RecruitingNCT06691061

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

Sponsor

Humanitas Clinical and Research Center

Enrollment

450 participants

Start Date

Aug 1, 2023

Study Type

OBSERVATIONAL

Conditions

Ulcerative Colitis (Disorder)

Summary

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

Min Age: 18 Years

Inclusion Criteria8

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 Criteria7

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.