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

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.

Study Overview

• Status: Recruiting
• Conditions: Ulcerative Colitis (Disorder)
• Intervention / Treatment: Drug: Vedolizumab; Drug: Ustekinumab - Standard Dosage; Drug: JAK Inhibitor

• Study Type: Observational
• Enrollment (Estimated): 450

Contacts and Locations

• Study Contact: Name: Alessandro Armuzzi; Phone Number: +39 02 8224 5555; Email: alessandro.armuzzi@hunimed.eu

Study Locations

• Italy
  • Mialn, Italy, 00168
    • Recruiting
    • Humanitas Research Hospital IRCSS
    • Contact: Alessandro Armuzzi; Phone Number: 0630159357; Email: alearmuzzi@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with ulcerative colitis

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Humanitas Clinical and Research Center

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2023
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: November 12, 2024
• First Submitted That Met QC Criteria: November 14, 2024
• First Posted (Actual): November 15, 2024

Study Record Updates

• Last Update Posted (Actual): November 15, 2024
• Last Update Submitted That Met QC Criteria: November 14, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Colitis; Colitis, Ulcerative; Ulcer; Molecular Mechanisms of Pharmacological Action; Gastrointestinal Agents; Enzyme Inhibitors; Dermatologic Agents; Protein Kinase Inhibitors; Ustekinumab; Janus Kinase Inhibitors; Vedolizumab
• Other Study ID Numbers: IBD-001-2023

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No