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Clinical Trials in the Netherlands / NCT03596645
Active, not recruiting Phase 3

A Study to Assess the Efficacy and Safety of Golimumab in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis

NCT03596645 · tracked via the Priya Life Science Netherlands tracker
Sponsor
Janssen Research & Development, LLC
Phase
Phase 3
Started
2018-10-29
Last updated
2026-08-31

Condition(s) studied

Colitis, Ulcerative

Investigational drug(s) / intervention(s)

Golimumab →Infliximab →

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 After the Week 54 evaluations, participants receiving infliximab will be withdrawn from study participation and transition to local standard of care which may include continued commercially available infliximab at the discretion of their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.

Study 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.

Eligibility

Sex
ALL
Min age
2 Years
Max age
17 Years
Healthy volunteers
No
Inclusion Criteria: * Must either be currently receiving treatment with, or have a history of having failed to respond to, or have a medical contraindication to at least 1 of the following therapies: oral or intravenous corticosteroids, 6-mercaptopurine, methotrexate or azathioprine OR must either have or have had a history of corticosteroid dependency (that is an inability to successfully taper corticosteroids without a return of the symptoms of ulcerative colitis \[UC\]) OR required more than 3 courses of corticosteroids in the past year * Moderately to severely active UC (as defined by baseline Mayo score of 6 through 12 \[endoscopy {sigmoidoscopy or colonoscopy} sub score assigned by local endoscopist\], inclusive), including a (sigmoidoscopy or colonoscopy) sub score greater than or equal to (\>=2) * If receiving enteral nutrition, must have been on a stable regimen for at least 2 weeks prior to the first administration of study intervention at Week 0. Participants who receive parenteral nutrition are not permitted to enroll in the trial * No history of latent or active tuberculosis prior to screening * Must be up to date with all immunizations (that is, measles, mumps, rubella, and varicella) in agreement with current local immunization guidelines for immunosuppressed participants before Week 0 Exclusion Criteria: * History of liver or renal insufficiency; significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric (including suicidality), or metabolic disturbances * History of malignancy or macrophage activation syndrome or hemophagocytic lymphohistiocytosis * Have UC limited to the rectum only or to \<20 percent (%) of the colon * Presence of a stoma * Presence or history of a fistula * Contraindications to the use of golimumab or infliximab or anti-tumor necrosis factor (TNF-alpha) therapy per local prescribing information

Primary outcome measure(s)

Trial sites (58)

FacilityCityRegionStatus
University of California San Francisco San Francisco California
Children's Hospital Colorado and University of Colorado Aurora Colorado
Rocky Mountain Pediatric Gastroenterology Lone Tree Colorado
Connecticut Children's Medical Center Hartford Connecticut
Nemours DuPont Hospital for Children Wilmington Delaware
Children's Center for Digestive Health Care Atlanta Georgia
Mayo Clinic Rochester Minnesota
Columbia University Medical Center New York New York
GI For Kids Knoxville Tennessee
Children's Medical Center of Dallas Dallas Texas
Cook Childrens Medical Center Fort Worth Texas
DHAT Research Institute Garland Texas
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

+ 18 more sites — see the full list on the official registry below.

On this site

📄 Simponi (golimumab) drug profile → 📄 Remicade (infliximab) drug profile →

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03596645 on ClinicalTrials.gov ↗ ← All trials in the Netherlands