The PODIUM Study - a Three-arm Comparison of Target Therapies After Anti-TNFα in Ulcerative Colitis

Launched by HUMANITAS CLINICAL AND RESEARCH CENTER · Nov 14, 2024

Keywords

ClinConnect Summary

The PODIUM Study is a research trial that aims to understand how effective and safe three different treatments—vedolizumab, ustekinumab, and JAK inhibitors—are for people with ulcerative colitis (UC) who have already tried at least one anti-TNF-alpha therapy. This study is looking for adult participants aged 18 and older who have been diagnosed with UC and are currently experiencing active symptoms. To be eligible, participants must have previously received treatment with anti-TNF-alpha medications like infliximab or adalimumab but have not yet started vedolizumab, ustekinumab, or JAK inhibitors.

If you choose to participate in the PODIUM Study, you’ll begin treatment with one of these three options and will have follow-up visits to monitor your progress. This is a chance to contribute to important research that may help improve future treatments for UC. The study is currently recruiting participants, and your involvement could provide valuable insights into how these therapies work in real-life settings.

Gender

ALL

Eligibility criteria

• 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.