NCT05190484Unknown不适用
An International, Prospective, Observational Study of Patients With Chronic Inflammatory Diseases, to Assess 12-months Persistence Drivers After Switching to an Adalimumab Biosimilar, Idacio®, in a Real World Setting
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 1,050
- 主要终点
- TREATMENT DISCONTINUATION
研究概览
简要总结
The study objective is aimed to describe all country, site, investigator and patient variables that lead to treatment persistence for at least 12 months among patients with rheumatologic and intestinal chronic inflammatory diseases who were switched to FK adalimumab, in order to develop a model to predict persistence at 12 months.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Age ≥18 years, male or female.
- •Patients diagnosed with one chronic inflammatory rheumatological (rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis) or chronic inflammatory bowel (Crohn's disease, ulcerative colitis) diseases.
- •Patients who have been switched to FK adalimumab from the reference product (Humira®) or another adalimumab biosimilar.
- •Patients who have been prescribed FK adalimumab according to the SmPC prior to the inclusion.
- •Patients able to understand and complete the study questionnaires in local language during the study visits.
- •Patients willing to sign informed consent to meet data protection requirements
排除标准
- •Unwillingness to provide written informed consent.
- •Patients participating or expected to participate in any randomised clinical trial during their treatment with FK adalimumab.
- •Patients not expected to be available for study visits during 12 months.
结局指标
主要结局
TREATMENT DISCONTINUATION
时间窗: 12 months
A patient will be considered to have discontinued FK adalimumab (not persistent) if the investigator reports a permanent discontinuation or if the patient has been more than 90 consecutive days not covered by treatment (based on the refills reported).
次要结局
未报告次要终点
研究者
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