84
Participants
Start Date
October 29, 2018
Primary Completion Date
November 21, 2023
Study Completion Date
February 20, 2027
Golimumab
Participants receive subcutaneous (SC) golimumab through Week 50, where doses will be based on body surface area. After the Week 54 evaluations, at the discretion of investigator, participants benefiting from continued SC golimumab will continue to receive SC golimumab in the extension until end of study.
Infliximab
Participants will receive infliximab intravenous (IV) through Week 46. Doses will be based on body weight. After the Week 54 evaluations, participants receiving infliximab will be withdrawn from study participation and transition to local standard of care which may include continued commercially available infliximab at the discretion of their physician.
National Taiwan University Hospital, Taipei
Taipei Veterans General Hospital, Taipei
Universitair Kinderziekenhuis Koningin Fabiola, Brussels
UZ Brussel, Jette
Cliniques Universitaires Saint Luc, Brussels
Columbia University Medical Center, New York
Nemours DuPont Hospital for Children, Wilmington
Hosp. Infantil Univ. Nino Jesus, Madrid
Hosp. Gral. Univ. Gregorio Maranon, Madrid
Hosp. Univ. 12 de Octubre, Madrid
Hosp Regional Univ de Malaga, Málaga
Children's Center for Digestive Health Care, Atlanta
Hopital Pellegrin CHU Bordeaux, Bordeaux
Chang Gung Memorial Hospital- Linkou, Taoyuan
IRCCS Materno Infantile Burlo Garofolo, Trieste
GI For Kids, Knoxville
Azienda USL di Bologna - Ospedale Maggiore, Bologna
Hosp. Virgen Del Rocio, Seville
Kyungpook National University Chilgok Hospital, Daegu
Hosp. Univ. de Cruces, Barakaldo
AOU Meyer, Florence
Sheba Medical Center, Ramat Gan
Mayo Clinic, Rochester
Assaf Harofeh Medical Center, Rishon LeZiyyon
Casa Sollievo Della Sofferenza IRCCS, San Giovanni Rotondo
Hôpital Necker, Paris
DHAT Research Institute, Garland
Children's Medical Center of Dallas, Dallas
Cook Childrens Medical Center, Fort Worth
Children's Hospital Colorado and University of Colorado, Aurora
Rocky Mountain Pediatric Gastroenterology, Lone Tree
Shaare Zedek Medical Center, Jerusalem
University of California San Francisco, San Francisco
AOU Policlinico G.Martino, Messina
Rambam Medical Center, Haifa
Schneider Children's Medical Center, Petah Tikva
Sourasky Medical Center, Tel Aviv
Connecticut Children's Medical Center, Hartford
MK Blumenau Pesquisa Clínica, Blumenau
Hospital Pequeno Principe, Curitiba
Irmandade Santa Casa de Misericordia de Porto Alegre, Porto Alegre
BR Trials, São Paulo
AOU Policlinico Umberto I, Roma
IRCCS Ospedale Pediatrico Bambino Gesu, Roma
Emma Children's Hospital Academic Medical Center, Amsterdam
Isala Kliniek, Zwolle
Szpital Uniwersytecki NR 1 IM Dr Antoniego Jurasza, Bydgoszcz
Szpital im. M. Kopernika, Gdansk
Uniwersytecki Szpital Dzieciecy w Krakowie, Krakow
Wojewodzki Specjalistyczny Szpital Dzieciecy im Prof Stanislawa Popowskiego, Olsztyn
Korczowski Bartosz Gabinet Lekarski, Rzeszów
Centrum Zdrowia Matki Dziecka i Mlodziezy, Warsaw
Szpital Pomnik Centrum Zdrowia Dziecka, Warsaw
Seoul National University Hospital, Seoul
Severance Hospital Yonsei University Health System, Seoul
Asan Medical Center, Seoul
Samsung Medical Center, Seoul
Hosp. Sant Joan de Deu, Barcelona
Janssen Research & Development, LLC
INDUSTRY