Comparing target therapies for ulcerative colitis after anti-TNFα treatment

Real-life Comparative Effectiveness of Vedolizumab, Ustekinumab and JAK Inhibitors in Patients with Ulcerative Colitis After Anti-TNFα Failure or Intolerance

This study is testing how well three different treatments work for adults with ulcerative colitis who haven't improved after their first anti-TNF-alpha therapy.

Quick facts

• Study type: Observational
• Enrollment: 450 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Humanitas Clinical and Research Center (other)
• Drugs / interventions: vedolizumab, ustekinumab, infliximab, adalimumab, golimumab, tofacitinib, upadacitinib, filgotinib
• Locations: 1 site (Mialn, Italy)
• Trial ID: NCT06691061 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older with an established diagnosis of ulcerative colitis who have previously been treated with anti-TNF-alpha therapies.

Not a fit: Patients with Crohn's colitis or other gastrointestinal inflammatory conditions, as well as those under 18 years old, will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into the most effective treatment options for patients with ulcerative colitis who have not responded to anti-TNF-alpha therapies.

How similar studies have performed: Other studies have shown success with similar approaches in evaluating treatment options for ulcerative colitis, making this study a continuation of ongoing efforts in this area.

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.

Where this trial is running

Mialn, Italy

• Humanitas Research Hospital IRCSS — Mialn, Italy, Italy (RECRUITING)

Study contacts

• Study coordinator: Alessandro Armuzzi

Conditions: Ulcerative Colitis