Phase
Condition
Joint Injuries
Arthritis And Arthritic Pain (Pediatric)
Rheumatoid Arthritis
Treatment
Baricitinib
Placebo
Tocilizumab
Clinical Study ID
Ages 1-17 All Genders
Study Summary
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
Connect with a study center
Instituto CAICI SRL
Rosario, Santa Fe S2000
ArgentinaActive - Recruiting
Centro Medico Privado de Reumatologia
San Miguel de Tucuman, Tucuman T4000AXL
ArgentinaSite Not Available
Centro Medico Privado de Reumatologia
SAN M. DE Tucuman, Tucumán T4000AXL
ArgentinaActive - Recruiting
Centro de Investigaciones Médicas Tucuman
SAN M. DE Tucuman, Tucumán T4000AXL
ArgentinaActive - Recruiting
Hospital General de Niños Dr. Pedro de Elizalde
Buenos Aires, 1270
ArgentinaSite Not Available
Centro Medico Privado de Reumatologia
Tucuman, T4000AXL
ArgentinaSite Not Available
Universitätsklinik Innsbruck
Innsbruck, Tirol 6020
AustriaSite Not Available
Medizinische Universität Wien
Wien, Vienna 1090
AustriaSite Not Available
Medizinische Universität Wien
Vienna, Wien 1090
AustriaSite Not Available
Medizinische Universität Wien - Kinder und Jugendheilkunde
Vienna, Wien 1090
AustriaSite Not Available
Cliniques universitaires Saint-Luc
Brussels, Bruxelles-Capitale, Région De 1200
BelgiumSite Not Available
UZ Gent-Reuma
Gent, East Flanders 9000
BelgiumActive - Recruiting
UZ Gent
Gent, Oost-Vlaanderen 9000
BelgiumActive - Recruiting
UZ Leuven
Leuven, Vlaams-Brabant 3000
BelgiumActive - Recruiting
Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg
Leuven, Vlaams-Brabant 3000
BelgiumActive - Recruiting
UCL- Saint Luc
Bruxelles, 1200
BelgiumSite Not Available
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande Do Sul 90035-903
BrazilActive - Recruiting
Hospital de Clinicas UNICAMP
Campinas, SP 13083-970
BrazilSite Not Available
Faculdade de Medicina da UNESP
Botucatu, São Paulo 18618-686
BrazilActive - Recruiting
Faculdade de Medicina de Botucatu
Botucatu, São Paulo 18618-970
BrazilActive - Recruiting
Hospital de Clínicas Da Universidade Estadual de Campinas
Campinas, São Paulo 13083-888
BrazilSite Not Available
Instituto da Crianca do Hospital das Clinicas da FMUSP
Sao Paulo, São Paulo 05403-000
BrazilActive - Recruiting
IPPMG - Biblioteca Asdrubal Costa
Rio de Janeiro, 21941-612
BrazilSite Not Available
IPITEC
São Paulo, 01221-020
BrazilActive - Recruiting
Universidade Federal de Sao Paulo
São Paulo, 04022-001
BrazilActive - Recruiting
Detska nemocnice FN Brno
Brno, Brno-město 613 00
CzechiaActive - Recruiting
Fakultni nemocnice Olomouc
Olomouc, 779 00
CzechiaActive - Recruiting
Lekarna Fakultni Nemocnice Olomouc
Olomouc, 779 00
CzechiaSite Not Available
Centrum detske revmatologie VFN, Klinika detskeho a dorostoveho lekarstvi 1.LFUK a VFN v Praze
Prague, 121 08
CzechiaSite Not Available
Vseobecna fakultni nemocnice v Praze
Praha 2, 12808
CzechiaActive - Recruiting
Aarhus Universitetshospital
Aarhus, Midtjylland 8200
DenmarkActive - Recruiting
Aarhus Universitetshospital, Skejby
Aarhus, Midtjylland 8200
DenmarkSite Not Available
Centre Hospitalier Universitaire de Nîmes - Hôpital Universitaire Carémeau
Nimes Cedex 9, Gard 30029
FranceSite Not Available
Centre Hospitalier Universitaire de Nîmes - Hôpital Universitaire Carémeau
Nîmes, Gard 30029
FranceActive - Recruiting
Centre Hospitalier Régional Universitaire de Nancy - Hôpitaux de Brabois
Vandoeuvre lès Nancy, Meurthe-et-Moselle 54500
FranceSuspended
Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre
Le Kremlin-Bicêtre, Paris 94270
FranceActive - Recruiting
Hospices Civils de Lyon - Hôpital Femme Mère Enfant
Bron, Rhône-Alpes 69500
FranceActive - Recruiting
Centre Hospitalier Universitaire de Poitiers
Poitiers, Vienne 86021
FranceActive - Recruiting
CHU Poitiers - Hopital Jean Bernard
Poitiers Cedex, Vienne 86021
FranceSite Not Available
Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre
Le Kremlin Bicetre, 94275
FranceSite Not Available
GH Necker - Enfants Malades
Paris, 75015
FranceActive - Recruiting
Hôpital Universitaire Necker Enfants Malades
Paris, 75015
FranceActive - Recruiting
CHU de Nancy Hop D'Enfants de Brabois
Vandoeuvre Les Nancy Cedex, 54511
FranceSite Not Available
Universitätsklinikum Freiburg
Freiburg im Breisgau, Baden-Württemberg 79106
GermanySite Not Available
Universitätsklinikum Münster
Münster, Nordrhein-Westfalen 48149
GermanySite Not Available
Asklepios Klinik Sankt Augustin
Saint Augustin, Nordrhein-Westfalen 53757
GermanySite Not Available
Universitätsklinikum Carl Gustav Carus
Dresden, Sachsen 01307
GermanySite Not Available
Charité Campus Virchow-Klinikum
Berlin, 13353
GermanySite Not Available
Klinikum Bremen-Mitte
Bremen, 28205
GermanySite Not Available
Hamburger Zentrum für Kinder und Jugendrheumatologie
Hamburg, 22081
GermanySite Not Available
Sri Ramachandra MedicaL College & Research Institute
Porur, Chennai 600116
IndiaSite Not Available
All India Institue of Medical Sciences (AIIMS)
New Delhi, Delhi 110029
IndiaSite Not Available
Sir Ganga Ram Hospital
New Delhi, Delhi 110060
IndiaActive - Recruiting
SRI Ramachandra Medical College and Hospital
Chennai, Tamil Nadu 600116
IndiaSite Not Available
Sri Ramachandra MedicaL College & Research Institute
Chennai, Tamil Nadu 600116
IndiaSite Not Available
Christian Medical College Vellore
Vellore, Tamil Nadu 632004
IndiaSite Not Available
Sanjay Gandhi Post Graduate Institute of Medical Sciences
Lucknow, Uttar Pradesh 226014
IndiaSite Not Available
Meir Medical Center
Kfar Saba, HaMerkaz 4428164
IsraelActive - Recruiting
Schneider Children's Medical Center
Petah Tikva, HaMerkaz 49202
IsraelActive - Recruiting
Sheba Medical Center
Ramat Gan, HaMerkaz 5262100
IsraelActive - Recruiting
Schneider Children's Medical Center
Petah Tiqva, 4920235
IsraelSite Not Available
University of Naples Federico II
Napoli, Campania 80131
ItalyActive - Recruiting
IRCCS Istituto Giannina Gaslini
Genova, Liguria 16147
ItalyActive - Recruiting
Ospedale Pediatrico Gaslini - Istituto Giannina Gaslini
Genova, Liguria 16147
ItalyActive - Recruiting
Centro Specialistico Ortopedico Traumatologico Gaetano Pini - CTO
Milano, Lombardia 20122
ItalyActive - Recruiting
Fondazione IRCCS Ca'Granda Ospedale Maggiore Policlinico
Milano, Lombardia 20122
ItalyActive - Recruiting
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
Milano, Lombardia 20122
ItalyActive - Recruiting
Azienda di Rilievo Nazionale e Alta Specializzazione Civico Di Cristina Benfratelli
Palermo, Sicilia 90127
ItalyActive - Recruiting
Azienda Ospedaliera Universitaria Pisana
Pisa, Toscana 56126
ItalySite Not Available
ASST Spedali Civili - Università degli Studi
Brescia, 25123
ItalyActive - Recruiting
Azienda Ospedaliera Spedali Civili di Brescia
Brescia, 25123
ItalyActive - Recruiting
Azienda Sanitaria Locale n. 2 - Lanciano Vasto Chieti
Chieti, 66100
ItalyCompleted
Ospedale SS. Annunziata
Chieti, 66100
ItalyActive - Recruiting
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
MilanoLombardia, 20122
ItalySite Not Available
Azienda Ospedaliera Universitaria Federico II
Napoli, 80131
ItalyActive - Recruiting
Ospedale Infantile Burlo Garofolo
Trieste, 34137
ItalyActive - Recruiting
Kanagawa Children's Medical Center
Yokohama, Kanagawa 232-8555
JapanActive - Recruiting
Yokohama City University Hospital
Yokohama, Kanagawa 236-0004
JapanActive - Recruiting
Miyagi Children's Hospital
Sendai, Miyagi 989-3126
JapanActive - Recruiting
Miyagi Children's Hospital
Sendai-shi, Miyagi 989 3126
JapanSite Not Available
Osaka Medical and Pharmaceutical University Hospital
Takatsuki, Osaka 569-8686
JapanActive - Recruiting
Tokyo Medical And Dental University Hospital
Bunkyo-ku, Tokyo 113-8519
JapanSite Not Available
Institute of Science Tokyo Hospital
Bunkyō, Tokyo 113-8510
JapanActive - Recruiting
Tokyo Medical And Dental University Medical Hospital
Bunkyō, Tokyo 113-8510
JapanActive - Recruiting
Tokyo Medical and Dental University Hospital
Bunkyō, Tokyo 113-8519
JapanActive - Recruiting
Chiba Children's Hospital
Chiba, 266-0007
JapanActive - Recruiting
Kagoshima University Hospital
Kagoshima, 890-8520
JapanActive - Recruiting
Clinstile, S.A. de C.V.
Mexico, Distrito Federal 06700
MexicoActive - Recruiting
Clinstile, S.A. de C.V.
Cuauhtemoc, Federal District 06700
MexicoSite Not Available
CREA de Guadalajara, S.C.
Guadalajara, Jalisco 44620
MexicoActive - Recruiting
Crea de Guadalajara
Guadalajara, Jalisco 44600
MexicoActive - Recruiting
Hospital Univ. "Dr. José Eleuterio González"
Monterrey, Nuevo León 64460
MexicoActive - Recruiting
Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
Monterrey, Nuevo León 66460
MexicoActive - Recruiting
Hospital Universitario Dr. José Eleuterio González, Universidad Autónoma de Nuevo León
Monterrey, Nuevo León 66460
MexicoActive - Recruiting
Investigacion y Biomedicina de Chihuahua
Chihuahua, 31000
MexicoActive - Recruiting
Instituto de Investigaciones Clínicas para la Salud
Durango, 34000
MexicoActive - Recruiting
Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji
Warsaw, Mazowieckie 02-637
PolandActive - Recruiting
Szpital Dzieciecy Sw. Ludwika
Krakow, Małopolskie 31-503
PolandActive - Recruiting
Wojewódzki Specjalistyczny Szpital Dziecięcy im. św. Ludwika w Krakowie
Krakow, Małopolskie 31-503
PolandActive - Recruiting
Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi
Łódź, Łódzkie 91-738
PolandActive - Recruiting
CSK, Uniwersyteckie Centrum Pediatrii im.M.Konopnickiej,Klinika Kardiologii i Reumatologii Dzieciecej
Lodz, 91-738
PolandSite Not Available
Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji
Warszawa, 02-637
PolandSite Not Available
Morozovsky Children's City Clinical Hospital
Moscow, 119049
Russian FederationSite Not Available
Saint-Petersburg State Pediatric Medical University
Saint-Petersburg, 194100
Russian FederationSite Not Available
Hospital Sant Joan de Déu
Esplugues de Llobregat, Barcelona [Barcelona] 08950
SpainActive - Recruiting
Hospital Infantil Universitario Niño Jesús
Madrid, Madrid, Comunidad De 28009
SpainActive - Recruiting
Hospital Universitario Ramón y Cajal
Madrid, Madrid, Comunidad De 28034
SpainActive - Recruiting
Hospital Universitario La Paz
Madrid, 28046
SpainActive - Recruiting
Hospital Universitario Virgen Del Rocio
Sevilla, 41013
SpainActive - Recruiting
Hospital Universitario La Fe de Valencia
Valencia, 46026
SpainSite Not Available
Hospital Universitari i Politecnic La Fe
València, 46026
SpainActive - Recruiting
Dokuz Eylül Üniversitesi
Izmir, Balçova 35340
TurkeyActive - Recruiting
Istanbul Universitesi-Cerrahpasa Cerrahpasa Tip Fakultesi Yerleskesi
Istanbul, 34098
TurkeyActive - Recruiting
Istanbul University-Cerrahpasa, Cerrahpasa Faculty of Medicine
Istanbul, 34098
TurkeyActive - Recruiting
9 Eylul University Hospital
Izmir, 35340
TurkeyActive - Recruiting
Bristol Royal Hospital for Children
Bristol, Bristol, City Of BS2 8BJ
United KingdomActive - Recruiting
Great Ormond Street Hospital For Children NHS Foundation Trust
London, Camden WC1N 3JH
United KingdomCompleted
Alder Hey Children's Hospital
Liverpool, England L12 2AB
United KingdomActive - Recruiting
Great Ormond Street Hospital
Bloomsbury, London WC1N 3JH
United KingdomSite Not Available
Oxford University Hospitals - Nuffield Orthopaedic Centre
Oxford, Oxfordshire OX3 7HE
United KingdomActive - Recruiting
The John Radcliffe Hospital
Oxford, Oxfordshire OX3 9DU
United KingdomActive - Recruiting
Leeds Teaching Hospital
Leeds, LS1 3EX
United KingdomSite Not Available
Sheffield Children's Hospital
Sheffield, S10 2TH
United KingdomActive - Recruiting
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