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โ† Trials
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PROactive and Early Infliximab Monitoring and OPTimization in Inflammatory Bowel Disease

RecruitingNAAges 18 Years - 75 YearsAllPontificia Universidad Catolica de Chile
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In plain words

What the trial is, and whether it could suit you

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). However, about one-third of IBD patients do not respond to this medications and a half will loss the response after an initial response. Researchers have shown that most of these phenomena occur due to low IFX concentrations sometimes accompanied by the development of anti-drug antiboides (ADA) againts IFX. Blood concentrations of IFX are widely variable among IBD patients despite receiving the same weight-based dose. Several patient factors including laboratory parameters and severity of intestinal inflammation

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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
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What it tests

  • Infliximab
  • Infliximab
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Where

1 site
Pontificia Universidad Catolica of Chile
Santiago, Chile
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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