The PODIUM Study - a Three-arm Comparison of Target Therapies After Anti-TNFα in Ulcerativ
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.
| Condition(s) | Ulcerative Colitis (Disorder) |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| Summary | 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 participate | 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 co |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Humanitas Clinical and Research Center |
| Locations | Mialn, Italy, Italy |
| Start date | 2023-08-01 |
| NCT ID | NCT06691061 |
| Official listing | https://clinicaltrials.gov/study/NCT06691061 |