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Recruiting

NCT Number: NCT06691061

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Humanitas Research Hospital IRCSS

Mialn, Italy, 00168

Location status: Recruiting

Location contact

Alessandro Armuzzi

CONTACT

[email protected]

0630159357

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • Diagnosis of Crohn's colitis, IBD-U or other gastrointestinal inflammatory conditions;
  • Age < 18 years-old;
  • Incapability of expressing informed consent;
  • Acute severe UC requiring hospitalization at baseline;
  • 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.

Treatment and study plan

Vedolizumab

Drug

UC patients treated with vedolizumab

Ustekinumab - Standard Dosage

Drug

UC patients treated with ustekinumab

JAK Inhibitor

Drug

UC patients treated with JAK inhibitors

Primary outcomes

  1. Clinical and endoscopic effectiveness of the three treatments

    Time frame: 12 months

    Rates of steroid-free clinical remission and endoscopic remission

Study contacts

Contact information is provided by the study sponsor or research team.

Alessandro Armuzzi

CONTACT

[email protected]

+39 02 8224 5555

Sponsors and collaborators

Lead sponsor

Humanitas Clinical and Research Center

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Nov 15, 2024
Registry last updated
Nov 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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