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

Официальное название

Acceptability and Therapeutic Maintenance of the Biosimilar Ustekinumab After Substitution

Обзор

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.

Подробное описание

This is an open-label, prospective, longitudinal, multicenter, observational cohort study involving a population of adult patients for whom the investigating physician, prior to inclusion, decided with their consent to replace Stelara® with Uzpruvo® (a biosimilar of ustekinumab).

This observational study does not alter the physician-patient relationship or standard patient care. Physicians retain freedom in their prescriptions and follow-up procedures; no specific procedures or tests are required of patients beyond the completion of self-assessment questionnaires. The study is longitudinal, and the proposed assessments remain within the framework of the patients' standard follow-up with their physician.

This study is classified as RIPH 3 (minimally or not at all interventional).

The conduct of the treatment (dosage, administration schedule, etc.) is left to the discretion of the investigating physician in compliance with the MA, according to their clinical practice and the patient's therapeutic history. Similarly, the investigating physician remains the sole judge of the continuation or interruption of ustekinumab or its replacement by another biotherapy or by any other treatment. All treatments associated with ustekinumab as part of the management of the condition that prompted biotherapy that will be prescribed during the study must be reported in the observation log.

Первичные конечные точки

• maintenance of treatment [Срок оценки: Month 12]

Вторичные конечные точки (12)

• Quality of life - SF-36 [Срок оценки: Inclusion]
• Quality of life - SF-36 [Срок оценки: Month 3]
• Quality of life - SF-36 [Срок оценки: Month 6]
• Quality of life - SF-36 [Срок оценки: Month 12]
• Quality of life - EQ-5D-5L [Срок оценки: Inclusion]
• Quality of life - EQ-5D-5L [Срок оценки: Month 3]
• Quality of life - EQ-5D-5L [Срок оценки: Month 6]
• Quality of life - EQ-5D-5L [Срок оценки: Month 12]
• Quality of life - SIBDQ [Срок оценки: Inclusion]
• Quality of life - SIBDQ [Срок оценки: Month 3]
• Quality of life - SIBDQ [Срок оценки: Month 6]
• Quality of life - SIBDQ [Срок оценки: Month 12]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Франция · 11 центров

• Cabinet Medical — Amiens
• Chu de La Côte Basque — Bayonne
• Chu Besançon - Hopital Jean Minjoz — Besançon
• Chu La Cavale Blanche — Brest
• Chu Montpellier - Hopital Saint Eloi — Montpellier
• Chu Nantes — Nantes
• Clinique Jules Verne — Nantes
• Institut Des Mici Groupe Hospitalier — Neuilly-sur-Seine
• … и ещё 3 центра

Идентификаторы

NCT: NCT07077681 · Etude ATLAS France 2025

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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