Clinical trial Recruiting at 1 site Interventional Ages 18 to 75

Optimizing Infliximab Treatment for Inflammatory Bowel Disease

Official title: Multicentric Evaluation of a Strategy for Early Infliximab Optimization Among Adult Inflammatory Bowel Disease Patients

Run by Pontificia Universidad Catolica de Chile · NCT06758024 · Data updated 2026-11-12

This study is testing a new way to give infliximab to adults with moderate-to-severe inflammatory bowel disease who haven't improved with steroids, to see if personalized dosing can help them feel better.

Quick facts

Study typeInterventional
Ages18 Years to 75 Years
SexAll
Enrollment72 (estimated)
SponsorPontificia Universidad Catolica de Chile
Academic / other
Drugs / interventionsinfliximab
Locations1 site (Santiago)
StatusRecruiting
StartedJanuary 24, 2025
Main results expectedJanuary 2026
Study endsJanuary 2027
Registry record updatedFebruary 28, 2025
Trial IDNCT06758024 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adult inpatients with Crohn's disease or ulcerative colitis experiencing moderate-to-severe flares who have failed intravenous corticosteroids.

Probably not a fit

Patients with non-controlled infectious diseases, those under 18 years, or those who cannot comply with the study protocol may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study focuses on improving the treatment of inflammatory bowel disease (IBD) by using infliximab, a monoclonal antibody that targets tumor necrosis factor. It aims to monitor and optimize infliximab dosing through a dashboard-guided approach, which considers individual patient factors and laboratory parameters. The study will involve adult inpatients with moderate-to-severe IBD who have not responded to intravenous corticosteroids and require infliximab therapy. By tailoring the treatment based on therapeutic drug monitoring, the researchers hope to enhance patient outcomes and reduce the incidence of treatment failure.

Why it matters

Potential benefit: If successful, this approach could lead to better management of IBD, improving symptoms and reducing the need for more aggressive treatments.

How similar studies have gone: Previous studies have shown that therapeutic drug monitoring can significantly improve treatment outcomes in similar patient populations, suggesting a promising approach.

Who can join: the full rules

Show full inclusion / exclusion criteria
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

Where it's running

  • Pontificia Universidad Catolica of Chile
    Santiago, Chile
    Recruiting

Study contacts

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.