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NCT02624037 · ClinicalTrials.gov registry record · NA
Precision IFX: Using a Dashboard to Individualize Infliximab Dosage
A NA study, sponsored by Icahn School of Medicine at Mount Sinai.
- Completed
- Registry status
- NA
- Development phase
- 189
- Enrollment target
NCT02624037: Completed NA study, sponsored by Icahn School of Medicine at Mount Sinai.
NCT02624037 is a NA study that has completed, run by Icahn School of Medicine at Mount Sinai. The registered enrollment target is 189 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02624037, a NA study, has completed, sponsored by Icahn School of Medicine at Mount Sinai.
- COMPLETED
- Registry status
- NA
- Development phase
- 189 participants
- Enrollment target
Study Summary
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.
Primary Outcome
use of Precision IFX dashboard - frequency of attaining and maintaining target drug trough levels
Interventions
- OTHER Individualized Dosage Precision IFX Dashboard
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 189 participants |
| Start Date | 2015-01 |
| Est. Completion | 2020-10-21 |
| Phase | NA |
What the finished NCT02624037 record still lists
NCT02624037 is an interventional study that assigns participants to a tested intervention. The registered 189 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (87% lower).
The record links to 0 conditions, and to 1 intervention - of which Individualized Dosage Precision IFX Dashboard is the first listed.
NCT02624037 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02624037 about?
NCT02624037 is a clinical study titled "Precision IFX: Using a Dashboard to Individualize Infliximab Dosage". 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 wer...
What is the current status of trial NCT02624037?
This trial is currently completed. It is a NA study. The enrollment target is 189 participants. The study started on 2015-01. Estimated completion is 2020-10-21.
What interventions are being tested in trial NCT02624037?
The interventions under investigation include: Individualized Dosage Precision IFX Dashboard (OTHER).
Who is sponsoring clinical trial NCT02624037?
This trial is sponsored by Icahn School of Medicine at Mount Sinai, which has 708 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02624037's enrollment target sits among peer trials
189 576th of 2000 higher than 1,425 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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