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NCT Number: NCT06802887

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

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, 40138, Italy

Location status: Recruiting

Location contact

Paolo Gionchetti, MD

CONTACT

[email protected]

+390512145312

Paolo Gionchetti, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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;

Study contacts

Contact information is provided by the study sponsor or research team.

Paolo Gionchetti, MD

CONTACT

[email protected]

+39 0512145312

Sponsors and collaborators

Lead sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2024
Study completion
2025
First posted
Jan 31, 2025
Registry last updated
Jan 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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