NCT07077681 Evaluation of the Acceptability and Therapeutic Maintenance After Substitution of Ustekinumab With a Biosimilar

Eligibility & Interventions

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What to Expect as a Participant

This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.

This trial targets 246 participants in total. It began in 2025-06-02 with a primary completion date of 2026-04-30.

Brief 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.

Eligibility Criteria

Inclusion Criteria: * Patient aged 18 years or older * Patient who has agreed to participate in the study and does not oppose the use of their health data * Patient with moderate to severe Crohn's disease treated with Stelara® in a pre-filled syringe according to the summary of product characteristics (SPC) with intervals of 8 or 12 weeks between injections * Patients presenting at least one of the following objective criteria: o PCR \< 5 mg/l o Calprotectin \< 250 μg/g o Harvey-Bradshaw index \< 5 * Patient in stable remission (defined by a stable ustekinumab dosage over the last 24 weeks and absence of corticosteroids for at least 3 months)• Patient for whom the investigator physician, prior to inclusion, has decided with their agreement, to replace Stelara® with Uzpruvo® * Patient having internet access enabling them to complete online questionnaires Exclusion Criteria: * Patient treated with ustekinumab with intervals between injections less than 8 weeks * Patients treated with ustekinumab in a pre-filled pen * Patient included in an interventional clinical trial at the time of inclusion * Patient refusing or unable to comply with the study follow-up procedures (patient unreachable by phone, unable to fill out the self-questionnaire or poorly speaking French...) * Patient under legal protection, under guardianship or under curatorship.

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