NCT05051943已完成不适用
A Prospective Observational Study of the Real-world Use of an Adalimumab Biosimilar and Evaluation of Nutritional Status on the Therapeutic Response
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 754
- 试验地点
- 1
- 主要终点
- Clinical Global Impression (CGI)
研究概览
简要总结
The aim of the study is to describe the real-world profile of patients treated with adalimumab FK in gastroenterology, dermatology or rheumatology in order to evaluate in this population the predictive factors of therapeutic response (in particular nutritional status) and generate hypothesis between nutritional status and therapeutic response.
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
- •Patients at least 18 years old who agree to participate in the study and do not object to the use of their health data
- •A disorder treated with anti-TNF therapy
- •Whose physician made the decision to initiate adalimumab treatment prior to the study
排除标准
- •Patients participating in an interventional therapeutic trial at the time of inclusion
- •Patients who are unwilling or unable to fulfil follow-up requirements (patients who cannot be reached by phone or complete the self-administered questionnaire or not fluent in French
结局指标
主要结局
Clinical Global Impression (CGI)
时间窗: 12 months
The CGI provides an overall clinician-determined summary measure that takes into account all available information, including a knowledge of the patient's history, psychosocial circumstances, symptoms, behavior, and the impact of the symptoms on the patient's ability to function.
次要结局
未报告次要终点
研究者
研究点 (1)
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