Assessment of Predictive Factors for Persistence of Treatment After Initiation of Adalimumab With a Biosimilar (Adalimumab Fresenius KaBI or Substitution of Reference Adalimumab With the Fresenius Kabi Adalimumab Biosimilar in Patients With Chronic Inflammatory Diseases
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 600
- 试验地点
- 72
- 主要终点
- Discontinuation of the biosimilar
研究概览
简要总结
A prospective, longitudinal, multicentre, observational cohort follow-up study conducted in France.
详细描述
In a population of adult patients who are targeted to initiate adalimumab or previously treated with Humira® to get switched to a biosimilar (FK adalimumab) and followed up for a period of 12 months under routine medical practice conditions.
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Primary objective: to define predictive factors for the persistence of treatment
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Secondary objectives:
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To assess the therapeutic benefit and the tolerability of the treatment
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To describe the reasons for treatment discontinuations occurring during follow-up
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 over
- •Patient who have been informed of the objectives and the conditions of the study and who did not object to its participation
- •Patient diagnosed with one chronic inflammatory rheumatological (rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis) or chronic inflammatory bowel (Crohn's disease, ulcerative colitis) diseases
- •Patient for whom the investigator has decided, with patient's agreement and prior to inclusion:
- •Or to initiate adalimumab by prescribing a biosimilar (Adalimumab FK)
- •Either to replace Humira® with a biosimilar (AdalimumabFK)
排除标准
- •Patient enrolled in an interventional therapeutic trial at the time of inclusion
- •Patient refusing or unable to comply with the study follow-up procedures (patient not contactable by telephone, unable to complete the self-administered questionnaire, or having poor French language skills, etc.)
结局指标
主要结局
Discontinuation of the biosimilar
时间窗: Month 12
Discontinuation of the biosimilar is defined as the definitive cessation of FK adalimumab
Persistence of the biosimilar
时间窗: Month 12
Persistence of the biosimilar is defined as the maintenance of FK adalimumab for the twelve-month study period
次要结局
- Tolerability evaluation(Month 12)
- Clinical status(Day 0)
- Emotional state(Month 12)
- Treatment acceptance(Day 0)
- Quality of life assessment(Month 12)
- Maintenance of therapeutic benefit(Month 12)