Unravelling Intestinal Fibrosis in Ulcerative Colitis
Launched by ACADEMISCH MEDISCH CENTRUM - UNIVERSITEIT VAN AMSTERDAM (AMC-UVA) · Sep 17, 2024
Trial Information
Current as of November 10, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial, titled "Unravelling Intestinal Fibrosis in Ulcerative Colitis," is studying how certain pathways in the body may contribute to a condition called fibrosis in patients with ulcerative colitis (UC), which is a type of inflammatory bowel disease. Researchers want to see how well a medication called filgotinib, which is already used to treat UC, works in identifying and monitoring fibrosis using special imaging techniques. The trial is currently looking for participants who are adults with a confirmed diagnosis of UC and have active disease. Specifically, men aged 30 and older and women aged 40 and older can join, as well as anyone 18 and over with UC who meets other health criteria.
Participants in this trial can expect to receive the medication filgotinib and undergo various tests, including endoscopy and imaging scans, to help understand their condition better. This could help doctors learn more about how to treat fibrosis in UC patients in the future. It's important to note that individuals who are pregnant, unable to give informed consent, or have certain serious conditions like colorectal cancer cannot participate in this study. Overall, this trial aims to provide valuable insights that could improve care for those living with ulcerative colitis.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Adults with confirmed diagnosis of UC - Group 1 criterion: ≥18 years of age regardless of gender
- • Group 2 criterion: ≥30 years of age for males and ≥40 years of age for females
- • Active disease confirmed by endoscopy (endoscopic Mayo score ≥ 2)
- • Indication to start treatment with filgotinib
- AND one of the following criteria:
- • Active disease confirmed by intestinal ultrasound (BWT \> 3 mm in at least one bowel segment and at least one other pathological IUS parameter) or
- • Increased CRP (\>5 mg/L) and/or fecal calprotectin levels (\>250 mg/kg)
- Exclusion Criteria:
- • Pregnancy
- • Unable to provide informed consent
- • Colorectal carcinoma or high-grade dysplasia
About Academisch Medisch Centrum Universiteit Van Amsterdam (Amc Uva)
The Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) is a leading academic medical center in the Netherlands, dedicated to advancing healthcare through innovative research, education, and patient care. Affiliated with the University of Amsterdam, AMC-UvA integrates clinical practice with cutting-edge biomedical research, fostering a multidisciplinary approach to medical challenges. The institution actively engages in clinical trials to enhance treatment options and improve patient outcomes, while promoting collaboration among healthcare professionals, researchers, and academic institutions globally. With a commitment to excellence and a focus on translational medicine, AMC-UvA plays a pivotal role in shaping the future of healthcare.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Amsterdam, Noord Holland, Netherlands
Patients applied
Trial Officials
Mark Lowenberg, MD PhD
Principal Investigator
Amsterdam University Medical Centers
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported