Comparing target therapies for ulcerative colitis after anti-TNFα treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to evaluate the real-life effectiveness and safety of three different target therapies—vedolizumab, ustekinumab, and JAK inhibitors—in patients with ulcerative colitis who have previously been treated with at least one anti-TNF-alpha therapy. Participants will be adults aged 18 and older with clinically active ulcerative colitis, and they will initiate one of the target therapies as a second-line treatment. The study will involve monitoring these patients over time to assess their response to the therapies.

Why it matters

Who can join: the full rules

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's running

• Humanitas Research Hospital IRCSS
  Mialn, Italy, Italy Recruiting

Study contacts

• Study coordinator: Alessandro Armuzzi
• Email: alessandro.armuzzi@hunimed.eu
• Phone: +39 02 8224 5555

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.