Long-term treatment with Ustekinumab for Crohn's Disease and Ulcerative Colitis
Long-term Treatment With Ustekinumab in Patients With Crohn's Disease and Ulcerative Colitis: a Monocentric, Observational, Retrospective/Prospective Cohort Study
This study looks at how well Ustekinumab works for people with Crohn's Disease and Ulcerative Colitis over two years to see if it helps them stay healthy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 12 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | IRCCS Azienda Ospedaliero-Universitaria di Bologna Academic / other |
| Drugs / interventions | Ustekinumab |
| Locations | 1 site (Bologna, Bologna) |
| Trial ID | NCT06802887 on ClinicalTrials.gov |
What this trial studies
This observational cohort study reviews clinical records of patients with Crohn's Disease and Ulcerative Colitis who began therapy with Ustekinumab between February 2019 and March 2021. The study aims to evaluate the persistence of treatment and its impact on the disease's natural history over a follow-up period of up to 24 months. Data will be collected both retrospectively and prospectively, focusing on approximately 350 eligible patients. The study is conducted at the IBD Unit of a prominent medical center.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older who have started Ustekinumab treatment for Crohn's Disease or Ulcerative Colitis during the specified time frame.
Not a fit: Patients who have not received Ustekinumab or are under 18 years old may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the long-term effectiveness of Ustekinumab in managing Crohn's Disease and Ulcerative Colitis.
How similar studies have performed: Other studies have shown positive outcomes with Ustekinumab in treating similar conditions, indicating a potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Bologna, Bologna
- IRCCS Azienda Ospedaliero-Universitaria di Bologna — Bologna, Bologna, Italy (Recruiting)
Study contacts
- Principal investigator: Paolo Gionchetti, MD — IRCCS Azienda Ospedaliero-Universitaria di Bologna
- Study coordinator: Paolo Gionchetti, MD
- Email: paolo.gionchetti@unibo.it
- Phone: +39 0512145312
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.