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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06691061

Enrollment

450

Registered

2024-11-15

Start date

2023-08-01

Completion date

2024-12-31

Last updated

2024-11-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ulcerative Colitis (Disorder)

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.

Interventions

DRUGVedolizumab

UC patients treated with vedolizumab

DRUGUstekinumab - Standard Dosage

UC patients treated with ustekinumab

DRUGJAK Inhibitor

UC patients treated with JAK inhibitors

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
Clinical and endoscopic effectiveness of the three treatments	12 months	Rates of steroid-free clinical remission and endoscopic remission

Countries

Italy

Contacts

Primary ContactAlessandro Armuzzi

alessandro.armuzzi@hunimed.eu+39 02 8224 5555

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026