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Active Not Recruiting
NCT05653791
Early Intestinal Ultrasound in Predicting Treatment Response to Filgotinib in Ulcerative Colitis
Conditions: Ulcerative Colitis
Sex: All
Ages: 18 Years – N/A
Enrollment: 20
Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Location: Netherlands
Summary
Objective disease assessment in inflammatory bowel diseases at the time of treatment initiation and during follow-up has become gold standard.
However, biomarkers, such as C-reactive protein and fecal calprotectin, fail to provide information on disease extent, location or complications.
Repeated endoscopic assessments are performed to evaluate mucosal response to treatment, though associated costs, availability, invasiveness and patient preference are considerable limitations.
Recently, intestinal ultrasound (IUS) has gained significant momentum as a non-invasive, easily accessible and low-cost alternative for objective assessment.
Accordingly, the ECCO-ESGAR guideline recognizes IUS as a potential tool for the diagnosis and for the monitoring of IBD.Our study aim is to evaluate the change in intestinal ultrasound parameters (as measured by B-mode and SWE at baseline and week 4) to predict endoscopic response and remission as defined by the follow-up endoscopy and measured by the Mayo endoscopic subscore and the UCEIS during treatment with filgotinib
Eligibility Criteria
Inclusion Criteria:≥18 years of ageEndoscopic and/or histological confirmed diagnosis of UCUC disease extent proximal to the rectum (ie, left-sided colitis or pancolitis)Moderately to severely active UC, defined by an endoscopic Mayo score of ≥ 2Indication for receiving filgotinib treatmentExclusion Criteria:PregnancyInability to give informed consentProctitis onlyOngoing gastroenteritis(Sub)total colectomyObesity (BMI >35 kg/m²)
Source: ClinicalTrials.gov (NCT05653791). StuddyBuddy aggregates publicly available trial information.