The PODIUM Study - a Three-arm Comparison of Target Therapies After Anti-TNFα in Ulcerative Colitis
Recruiting · NCT06691061 · Observational (researchers observe without assigning treatment) · Lead sponsor: Humanitas Clinical and Research Center
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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.
Where it is running
1 location listed.
- Humanitas Research Hospital IRCSS - Mialn, Italy, Italy