Acceptability and Therapeutic Maintenance of the Biosimilar Ustekinumab After Substitution
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 246
- 试验地点
- 11
- 主要终点
- maintenance of treatment
研究概览
简要总结
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.
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Main objective: To assess the maintenance of the biosimilar of ustekinumab at 12 months without returning to the reference treatment
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Secondary objectives:
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To describe the factors associated with the maintenance of the biosimilar
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To evaluate the evolution of patients' quality of life
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To assess the rate of maintenance of clinical remission at M12
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To describe the acceptability of the biosimilar treatment by patients
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To evaluate patient satisfaction
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To evaluate treatment tolerance
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To describe the reasons for treatment discontinuation that occurred during follow-up
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To describe the profile of patients who discontinued treatment upon their request.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
maintenance of treatment
时间窗: Month 12
The maintenance of treatment is defined by the continuation of treatment with Uzpruvo®, the biosimilar of ustekinumab, during the twelve months of the study.
次要结局
- Quality of life - SF-36(Month 12)
- Quality of life - EQ-5D-5L(Month 12)
- Quality of life - SIBDQ(Month 12)
- Crohn's disease activity(Month 12)
- Abdominal pain(Month 12)
- Intestinal urgency(Month 12)