drugset / Trial / NCT03596645

A Study to Assess the Efficacy and Safety of Golimumab in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis

NCT03596645

Phase 3 Active not recruiting 84 enrolled Janssen Research & Development, LLC
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2018-10-29
Primary completion
2023-11-21
Completion
2027-02-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Golimumab Monoclonal antibody Subcutaneous
Subject Infliximab Monoclonal antibody Intravenous

Indications