RECRUITINGOBSERVATIONAL
The PODIUM Study - a Three-arm Comparison of Target Therapies After Anti-TNFα in Ulcerative Colitis
Real-life Comparative Effectiveness of Vedolizumab, Ustekinumab and JAK Inhibitors in Patients with Ulcerative Colitis After Anti-TNFα Failure or Intolerance
About This Trial
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 May Be Eligible (Plain English)
Who May Qualify:
- Established diagnosis of UC according to the current European Crohn's and Colitis Organization (ECCO) guidelines7;
- Age ≥ 18 years-old;
- Capability of expressing willing to sign a consent form;
- 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
Who Should NOT Join This Trial:
- Diagnosis of Crohn's colitis, IBD-U or other gastrointestinal inflammatory conditions;
- Age \< 18 years-old;
- Incapability of expressing willing to sign a consent form;
- 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.
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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.
Treatments Being Tested
DRUG
Vedolizumab
UC patients treated with vedolizumab
DRUG
Ustekinumab - Standard Dosage
UC patients treated with ustekinumab
DRUG
JAK Inhibitor
UC patients treated with JAK inhibitors
Locations (1)
Humanitas Research Hospital IRCSS
Mialn, Italy, Italy