Early Intestinal Ultrasound in Predicting Treatment Response to Filgotinib in Ulcerative Colitis

NCT ID: NCT05653791

Last Updated: 2022-12-16

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-10-01
• Study Completion Date: 2024-10-01

Brief 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

Conditions

Ulcerative Colitis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Filgotinib treated patients

Intestinal ultrasound

Intervention Type: DIAGNOSTIC_TEST

Ulcerative colitis patients treated with filgotinib will undergo intestinal transabdominal ultrasound at baseline, week 4 and at the time of the follow-up endoscopy (week 10-16)

Interventions

Intestinal ultrasound

Ulcerative colitis patients treated with filgotinib will undergo intestinal transabdominal ultrasound at baseline, week 4 and at the time of the follow-up endoscopy (week 10-16)

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Galapagos NV

INDUSTRY

Sponsor Role: collaborator

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

OTHER

Sponsor Role: lead

Responsible Party

Krisztina Gecse

Dr. K.B. Gecse, MD PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Amsterdam UMC

Amsterdam-Zuidoost, North Holland, Netherlands

Countries

Netherlands

Other Identifiers

W22_205 # 22.254

Identifier Type: -

Identifier Source: org_study_id