A Collaborative Study to Evaluate the Efficacy of Prospective Post-Induction Infliximab Dosing Based on Trough Levels at Week 12 and 28 in subjects with Crohn’s Disease and Ulcerative Colitis

Principal Investigator: Emanuelle Araujo Lima Bellaguarda, MD

The drug infliximab (Remicade) offers relief to millions of people with Crohn’s disease and ulcerative colitis. Yet, which dose is the best dose for effectively treating disease? The same dose does not work for all to prevent flare ups and improve quality of life. And how best to calibrate the dosage before the drug loses it efficacy and patients begin to experience the debilitating symptoms of their inflammatory bowel disease?

Checking Remicade levels and adjusting the dosage after patients become unresponsive to the drug is already too late. Timing between infusions also becomes critical for modifying the dosage. Checking at the end of a dosage cycle doesn’t allow adequate time to adjust for the next infusion dose since it takes one week to turn around test results.

Better personalizing the use of infliximab, Emanuelle Araujo Lima Bellaguarda, MD, a gastroenterology faculty member at Northwestern Medicine and her research team have designed a study to monitor and adjust dosing of the medication. In particular, they are interested in two key times during the therapeutic infusion timeline. The investigators hypothesize that adjusting infliximab at trough levels (the amount of drug present in the body at its lowest therapeutic concentration before the next dose) at weeks 12 and 28 may improve rates of sustained remission. This proactive screening approach has the potential to fully optimize the therapeutic effectiveness of infliximab for each and every patient.

A study of this nature will require dedicated logistical coordination. Funding from the Digestive Health Foundation will support a study coordinator to manage patient enrollment, monitoring and outcomes during the one-year project.

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June 23, 2017