Phase
Condition
Fever
Arthritis And Arthritic Pain (Pediatric)
Rheumatoid Arthritis
Treatment
Placebo
Tocilizumab
Baricitinib
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 M. DE Tucuman, Tucumán T4000AXL
ArgentinaActive - Recruiting
Centro de Investigaciones Médicas Tucuman
SAN M. DE Tucuman, Tucumán T4000AXL
ArgentinaActive - Recruiting
Instituto CAICI SRL
Rosario, S2000
ArgentinaSite Not Available
Centro Medico Privado de Reumatologia
SAN M. de Tucuman, T4000AXL
ArgentinaCompleted
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
UZ Gent
Ghent, 9000
BelgiumActive - Recruiting
Faculdade de Medicina de Botucatu
Botucatu, São Paulo 18618-970
BrazilActive - Recruiting
Instituto da Crianca do Hospital das Clinicas da FMUSP
Sao Paulo, São Paulo 05403-000
BrazilActive - Recruiting
Faculdade de Medicina da UNESP
Botucatu, 18618-686
BrazilActive - Recruiting
Hospital de Clinicas de Porto Alegre
Porto Alegre, 90035-903
BrazilActive - Recruiting
IPITEC
São Paulo, 01221-020
BrazilSite Not Available
Instituto da Crianca do Hospital das Clinicas da FMUSP
São Paulo, 05403-000
BrazilActive - Recruiting
Universidade Federal de Sao Paulo
São Paulo, 04024-001
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, 04022-001
BrazilActive - Recruiting
Detska nemocnice FN Brno
Brno, 613 00
CzechiaActive - Recruiting
Fakultni nemocnice Olomouc
Olomouc, 779 00
CzechiaActive - Recruiting
Vseobecna fakultni nemocnice v Praze
Prague, 12808
CzechiaActive - Recruiting
Aarhus Universitetshospital
Aarhus, Midtjylland 8200
DenmarkActive - Recruiting
Centre Hospitalier Régional Universitaire de Nancy - Hôpitaux de Brabois
Vandoeuvre lès Nancy, Meurthe-et-Moselle 54500
FranceSuspended
Hospices Civils de Lyon - Hôpital Femme Mère Enfant
Bron, 69500
FranceCompleted
Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre
Le Kremlin-Bicêtre, 94270
FranceSite Not Available
Centre Hospitalier Universitaire de Nîmes - Hôpital Universitaire Carémeau
Nîmes, 30029
FranceCompleted
GH Necker - Enfants Malades
Paris, 75015
FranceActive - Recruiting
Hôpital Universitaire Necker Enfants Malades
Paris, 75015
FranceActive - Recruiting
Centre Hospitalier Universitaire de Poitiers
Poitiers, 86021
FranceActive - Recruiting
Christian Medical College Vellore
Vellore, Tamil Nadu 632 004
IndiaCompleted
Sir Ganga Ram Hospital
New Delhi, 110060
IndiaActive - Recruiting
Meir Medical Center
Kfar Saba, 4428164
IsraelActive - Recruiting
Schneider Children's Medical Center
Petah Tikva, 49202
IsraelActive - Recruiting
Sheba Medical Center
Ramat Gan, 5262100
IsraelActive - Recruiting
University of Naples Federico II
Napoli, Campania 80131
ItalyActive - Recruiting
Ospedale Pediatrico Gaslini - Istituto Giannina Gaslini
Genova, Liguria 16147
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
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
IRCCS Istituto Giannina Gaslini
Genova, 16147
ItalyCompleted
Centro Specialistico Ortopedico Traumatologico Gaetano Pini - CTO
Milan, 20122
ItalyActive - Recruiting
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
Milan, 20122
ItalyCompleted
Centro Specialistico Ortopedico Traumatologico Gaetano Pini - CTO
Milan 6951411, 20122
ItalyActive - Recruiting
Centro Specialistico Ortopedico Traumatologico Gaetano Pini - CTO
Milano, 20122
ItalyActive - Recruiting
University of Naples Federico II
Naples, 80131
ItalyCompleted
Azienda Ospedaliera Universitaria Federico II
Napoli, 80131
ItalyActive - Recruiting
Azienda di Rilievo Nazionale e Alta Specializzazione Civico Di Cristina Benfratelli
Palermo, 90127
ItalyActive - Recruiting
Ospedale Infantile Burlo Garofolo
Trieste, 34137
ItalyActive - 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
Institute of Science Tokyo Hospital
Bunkyō, 113-8510
JapanActive - Recruiting
Chiba Children's Hospital
Chiba, 266-0007
JapanActive - Recruiting
Kagoshima University Hospital
Kagoshima, 890-8520
JapanActive - Recruiting
Miyagi Children's Hospital
Sendai, 989-3126
JapanActive - Recruiting
Osaka Medical and Pharmaceutical University Hospital
Takatsuki, 569-8686
JapanActive - Recruiting
Kanagawa Children's Medical Center
Yokohama, 232-8555
JapanActive - Recruiting
Yokohama City University Hospital
Yokohama, 236-0004
JapanActive - Recruiting
Kanagawa Children's Medical Center
Yokohama 1848354, 232-8555
JapanActive - Recruiting
Clinstile, S.A. de C.V.
Mexico, Distrito Federal 06700
MexicoActive - Recruiting
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 City, 31000
MexicoCompleted
Instituto de Investigaciones Clínicas para la Salud
Durango, 34000
MexicoCompleted
Crea de Guadalajara
Guadalajara, 44600
MexicoCompleted
Hospital Universitario Dr. José Eleuterio González, Universidad Autónoma de Nuevo León
Monterrey, 66460
MexicoSite Not Available
Clinstile, S.A. de C.V.
México, 06700
MexicoCompleted
Szpital Dzieciecy Sw. Ludwika
Krakow, Małopolskie 31-503
PolandActive - Recruiting
Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi
Łódź, Łódzkie 91-738
PolandActive - Recruiting
Wojewódzki Specjalistyczny Szpital Dziecięcy im. św. Ludwika w Krakowie
Krakow, 31-503
PolandActive - Recruiting
Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi
Lodz, 91-738
PolandActive - Recruiting
Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji
Warsaw, 02-637
PolandActive - Recruiting
Hospital Sant Joan de Déu
Esplugues de Llobregat, 08950
SpainActive - Recruiting
Hospital Infantil Universitario Niño Jesús
Madrid, 28009
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 Ramón y Cajal
Madrid 3117735, 28034
SpainActive - Recruiting
Hospital Universitario Virgen Del Rocio
Seville, 41013
SpainActive - Recruiting
Hospital Universitari i Politecnic La Fe
Valencia, 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
Turkey (Türkiye)Active - Recruiting
9 Eylul University Hospital
Izmir, 35340
Turkey (Türkiye)Active - Recruiting
The John Radcliffe Hospital
Oxford, Oxfordshire OX3 9DU
United KingdomActive - Recruiting
Bristol Royal Hospital for Children
Bristol, BS2 8BJ
United KingdomSite Not Available
Alder Hey Children's Hospital
Liverpool, L12 2AB
United KingdomCompleted
Great Ormond Street Hospital For Children NHS Foundation Trust
London, WC1N 3JH
United KingdomCompleted
Oxford University Hospitals - Nuffield Orthopaedic Centre
Oxford, OX3 7HE
United KingdomSite Not Available
Sheffield Children's Hospital
Sheffield, S10 2TH
United KingdomCompleted

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