Unravelling intestinal fibrosis in ulcerative colitis: INTERACT study
Key facts
- Where
- Amsterdam, HollandiaSee the site
- Phase
- 4. fázis
Where in Hollandia
- Amsterdam UMCAmsterdam, HollandiaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Amsterdam UMC
- Trial code
- EU 2023-507907-73-00
- Record updated
- 2023. december 8.
- Original description
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 using FAPi-PET/CT imaging.Read full original descriptionShow less
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 using FAPi-PET/CT imaging.
Inclusion: In order to be eligible to participate in this study, a subject must meet all of the following criteria: - Adults ≥18 years with confirmed diagnosis of ulcerative colitis - Active disease confirmed by endoscopy (endoscopic Mayo score ≥ 2) - Indication to start treatment with filgotinib AND one of the following: - Active disease confirmed by intestinal ultrasound (BWT > 3 mm in atleast one bowel segment and atleast one other pathological IUS parameter) or - Increased CRP (>5 mg/L) and/or fecal calprotectin levels (>250 mg/kg).
Exclusion: A potential subject who meets any of the following criteria will be excluded from participation in this study: - Pregnancy - Unable to provide informed consent - Colorectal carcinoma or high grade dysplasia.