A Study of Baricitinib (LY3009104) in Participants From 1 Year to Less Than 18 Years Old With Systemic Juvenile Idiopathic Arthritis (sJIA)

Last updated: June 25, 2025
Sponsor: Eli Lilly and Company
Overall Status: Active - Recruiting

Phase

3

Condition

Joint Injuries

Arthritis And Arthritic Pain (Pediatric)

Rheumatoid Arthritis

Treatment

Baricitinib

Placebo

Tocilizumab

Clinical Study ID

NCT04088396
16275
I4V-MC-JAHU
2017-004495-60
2023-507883-38-00
  • Ages 1-17
  • All Genders

Study Summary

The reason for this study is to see if the study drug baricitinib is safe and effective in participants from 1 year to less than 18 years old with systemic juvenile idiopathic arthritis (sJIA). Participants are assigned to 1 of 2 cohorts. In cohort 1, participants will receive baricitinib or tocilizumab reference. In cohort 2, participants will receive baricitinib.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Participants must have a diagnosis of systemic Juvenile Idiopathic Arthritis (sJIA)as defined by International League of Associations for Rheumatology (ILAR) criteriawith onset before the age of 16 years

  • Participants must have at least 2 active joints at screening and baseline

  • Cohort 1 (IL-6 inhibitor therapy naive): Participants who are at least 1 year andless than 18 years of age, except in countries that restrict use of tocilizumab inparticipants less than 2 years of age

  • Cohort 2 (open-label baricitinib): Participants who are at least 1 year and lessthan 18 years of age

Exclusion

Exclusion Criteria:

  • Participants must not have polyarticular JIA (positive or negative for rheumatoidfactor), extended oligoarticular JIA, enthesitis-related JIA, or juvenile psoriaticarthritis

  • Participants must not have persistent oligoarticular arthritis as defined by theILAR criteria

  • Participants must not have a history or presence of any autoimmune inflammatorycondition other than JIA

  • Participants must not have active anterior uveitis or are receiving concurrenttreatment for anterior uveitis

  • Participants must not have active fibromyalgia or other chronic pain conditionsthat, in the investigator's opinion, would make it difficult to appropriately assessdisease activity for the purposes of this study

  • Participants must not have biologic features of Macrophage Activation Syndrome (MAS)over the past 12 weeks

  • Participants must not have a current or recent (<4 weeks prior to baseline)clinically serious infection

  • Participants must not have a positive test for hepatitis B virus

  • Participants must not have evidence of active tuberculosis (TB) or untreated latentTB

Study Design

Total Participants: 58
Treatment Group(s): 3
Primary Treatment: Baricitinib
Phase: 3
Study Start date:
February 12, 2020
Estimated Completion Date:
May 31, 2026

Connect with a study center

  • Instituto CAICI SRL

    Rosario, Santa Fe S2000
    Argentina

    Active - Recruiting

  • Centro Medico Privado de Reumatologia

    San Miguel de Tucuman, Tucuman T4000AXL
    Argentina

    Site Not Available

  • Centro Medico Privado de Reumatologia

    SAN M. DE Tucuman, Tucumán T4000AXL
    Argentina

    Active - Recruiting

  • Centro de Investigaciones Médicas Tucuman

    SAN M. DE Tucuman, Tucumán T4000AXL
    Argentina

    Active - Recruiting

  • Hospital General de Niños Dr. Pedro de Elizalde

    Buenos Aires, 1270
    Argentina

    Site Not Available

  • Centro Medico Privado de Reumatologia

    Tucuman, T4000AXL
    Argentina

    Site Not Available

  • Universitätsklinik Innsbruck

    Innsbruck, Tirol 6020
    Austria

    Site Not Available

  • Medizinische Universität Wien

    Wien, Vienna 1090
    Austria

    Site Not Available

  • Medizinische Universität Wien

    Vienna, Wien 1090
    Austria

    Site Not Available

  • Medizinische Universität Wien - Kinder und Jugendheilkunde

    Vienna, Wien 1090
    Austria

    Site Not Available

  • Cliniques universitaires Saint-Luc

    Brussels, Bruxelles-Capitale, Région De 1200
    Belgium

    Site Not Available

  • UZ Gent-Reuma

    Gent, East Flanders 9000
    Belgium

    Active - Recruiting

  • UZ Gent

    Gent, Oost-Vlaanderen 9000
    Belgium

    Active - Recruiting

  • UZ Leuven

    Leuven, Vlaams-Brabant 3000
    Belgium

    Active - Recruiting

  • Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg

    Leuven, Vlaams-Brabant 3000
    Belgium

    Active - Recruiting

  • UCL- Saint Luc

    Bruxelles, 1200
    Belgium

    Site Not Available

  • Hospital de Clinicas de Porto Alegre

    Porto Alegre, Rio Grande Do Sul 90035-903
    Brazil

    Active - Recruiting

  • Hospital de Clinicas UNICAMP

    Campinas, SP 13083-970
    Brazil

    Site Not Available

  • Faculdade de Medicina da UNESP

    Botucatu, São Paulo 18618-686
    Brazil

    Active - Recruiting

  • Faculdade de Medicina de Botucatu

    Botucatu, São Paulo 18618-970
    Brazil

    Active - Recruiting

  • Hospital de Clínicas Da Universidade Estadual de Campinas

    Campinas, São Paulo 13083-888
    Brazil

    Site Not Available

  • Instituto da Crianca do Hospital das Clinicas da FMUSP

    Sao Paulo, São Paulo 05403-000
    Brazil

    Active - Recruiting

  • IPPMG - Biblioteca Asdrubal Costa

    Rio de Janeiro, 21941-612
    Brazil

    Site Not Available

  • IPITEC

    São Paulo, 01221-020
    Brazil

    Active - Recruiting

  • Universidade Federal de Sao Paulo

    São Paulo, 04022-001
    Brazil

    Active - Recruiting

  • Detska nemocnice FN Brno

    Brno, Brno-město 613 00
    Czechia

    Active - Recruiting

  • Fakultni nemocnice Olomouc

    Olomouc, 779 00
    Czechia

    Active - Recruiting

  • Lekarna Fakultni Nemocnice Olomouc

    Olomouc, 779 00
    Czechia

    Site Not Available

  • Centrum detske revmatologie VFN, Klinika detskeho a dorostoveho lekarstvi 1.LFUK a VFN v Praze

    Prague, 121 08
    Czechia

    Site Not Available

  • Vseobecna fakultni nemocnice v Praze

    Praha 2, 12808
    Czechia

    Active - Recruiting

  • Aarhus Universitetshospital

    Aarhus, Midtjylland 8200
    Denmark

    Active - Recruiting

  • Aarhus Universitetshospital, Skejby

    Aarhus, Midtjylland 8200
    Denmark

    Site Not Available

  • Centre Hospitalier Universitaire de Nîmes - Hôpital Universitaire Carémeau

    Nimes Cedex 9, Gard 30029
    France

    Site Not Available

  • Centre Hospitalier Universitaire de Nîmes - Hôpital Universitaire Carémeau

    Nîmes, Gard 30029
    France

    Active - Recruiting

  • Centre Hospitalier Régional Universitaire de Nancy - Hôpitaux de Brabois

    Vandoeuvre lès Nancy, Meurthe-et-Moselle 54500
    France

    Suspended

  • Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre

    Le Kremlin-Bicêtre, Paris 94270
    France

    Active - Recruiting

  • Hospices Civils de Lyon - Hôpital Femme Mère Enfant

    Bron, Rhône-Alpes 69500
    France

    Active - Recruiting

  • Centre Hospitalier Universitaire de Poitiers

    Poitiers, Vienne 86021
    France

    Active - Recruiting

  • CHU Poitiers - Hopital Jean Bernard

    Poitiers Cedex, Vienne 86021
    France

    Site Not Available

  • Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre

    Le Kremlin Bicetre, 94275
    France

    Site Not Available

  • GH Necker - Enfants Malades

    Paris, 75015
    France

    Active - Recruiting

  • Hôpital Universitaire Necker Enfants Malades

    Paris, 75015
    France

    Active - Recruiting

  • CHU de Nancy Hop D'Enfants de Brabois

    Vandoeuvre Les Nancy Cedex, 54511
    France

    Site Not Available

  • Universitätsklinikum Freiburg

    Freiburg im Breisgau, Baden-Württemberg 79106
    Germany

    Site Not Available

  • Universitätsklinikum Münster

    Münster, Nordrhein-Westfalen 48149
    Germany

    Site Not Available

  • Asklepios Klinik Sankt Augustin

    Saint Augustin, Nordrhein-Westfalen 53757
    Germany

    Site Not Available

  • Universitätsklinikum Carl Gustav Carus

    Dresden, Sachsen 01307
    Germany

    Site Not Available

  • Charité Campus Virchow-Klinikum

    Berlin, 13353
    Germany

    Site Not Available

  • Klinikum Bremen-Mitte

    Bremen, 28205
    Germany

    Site Not Available

  • Hamburger Zentrum für Kinder und Jugendrheumatologie

    Hamburg, 22081
    Germany

    Site Not Available

  • Sri Ramachandra MedicaL College & Research Institute

    Porur, Chennai 600116
    India

    Site Not Available

  • All India Institue of Medical Sciences (AIIMS)

    New Delhi, Delhi 110029
    India

    Site Not Available

  • Sir Ganga Ram Hospital

    New Delhi, Delhi 110060
    India

    Active - Recruiting

  • SRI Ramachandra Medical College and Hospital

    Chennai, Tamil Nadu 600116
    India

    Site Not Available

  • Sri Ramachandra MedicaL College & Research Institute

    Chennai, Tamil Nadu 600116
    India

    Site Not Available

  • Christian Medical College Vellore

    Vellore, Tamil Nadu 632004
    India

    Site Not Available

  • Sanjay Gandhi Post Graduate Institute of Medical Sciences

    Lucknow, Uttar Pradesh 226014
    India

    Site Not Available

  • Meir Medical Center

    Kfar Saba, HaMerkaz 4428164
    Israel

    Active - Recruiting

  • Schneider Children's Medical Center

    Petah Tikva, HaMerkaz 49202
    Israel

    Active - Recruiting

  • Sheba Medical Center

    Ramat Gan, HaMerkaz 5262100
    Israel

    Active - Recruiting

  • Schneider Children's Medical Center

    Petah Tiqva, 4920235
    Israel

    Site Not Available

  • University of Naples Federico II

    Napoli, Campania 80131
    Italy

    Active - Recruiting

  • IRCCS Istituto Giannina Gaslini

    Genova, Liguria 16147
    Italy

    Active - Recruiting

  • Ospedale Pediatrico Gaslini - Istituto Giannina Gaslini

    Genova, Liguria 16147
    Italy

    Active - Recruiting

  • Centro Specialistico Ortopedico Traumatologico Gaetano Pini - CTO

    Milano, Lombardia 20122
    Italy

    Active - Recruiting

  • Fondazione IRCCS Ca'Granda Ospedale Maggiore Policlinico

    Milano, Lombardia 20122
    Italy

    Active - Recruiting

  • Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico

    Milano, Lombardia 20122
    Italy

    Active - Recruiting

  • Azienda di Rilievo Nazionale e Alta Specializzazione Civico Di Cristina Benfratelli

    Palermo, Sicilia 90127
    Italy

    Active - Recruiting

  • Azienda Ospedaliera Universitaria Pisana

    Pisa, Toscana 56126
    Italy

    Site Not Available

  • ASST Spedali Civili - Università degli Studi

    Brescia, 25123
    Italy

    Active - Recruiting

  • Azienda Ospedaliera Spedali Civili di Brescia

    Brescia, 25123
    Italy

    Active - Recruiting

  • Azienda Sanitaria Locale n. 2 - Lanciano Vasto Chieti

    Chieti, 66100
    Italy

    Completed

  • Ospedale SS. Annunziata

    Chieti, 66100
    Italy

    Active - Recruiting

  • Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico

    MilanoLombardia, 20122
    Italy

    Site Not Available

  • Azienda Ospedaliera Universitaria Federico II

    Napoli, 80131
    Italy

    Active - Recruiting

  • Ospedale Infantile Burlo Garofolo

    Trieste, 34137
    Italy

    Active - Recruiting

  • Kanagawa Children's Medical Center

    Yokohama, Kanagawa 232-8555
    Japan

    Active - Recruiting

  • Yokohama City University Hospital

    Yokohama, Kanagawa 236-0004
    Japan

    Active - Recruiting

  • Miyagi Children's Hospital

    Sendai, Miyagi 989-3126
    Japan

    Active - Recruiting

  • Miyagi Children's Hospital

    Sendai-shi, Miyagi 989 3126
    Japan

    Site Not Available

  • Osaka Medical and Pharmaceutical University Hospital

    Takatsuki, Osaka 569-8686
    Japan

    Active - Recruiting

  • Tokyo Medical And Dental University Hospital

    Bunkyo-ku, Tokyo 113-8519
    Japan

    Site Not Available

  • Institute of Science Tokyo Hospital

    Bunkyō, Tokyo 113-8510
    Japan

    Active - Recruiting

  • Tokyo Medical And Dental University Medical Hospital

    Bunkyō, Tokyo 113-8510
    Japan

    Active - Recruiting

  • Tokyo Medical and Dental University Hospital

    Bunkyō, Tokyo 113-8519
    Japan

    Active - Recruiting

  • Chiba Children's Hospital

    Chiba, 266-0007
    Japan

    Active - Recruiting

  • Kagoshima University Hospital

    Kagoshima, 890-8520
    Japan

    Active - Recruiting

  • Clinstile, S.A. de C.V.

    Mexico, Distrito Federal 06700
    Mexico

    Active - Recruiting

  • Clinstile, S.A. de C.V.

    Cuauhtemoc, Federal District 06700
    Mexico

    Site Not Available

  • CREA de Guadalajara, S.C.

    Guadalajara, Jalisco 44620
    Mexico

    Active - Recruiting

  • Crea de Guadalajara

    Guadalajara, Jalisco 44600
    Mexico

    Active - Recruiting

  • Hospital Univ. "Dr. José Eleuterio González"

    Monterrey, Nuevo León 64460
    Mexico

    Active - Recruiting

  • Hospital Universitario "Dr. Jose Eleuterio Gonzalez"

    Monterrey, Nuevo León 66460
    Mexico

    Active - Recruiting

  • Hospital Universitario Dr. José Eleuterio González, Universidad Autónoma de Nuevo León

    Monterrey, Nuevo León 66460
    Mexico

    Active - Recruiting

  • Investigacion y Biomedicina de Chihuahua

    Chihuahua, 31000
    Mexico

    Active - Recruiting

  • Instituto de Investigaciones Clínicas para la Salud

    Durango, 34000
    Mexico

    Active - Recruiting

  • Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji

    Warsaw, Mazowieckie 02-637
    Poland

    Active - Recruiting

  • Szpital Dzieciecy Sw. Ludwika

    Krakow, Małopolskie 31-503
    Poland

    Active - Recruiting

  • Wojewódzki Specjalistyczny Szpital Dziecięcy im. św. Ludwika w Krakowie

    Krakow, Małopolskie 31-503
    Poland

    Active - Recruiting

  • Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi

    Łódź, Łódzkie 91-738
    Poland

    Active - Recruiting

  • CSK, Uniwersyteckie Centrum Pediatrii im.M.Konopnickiej,Klinika Kardiologii i Reumatologii Dzieciecej

    Lodz, 91-738
    Poland

    Site Not Available

  • Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji

    Warszawa, 02-637
    Poland

    Site Not Available

  • Morozovsky Children's City Clinical Hospital

    Moscow, 119049
    Russian Federation

    Site Not Available

  • Saint-Petersburg State Pediatric Medical University

    Saint-Petersburg, 194100
    Russian Federation

    Site Not Available

  • Hospital Sant Joan de Déu

    Esplugues de Llobregat, Barcelona [Barcelona] 08950
    Spain

    Active - Recruiting

  • Hospital Infantil Universitario Niño Jesús

    Madrid, Madrid, Comunidad De 28009
    Spain

    Active - Recruiting

  • Hospital Universitario Ramón y Cajal

    Madrid, Madrid, Comunidad De 28034
    Spain

    Active - Recruiting

  • Hospital Universitario La Paz

    Madrid, 28046
    Spain

    Active - Recruiting

  • Hospital Universitario Virgen Del Rocio

    Sevilla, 41013
    Spain

    Active - Recruiting

  • Hospital Universitario La Fe de Valencia

    Valencia, 46026
    Spain

    Site Not Available

  • Hospital Universitari i Politecnic La Fe

    València, 46026
    Spain

    Active - Recruiting

  • Dokuz Eylül Üniversitesi

    Izmir, Balçova 35340
    Turkey

    Active - Recruiting

  • Istanbul Universitesi-Cerrahpasa Cerrahpasa Tip Fakultesi Yerleskesi

    Istanbul, 34098
    Turkey

    Active - Recruiting

  • Istanbul University-Cerrahpasa, Cerrahpasa Faculty of Medicine

    Istanbul, 34098
    Turkey

    Active - Recruiting

  • 9 Eylul University Hospital

    Izmir, 35340
    Turkey

    Active - Recruiting

  • Bristol Royal Hospital for Children

    Bristol, Bristol, City Of BS2 8BJ
    United Kingdom

    Active - Recruiting

  • Great Ormond Street Hospital For Children NHS Foundation Trust

    London, Camden WC1N 3JH
    United Kingdom

    Completed

  • Alder Hey Children's Hospital

    Liverpool, England L12 2AB
    United Kingdom

    Active - Recruiting

  • Great Ormond Street Hospital

    Bloomsbury, London WC1N 3JH
    United Kingdom

    Site Not Available

  • Oxford University Hospitals - Nuffield Orthopaedic Centre

    Oxford, Oxfordshire OX3 7HE
    United Kingdom

    Active - Recruiting

  • The John Radcliffe Hospital

    Oxford, Oxfordshire OX3 9DU
    United Kingdom

    Active - Recruiting

  • Leeds Teaching Hospital

    Leeds, LS1 3EX
    United Kingdom

    Site Not Available

  • Sheffield Children's Hospital

    Sheffield, S10 2TH
    United Kingdom

    Active - Recruiting

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