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

Humanitas Clinical and Research Center

Status: Enrolling

Conditions: Ulcerative Colitis (Disorder)

Treatments: Drug: Vedolizumab; Drug: Ustekinumab - Standard Dosage; Drug: JAK Inhibitor

Study type: Observational

Funder types: Other

Identifiers

NCT06691061

IBD-001-2023

Details and patient eligibility

About

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.

Enrollment: 450 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.