Long-term Treatment With Ustekinumab in Patients With Crohn's Disease and Ulcerative Colitis: a Cohort Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: IBD - Inflammatory Bowel Disease. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Long-term Treatment With Ustekinumab in Patients With Crohn's Disease and Ulcerative Colitis: a Monocentric, Observational, Retrospective/Prospective Cohort Study
Overview
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.
Primary outcome measures
- Overall persistence of patients with Crohn's Disease and Ulcerative Colitis who started Ustekinumab. [Time frame: Baseline; through study completion, an average of 2 years]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Italy · 1 center
- IRCCS Azienda Ospedaliero-Universitaria di Bologna — Bologna
Identifiers
NCT: NCT06802887 · USK-IBD