Phase
Condition
Arthritis And Arthritic Pain (Pediatric)
Rheumatoid Arthritis (Pediatric)
Rheumatoid Arthritis
Treatment
Tocilizumab
Baricitinib
Placebo
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
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
Instituto CAICI SRL
Rosario, S2000
ArgentinaSite Not Available
Instituto CAICI SRL
Rosario 3838583, S2000
ArgentinaActive - Recruiting
Centro Medico Privado de Reumatologia
SAN M. de Tucuman, T4000AXL
ArgentinaActive - Recruiting
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
Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg
Leuven, Vlaams-Brabant 3000
BelgiumActive - Recruiting
UCL- Saint Luc
Bruxelles, 1200
BelgiumSite Not Available
UZ Gent
Gent, 9000
BelgiumSite Not Available
UZ Gent
Ghent 2797656, 9000
BelgiumActive - Recruiting
UZ Leuven
Leuven, 3000
BelgiumSite Not Available
UZ Leuven
Leuven 2792482, 3000
BelgiumSite Not Available
Hospital de Clinicas UNICAMP
Campinas, SP 13083-970
BrazilSite Not Available
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
Faculdade de Medicina da UNESP
Botucatu, 18618-686
BrazilSite Not Available
Faculdade de Medicina da UNESP
Botucatu 3469136, 18618-686
BrazilActive - Recruiting
Hospital de Clinicas de Porto Alegre
Porto Alegre, 90035-903
BrazilSite Not Available
Hospital de Clinicas de Porto Alegre
Porto Alegre 3452925, 90035-903
BrazilActive - Recruiting
IPPMG - Biblioteca Asdrubal Costa
Rio de Janeiro, 21941-612
BrazilSite Not Available
Instituto da Crianca do Hospital das Clinicas da FMUSP
Sao Paulo, 05403-000
BrazilSite Not Available
IPITEC
São Paulo, 01221-020
BrazilSite Not Available
Universidade Federal de Sao Paulo
São Paulo, 04022-001
BrazilActive - Recruiting
IPITEC
São Paulo 3448439, 01221-020
BrazilSite Not Available
Instituto da Crianca do Hospital das Clinicas da FMUSP
São Paulo 3448439, 05403-000
BrazilActive - Recruiting
Universidade Federal de Sao Paulo
São Paulo 3448439, 04024-001
BrazilActive - Recruiting
Detska nemocnice FN Brno
Brno, Brno-město 613 00
CzechiaSite Not Available
Detska nemocnice FN Brno
Brno 3078610, 613 00
CzechiaActive - Recruiting
Fakultni nemocnice Olomouc
Olomouc, 779 00
CzechiaActive - Recruiting
Lekarna Fakultni Nemocnice Olomouc
Olomouc, 779 00
CzechiaSite Not Available
Fakultni nemocnice Olomouc
Olomouc 3069011, 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
Prague 3067696, 12808
CzechiaActive - Recruiting
Vseobecna fakultni nemocnice v Praze
Praha 2, 12808
CzechiaSite Not Available
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
CHU Poitiers - Hopital Jean Bernard
Poitiers Cedex, Vienne 86021
FranceSite Not Available
Hospices Civils de Lyon - Hôpital Femme Mère Enfant
Bron, 69500
FranceSite Not Available
Hospices Civils de Lyon - Hôpital Femme Mère Enfant
Bron 3029931, 69500
FranceActive - Recruiting
Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre
Le Kremlin Bicetre, 94275
FranceSite Not Available
Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre
Le Kremlin-Bicêtre, 94270
FranceSite Not Available
Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre
Le Kremlin-Bicêtre 3003737, 94270
FranceActive - Recruiting
Centre Hospitalier Universitaire de Nîmes - Hôpital Universitaire Carémeau
Nîmes, 30029
FranceSite Not Available
Centre Hospitalier Universitaire de Nîmes - Hôpital Universitaire Carémeau
Nîmes 2990363, 30029
FranceActive - Recruiting
GH Necker - Enfants Malades
Paris, 75015
FranceActive - Recruiting
Hôpital Universitaire Necker Enfants Malades
Paris, 75015
FranceSite Not Available
Hôpital Universitaire Necker Enfants Malades
Paris 2988507, 75015
FranceActive - Recruiting
Centre Hospitalier Universitaire de Poitiers
Poitiers, 86021
FranceSite Not Available
Centre Hospitalier Universitaire de Poitiers
Poitiers 2986495, 86021
FranceActive - Recruiting
CHU de Nancy Hop D'Enfants de Brabois
Vandoeuvre Les Nancy Cedex, 54511
FranceSite Not Available
Centre Hospitalier Régional Universitaire de Nancy - Hôpitaux de Brabois
Vandoeuvre lès Nancy, 54500
FranceSite Not Available
Centre Hospitalier Régional Universitaire de Nancy - Hôpitaux de Brabois
Vandœuvre-lès-Nancy 2970797, 54500
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
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
Sir Ganga Ram Hospital
New Delhi, 110060
IndiaSite Not Available
Sir Ganga Ram Hospital
New Delhi 1261481, 110060
IndiaActive - Recruiting
Meir Medical Center
Kfar Saba, HaMerkaz 4428164
IsraelSite Not Available
Meir Medical Center
Kfar Saba 294514, 4428164
IsraelActive - Recruiting
Schneider Children's Medical Center
Petah Tikva, 49202
IsraelSite Not Available
Schneider Children's Medical Center
Petah Tikva 293918, 49202
IsraelActive - Recruiting
Schneider Children's Medical Center
Petah Tiqva, 4920235
IsraelSite Not Available
Sheba Medical Center
Ramat Gan, 5262100
IsraelSite Not Available
Sheba Medical Center
Ramat Gan 293788, 5262100
IsraelActive - Recruiting
Ospedale Pediatrico Gaslini - Istituto Giannina Gaslini
Genova, Liguria 16147
ItalyActive - Recruiting
Fondazione IRCCS Ca'Granda Ospedale Maggiore Policlinico
Milano, Lombardia 20122
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
ItalySite Not Available
Azienda Ospedaliera Spedali Civili di Brescia
Brescia 3181554, 25123
ItalyActive - Recruiting
Azienda Sanitaria Locale n. 2 - Lanciano Vasto Chieti
Chieti, 66100
ItalySite Not Available
Ospedale SS. Annunziata
Chieti, 66100
ItalyActive - Recruiting
Azienda Sanitaria Locale n. 2 - Lanciano Vasto Chieti
Chieti 3178796, 66100
ItalyCompleted
IRCCS Istituto Giannina Gaslini
Genova, 16147
ItalySite Not Available
IRCCS Istituto Giannina Gaslini
Genova 8969657, 16147
ItalyActive - Recruiting
Centro Specialistico Ortopedico Traumatologico Gaetano Pini - CTO
Milan 6951411, 20122
ItalyActive - Recruiting
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
Milan 6951411, 20122
ItalyCompleted
Centro Specialistico Ortopedico Traumatologico Gaetano Pini - CTO
Milano, 20122
ItalyActive - Recruiting
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
Milano, 20122
ItalySite Not Available
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
MilanoLombardia, 20122
ItalySite Not Available
Azienda Ospedaliera Universitaria Federico II
Napoli, 80131
ItalyActive - Recruiting
University of Naples Federico II
Napoli, 80131
ItalySite Not Available
University of Naples Federico II
Napoli 9031661, 80131
ItalyActive - Recruiting
Azienda di Rilievo Nazionale e Alta Specializzazione Civico Di Cristina Benfratelli
Palermo, 90127
ItalySite Not Available
Azienda di Rilievo Nazionale e Alta Specializzazione Civico Di Cristina Benfratelli
Palermo 2523920, 90127
ItalyActive - Recruiting
Ospedale Infantile Burlo Garofolo
Trieste, 34137
ItalySite Not Available
Ospedale Infantile Burlo Garofolo
Trieste 3165185, 34137
ItalyActive - Recruiting
Miyagi Children's Hospital
Sendai-shi, Miyagi 989 3126
JapanSite Not Available
Tokyo Medical And Dental University Hospital
Bunkyo-ku, Tokyo 113-8519
JapanSite Not Available
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
Institute of Science Tokyo Hospital
Bunkyō, 113-8510
JapanSite Not Available
Institute of Science Tokyo Hospital
Bunkyō 11077909, 113-8510
JapanActive - Recruiting
Chiba Children's Hospital
Chiba, 266-0007
JapanSite Not Available
Chiba Children's Hospital
Chiba 2113015, 266-0007
JapanActive - Recruiting
Kagoshima University Hospital
Kagoshima, 890-8520
JapanSite Not Available
Kagoshima University Hospital
Kagoshima 1860827, 890-8520
JapanActive - Recruiting
Miyagi Children's Hospital
Sendai, 989-3126
JapanSite Not Available
Miyagi Children's Hospital
Sendai 2111149, 989-3126
JapanActive - Recruiting
Osaka Medical and Pharmaceutical University Hospital
Takatsuki, 569-8686
JapanSite Not Available
Osaka Medical and Pharmaceutical University Hospital
Takatsuki 1850910, 569-8686
JapanActive - Recruiting
Kanagawa Children's Medical Center
Yokohama, 232-8555
JapanActive - Recruiting
Yokohama City University Hospital
Yokohama, 236-0004
JapanSite Not Available
Kanagawa Children's Medical Center
Yokohama 1848354, 232-8555
JapanActive - Recruiting
Yokohama City University Hospital
Yokohama 1848354, 236-0004
JapanActive - Recruiting
Clinstile, S.A. de C.V.
Cuauhtemoc, Federal District 06700
MexicoSite Not Available
CREA de Guadalajara, S.C.
Guadalajara, Jalisco 44620
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
Investigacion y Biomedicina de Chihuahua
Chihuahua, 31000
MexicoSite Not Available
Investigacion y Biomedicina de Chihuahua
Chihuahua City 4014338, 31000
MexicoActive - Recruiting
Instituto de Investigaciones Clínicas para la Salud
Durango, 34000
MexicoSite Not Available
Instituto de Investigaciones Clínicas para la Salud
Durango 4011743, 34000
MexicoActive - Recruiting
Crea de Guadalajara
Guadalajara, 44600
MexicoSite Not Available
Crea de Guadalajara
Guadalajara 4005539, 44600
MexicoActive - Recruiting
Clinstile, S.A. de C.V.
Mexico, 06700
MexicoSite Not Available
Hospital Universitario Dr. José Eleuterio González, Universidad Autónoma de Nuevo León
Monterrey, 66460
MexicoSite Not Available
Hospital Universitario Dr. José Eleuterio González, Universidad Autónoma de Nuevo León
Monterrey 3995465, 66460
MexicoActive - Recruiting
Clinstile, S.A. de C.V.
México 10248874, 06700
MexicoActive - Recruiting
Clinstile, S.A. de C.V.
México 4011515, 06700
MexicoSite Not Available
Szpital Dzieciecy Sw. Ludwika
Krakow, Małopolskie 31-503
PolandActive - Recruiting
Wojewódzki Specjalistyczny Szpital Dziecięcy im. św. Ludwika w Krakowie
Krakow, 31-503
PolandSite Not Available
Wojewódzki Specjalistyczny Szpital Dziecięcy im. św. Ludwika w Krakowie
Krakow 3094802, 31-503
PolandActive - Recruiting
CSK, Uniwersyteckie Centrum Pediatrii im.M.Konopnickiej,Klinika Kardiologii i Reumatologii Dzieciecej
Lodz, 91-738
PolandSite Not Available
Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi
Lodz 3093133, 91-738
PolandActive - Recruiting
Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji
Warsaw, 02-637
PolandSite Not Available
Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji
Warsaw 756135, 02-637
PolandActive - Recruiting
Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji
Warszawa, 02-637
PolandSite Not Available
Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi
Łódź, 91-738
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 Infantil Universitario Niño Jesús
Madrid, Madrid, Comunidad De 28009
SpainSite Not Available
Hospital Sant Joan de Déu
Esplugues de Llobregat, 08950
SpainSite Not Available
Hospital Sant Joan de Déu
Esplugues de Llobregat 3122826, 08950
SpainActive - Recruiting
Hospital Universitario La Paz
Madrid, 28046
SpainActive - Recruiting
Hospital Universitario Ramón y Cajal
Madrid, 28034
SpainActive - Recruiting
Hospital Infantil Universitario Niño Jesús
Madrid 3117735, 28009
SpainActive - Recruiting
Hospital Universitario La Paz
Madrid 3117735, 28046
SpainActive - Recruiting
Hospital Universitario Ramón y Cajal
Madrid 3117735, 28034
SpainActive - Recruiting
Hospital Universitario Virgen del Rocio
Sevilla, 41013
SpainSite Not Available
Hospital Universitario Virgen Del Rocio
Seville 2510911, 41013
SpainActive - Recruiting
Hospital Universitario La Fe de Valencia
Valencia, 46026
SpainSite Not Available
Hospital Universitari i Politecnic La Fe
Valencia 2509954, 46026
SpainActive - Recruiting
Hospital Universitari i Politecnic La Fe
València, 46026
SpainSite Not Available
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
TurkeySite Not Available
9 Eylul University Hospital
Izmir, 35340
TurkeySite Not Available
Istanbul University-Cerrahpasa, Cerrahpasa Faculty of Medicine
Istanbul 745044, 34098
Turkey (Türkiye)Active - Recruiting
9 Eylul University Hospital
Izmir 311046, 35340
Turkey (Türkiye)Active - Recruiting
Bristol Royal Hospital for Children
Bristol, Bristol, City Of BS2 8BJ
United KingdomSite Not Available
Great Ormond Street Hospital For Children NHS Foundation Trust
London, Camden WC1N 3JH
United KingdomSite Not Available
Great Ormond Street Hospital
Bloomsbury, London WC1N 3JH
United KingdomSite Not Available
The John Radcliffe Hospital
Oxford, Oxfordshire OX3 9DU
United KingdomActive - Recruiting
Bristol Royal Hospital for Children
Bristol 2654675, BS2 8BJ
United KingdomActive - Recruiting
Leeds Teaching Hospital
Leeds, LS1 3EX
United KingdomSite Not Available
Alder Hey Children's Hospital
Liverpool, L12 2AB
United KingdomSite Not Available
Alder Hey Children's Hospital
Liverpool 2644210, L12 2AB
United KingdomActive - Recruiting
Great Ormond Street Hospital For Children NHS Foundation Trust
London 2643743, WC1N 3JH
United KingdomCompleted
Oxford University Hospitals - Nuffield Orthopaedic Centre
Oxford, OX3 7HE
United KingdomSite Not Available
Oxford University Hospitals - Nuffield Orthopaedic Centre
Oxford 2640729, OX3 7HE
United KingdomActive - Recruiting
Sheffield Children's Hospital
Sheffield, S10 2TH
United KingdomSite Not Available
Sheffield Children's Hospital
Sheffield 2638077, S10 2TH
United KingdomActive - Recruiting

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