RECRUITINGPhase 2 / Phase 3INTERVENTIONAL
Unravelling Intestinal Fibrosis in Ulcerative Colitis
About This Trial
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
Who May Be Eligible (Plain English)
Who May Qualify:
- 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)
Who Should NOT Join This Trial:
- Pregnancy
- Unable to provide willing to sign a consent form
- Colorectal carcinoma or high-grade dysplasia
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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
Treatments Being Tested
DIAGNOSTIC_TEST
Fibroblast Activation Protein Inhibitor
PET CT imaging using the fibroblast activation protein inhibitor tracer
Locations (1)
Amsterdam UMC
Amsterdam, North Holland, Netherlands