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

NCT06802887 | Recruiting

• 1 other identifier: USK-IBD
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

IBD - Inflammatory Bowel Disease

Outcome Measures

Primary Outcomes (1)

• Overall persistence of patients with Crohn's Disease and Ulcerative Colitis who started Ustekinumab.

  Evaluate the percentage of treatment discontinuation; Evaluate the percentage of patients for whom therapy optimization was necessary through the reduction of the interval between administrations; Evaluate the percentage of patients for whom it was necessary to switch to another therapy;

  Baseline; through study completion, an average of 2 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• None

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (1)

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, Bologna, 40138, Italy

RECRUITING

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Paolo Gionchetti, MD

  IRCCS Azienda Ospedaliero-Universitaria di Bologna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Paolo Gionchetti, MD

CONTACT

+39 0512145312; paolo.gionchetti@unibo.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2024
• First Posted: January 31, 2025
• Study Start: July 18, 2021
• Primary Completion: December 31, 2024
• Study Completion: December 1, 2025
• Last Updated: January 31, 2025

Record last verified: 2024-10

Locations

IT (1)