Individualized Infiximab Dosing-Proof of Concept Study

Status Active, not recruiting

Clinical Trial Summary

The purpose of this study is to determine which early infliximab pharmacokinetic level is most associated with clinical remission at weeks 30 and 54 in pediatric IBD patients.

Clinical Trial Description

Our aims are:

1. to determine which early pk level; week 6 (peak), week 8 (2 week) or week 14 (trough), is most associated with week 30 and 54 outcomes in pediatric IBD patients.

2. to determine if the forecasted PK determined by a newly developed Population PK Model software program is in agreement with the observed PK in IBD patients receiving infliximab.

Subject recruitment is limited to patients of the principal investigator only. Subjects will be approached for participation in the research in person during a routine clinic visit by a member of the study team. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02027727
Study type	Observational
Source	Cedars-Sinai Medical Center
Contact
Status	Active, not recruiting
Phase	N/A
Start date	November 2013
Completion date	March 2018

View Details

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