Clinical trial NCT06802887: Long-term Treatment With Ustekinumab in Patients With Crohn's Disease and Ulcerative Colitis: a Cohort Study
Official title: Long-term Treatment With Ustekinumab in Patients With Crohn's Disease and Ulcerative Colitis: a Monocentric, Observational, Retrospective/Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: IBD - Inflammatory Bowel Disease
Lead sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Sponsor class: OTHER
First posted: 2025-01-31
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: It is expected to enroll approximately 300 patients with Crohn's Disease and 50 patients with Ulcerative Colitis who started therapy with Ustekinumab during the period from February 2019 to March 2021, as part of the normal care pathway, at the Regional Reference Center for Inflammatory Bowel Diseases in Emilia-Romagna.

Brief summary: Monocentric observational retrospective/prospective pharmacological study. Clinical records of patients with Ulcerative Colitis and Crohn's Disease who started therapy with Ustekinumab between February 2019 and March 2021 at the IBD Unit will be reviewed. The main objective is to evaluate the overall persistence of patients with Crohn's Disease and Ulcerative Colitis who started Ustekinumab between February 2019 and March 2021, as well as the impact of treatment on the natural history of the disease. The study involves the collection of follow-up data for a maximum period of 24 months from the start of therapy. For patients who began therapy with Ustekinumab from February 2019 up to 24 months before the start of enrollment, data collection will be conducted retrospectively. For patients who have undergone therapy with Ustekinumab within 24 months prior to the start of enrollment, and up to March 2021, data will be collected both retrospectively and prospectively.

Detailed description: The medical records of patients with Crohn's Disease and Ulcerative Colitis who started therapy with Ustekinumab between February 2019 and March 2021 have been selected. Initially, it was estimated that approximately 350 patients would be eligible for enrollment in the study.

Eligibility criteria: Inclusion Criteria:

* Signed informed consent
* Male and female patients, aged ≥18 years
* Patients who began treatment with Ustekinumab according to the indications for marketing authorization, following clinical practice and the information contained in the product's technical data sheet, during the period from February 2019 to March 2021.

Exclusion Criteria:

* None

Primary outcomes:
measure: Overall persistence of patients with Crohn's Disease and Ulcerative Colitis who started Ustekinumab.
timeFrame: Baseline; through study completion, an average of 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Study officials:
affiliation: IRCCS Azienda Ospedaliero-Universitaria di Bologna
name: Paolo Gionchetti, MD
role: PRINCIPAL_INVESTIGATOR
References: