Actively Recruiting
The PODIUM Study - a Three-arm Comparison of Target Therapies After Anti-TNFα in Ulcerative Colitis
Led by Humanitas Clinical and Research Center · Updated on 2024-11-15
450
Participants Needed
1
Research Sites
74 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this observational study is to compare the real-life effectiveness and safety of vedolizumab, ustekinumab and JAK inhibitors in patients with UC who had been exposed to at least one anti-TNF-alpha therapy.
CONDITIONS
Official Title
The PODIUM Study - a Three-arm Comparison of Target Therapies After Anti-TNFα in Ulcerative Colitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Established diagnosis of ulcerative colitis according to European Crohn's and Colitis Organization guidelines
- Age 18 years or older
- Ability to provide informed consent
- Clinically active ulcerative colitis at baseline
- Starting vedolizumab, ustekinumab, or JAK inhibitors as second-line therapy at baseline
- Previous treatment with at least one anti-TNF-alpha drug licensed for ulcerative colitis
- No prior exposure to vedolizumab, ustekinumab, or JAK inhibitors before baseline
- At least one follow-up visit after baseline
You will not qualify if you...
- Diagnosis of Crohn's colitis, IBD-U, or other inflammatory bowel conditions
- Age under 18 years
- Unable to provide informed consent
- Acute severe ulcerative colitis requiring hospitalization at baseline
- No prior exposure to anti-TNF-alpha therapies
- Previous treatment with non-anti-TNF-alpha targeted therapies for ulcerative colitis before baseline
- Ustekinumab or JAK inhibitors induction with non-standard dosing for ulcerative colitis
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Humanitas Research Hospital IRCSS
Mialn, Italy, Italy, 00168
Actively Recruiting
Research Team
A
Alessandro Armuzzi
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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