A 10-Year, Post-marketing, Observational Study to Assess Long Term Safety of HUMIRA® (Adalimumab) in Adult Patients With Chronic Plaque Psoriasis (PS)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 6,065
- 试验地点
- 339
- 主要终点
- Adverse Events that lead to permanent discontinuation of HUMIRA®
研究概览
简要总结
The purpose of this study is to evaluate the long-term safety of Humira® in Adult Patients with Chronic Plaque Psoriasis (Ps).
详细描述
ESPRIT is a 10 year registry of patients taking HUMIRA® for Psoriasis. Patients who volunteer to participate will be asked to provide information about their medical history and experiences with HUMIRA®. No registry specific testing will be performed. Patients will be asked to provide data on their experiences with HUMIRA® approximately every 6 months, or as determined by the study doctor. No drug will be provided as a result of participation in the registry. All treatment decisions are independent of participation in the registry.
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 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •An adult patient (18 years of age or older) with chronic plaque psoriasis who has been prescribed HUMIRA® therapy according to the local product labeling and meets one of the following criteria:
- •New initiated (within 4 weeks of registry entry) on HUMIRA® therapy;
- •Initiated HUMIRA® therapy in the past and:
- •Has received continuous (no more than 70 consecutive days off drug) HUMIRA® therapy and the physician can provide source documentation of SAEs, AEs, of Special Interest, and dosing information since initiation of therapy.
- •Is entering after participation in an AbbVie HUMIRA (adalimumab) sponsored study and has received continuous (no more than 70 consecutive days off drug) HUMIRA® therapy after the completion of AbbVie sponsored study and physician can provide source documentation of SAEs, AEs of Special Interest, and dosing information since initiation of commercial HUMIRA® (defined as a prescribed/non study drug).
- •Patient is willing to consent to data being collected and provided to AbbVie;
- •Patient is capable of and willing to give written informed consent and to comply with the requirements of the registry.
排除标准
- •Patient should not be enrolled if he/she cannot be treated in accordance with the local product label.
结局指标
主要结局
Adverse Events that lead to permanent discontinuation of HUMIRA®
时间窗: Duration of study
Incidence of Adverse Events that lead to permanent discontinuation of HUMIRA® is calculated upon all events that lead to permanent discontinuation of HUMIRA® during registry, during exposure to HUMIRA® prior to entry of registry, and in Health Care Provider process.
Incidence of Serious Adverse Events
时间窗: Duration of study
Incidence of Adverse Events is calculated upon all events that occur during registry, during exposure to HUMIRA® prior to entry of registry, and in Health Care Provider process.
Incidence of Adverse Events of Special Interest
时间窗: Duration of study
Incidence of Adverse Events is calculated upon all events that occur during registry, during exposure to HUMIRA® prior to entry of registry, and in Health Care Provider process.
次要结局
- Health Care Utilization(Duration of study)
- Patient Health Question-9(Duration of study)
- Medical Outcomes Social Activities Scale(Duration of study)
- Illness Cognition(Duration of study)
- Patient reported outcome - Dermatology Life Quality Index(Duration of study)
- Census(Duration of study)
- Psoriasis Impact and Experience(Duration of study)
- Rosenberg Self-Esteem Scale(Duration of study)
- Physician's Global Assessment(Collected approximately every six months.)
- Work Productivity and Activity Impairment Questionnaire: Specific Health Problem(Duration of study)
- Patient Global Assessment(Duration of study)
- Insurance Status(Duration of study)