Systemic Treatment for Psoriasis Patients: A Prospective Multicentric Observational Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 4,613
- 试验地点
- 1
- 主要终点
- Occurrence of skin cancer
研究概览
简要总结
PSOBIOTEQ is a national multicentric prospective cohort of cutaneous psoriasis patients receiving systemic treatment (biotherapy or DMARDs) for moderate to severe cutaneous psoriasis. It is resulting from the merging of two studies that share the same study population but address different objectives: PSOBIO, developed by academic dermatologists and epidemiologists and supported by the National Drug Agency (AGENCE NATIONALE DE SECURITE DU MEDICAMENT ET DES PRODUITS DE SANTE,ANSM) and the ministry of health (PHRC 2009) focusing on safety issues, and Pso-TEQ, developed by industrials at the request of the French Transparency Commission (HAUTE AUTORITE DE SANTE) focusing on utilisation issues.
The overall general objective of PSOBIO is to assess "in real life" the safety and efficacy of biotherapies in the treatment of cutaneous psoriasis in comparison with major conventional systemic therapy while Pso-TEQ has a descriptive objective concerning the modalities of use of biological therapies "in real life" and long-term benefit.
详细描述
PSOBIOTEQ is a national multicentric prospective cohort, including patients receiving systemic treatment (biotherapy or DMARDs) for moderate to severe cutaneous psoriasis.
The exposure of interest is the exposure to a biological therapy: infliximab, adalimumab, etanercept, ustekinumab and other biotherapy entering the market.
The nature of the systemic treatment as well as its administration modalities are defined by the investigator according to usual practice.
All dermatology departments located in the French metropolitan area and using biotherapies as treatment of cutaneous psoriasis will be solicited for participation to the cohort.
The inclusion will last at least 3 years with a follow-up of at least 5 years for each patient (8 years maximum), with a 6 month periodicity for the data collection (complying with good clinical practice for these patients). Follow-up duration may be extended in the case of the identification of safety signals in the early years.
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Occurrence of skin cancer
时间窗: Each patient will be followed for at least 5 years(8 years maximum), data being collected at each visit (approximately every 6 month)
Occurrence of skin cancer (spinocellular carcinomas \[including carcinoma in situ (Bowen) and keratoacanthomas\], basocellular carcinomas and melanomas).
次要结局
- Event-free survival; incidence of serious adverse events;effectiveness;therapeutic strategy,long-term safety(serious and non-serious adverse events,quality of life, rebounds after treatment discontinuation;maintenance of a therapeutic response over time(Each patient will be followed for at least 5 years(8 years maximum), data being collected at each visit (approximately every 6 month))