PROactive and Early Infliximab Monitoring and OPTimization in Inflammatory Bowel Disease

Launched by PONTIFICIA UNIVERSIDAD CATOLICA DE CHILE · Dec 26, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating whether early testing of blood levels of Infliximab (IFX), a medication used to treat inflammatory bowel disease (IBD) like Crohn's disease and ulcerative colitis, can help improve patient outcomes. The goal is to see if using a special software to guide dosing—based on individual patient factors and blood test results—can lead to better control of inflammation and fewer side effects compared to standard dosing methods. Researchers will measure IFX levels before the second and third doses of the medication and adjust the treatment accordingly.

To participate, you need to be an adult patient with moderate-to-severe IBD who has not responded to intravenous steroids. Participants will provide health information and blood samples at the start of the trial and before each infusion over the course of a year. You'll also have regular check-ups every three months. This trial is currently looking for patients aged 18 and older, and it's important to note that those with certain health conditions, such as uncontrolled infections or specific surgeries, will not be eligible. If you decide to join, you could help researchers learn more about how to use IFX more effectively for IBD patients.

Gender

ALL

Eligibility 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