The PODIUM Study - a Three-arm Comparison of Target Therapies After Anti-TNFα in Ulcerative Colitis
Recruiting now
Conditions studied: Ulcerative Colitis (Disorder)
In brief
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.
Key facts
- Study ID
- NCT06691061
- Run by
- Humanitas Clinical and Research Center
- People needed
- 450
- Starts
- 2023-08-01
- Expected to finish
- 2024-12-31
- Last updated by the study team
- 2024-11-15
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
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.
Where it is running
- Humanitas Research Hospital IRCSS — Mialn, Italy, Italy (enrolling)
Full record on ClinicalTrials.gov
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