Clinical Trials in Taiwan / 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 Taiwan tracker
Condition(s) studied
Colitis, Ulcerative
Investigational drug(s) / intervention(s)
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 After the Week 54 evaluations, participants receiving infliximab will be withdrawn from study participation and transition to local standard of care which may include continued commercially available infliximab at the discretion of their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
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)
- Percentage of Participants With Clinical Remission at Week 6 as Assessed by the Mayo Score — Week 6
Percentage of participants with clinical remission at Week 6 as assessed by the Mayo score was reported. Clinical remission was defined as a Mayo score of less than or equal to (\<=) 2 point, with no individual sub-score greater than (\>) 1. The Mayo score was sum of 4 sub-scores (that is, stool frequency, rectal bleeding, endoscopic findings, and physician's global assessment); each rated on a scale from 0 to 3, with higher scores indicating more severe disease. The total score was calculated as the sum of the 4 sub scores and values ranged from 0 to 12. A score of 3 to 5 points indicated mildly active disease; a score of 6 to 10 indicated moderately active disease; and a score of 11 to 12 indicated severe disease.
Trial sites (58)
| Facility | City | Region | Status |
|---|---|---|---|
| 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.
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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 Taiwan