Proactive infliximab optimization using a pharmacokinetic dashboard versus standard of care in patients with Crohn s disease: The OPTIMIZE Trial

Brief description of study

The purpose of this study is to find out if using a computer program (called iDose) to guide infliximab dosing is more effective and safer than using standard infliximab dosing over 52 weeks. All patients in this study will be receiving infliximab as part of their medical care, this study is only looking at two different methods of determining the dose and timing of administration. iDose is a computer program that uses personalized information entered by an iDose Operator (person who is not involved in your clinical care) including previous infliximab doses, your current blood levels of infliximab, and other lab values such as albumin to predict the amount of infliximab that will be used by your body in the future. This information can help your gastroenterologist recommend a personalized schedule of dosing to maintain the target level of infliximab in your body. This is different from standard dosing where the dose and schedule is the same for everyone, and would only be altered later if the drug first doesn’t work or stops working for you.


Clinical Study Identifier: s21-00978
ClinicalTrials.gov Identifier: NCT04835506
Principal Investigator: David P Hudesman.
Other Investigators: Elie S Al Kazzi, Shannon Chang, Adam Faye, Simon J Hong, Ariela Holmer, Jordan E Axelrad.


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