NCT06802887 Long-term Treatment With Ustekinumab in Patients With Crohn's Disease and Ulcerative Colitis: a Cohort Study
| NCT ID | NCT06802887 |
| Status | Recruiting |
| Phase | — |
| Sponsor | IRCCS Azienda Ospedaliero-Universitaria di Bologna |
| Condition | IBD - Inflammatory Bowel Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 12 participants |
| Start Date | 2021-07-18 |
| Primary Completion | 2024-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 12 participants in total. It began in 2021-07-18 with a primary completion date of 2024-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Paolo Gionchetti, MD
PRINCIPAL INVESTIGATOR
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Frequently Asked Questions
Who can join the NCT06802887 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying IBD - Inflammatory Bowel Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06802887 currently recruiting?
Yes, NCT06802887 is actively recruiting participants. Contact the research team at paolo.gionchetti@unibo.it for enrollment information.
Where is the NCT06802887 trial being conducted?
This trial is being conducted at Bologna, Italy.
Who is sponsoring the NCT06802887 clinical trial?
NCT06802887 is sponsored by IRCCS Azienda Ospedaliero-Universitaria di Bologna. The principal investigator is Paolo Gionchetti, MD at IRCCS Azienda Ospedaliero-Universitaria di Bologna. The trial plans to enroll 12 participants.