drugset / Trial / NCT02566889

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

NCT02566889

Phase 4 Terminated 53 enrolled Janssen Scientific Affairs, LLC
Non-randomizedParallel-groupOpen-labelTreatment

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

Drugs

EvaluationDrugModalityDoseRoute
Subject Infliximab Monoclonal antibody 5 mg/kg
Subject Infliximab Monoclonal antibody 10 mg/kg