The PODIUM Study - a Three-arm Comparison of Target Therapies After Anti-TNFα in Ulcerative Colitis
Observational · No treatment assigned · 1 site · Humanitas Clinical and Research Center
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
Condition(s) listed: Ulcerative Colitis (Disorder). This is an observational study: researchers collect information (for example questionnaires, samples, or scans) but the study does not assign a treatment.
Who can join
- Ages 18 and older
- Any sex
Some of the main requirements, copied from the record:
- 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;
Plus 5 more requirement(s). There are also 7 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 450 participants are expected to take part.
- Start date: 2023-08-01.
- Main results expected around 2024-12-31 (estimate from the record).
- 1 study site listed (1 marked recruiting) in Italy.
Main thing being measured
- Clinical and endoscopic effectiveness of the three treatments (12 months)
In the researchers’ words
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.
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Observational |
| Study type | Observational |
| Conditions | Ulcerative Colitis (Disorder) |
| Lead sponsor | Humanitas Clinical and Research Center |
| Enrollment | 450 (estimated) |
| Start date | 2023-08-01 |
| Primary completion (est.) | 2024-12-31 |
| First posted | 2024-11-15 |
| Last updated | 2024-11-15 |
| Official title | Real-life Comparative Effectiveness of Vedolizumab, Ustekinumab and JAK Inhibitors in Patients with Ulcerative Colitis After Anti-TNFα Failure or Intolerance |
| ClinicalTrials.gov ID | NCT06691061 |
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
Full eligibility criteria (from the record)
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.
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| Humanitas Research Hospital IRCSS | Mialn, Italy | Italy | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.