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

January 26, 2025 updated by: IRCCS Azienda Ospedaliero-Universitaria di Bologna

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

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.

Study Overview

Status

Recruiting

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

12

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
      • Bologna, Italy, 40138
        • Recruiting
        • IRCCS Azienda Ospedaliero-Universitaria di Bologna
        • Contact:
          • Paolo Gionchetti, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Investigators

  • Principal Investigator: Paolo Gionchetti, MD, IRCCS Azienda Ospedaliero-Universitaria di Bologna

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 18, 2021

Primary Completion (Actual)

December 31, 2024

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

December 1, 2024

First Submitted That Met QC Criteria

January 26, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 26, 2025

Last Verified

October 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • USK-IBD

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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