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.
Who is this study for? Child to young adult patients with Juvenile Idiopathic Arthritis
What treatments are being studied? Baricitinib
Status: Recruiting
Location: See all (55) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 1
Maximum Age: 17
Healthy Volunteers: f
View:
• Participants must have a diagnosis of systemic Juvenile Idiopathic Arthritis (sJIA) as defined by International League of Associations for Rheumatology (ILAR) criteria with 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 and less than 18 years of age, except in countries that restrict use of tocilizumab in participants less than 2 years of age
• Cohort 2 (open-label baricitinib): Participants who are at least 1 year and less than 18 years of age
Locations
Other Locations
Argentina
Instituto CAICI SRL
RECRUITING
Rosario
Centro Medico Privado de Reumatologia
RECRUITING
San M. De Tucuman
Belgium
UZ Gent
RECRUITING
Ghent
UZ Leuven
RECRUITING
Leuven
Brazil
Faculdade de Medicina da UNESP
RECRUITING
Botucatu
Hospital de Clinicas de Porto Alegre
RECRUITING
Porto Alegre
Instituto da Crianca do Hospital das Clinicas da FMUSP
RECRUITING
São Paulo
IPITEC
RECRUITING
São Paulo
Universidade Federal de Sao Paulo
RECRUITING
São Paulo
France
Hospices Civils de Lyon - Hôpital Femme Mère Enfant
RECRUITING
Bron
Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre
RECRUITING
Le Kremlin-bicêtre
Centre Hospitalier Universitaire de Nîmes - Hôpital Universitaire Carémeau
RECRUITING
Nîmes
Hôpital Universitaire Necker Enfants Malades
RECRUITING
Paris
Centre Hospitalier Universitaire de Poitiers
RECRUITING
Poitiers
Centre Hospitalier Régional Universitaire de Nancy - Hôpitaux de Brabois
SUSPENDED
Vandœuvre-lès-nancy
India
Sir Ganga Ram Hospital
RECRUITING
New Delhi
Israel
Meir Medical Center
RECRUITING
Kfar Saba
Schneider Children's Medical Center
RECRUITING
Petah Tikva
Sheba Medical Center
RECRUITING
Ramat Gan
Italy
Azienda Ospedaliera Spedali Civili di Brescia
RECRUITING
Brescia
Azienda Sanitaria Locale n. 2 - Lanciano Vasto Chieti
COMPLETED
Chieti
IRCCS Istituto Giannina Gaslini
RECRUITING
Genova
Centro Specialistico Ortopedico Traumatologico Gaetano Pini - CTO
RECRUITING
Milan
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
RECRUITING
Milan
University of Naples Federico II
RECRUITING
Napoli
Azienda di Rilievo Nazionale e Alta Specializzazione Civico Di Cristina Benfratelli
RECRUITING
Palermo
Ospedale Infantile Burlo Garofolo
RECRUITING
Trieste
Japan
Institute of Science Tokyo Hospital
RECRUITING
Bunkyō
Chiba Children's Hospital
RECRUITING
Chiba
Kagoshima University Hospital
RECRUITING
Kagoshima
Miyagi Children's Hospital
RECRUITING
Sendai
Osaka Medical and Pharmaceutical University Hospital
RECRUITING
Takatsuki
Kanagawa Children's Medical Center
RECRUITING
Yokohama
Yokohama City University Hospital
RECRUITING
Yokohama
Mexico
Investigacion y Biomedicina de Chihuahua
RECRUITING
Chihuahua City
Instituto de Investigaciones Clínicas para la Salud
RECRUITING
Durango
Crea de Guadalajara
RECRUITING
Guadalajara
Clinstile, S.A. de C.V.
RECRUITING
México
Hospital Universitario Dr. José Eleuterio González, Universidad Autónoma de Nuevo León
RECRUITING
Monterrey
Poland
Wojewódzki Specjalistyczny Szpital Dziecięcy im. św. Ludwika w Krakowie
RECRUITING
Krakow
Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi
RECRUITING
Lodz
Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji
RECRUITING
Warsaw
Spain
Hospital Sant Joan de Déu
RECRUITING
Esplugues De Llobregat
Hospital Infantil Universitario Niño Jesús
RECRUITING
Madrid
Hospital Universitario La Paz
RECRUITING
Madrid
Hospital Universitario Ramón y Cajal
RECRUITING
Madrid
Hospital Universitario Virgen Del Rocio
RECRUITING
Seville
Hospital Universitari i Politecnic La Fe
RECRUITING
Valencia
Turkey
Istanbul University-Cerrahpasa, Cerrahpasa Faculty of Medicine
RECRUITING
Istanbul
9 Eylul University Hospital
RECRUITING
Izmir
United Kingdom
Bristol Royal Hospital for Children
RECRUITING
Bristol
Alder Hey Children's Hospital
RECRUITING
Liverpool
Great Ormond Street Hospital For Children NHS Foundation Trust
COMPLETED
London
Oxford University Hospitals - Nuffield Orthopaedic Centre
RECRUITING
Oxford
Sheffield Children's Hospital
RECRUITING
Sheffield
Contact Information
Primary
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
LillyTrials@Lilly.com
1-317-615-4559
Backup
Physicians interested in becoming principal investigators please contact
clinical_inquiry_hub@lilly.com
Time Frame
Start Date: 2020-02-12
Estimated Completion Date: 2026-05
Participants
Target number of participants: 58
Treatments
Experimental: Cohort 1 Baricitinib
Baricitinib given orally.
Active_comparator: Cohort 1 Tocilizumab
Tocilizumab given Subcutaneously (SC).
Experimental: Cohort 2 Baricitinib
Baricitinib given orally.
Authors
Marisol Comacho Lovillo, Kamran Mahmood, Dirk Foell, Jürgen Brunner, Frank Weller-Heinemann, Daniel Philip Hawley, Reinhard Berner, Markus Hufnagel, Kirsten Minden, Alexandre Belot, Irène Lemelle, Rolando Cimaz, Akhila Kavirayani, Gerd Horneff, Athimalaipet Vaidyanathan Ramanan, Ivan Foeldvari, Mark Edward Wood, Ralf Trauzeddel, Elisabeth Solau-Gervais, Liora Harel, Yoshifumi Kawano, Wolfgang Emminger, Claudia Saad Magalhães, Piotr Marek Gietka, Cecile Boulanger, Ruben José Cuttica, Daniel Clemente, Inmaculada Calvo, Zbigniew Michal Zuber, Irina Nikishina, Alberto Jorge Spindler, Maria Terreri, Bernard Lauwerys, Narendra Kumar Bagri, Yuzaburo Inoue, FLAVIO ROBERTO SZTAJNBOK, Mahesh Janarthanan, Cesar Francisco Pacheco-Tena, Simone Appenzeller, Vyacheslav Chasnyk, Luciana Breda, Ekaterina Alexeeva, Serena Pastore, Rita Consolini, Yosef Uziel, Mia Glerup
Related Therapeutic Areas
Sponsors
Leads: Eli Lilly and Company