A Phase 3 Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients From 1 Year to <18 Years of Age With Juvenile Idiopathic Arthritis (JIA)
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 (81) 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 the treatment of JIA in participants ages 1 to 17. This study is for participants that have been enrolled in studies I4V-MC-JAHV (NCT03773978) or I4V-MC-JAHU.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 1
Maximum Age: 18
Healthy Volunteers: f
View:
• Participants must have completed a previous study of baricitinib for the treatment of JIA.
Locations
Other Locations
Argentina
Instituto CAICI SRL
RECRUITING
Rosario
Centro de Investigaciones Médicas Tucuman
RECRUITING
San M. De Tucuman
Australia
Royal Children's Hospital
NOT_YET_RECRUITING
Melbourne
Perth Children's Hospital
NOT_YET_RECRUITING
Perth
The Children's Hospital at Westmead
ACTIVE_NOT_RECRUITING
Westmead
Austria
Landeskrankenhaus Bregenz
COMPLETED
Bregenz
Belgium
Cliniques universitaires Saint-Luc
COMPLETED
Brussels
UZ Gent
RECRUITING
Ghent
UZ Leuven
RECRUITING
Leuven
Brazil
Faculdade de Medicina da UNESP
RECRUITING
Botucatu
Hospital de Clinicas de Porto Alegre
NOT_YET_RECRUITING
Porto Alegre
Instituto da Crianca do Hospital das Clinicas da FMUSP
RECRUITING
São Paulo
IPITEC
NOT_YET_RECRUITING
São Paulo
Universidade Federal de Sao Paulo
RECRUITING
São Paulo
China
Beijing Children's hospital, Capital Medical University
ACTIVE_NOT_RECRUITING
Beijing
Beijing Peking Union Medical College Hospital
NOT_YET_RECRUITING
Beijing
The Children's Hospital of Chongqing Medical University
ACTIVE_NOT_RECRUITING
Chongqing
The Second Affiliated Hospital Chongqing Medical University
NOT_YET_RECRUITING
Chongqing
Childrens Hospital of Nanjing Medical University
RECRUITING
Nanjing
Children's Hospital of Soochow University
RECRUITING
Suzhou
Denmark
Aarhus Universitetshospital, Skejby
RECRUITING
Aarhus
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
Germany
Charité Campus Virchow-Klinikum
COMPLETED
Berlin
Helios Klinikum Berlin-Buch
ACTIVE_NOT_RECRUITING
Berlin
Praxis Kinder- und Jugendrheumatologie Dr. Ivan Foeldvari
ACTIVE_NOT_RECRUITING
Hamburg
Universitätsklinikum Heidelberg
COMPLETED
Heidelberg
Asklepios Klinik Sankt Augustin
ACTIVE_NOT_RECRUITING
Sankt Augustin
Universitaetsklinikum Tuebingen
ACTIVE_NOT_RECRUITING
Tübingen
India
Sri Ramachandra MedicaL College & Research Institute
COMPLETED
Chennai
Sir Ganga Ram Hospital
RECRUITING
New Delhi
Christian Medical College Vellore
RECRUITING
Vellore
Israel
Rambam Health Care Campus
RECRUITING
Haifa
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
NOT_YET_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
NOT_YET_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
Kanazawa University Hospital
RECRUITING
Kanazawa
Niigata University Medical & Dental Hospital
RECRUITING
Niigata
Saitama Children's Medical Center
RECRUITING
Saitama-shi
Miyagi Children's Hospital
RECRUITING
Sendai
Tokyo Women's Medical University Hospital
RECRUITING
Shinjuku-ku
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. Jose Eleuterio Gonzalez
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
Russian Federation
Federal State Budgetary Scientific Institution Research Institute Rheumatology named after V.A.Nasonova
NOT_YET_RECRUITING
Moscow
Scientific Center of Children's Health
NOT_YET_RECRUITING
Moscow
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
NOT_YET_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
RECRUITING
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: 2019-04-05
Estimated Completion Date: 2031-07
Participants
Target number of participants: 190
Treatments
Experimental: Baricitinib
Baricitinib given orally.
Authors
Marisol Comacho Lovillo, Kamran Mahmood, Dirk Foell, Corinne Fisher, Jürgen Brunner, Frank Weller-Heinemann, Daniel Philip Hawley, Reinhard Berner, Markus Hufnagel, Kirsten Minden, Alexandre Belot, Irène Lemelle, Rolando Cimaz, Akhila Kavirayani, Jasmin Kümmerle-Deschner, Gerd Horneff, Athimalaipet V Vaidyanathan Ramanan, Jürgen Grulich-Henn, Ivan Foeldvari, Mark E Wood, Ralf Trauzeddel, Elisabeth Solau-Gervais, Christian Huemer, Susan Nielsen, Kenichi Yamaguchi, Natsumi Inoue, Zhixuan Zhou, Liora Harel, Yoshifumi Kawano, Wolfgang Emminger, Claudia Saad Magalhães, Charlotte Myrup, Piotr Marek Gietka, Thomas Lutz, Cecile Boulanger, Ruben Cuttica, Daniel Clemente, Inmaculada Calvo, Zbigniew Michal Zuber, Jeffrey Chaitow, Alberto Jorge Spindler, Bernard Lauwerys, Narendra Kumar Bagri, Yuzaburo Inoue, FLAVIO ROBERTO SZTAJNBOK, Yutaka Kawano, Teresa Giani, Mahesh Janarthanan, Bianca Lattanzi, Cesar Francisco Pacheco-Tena, Elena Zholobova, Simone Appenzeller, Vyacheslav Chasnyk, Luciana Breda, Serena Pastore, Troels Herlin, Rita Consolini, Xuemei Tang, Yosef Uziel
Related Therapeutic Areas
Sponsors
Leads: Eli Lilly and Company