Unravelling Intestinal Fibrosis in Ulcerative Colitis

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Phase 2/Phase 3
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 using FAPi-PET/CT imaging

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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)

Locations
Other Locations
Netherlands
Amsterdam UMC
RECRUITING
Amsterdam
Contact Information
Primary
Dalia A Lartey, MD
d.a.lartey@amsterdamumc.nl
+31205668160
Backup
Kelly van Wijnbergen, Msc
k.vanwijnbergen@amsterdamumc.nl
+31205668160
Time Frame
Start Date: 2024-04-03
Estimated Completion Date: 2026-04-03
Participants
Target number of participants: 10
Treatments
Experimental: Group 2
This group undergoes FAPi-PET CT imaging
No_intervention: Group 1
Does not undergo a FAPi scan
Sponsors
Leads: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

This content was sourced from clinicaltrials.gov