A Study to Assess the Efficacy and Safety of Golimumab in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis (NCT03596645)
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
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: University of California San Francisco — San Francisco, California
Age range: 2 Years to 17 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (58 Sites)
Showing the first 25 of 58 sites.
- 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,
- Cliniques Universitaires Saint Luc — Brussels,
- UZ Brussel — Jette,
- MK Blumenau Pesquisa Clínica — Blumenau,
- Hospital Pequeno Principe — Curitiba,
- Irmandade Santa Casa de Misericordia de Porto Alegre — Porto Alegre,
- BR Trials — São Paulo,
- Hopital Pellegrin CHU Bordeaux — Bordeaux,
- Hôpital Necker — Paris,
- Rambam Medical Center — Haifa,
- Shaare Zedek Medical Center — Jerusalem,
- Schneider Children's Medical Center — Petah Tikva,
- Sheba Medical Center — Ramat Gan,
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Colitis, Ulcerative
- A Study of Guselkumab in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis — Oakland, California
- A Study of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis — Arcadia, California
- A Study of Guselkumab Therapy in Participants With Moderately to Severely Active Ulcerative Colitis — Litchfield Park, Arizona
- Determination of the Optimal Treatment Target in Ulcerative Colitis — Ypsilanti, Michigan
- A Study to Learn About the Effectiveness of Etrasimod in People With Ulcerative Colitis — Kelowna, British Columbia
Explore by condition: All Colitis, Ulcerative clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.