinik Sankt Augustin
Sankt Augustin, 53757
- Active, not recruiting
Universitaetsklinikum Tuebingen
Tübingen, 72076
France5 sites, 5 recruiting
- Recruiting
Hospices Civils de Lyon - Hôpital Femme Mère Enfant
Bron, 69500
Alexandre BELOT
- Recruiting
Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre
Le Kremlin-Bicêtre, 94270
isabelle Kone-Paut
- Recruiting
Centre Hospitalier Universitaire de Nîmes - Hôpital Universitaire Carémeau
Nîmes, 30029
Tu-Anh TRAN
- Recruiting
Hôpital Universitaire Necker Enfants Malades
Paris, 75015
+33144494828
Pierre Quartier Dit Maire
- Recruiting
Centre Hospitalier Universitaire de Poitiers
Poitiers, 86021
Elisabeth Gervais
Mexico5 sites, 5 recruiting
- Recruiting
Investigacion y Biomedicina de Chihuahua
Chihuahua City, 31000
526144373003
Cesar Pacheco-Tena
- Recruiting
Instituto de Investigaciones Clínicas para la Salud
Durango, 34000
+52 1 618 812 5351
Edgar Hernandez
- Recruiting
Crea de Guadalajara
Guadalajara, 44600
Gabriel Vega Cornejo
- Recruiting
Clinstile, S.A. de C.V.
México, 6700
525552561496
Favio Edmundo Enriquez Sosa
- Recruiting
Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
Monterrey, 66460
8183338623
Nadina Rubio Perez
Spain5 sites, 4 recruiting
- Recruiting
Hospital Sant Joan de Déu
Esplugues de Llobregat, 8950
(34)936009733
Jordi Anton
- Recruiting
Hospital Universitario Ramón y Cajal
Madrid, 28034
Alina Lucica Boteanu
- Recruiting
Hospital Universitario La Paz
Madrid, 28046
Rosa Alcobendas
- Not yet recruiting
Hospital Universitario Virgen Del Rocio
Seville, 41013
Marisol Camacho Lovillo
- Active, not recruiting
Hospital Universitari i Politecnic La Fe
Valencia, 46026
United Kingdom5 sites, 5 recruiting
- Recruiting
Bristol Royal Hospital for Children
Bristol, BS2 8BJ
Athimalaipet Ramanan
- Recruiting
Alder Hey Children's Hospital
Liverpool, L14 5AB
Beverley Almeida
- Recruiting
Great Ormond Street Hospital For Children NHS Foundation Trust
London, WC1N 3JH
Muthana Al Obaidi
- Recruiting
Oxford University Hospitals - Nuffield Orthopaedic Centre
Oxford, OX3 7LD
Inga Turtsevich
- Recruiting
Sheffield Children's Hospital
Sheffield, S10 2TH
Daniel Hawley
China4 sites, 2 recruiting
- Active, not recruiting
Beijing Children's hospital, Capital Medical University
Beijing, 100045
- Active, not recruiting
The Children's Hospital of Chongqing Medical University
Chongqing, 400065
- Not yet recruiting
Childrens Hospital of Nanjing Medical University
Nanjing, 210008
Haiguo Yu
- Recruiting
Children's Hospital of Soochow University
Suzhou, 215000
Qihua Feng
Israel4 sites, 4 recruiting
- Recruiting
Rambam Health Care Campus
Haifa, 3109601
9727774513
Yonatan Butbul
- Recruiting
Meir Medical Center
Kfar Saba, 4428164
Ruby Haviv
- Recruiting
Schneider Children's Medical Center
Petah Tikva, 49202
Gil Amarilyo
- Recruiting
Sheba Medical Center
Ramat Gan, 5262100
Irit Tirosh
Australia3 sites, 2 recruiting
- Not yet recruiting
Royal Children's Hospital
Melbourne, 3052
Jonathan Akikusa
- Not yet recruiting
Perth Children's Hospital
Perth, 6009
61264564348
Kevin Murray
- Active, not recruiting
The Children's Hospital at Westmead
Westmead, 2145
Belgium3 sites, 2 recruiting
- Completed
Cliniques universitaires Saint-Luc
Brussels, 1200
- Recruiting
UZ Gent
Ghent, 9000
Joke Dehoorne
- Recruiting
UZ Leuven
Leuven, 3000
3216343801
Lien De Somer
Brazil3 sites, 3 recruiting
- Recruiting
Faculdade de Medicina da UNESP
Botucatu, 18618-686
Claudia Magalhaes
- Recruiting
Universidade Federal de Sao Paulo
São Paulo, 04024-002
5511 55792581
Maria Teresa Terreri
- Recruiting
Instituto da Crianca do Hospital das Clinicas da FMUSP
São Paulo, 05403-000
551126618840
Clovis Silva
Czechia3 sites, 3 recruiting
- Recruiting
Detska nemocnice FN Brno
Brno, 613 00
420532234482
Marcel Schuller
- Recruiting
Vseobecna fakultni nemocnice v Praze
Prague, 12808
Pavla Dolezalova
- Recruiting
Fakultni nemocnice Motol
Prague, 150 06
420727812317
Rudolf Horvath
India3 sites, 2 recruiting
- Completed
Sri Ramachandra MedicaL College & Research Institute
Chennai, 600116
- Recruiting
Sir Ganga Ram Hospital
New Delhi, 110060
Sujata Sawhney
- Recruiting
Christian Medical College Vellore
Vellore, 632004
Sathish Kumar
Poland3 sites, 3 recruiting
- Recruiting
Wojewódzki Specjalistyczny Szpital Dziecięcy im. św. Ludwika w Krakowie
Krakow, 31-503
+48 126198630
Zbigniew Zuber
- Recruiting
Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi
Lodz, 91-738
+48426177700
Elzbieta Smolewska
- Recruiting
Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji
Warsaw, 02-637
Piotr Gietka
Argentina2 sites
- Active, not recruiting
Instituto CAICI SRL
Rosario, S2000
- Active, not recruiting
Centro de Investigaciones Médicas Tucuman
SAN M. de Tucuman, T4000AXL
Russia2 sites
- Completed
Federal State Budgetary Scientific Institution Research Institute Rheumatology named after V.A.Nasonova
Moscow, 115522
- Completed
Scientific Center of Children's Health
Moscow, 119991
Denmark1 site, 1 recruiting
- Recruiting
Aarhus Universitetshospital, Skejby
Aarhus, 8200
+45 61333138
Mia Glerup
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Istanbul University-Cerrahpasa, Cerrahpasa Faculty of Medicine
Istanbul, 34098
Ozgur Kasapcopur
About this study
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)
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.
- Conditions
- Juvenile Idiopathic Arthritis
- Being tested
- Baricitinib
- Keywords
- Polyarticular JIA, Oligoarthritis, Juvenile psoriatic arthritis (JPsA), Enthesitis-related juvenile idiopathic arthritis (ERA), Systemic JIA with and without systemic features
- Medical subject headings
- Arthritis, Juvenile, Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BaricitinibDrug
Also called LY3009104
Administered orally.
| Study group | Role | What they receive |
|---|---|---|
| Baricitinib | Experimental | Baricitinib given orally. Receives: Drug: Baricitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with One or More Serious Adverse Event(s) (SAEs)
Number of participants with one or more SAEs
Measured: Baseline through Week 264
Number of Participants with Permanent Investigational Product Discontinuations
Number of participants with permanent investigational product discontinuations
Measured: Baseline through Week 264
Secondary outcomes (13)
Proportion of Participants Achieving Pediatric American College of Rheumatology 30 Responder Index (PedACR30)
Proportion of participants achieving PedACR30
Measured: Week 264
Proportion of Participants who have Disease Flare
Proportion of participants who have disease flare
Measured: Baseline through Week 264
Proportion of Participants with Inactive Disease
Proportion of participants with inactive disease
Measured: Week 264
Proportion of Participants with Minimal Disease Activity
Proportion of participants with minimal disease activity
Measured: Week 264
Proportion of Participants in Remission
Proportion of participants in remission
Measured: Week 264
Change from Baseline in Juvenile Arthritis Disease Activity Score-27 (JADAS27)
Change from baseline of originating study in JADAS27
Measured: 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
Change from baseline in arthritis-related pain severity as measured by the CHAQ pain VAS item
Measured: Baseline, Week 264
Change from Baseline in Psoriasis Area and Severity Index (PASI)
Change from baseline in PASI
Measured: Baseline, Week 264
Change from Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index
Change from baseline in SPARCC enthesitis index
Measured: Baseline, Week 264
Change from Baseline in Juvenile Spondyloarthritis Disease Activity Index (JSpADA)
Change from baseline in JSpADA
Measured: Baseline, Week 264
Change from Baseline in Immunoglobulin Levels
Change from baseline in immunoglobulin levels
Measured: Baseline, Week 264
Change from Baseline in Immunophenotyping (T Cells)
Change from baseline in immunophenotyping (T Cells)
Measured: Baseline, Week 264
Change of Immunoglobulin G (IgG) Titers
Change of IgG titers
Measured: Pre-Vaccination to 12 Weeks Post-Vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2018
- Study start5 Apr 2019
- Primary completionJul 2031 (estimated)
- Study completionJul 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Juvenile Idiopathic ArthritisStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 190 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- 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, Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03773965
- Sponsor's protocol ID
- 16278
- Other IDs
- I4V-MC-JAHX, 2017-004471-31, 2017
- Acronym
- JUVE-X
- Status last verified
- Oct 2026
- First submitted
- 11 Dec 2018
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.