Status:
RECRUITING
Unravelling Intestinal Fibrosis in Ulcerative Colitis
Lead Sponsor:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Conditions:
Ulcerative Colitis (UC)
Inflammatory Bowel Disease (IBD)
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
The main objectives are: (i) to identify candidate fibrotic cellular pathways in UC patients treated with a JAK inhibitor filgotinib), and (ii) to detect and monitor in vivo fibrosis in UC patients us...
Eligibility Criteria
Inclusion
- 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
- Pregnancy
- Unable to provide informed consent
- Colorectal carcinoma or high-grade dysplasia
Key Trial Info
Start Date :
April 3 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 3 2026
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT06604273
Start Date
April 3 2024
End Date
April 3 2026
Last Update
September 19 2024
Active Locations (1)
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1
Amsterdam UMC
Amsterdam, North Holland, Netherlands, 1081BT