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NCT03596645CompletedPhase 3

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

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

Source: EU CTIS (euclinicaltrials.eu) · Last updated 24 Nov 2024

Brief summary (registry, in English)

1. To evaluate the efficacy of golimumab in inducing clinical remission as assessed by the Mayo score, in pediatric participants with moderately to severely active UC. 2. To evaluate the safety profile of golimumab, in pediatric participants with moderately to severely active UC.

Status (registry)
Completed
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
7 (actual)
First submitted
12 Jun 2024
Start date
9 Jan 2019
Lead sponsor
Janssen - Cilag International
EU CT number
2023-507142-83-00
EudraCT number
2017-004496-31

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 7
  • 5 sites in 3 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study, not your situation.

Who cannot take part

Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Contraindications to the use of golimumab or infliximab or anti-tumor necrosis factor (TNF-alpha) therapy per local prescribing information

Other illness

  • 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
  • Presence or history of a fistula

Other

  • Have UC limited to the rectum only or to \<20 percent (%) of the colon
  • Presence of a stoma

Who the study is looking for

  • 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

Age in the registry: 2 years to 17 years · Sex: All · Does not accept healthy volunteers

Full criteria on EU CTIS (euclinicaltrials.eu)

Sites (47)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Universitair Kinderziekenhuis Koningin Fabiola
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BrusselsBelgiumUnknown status
Cliniques universitaires Saint-Luc
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BrusselsBelgiumUnknown status
UZ Brussel
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JetteBelgiumUnknown status
MK Blumenau Pesquisa Clínica
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BlumenauBrazilUnknown status
Hospital Pequeno Príncipe
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CuritibaBrazilUnknown status
Irmandade Santa Casa de Misericordia de Porto Alegre
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Porto AlegreBrazilUnknown status
BR Trials
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São PauloBrazilUnknown status
Hosp. Univ. de Cruces
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BarakaldoSpainUnknown status
Hosp. Sant Joan de Deu
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BarcelonaSpainUnknown status
Hosp. Univ. 12 de Octubre
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MadridSpainUnknown status
Hosp. Gral. Univ. Gregorio Maranon
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MadridSpainUnknown status
Hosp. Infantil Univ. Nino Jesus
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MadridSpainUnknown status
Hosp Regional Univ de Malaga
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MálagaSpainUnknown status
Hosp. Virgen Del Rocio
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SevilleSpainUnknown status
Hopital Necker Enfants Malades
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ParisFranceCompleted
Rambam Medical Center
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HaifaIsraelUnknown status
Shaare Zedek Medical Center
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JerusalemIsraelUnknown status
Schneider Children's Medical Center
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Petah TikvaIsraelUnknown status
Sheba medical center
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Ramat GanIsraelUnknown status
Assaf Harofeh Medical Center
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Rishon LeZiyyonIsraelUnknown status
Sourasky Medical Center
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Tel AvivIsraelUnknown status
Casa Sollievo della Sofferenza
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San Giovanni RotondoItalyCompleted
Kyungpook National University Chilgok Hospital
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DaeguSouth KoreaUnknown status
Asan Medical Center
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SeoulSouth KoreaUnknown status
Seoul National University Hospital
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SeoulSouth KoreaUnknown status
Samsung Medical Center
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SeoulSouth KoreaUnknown status
Severance Hospital, Yonsei University Health System
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SeoulSouth KoreaUnknown status
Emma Children's Hospital Academic Medical Center
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AmsterdamNetherlandsUnknown status
Isala Kliniek
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ZwolleNetherlandsUnknown status
Uniwersytecki Szpital Dzieciecy W Krakowie
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CracowPolandCompleted
Copernicus Podmiot Leczniczy Sp. z o.o
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GdanskPolandCompleted
Korczowski Bartosz, Gabinet Lekarski
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RzeszówPolandCompleted
Taipei Veterans General Hospital
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TaipeiTaiwanUnknown status
National Taiwan University Hospital
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TaipeiTaiwanUnknown status
Chang Gung Memorial Hospital Linkou
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Taoyuan CityTaiwanUnknown status
Children's Center for Digestive Health Care
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AtlantaUnited StatesUnknown status
Children's Hospital Colorado and University of Colorado
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AuroraUnited StatesUnknown status
Children's Medical Center of Dallas
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DallasUnited StatesUnknown status
Cook Childrens Medical Center
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Fort WorthUnited StatesUnknown status
DHAT Research Institute
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GarlandUnited StatesUnknown status
Connecticut Children's Medical Center
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HartfordUnited StatesUnknown status
GI For Kids
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KnoxvilleUnited StatesUnknown status
Rocky Mountain Pediatric Gastroenterology
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Lone TreeUnited StatesUnknown status
Columbia University Medical Center
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New YorkUnited StatesUnknown status
Mayo Clinic
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RochesterUnited StatesUnknown status
University of California San Francisco
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San FranciscoUnited StatesUnknown status
Nemours DuPont Hospital for Children
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WilmingtonUnited StatesUnknown status

Related publications

This page is information, not medical advice. Discuss any trial with your doctor.