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

Recruiting

• Conditions: Ulcerative Colitis (Disorder)

• Registration Number: NCT06691061
• Lead Sponsor: Humanitas Clinical and Research Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-08-01
• Status Verified: 2024-11
• Study First Submitted: 2024-11-12
• Study First Submitted QC: 2024-11-14
• Last Update Submitted: 2024-11-14
• Study First Posted: 2024-11-15
• Last Update Posted: 2024-11-15
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 450

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical and endoscopic effectiveness of the three treatments	12 months	Rates of steroid-free clinical remission and endoscopic remission

Trial Locations

Locations (1)

Humanitas Research Hospital IRCSS; 🇮🇹 Mialn, Italy