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A Study to Assess the Efficacy and Safety of Golimumab in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis
Sponsor: Janssen Research & Development, LLC
Summary
The purpose of this study is to evaluate efficacy of golimumab in inducing clinical remission as assessed by the Mayo score, in pediatric participants with moderately to severely active ulcerative colitis (UC). In addition, the safety profile of golimumab, in pediatric participants with moderately to severely active UC will be assessed.
Official title: A Phase 3 Randomized, Open-Label Study to Assess the Efficacy, Safety, and Pharmacokinetics of Golimumab Treatment, a Human Anti-TNFα Monoclonal Antibody, Administered Subcutaneously in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis
Key Details
Gender
All
Age Range
2 Years - 17 Years
Study Type
INTERVENTIONAL
Enrollment
84
Start Date
2018-10-29
Completion Date
2027-02-20
Last Updated
2026-03-19
Healthy Volunteers
No
Conditions
Interventions
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 After the Week 54 evaluations, participants receiving infliximab will be withdrawn from study participation and transition to local standard of care which may include continued commercially available infliximab at the discretion of their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.
Locations (58)
University of California San Francisco
San Francisco, California, United States
Children's Hospital Colorado and University of Colorado
Aurora, Colorado, United States
Rocky Mountain Pediatric Gastroenterology
Lone Tree, Colorado, United States
Connecticut Children's Medical Center
Hartford, Connecticut, United States
Nemours DuPont Hospital for Children
Wilmington, Delaware, United States
Children's Center for Digestive Health Care
Atlanta, Georgia, United States
Mayo Clinic
Rochester, Minnesota, United States
Columbia University Medical Center
New York, New York, United States
GI For Kids
Knoxville, Tennessee, United States
Children's Medical Center of Dallas
Dallas, Texas, United States
Cook Childrens Medical Center
Fort Worth, Texas, United States
DHAT Research Institute
Garland, Texas, United States
Universitair Kinderziekenhuis Koningin Fabiola
Brussels, Belgium
Cliniques Universitaires Saint Luc
Brussels, Belgium
UZ Brussel
Jette, Belgium
MK Blumenau Pesquisa Clínica
Blumenau, Brazil
Hospital Pequeno Principe
Curitiba, Brazil
Irmandade Santa Casa de Misericordia de Porto Alegre
Porto Alegre, Brazil
BR Trials
São Paulo, Brazil
Hopital Pellegrin CHU Bordeaux
Bordeaux, France
Hôpital Necker
Paris, France
Rambam Medical Center
Haifa, Israel
Shaare Zedek Medical Center
Jerusalem, Israel
Schneider Children's Medical Center
Petah Tikva, Israel
Sheba Medical Center
Ramat Gan, Israel
Assaf Harofeh Medical Center
Rishon LeZiyyon, Israel
Sourasky Medical Center
Tel Aviv, Israel
Azienda USL di Bologna - Ospedale Maggiore
Bologna, Italy
AOU Meyer
Florence, Italy
AOU Policlinico G.Martino
Messina, Italy
AOU Policlinico Umberto I
Roma, Italy
IRCCS Ospedale Pediatrico Bambino Gesu
Roma, Italy
Casa Sollievo Della Sofferenza IRCCS
San Giovanni Rotondo, Italy
IRCCS Materno Infantile Burlo Garofolo
Trieste, Italy
Emma Children's Hospital Academic Medical Center
Amsterdam, Netherlands
Isala Kliniek
Zwolle, Netherlands
Szpital Uniwersytecki NR 1 IM Dr Antoniego Jurasza
Bydgoszcz, Poland
Szpital im. M. Kopernika
Gdansk, Poland
Uniwersytecki Szpital Dzieciecy w Krakowie
Krakow, Poland
Wojewodzki Specjalistyczny Szpital Dzieciecy im Prof Stanislawa Popowskiego
Olsztyn, Poland
Korczowski Bartosz Gabinet Lekarski
Rzeszów, Poland
Centrum Zdrowia Matki Dziecka i Mlodziezy
Warsaw, Poland
Szpital Pomnik Centrum Zdrowia Dziecka
Warsaw, Poland
Kyungpook National University Chilgok Hospital
Daegu, South Korea
Seoul National University Hospital
Seoul, South Korea
Severance Hospital Yonsei University Health System
Seoul, South Korea
Asan Medical Center
Seoul, South Korea
Samsung Medical Center
Seoul, South Korea
Hosp. Univ. de Cruces
Barakaldo, Spain
Hosp. Sant Joan de Deu
Barcelona, Spain
Hosp. Infantil Univ. Nino Jesus
Madrid, Spain
Hosp. Gral. Univ. Gregorio Maranon
Madrid, Spain
Hosp. Univ. 12 de Octubre
Madrid, Spain
Hosp Regional Univ de Malaga
Málaga, Spain
Hosp. Virgen Del Rocio
Seville, Spain
National Taiwan University Hospital
Taipei, Taiwan
Taipei Veterans General Hospital
Taipei, Taiwan
Chang Gung Memorial Hospital- Linkou
Taoyuan, Taiwan