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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorHumanitas Clinical and Research Center

About this trial

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 criteria

Qualifiers

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;

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • Vedolizumab
  • Ustekinumab - Standard Dosage
  • JAK Inhibitor

Treatment groups

No treatment groups listed

Locations

1

Map coordinates are unavailable for these locations. Locations are shown below instead.

Humanitas Research Hospital IRCSSRecruiting00168, Mialn, ItalyItalyItaly