NCT06691061Recruiting
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
Source: ClinicalTrials.gov · Last updated 15 Nov 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 450 (estimated)
- First submitted
- 12 Nov 2024
- Start date
- 1 Aug 2023
- Primary completion date
- 31 Dec 2024
- Lead sponsor
- Humanitas Clinical and Research Center
- Diseases
- Ulcerative colitis
- NCT number
- NCT06691061
What you commit to
- Study type: Observational
- Planned participants: 450
- From 1 Aug 2023 to the primary completion date, 31 Dec 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- Diagnosis of Crohn's colitis, IBD-U or other gastrointestinal inflammatory conditions;
Age
- Age \< 18 years-old;
Other
- Incapability of expressing informed consent;
- Acute severe UC requiring hospitalization at baseline;
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Humanitas Research Hospital IRCSS Coordinator of this site? Confirm its status | Mialn | Italy | Recruiting |
Related publications
- Ustekinumab and Janus Kinase Inhibitors Outperform Vedolizumab as Second-Line Therapy in Anti-Tumor Necrosis Factor-Experienced Patients With Ulcerative Colitis.Clin Gastroenterol Hepatol · 2026 · PMID 41616901
This page is information, not medical advice. Discuss any trial with your doctor.