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

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.

Timeline

Start

2016-04

Primary completion

2019-07

Completion

2019-07

Outcome

Outcome not reported

Stopped (Enrollment): “Study was terminated due to the inability to enroll a sufficient number of the required subject population”

Drugs

Indications