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RECRUITINGOBSERVATIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

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.

Who May Be Eligible (Plain English)

Who May Qualify: - Established diagnosis of UC according to the current European Crohn's and Colitis Organization (ECCO) guidelines7; - Age ≥ 18 years-old; - Capability of expressing willing to sign a consent form; - 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 Who Should NOT Join This Trial: - Diagnosis of Crohn's colitis, IBD-U or other gastrointestinal inflammatory conditions; - Age \< 18 years-old; - Incapability of expressing willing to sign a consent form; - 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

DRUG

Vedolizumab

UC patients treated with vedolizumab

DRUG

Ustekinumab - Standard Dosage

UC patients treated with ustekinumab

DRUG

JAK Inhibitor

UC patients treated with JAK inhibitors

Locations (1)

Humanitas Research Hospital IRCSS
Mialn, Italy, Italy