Long Term Documentation of the Safety and Efficacy as Well as the Effects on Quality of Life and Work Productivity in Patients With Psoriatic Arthritis Under HUMIRA® (Adalimumab) in Routine Clinical Practice
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- Abbott
- 主要终点
- Improvement in: number of missed working days, self-assessed workability, severity of clinical symptoms and functional impairment, health-related quality of life; safety an tolerability: documentation of adverse events and serious adverse events
研究概览
简要总结
Safety and effectiveness, quality of life and work productivity of Humira in patients with psoriatic arthritis in clinical routine.
详细描述
The primary objective of the Non-Interventional Study is to explore the therapeutic success, measured by improvements in the following target variables (with regard to the respective baseline value):
- The number of missed working days
- The self-assessed workability
- The severity of clinical symptoms (number of tender and swollen joints, C-reactive Protein and erythrocyte sedimentation rate respectively; total score Disease Activity Score 28, Psoriasis Area and Severity Index)
- The severity of functional impairment (Health Assessment Questionnaire)
- The health-related quality of life .
All of the patient and disease characteristics which are documented at baseline will be evaluated for their additional impact on the target variables (therapeutic success). Particularly the impact of previous biologic therapies on clinical target variables will be evaluated.
The secondary objective is to document the therapeutic success by the following variables:
- The number of physician visit
- The number and duration of hospitalization
- The number of days of impairment in non-occupational activities
- Pain, exhaustion/fatigue
- The reduction of number and dose of concomitant medication
- Patient's assessment of adalimumab therapy compared to previous therapies.
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
- •Active and progressive psoriatic arthritis in adults with insufficient response to prior basic therapy
排除标准
- •Hypersensitivity against the drug or one of the other ingredients
- •Active tuberculosis or other severe infections (e.g. sepsis and opportunistic infections)
- •Moderate to severe cardiac insufficiency.
结局指标
主要结局
Improvement in: number of missed working days, self-assessed workability, severity of clinical symptoms and functional impairment, health-related quality of life; safety an tolerability: documentation of adverse events and serious adverse events
时间窗: Months 0, 3, 6, 12, 24, 36, 48, 60
次要结局
- Number and duration of hospitalization; reduction of number and dose of concomitant medication: patient's assessment of adalimumab therapy compared to previous therapies.(Months 0, 3, 6, 12, 24, 36, 48, 60)
