Overview

An Efficacy and Safety Study of Infliximab Dose Escalation in Pediatric Participants With Inflammatory Bowel Disease

Status:
Terminated
Trial end date:
2019-07-01
Target enrollment:
Participant gender:
Summary
The purpose of this study is to evaluate whether trough serum infliximab concentrations at the time of loss of clinical response will identify pediatric participants with inflammatory bowel disease (IBD) who would benefit (regain clinical response) from dose escalation above the currently approved dose [5 milligram (mg)/kilogram (kg) every 8 weeks (q8wk)] and the safety of that dose escalation.
Phase:
Phase 4
Details
Lead Sponsor:
Janssen Scientific Affairs, LLC
Treatments:
Infliximab