Precision IFX: Using a Dashboard to Individualize Infliximab Dosage
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02624037|
Recruitment Status : Recruiting
First Posted : December 8, 2015
Last Update Posted : December 24, 2018
The introduction of infliximab (IFX) and other monoclonal antibodies (MAbs) targeting tumor necrosis factor (TNF) was a major advancement in the management of inflammatory bowel disease (IBD). These biologics were able to improve the health outcomes of many IBD patients for whom other treatments were neither satisfactory nor sufficient. Despite clear advantages and increased use of these treatments, physicians still see a loss of response in up to 50% of their IBD patients within one year of initiating these therapies. Most of these phenomena are attributed to low drug concentrations in the presence or absence of anti-drug antibodies (ADA).
The fundamental issue is that approved/on-label dosing of these drug therapies does not take into account the various factors that impact the way an individual's body responds and processes these therapies. Dashboard software systems can quickly integrate patient data and serve as a revolutionary decision-support tool for physicians. The Precision IFX dashboard prototype was specifically developed to facilitate dosing of therapeutic monoclonal antibodies by integrating patient's clinical characteristics and drug concentrations into pharmacokinetic (PK) algorithms. Using clinical observations and patient laboratories, the system provides multiple dosing regimens that could allow the patient to attain and sustain a therapeutic drug trough level.
Using the Precision IFX dashboard to analyze and forecast optimal dosing regimens with prospectively collected individual patient data, the clinician will select an appropriate dose to actively maintain therapeutic drug trough levels throughout the infliximab maintenance period. This study aims to examine the outcomes of one year of maintenance infusions in IBD patients dosed using the Precision IFX dashboard prototype and compare the results with historical controls.
|Condition or disease||Intervention/treatment||Phase|
|Inflammatory Bowel Disease||Other: Individualized Dosage Precision IFX Dashboard||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||800 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Precision IFX: Using a Pharmacokinetic Dashboard to Optimize and Individualize Infliximab Dosage for Pediatric Inflammatory Bowel Disease Patients|
|Study Start Date :||January 2015|
|Estimated Primary Completion Date :||December 2021|
|Estimated Study Completion Date :||December 2024|
Experimental: Individualized Dosage Precision IFX Dashboard
A clinician will select a dose and dosing frequency that is populated by a pharmacokinetic dashboard system that monitors and aims to dose patients to maintain a target trough infliximab concentration. Dosage and dosing frequency may vary from each patient.
Other: Individualized Dosage Precision IFX Dashboard
Pharmacokinetic Dashboard Recommended Dosage and Dosing Frequency of Infliximab
- drug trough levels [ Time Frame: Week 54 ]use of Precision IFX dashboard - frequency of attaining and maintaining target drug trough levels
- anti-drug antibody level [ Time Frame: Week 54 ]use of Precision IFX dashboard reduce - frequency of anti-drug antibody development prior to one year of maintenance therapy
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02624037
|Contact: Becky L Phan, BScemail@example.com|
|Contact: Marla C Dubinsky, MDfirstname.lastname@example.org|
|United States, New York|
|Susan and Leonard Feinstein Inflammatory Bowel Disease Clinical Center||Recruiting|
|New York, New York, United States, 10029|
|Contact: Becky L Phan, BSc 212-842-7785 email@example.com|
|Principal Investigator: Marla C Dubinsky, MD|
|Principal Investigator:||Marla C Dubinsky, MD||Icahn School of Medicine at Mount Sinai|