Compares vedolizumab, ustekinumab and JAK inhibitors in ulcerative colitis after anti-TNF treatment
Compares how well and how safely these drugs work in adults with ulcerative colitis.
Plain-language title generated from the registry record
Registry title: The PODIUM Study - a Three-arm Comparison of Target Therapies After Anti-TNFα in Ulcerative Colitis
Key facts
- Where
- Mialn, ItalySee the site
Where in Italy
- Humanitas Research Hospital IRCSSMialn, ItalyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Humanitas Clinical and Research Center
- Trial code
- NCT06691061
- Record updated
- 15 November 2024
- Original description
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.Read full original descriptionShow less
Real-life Comparative Effectiveness of Vedolizumab, Ustekinumab and JAK Inhibitors in Patients with Ulcerative Colitis After Anti-TNFα Failure or Intolerance
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.
Inclusion: 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: 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; 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.