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A Study of Baricitinib (LY3009104) in Participants From 1 Year to Less Than 18 Years Old With Systemic Juvenile Idiopathic Arthritis (sJIA)
Sponsor: Eli Lilly and Company
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.
Official title: Open-Label, Randomized Study With a Tocilizumab Reference Arm to Evaluate Safety, Efficacy and Pharmacokinetics of Baricitinib in Children From 1 to Less Than 18 Years of Age With Systemic Juvenile Idiopathic Arthritis.
Key Details
Gender
All
Age Range
1 Year - 17 Years
Study Type
INTERVENTIONAL
Enrollment
58
Start Date
2020-02-12
Completion Date
2026-09
Last Updated
2026-02-10
Healthy Volunteers
No
Conditions
Interventions
Baricitinib
Administered orally
Tocilizumab
Administered SC
Locations (55)
Instituto CAICI SRL
Rosario, Argentina
Centro Medico Privado de Reumatologia
SAN M. de Tucuman, Argentina
UZ Gent
Ghent, Belgium
Faculdade de Medicina da UNESP
Botucatu, Brazil
Hospital de Clinicas de Porto Alegre
Porto Alegre, Brazil
IPITEC
São Paulo, Brazil
Universidade Federal de Sao Paulo
São Paulo, Brazil
Instituto da Crianca do Hospital das Clinicas da FMUSP
São Paulo, Brazil
Detska nemocnice FN Brno
Brno, Czechia
Vseobecna fakultni nemocnice v Praze
Prague, Czechia
Hospices Civils de Lyon - Hôpital Femme Mère Enfant
Bron, France
Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre
Le Kremlin-Bicêtre, France
Centre Hospitalier Universitaire de Nîmes - Hôpital Universitaire Carémeau
Nîmes, France
Hôpital Universitaire Necker Enfants Malades
Paris, France
Centre Hospitalier Universitaire de Poitiers
Poitiers, France
Sir Ganga Ram Hospital
New Delhi, India
Meir Medical Center
Kfar Saba, Israel
Schneider Children's Medical Center
Petah Tikva, Israel
Sheba Medical Center
Ramat Gan, Israel
Azienda Ospedaliera Spedali Civili di Brescia
Brescia, Italy
Azienda Sanitaria Locale n. 2 - Lanciano Vasto Chieti
Chieti, Italy
IRCCS Istituto Giannina Gaslini
Genova, Italy
Centro Specialistico Ortopedico Traumatologico Gaetano Pini - CTO
Milan, Italy
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
Milan, Italy
University of Naples Federico II
Naples, Italy
Azienda di Rilievo Nazionale e Alta Specializzazione Civico Di Cristina Benfratelli
Palermo, Italy
Ospedale Infantile Burlo Garofolo
Trieste, Italy
Institute of Science Tokyo Hospital
Bunkyō, Japan
Chiba Children's Hospital
Chiba, Japan
Kagoshima University Hospital
Kagoshima, Japan
Miyagi Children's Hospital
Sendai, Japan
Osaka Medical and Pharmaceutical University Hospital
Takatsuki, Japan
Kanagawa Children's Medical Center
Yokohama, Japan
Yokohama City University Hospital
Yokohama, Japan
Investigacion y Biomedicina de Chihuahua
Chihuahua City, Mexico
Instituto de Investigaciones Clínicas para la Salud
Durango, Mexico
Crea de Guadalajara
Guadalajara, Mexico
Clinstile, S.A. de C.V.
México, Mexico
Hospital Universitario Dr. José Eleuterio González, Universidad Autónoma de Nuevo León
Monterrey, Mexico
Wojewódzki Specjalistyczny Szpital Dziecięcy im. św. Ludwika w Krakowie
Krakow, Poland
Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi
Lodz, Poland
Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji
Warsaw, Poland
Hospital Sant Joan de Déu
Esplugues de Llobregat, Spain
Hospital Infantil Universitario Niño Jesús
Madrid, Spain
Hospital Universitario Ramón y Cajal
Madrid, Spain
Hospital Universitario La Paz
Madrid, Spain
Hospital Universitario Virgen Del Rocio
Seville, Spain
Hospital Universitari i Politecnic La Fe
Valencia, Spain
Istanbul University-Cerrahpasa, Cerrahpasa Faculty of Medicine
Istanbul, Turkey (Türkiye)
9 Eylul University Hospital
Izmir, Turkey (Türkiye)
Bristol Royal Hospital for Children
Bristol, United Kingdom
Alder Hey Children's Hospital
Liverpool, United Kingdom
Great Ormond Street Hospital For Children NHS Foundation Trust
London, United Kingdom
Oxford University Hospitals - Nuffield Orthopaedic Centre
Oxford, United Kingdom
Sheffield Children's Hospital
Sheffield, United Kingdom