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
- Diseases
- Ulcerative colitis
- 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
Sites (47)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Universitair Kinderziekenhuis Koningin Fabiola Coordinator of this site? Confirm its status | Brussels | Belgium | Unknown status |
| Cliniques universitaires Saint-Luc Coordinator of this site? Confirm its status | Brussels | Belgium | Unknown status |
| UZ Brussel Coordinator of this site? Confirm its status | Jette | Belgium | Unknown status |
| MK Blumenau Pesquisa Clínica Coordinator of this site? Confirm its status | Blumenau | Brazil | Unknown status |
| Hospital Pequeno Príncipe Coordinator of this site? Confirm its status | Curitiba | Brazil | Unknown status |
| Irmandade Santa Casa de Misericordia de Porto Alegre Coordinator of this site? Confirm its status | Porto Alegre | Brazil | Unknown status |
| BR Trials Coordinator of this site? Confirm its status | São Paulo | Brazil | Unknown status |
| Hosp. Univ. de Cruces Coordinator of this site? Confirm its status | Barakaldo | Spain | Unknown status |
| Hosp. Sant Joan de Deu Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Hosp. Univ. 12 de Octubre Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Hosp. Gral. Univ. Gregorio Maranon Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Hosp. Infantil Univ. Nino Jesus Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Hosp Regional Univ de Malaga Coordinator of this site? Confirm its status | Málaga | Spain | Unknown status |
| Hosp. Virgen Del Rocio Coordinator of this site? Confirm its status | Seville | Spain | Unknown status |
| Hopital Necker Enfants Malades Coordinator of this site? Confirm its status | Paris | France | Completed |
| Rambam Medical Center Coordinator of this site? Confirm its status | Haifa | Israel | Unknown status |
| Shaare Zedek Medical Center Coordinator of this site? Confirm its status | Jerusalem | Israel | Unknown status |
| Schneider Children's Medical Center Coordinator of this site? Confirm its status | Petah Tikva | Israel | Unknown status |
| Sheba medical center Coordinator of this site? Confirm its status | Ramat Gan | Israel | Unknown status |
| Assaf Harofeh Medical Center Coordinator of this site? Confirm its status | Rishon LeZiyyon | Israel | Unknown status |
| Sourasky Medical Center Coordinator of this site? Confirm its status | Tel Aviv | Israel | Unknown status |
| Casa Sollievo della Sofferenza Coordinator of this site? Confirm its status | San Giovanni Rotondo | Italy | Completed |
| Kyungpook National University Chilgok Hospital Coordinator of this site? Confirm its status | Daegu | South Korea | Unknown status |
| Asan Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Seoul National University Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Samsung Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Severance Hospital, Yonsei University Health System Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Emma Children's Hospital Academic Medical Center Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Unknown status |
| Isala Kliniek Coordinator of this site? Confirm its status | Zwolle | Netherlands | Unknown status |
| Uniwersytecki Szpital Dzieciecy W Krakowie Coordinator of this site? Confirm its status | Cracow | Poland | Completed |
| Copernicus Podmiot Leczniczy Sp. z o.o Coordinator of this site? Confirm its status | Gdansk | Poland | Completed |
| Korczowski Bartosz, Gabinet Lekarski Coordinator of this site? Confirm its status | Rzeszów | Poland | Completed |
| Taipei Veterans General Hospital Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
| National Taiwan University Hospital Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
| Chang Gung Memorial Hospital Linkou Coordinator of this site? Confirm its status | Taoyuan City | Taiwan | Unknown status |
| Children's Center for Digestive Health Care Coordinator of this site? Confirm its status | Atlanta | United States | Unknown status |
| Children's Hospital Colorado and University of Colorado Coordinator of this site? Confirm its status | Aurora | United States | Unknown status |
| Children's Medical Center of Dallas Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| Cook Childrens Medical Center Coordinator of this site? Confirm its status | Fort Worth | United States | Unknown status |
| DHAT Research Institute Coordinator of this site? Confirm its status | Garland | United States | Unknown status |
| Connecticut Children's Medical Center Coordinator of this site? Confirm its status | Hartford | United States | Unknown status |
| GI For Kids Coordinator of this site? Confirm its status | Knoxville | United States | Unknown status |
| Rocky Mountain Pediatric Gastroenterology Coordinator of this site? Confirm its status | Lone Tree | United States | Unknown status |
| Columbia University Medical Center Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Mayo Clinic Coordinator of this site? Confirm its status | Rochester | United States | Unknown status |
| University of California San Francisco Coordinator of this site? Confirm its status | San Francisco | United States | Unknown status |
| Nemours DuPont Hospital for Children Coordinator of this site? Confirm its status | Wilmington | United States | Unknown status |
Related publications
- Efficacy, Safety, and Pharmacokinetics of Golimumab in Children with Moderately-To-Severely Active Ulcerative Colitis: Results from the PURSUIT 2 Study.Inflamm Bowel Dis · 2026 · PMID 41503939
This page is information, not medical advice. Discuss any trial with your doctor.