Summary

Eligibility
for people ages 2-17 (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
completion around

Description

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.

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

Keywords

Colitis, Ulcerative, Colitis, Ulcerative Colitis, Ulcer, Infliximab, Golimumab

Eligibility

Locations

  • UCSF
    San Francisco California 94158 United States
  • Rocky Mountain Pediatric Gastroenterology
    Lone Tree Colorado 80124 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Janssen Research & Development, LLC
ID
NCT03596645
Phase
Phase 3 research study
Study Type
Interventional
Participants
About 84 people participating
Last Updated