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Evaluation of the Acceptability and Therapeutic Maintenance After Substitution of Ustekinumab With a Biosimilar

NCT07077681 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 246

Last updated 2025-07-22

No results posted yet for this study

Summary

In a population of adult patients followed for Crohn's disease, who had previously agreed to replace Stelara® with a biosimilar of ustekinumab (Uzpruvo®) and were followed over a period of 12 months under usual medical practice conditions.

* Main objective: To assess the maintenance of the biosimilar of ustekinumab at 12 months without returning to the reference treatment
* Secondary objectives:

* To describe the factors associated with the maintenance of the biosimilar
* To evaluate the evolution of patients' quality of life
* To assess the rate of maintenance of clinical remission at M12
* To describe the acceptability of the biosimilar treatment by patients
* To evaluate patient satisfaction
* To evaluate treatment tolerance
* To describe the reasons for treatment discontinuation that occurred during follow-up
* To describe the profile of patients who discontinued treatment upon their request.

Conditions

  • Crohn Disease (CD)

Sponsors & Collaborators

  • EG Labo

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-02
Primary Completion
2026-04-30
Completion
2027-12-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07077681 on ClinicalTrials.gov