Actively Recruiting

Age: 18Years +
All Genders
NCT06691061

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Trial Site Locations

Total: 1 location

1

Humanitas Research Hospital IRCSS

Mialn, Italy, Italy, 00168

Actively Recruiting

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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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