Retrospective Observational Study to Analyze the Effectiveness of Adalimumab
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 604
- 试验地点
- 1
- 主要终点
- Median time of survival (months) of adalimumab biosimilar in clinical practice
研究概览
简要总结
This is an observational, retrospective, multicenter, and descriptive study of patients treated with adalimumab biosimilar for psoriasis, according to clinical practice.
Existing data will be collected from the Dermatology Services database of the hospitals participating in the study, from the medical histories of all treated patients who meet the inclusion criteria and sign informed consent.
The aim of the study is to determine the effectiveness of the different adalimumab biosimilars in clinical practice.
详细描述
Adalimumab is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic treatment. There are currently several biosimilar drugs (Amgevita, Imraldi, Hyrimoz, Idacio, Hulio,...) in addition to the reference product (Humira).
The reduction in the cost of production of biosimilar drugs with respect to reference products has led to their replacement by biosimilar drugs in patients initiating biological therapy, but some centers are also switching to adalimumab biosimilar in patients who are controlled with original adalimumab (Humira).
There are no actual clinical efficacy / safety data in our setting on the use of adalimumab biosimilars.
There is also no evidence of maintenance response in patients who are switched from adalimumab (Humira) to biosimilar adalimumab in clinical practice.
This retrospective study will collect demographic and disease data of the psoriasis patient treated with the different biosimilars of adalimumab, as well as their comorbidities, response to treatment, and safety. In this way, data will be available in usual clinical practice to improve the management of the patient with psoriasis treated with biosimilar drugs.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 2 Years 至 90 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients of both sexes who have received treatment with adalimumab and who have signed an informed consent.
排除标准
- •Refusal to participate.
- •Any other cause of exclusion based on clinical criteria and the technical data sheet of the drug.
结局指标
主要结局
Median time of survival (months) of adalimumab biosimilar in clinical practice
时间窗: 1 year
Median time of survival (months) of patients under treatment with adalimumab biosimilar in clinical practice
次要结局
未报告次要终点