RecruitingNCT06802887

Long-term Treatment With Ustekinumab in Patients With Crohn's Disease and Ulcerative Colitis: a Cohort Study

Long-term Treatment With Ustekinumab in Patients With Crohn's Disease and Ulcerative Colitis: a Monocentric, Observational, Retrospective/Prospective Cohort Study


Sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Enrollment

12 participants

Start Date

Jul 18, 2021

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This is a real-world data study following patients with Crohn's disease or ulcerative colitis who have been treated with ustekinumab (a biologic medication that reduces intestinal inflammation) to understand how well it works over the long term. **You may be eligible if...** - You are 18 or older - You have Crohn's disease or ulcerative colitis - You started treatment with ustekinumab between February 2019 and March 2021 according to its approved indications - You have signed the informed consent form **You may NOT be eligible if...** - There are no specific exclusion criteria for this study — all patients meeting the above criteria can participate Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(1)

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, Bologna, Italy

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NCT06802887


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