PROactive and Early Infliximab Monitoring and OPTimization in Inflammatory Bowel Disease
Not applicable · Testing Infliximab · 1 site · Pontificia Universidad Catolica de Chile
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing Infliximab (a drug) and Infliximab (a drug) as a possible treatment. Condition(s) listed: Inflammatory Bowel Disease (IBD), Crohn Disease (CD) and Ulcerative Colitis (UC).
Participants are assigned to groups by chance (randomized).
It is open-label: participants know what they are receiving.
This study does not use drug-development phases (it may test a device, diet, procedure, app, or care approach).
Who can join
- Ages 18 to 75
- Any sex
Some of the main requirements, copied from the record:
- 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
There are also 6 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 72 participants are expected to take part.
- Start date: 2025-01-24.
- Main results expected around 2026-01 (estimate from the record).
- 1 study site listed (1 marked recruiting) in Chile.
Main thing being measured
- Infliximab optimal concentration (Week 14)
In the researchers’ words
Infliximab (IFX) is a Food and Drug administration (FDA)-appoved monoclonal antibody medication targeting tumor necrosis factor (TNF) widely used in inflammatory bowel disease (IBD) to treat intestinal inflammation and improve patient's symptoms. Intravenous (iv) IFX is effective to treat hospitalized IBD patients with moderate-to-severe flares who fail iv corticosteroids (CS).
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Not applicable |
| Study type | Interventional |
| Conditions | Inflammatory Bowel Disease (IBD); Crohn Disease (CD); Ulcerative Colitis (UC) |
| Lead sponsor | Pontificia Universidad Catolica de Chile |
| Collaborators | Clínica Universidad de los Andes; Hospital San Juan de Dios,Chile; University of Chile; Clinica Indisa; Universidad de La Frontera |
| Enrollment | 72 (estimated) |
| Start date | 2025-01-24 |
| Primary completion (est.) | 2026-01 |
| First posted | 2025-01-03 |
| Last updated | 2025-02-28 |
| Official title | Multicentric Evaluation of a Strategy for Early Infliximab Optimization Among Adult Inflammatory Bowel Disease Patients |
| ClinicalTrials.gov ID | NCT06758024 |
Interventions
- Infliximab (Drug)
IFX therapeutic drug monitoring before the second and third infusion and subsequent dashboard-guided dosing regimes suggested to attending gastroenterologists based on clinical and pharmacokinetics data - Infliximab (Drug)
No IFX therapeutic drug monitoring before the second and third infusion and subsequent dosing regimes based on clinical data
Full eligibility criteria (from the record)
Inclusion Criteria: * 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 Exclusion Criteria: * Participant younger than 18 years * Non-controlled infectious diseases * Permanent ileostomy or Ileal pouch-anal anastomosis * Pregnancy * Patients do not consent to participate in study * Patients unable to comply with protocol
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| Pontificia Universidad Catolica of Chile | Santiago | Chile | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.