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

This trial does not accept healthy volunteers

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 population

Patients with ulcerative colitis

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

  • 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

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

Clinical and endoscopic effectiveness of the three treatments

Rates of steroid-free clinical remission and endoscopic remission

Time frame
12 months

Secondary outcomes

Other outcomes

Locations

1

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

Humanitas Research Hospital IRCSSRecruiting00168, Mialn, ItalyItalyItaly

Sponsors and contacts

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