2023-507907-73-00CompletedPhase 4
Unravelling intestinal fibrosis in ulcerative colitis: INTERACT study
Source: EU CTIS (euclinicaltrials.eu) · Last updated 8 Dec 2023
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 10 (actual)
- First submitted
- 8 Sept 2023
- Start date
- 3 Apr 2024
- Lead sponsor
- Amsterdam UMC
- Diseases
- Ulcerative colitis
- EU CT number
- 2023-507907-73-00
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 10
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Other
- 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
Who the study is looking for
- 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)
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Amsterdam UMC | Amsterdam | Netherlands | Completed |
This page is information, not medical advice. Discuss any trial with your doctor.