RecruitingNCT06691061

The PODIUM Study - a Three-arm Comparison of Target Therapies After Anti-TNFα in Ulcerative Colitis

Real-life Comparative Effectiveness of Vedolizumab, Ustekinumab and JAK Inhibitors in Patients with Ulcerative Colitis After Anti-TNFα Failure or Intolerance


Sponsor

Humanitas Clinical and Research Center

Enrollment

450 participants

Start Date

Aug 1, 2023

Study Type

OBSERVATIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study (PODIUM) is comparing three targeted treatments — vedolizumab, ustekinumab, and JAK inhibitors (such as tofacitinib or upadacitinib) — for people with ulcerative colitis (UC) whose condition did not respond well enough to anti-TNF drugs (like infliximab or adalimumab), a common first targeted treatment for UC. **You may be eligible if...** - You are 18 or older - You have a confirmed diagnosis of ulcerative colitis - Your UC is currently active and causing symptoms - You have already tried and not responded adequately to at least one anti-TNF drug (like infliximab or adalimumab) - You are starting one of the three study medications (vedolizumab, ustekinumab, or a JAK inhibitor) as your next treatment **You may NOT be eligible if...** - You have Crohn's disease (not UC) - You have never tried anti-TNF therapy - You have active serious infections or other conditions that prevent treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGVedolizumab

UC patients treated with vedolizumab

DRUGUstekinumab - Standard Dosage

UC patients treated with ustekinumab

DRUGJAK Inhibitor

UC patients treated with JAK inhibitors


Locations(1)

Humanitas Research Hospital IRCSS

Mialn, Italy, Italy

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NCT06691061


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