clinical trial · NCT03596645
A Study to Assess the Efficacy and Safety of Golimumab in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis
Janssen Research & Development, LLC·phase3·active not recruiting·n = 84
Colitis, UlcerativeGolimumabInfliximab
brief 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.
started
Oct 29, 2018
primary completion
Nov 21, 2023
completion
Feb 1, 2027
last updated
Jun 8, 2026
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
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol