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

NCT06691061 | Recruiting

• 1 other identifier: IBD-001-2023
• Study Type: observational
• Target: 450
• Locations: 1 country
• Sites: 1

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.

Conditions

Ulcerative Colitis (Disorder)

Outcome Measures

Primary Outcomes (1)

• Clinical and endoscopic effectiveness of the three treatments

  Rates of steroid-free clinical remission and endoscopic remission

  12 months

Interventions

Vedolizumab DRUG

UC patients treated with vedolizumab

Ustekinumab - Standard Dosage DRUG

UC patients treated with ustekinumab

JAK Inhibitor DRUG

UC patients treated with JAK inhibitors

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with ulcerative colitis

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Humanitas Clinical and Research Center: lead

Study Sites (1)

Humanitas Research Hospital IRCSS

Mialn, Italy, 00168, Italy

RECRUITING

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

vedolizumab; Janus Kinase Inhibitors

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Protein Kinase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses

Central Study Contacts

Alessandro Armuzzi

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 12, 2024
• First Posted: November 15, 2024
• Study Start: August 1, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: November 15, 2024

Record last verified: 2024-11

Locations

IT (1)