PROMPT-IBDEarly Infliximab Optimization for IBD Patients Using Bayesian Model
Infliximab
Colitis+6
+ Colitis, Ulcerative
+ Colonic Diseases
Treatment Study
Summary
Study start date: January 24, 2025
Actual date on which the first participant was enrolled.Inflammatory bowel disease (IBD), which includes Crohn's disease and ulcerative colitis, is a long-lasting condition that often requires costly treatments like biologic therapies. Anti-TNF medications, such as infliximab, are effective but not all patients respond well to them initially or over time. In Chile, these medications are provided by a national program. The study aims to explore if adjusting infliximab doses early, using a special monitoring method called therapeutic drug monitoring (TDM) and a Bayesian model, can help more patients achieve the right drug levels, reduce the chance of the body reacting against the drug, and increase the likelihood of the disease going into remission. Participants in this study are adults in Chile with moderate-to-severe IBD that hasn't responded to standard steroid treatments. They will be randomly divided into two groups. One group will have their infliximab doses adjusted using a dashboard-guided method with regular monitoring, while the other group will have doses adjusted based on standard clinical assessments. Researchers will check drug levels and immune reactions at various points, specifically at weeks 14, 26, and 52. The study aims to see if the first method leads to better drug levels and fewer adverse reactions, ultimately improving the patients' condition.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.72 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 75 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
Group II
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Pontificia Universidad Catolica of Chile
Santiago, ChileOpen Pontificia Universidad Catolica of Chile in Google Maps