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NCT06691061Recruiting

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

Source: ClinicalTrials.gov · Last updated 15 Nov 2024 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
450 (estimated)
First submitted
12 Nov 2024
Start date
1 Aug 2023
Primary completion date
31 Dec 2024
Lead sponsor
Humanitas Clinical and Research Center
NCT number
NCT06691061

What you commit to

  • Study type: Observational
  • Planned participants: 450
  • From 1 Aug 2023 to the primary completion date, 31 Dec 2024
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • No previous exposure to anti-TNFα therapies;
  • Previous treatment with target therapies other than anti-TNF-α for UC before baseline;
  • Ustekinumab or JAK inhibitors induction with a non-standard posology for UC.

Other illness

  • Diagnosis of Crohn's colitis, IBD-U or other gastrointestinal inflammatory conditions;

Age

  • Age \< 18 years-old;

Other

  • Incapability of expressing informed consent;
  • Acute severe UC requiring hospitalization at baseline;

Who the study is looking for

  • Established diagnosis of UC according to the current European Crohn's and Colitis Organization (ECCO) guidelines7;
  • Age ≥ 18 years-old;
  • Capability of expressing informed consent;
  • Clinically active ulcerative colitis (cf. 'operative clinical measures', below) at baseline;
  • Initiation of vedolizumab, ustekinumab or JAK inhibitors (tofacitinib, upadacitinib or filgotinib) as second-line target therapy at baseline;
  • Previous treatment with at least one anti-TNFα drug licenced for the treatment of UC (i.e., infliximab, adalimumab and/or golimumab);
  • No exposure to vedolizumab, ustekinumab and JAK inhibitors before baseline;
  • At least 1 follow-up visit after baseline

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Humanitas Research Hospital IRCSS
Coordinator of this site? Confirm its status
MialnItalyRecruiting

Related publications

This page is information, not medical advice. Discuss any trial with your doctor.