Early Intestinal Ultrasound in Predicting Treatment Response to Filgotinib in Ulcerative Colitis (STEER)

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Status: Active, not recruiting

Conditions: Ulcerative Colitis

Treatments: Diagnostic Test: Intestinal ultrasound

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT05653791

W22_205 # 22.254

Details and patient eligibility

About

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

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• ≥18 years of age
• Endoscopic and/or histological confirmed diagnosis of UC
• UC disease extent proximal to the rectum (ie, left-sided colitis or pancolitis)
• Moderately to severely active UC, defined by an endoscopic Mayo score of ≥ 2
• Indication for receiving filgotinib treatment

Exclusion criteria

• Pregnancy
• Inability to give informed consent
• Proctitis only
• Ongoing gastroenteritis
• (Sub)total colectomy
• Obesity (BMI >35 kg/m²)

Trial design

20 participants in 1 patient group

Filgotinib treated patients

Treatment:

Diagnostic Test: Intestinal ultrasound