Projects
REMODEL-CD Clinical Trial
Our team is conducting a multicenter, cluster-randomized, pragmatic clinical trial to identify the superior method to dose and manage patients receiving infliximab for Crohn’s disease. In this investigator-initiated clinical trial we will assess the rates of intestinal healing for children and young adults (6-22 years old) after one year of treatment with infliximab.
Participants in the study will either receive infliximab with standard conventional dosing or with a more novel method of dosing infliximab. All participants will receive infliximab at no cost during the first year of therapy (thanks to the in-kind, drug only support from Janssen Scientific Affairs, LLC).
For more information, visit the REMODEL-CD Trial website or the study page on clinicaltrials.gov.
Funding
- National Institutes of Health
- National Institute of Diabetes and Digestive and Kidney Diseases
ENVISION Observational Study
The ENVISION study is a multicenter, observational study to discover a peripheral blood biomarker that accurately predicts the probability of deep remission to anti-TNF therapy. We are investigating over 7,000 plasma proteins using a comprehensive proteomic discovery platform. Learn more about this study at clinicaltrials.gov.
Funding
- The Helmsley Charitable Trust
PI-SQ Observation Study
In this study, we are conducting a multicenter, observational study to discover novel pharmacokinetic and pharmacodynamic biomarkers for the currently FDA approved advanced therapies. In a prior study, we discovered that the inclusion of the patient’s weight and the biomarkers serum albumin, erythrocyte sedimentation rate and the neutrophil CD4 improved the predicted drug clearance of infliximab.
With a collaborative team approach, we will also update our clinical decision support tool (RoadMAB) with more advanced features to simplify the individualized dosing of advanced therapies.
Funding
- The Crohn’s and Colitis Foundation
The RoadMABTM precision dosing platform incorporates patient factors, results of blood and stool biomarkers and the prior dosing history to present the user with an individualized dosing regimen of infliximab using model-informed dosing. RoadMABTM has been integrated within the electronic medical record and is used as a web-based tool to provide access to precision dosing at the bedside.
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