Recruiting

PROMPT-IBDEarly Infliximab Optimization for IBD Patients Using Bayesian Model

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What is being tested

Infliximab

Drug
Who is being recruted

Colitis+6

+ Colitis, Ulcerative

+ Colonic Diseases

From 18 to 75 Years
+8 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: January 2025
See protocol details

Summary

Principal SponsorPontificia Universidad Catolica de Chile
Study ContactCristian Hernández-Rocha Cristian Hernández-Rocha, MDMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

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.

Official TitleMulticentric Evaluation of a Strategy for Early Infliximab Optimization Among Adult Inflammatory Bowel Disease Patients
NCT06758024
Principal SponsorPontificia Universidad Catolica de Chile
Study ContactCristian Hernández-Rocha Cristian Hernández-Rocha, MDMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

72 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

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

ColitisColitis, UlcerativeColonic DiseasesCrohn DiseaseDigestive System DiseasesGastroenteritisGastrointestinal DiseasesIntestinal DiseasesInflammatory Bowel Diseases

Criteria

2 inclusion criteria required to participate
Adult inpatients with Crohn's disease, ulcerative colitis or inflammatory bowel disease-unclassified.

Moderate-to-severe flare who fail to iv steroids and require infliximab as per standard of care by treating gastroenterologist

6 exclusion criteria prevent from participating
Participant younger than 18 years

Non-controlled infectious diseases

Permanent ileostomy or Ileal pouch-anal anastomosis

Pregnancy

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Eligible patients will receive IFX with proactive therapeutic drug monitoring during induction (week 2 and 6) and dashboard-guided dosing options will be suggested to their attending gastroenterologists

Group II

Eligible patients will receive IFX standard dosing during induction based solely on clinical data

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

Recruiting

Pontificia Universidad Catolica of Chile

Santiago, ChileOpen Pontificia Universidad Catolica of Chile in Google Maps
Recruiting
One Study Center