A Study to Assess the Efficacy and Safety of Golimumab in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis
Public ClinicalTrials.gov record NCT03596645. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT03596645
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 84 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 2 Years to 17 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 29, 2018 (Actual)
- Primary completion
- Nov 21, 2023 (Actual)
- Completion
- Feb 1, 2027 (Estimated)
- Last update posted
- Sep 28, 2026
2018 – 2027
United States locations
- U.S. sites
- 12
- U.S. states
- 9
- U.S. cities
- 12
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of California San Francisco | San Francisco | California | 94158 | — |
| Children's Hospital Colorado and University of Colorado | Aurora | Colorado | 80045 | — |
| Rocky Mountain Pediatric Gastroenterology | Lone Tree | Colorado | 80124 | — |
| Connecticut Children's Medical Center | Hartford | Connecticut | 06106 | — |
| Nemours DuPont Hospital for Children | Wilmington | Delaware | 19803 | — |
| Children's Center for Digestive Health Care | Atlanta | Georgia | 30342 | — |
| Mayo Clinic | Rochester | Minnesota | 55905 | — |
| Columbia University Medical Center | New York | New York | 10032 | — |
| GI For Kids | Knoxville | Tennessee | 37922 | — |
| Children's Medical Center of Dallas | Dallas | Texas | 75207 | — |
| Cook Childrens Medical Center | Fort Worth | Texas | 76104 | — |
| DHAT Research Institute | Garland | Texas | 75044 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 46 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03596645, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 28, 2026 · Synced Oct 17, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03596645 live on ClinicalTrials.gov.