Long Term Documentation of the Safety and Efficacy as Well as the Effects on Work Productivity in Patients With Moderate to Severe Plaque Psoriasis Treated With HUMIRA (Adalimumab) in Routine Clinical Practice (LOTOS)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 5,442
- 试验地点
- 641
- 主要终点
- Changes in healthcare parameters: number of missed working days due to psoriasis; number of visits at the doctor's office; number and duration of hospitalizations, self-assessed workability.
研究概览
简要总结
Safety and Effectiveness of adalimumab (Humira) in Psoriasis Patients in Routine Clinical Practice.
详细描述
Postmarketing Observational Study to Evaluate the Work Productivity, Safety and Efficacy of Humira for the Treatment of Moderate to Severe Plaque Psoriasis in Daily Clinical Practice. The primary objectives of the PMOS are to explore changes in health related care utilization data by the evaluation of:
- the number of missed working days
- the number of visits to doctor's office
- the number and duration of hospitalizations
- work ability to assess efficacy for different subgroups by
- the number of patients achieving a PASI 75 response to evaluate safety by
- the documentation and analysis of adverse events for all patients and subgroups with concomitant diseases Secondary objectives include the exploration of changes in quality of life measurements, of the influence of age, gender and duration of disease
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 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Moderate to severe plaque psoriasis in adults with no response to other systemic therapy (e.g. cyclosporine, methotrexate or PUVA (photochemical therapy)) or patients with a contraindication or hypersensitivity to such a 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
Changes in healthcare parameters: number of missed working days due to psoriasis; number of visits at the doctor's office; number and duration of hospitalizations, self-assessed workability.
时间窗: At 24, 48 and 60 months
Changes in Psoriasis Area and Severity Index; number of patients with Psoriasis Area and Severity Index-75 reduction.
时间窗: At 24, 48 and 60 months
Safety and tolerability assessed by analyzing serious and non-serous adverse events.
时间窗: At 24, 48 and 60 months
次要结局
- Influence of body mass index and weight on efficacy measurement.(At 24, 48 and 60 months)
- Global physician's assessment on Humira treatment.(At 24, 48 and 60 months)
- Target Nail Psoriasis Severity Index (target NAPSI).(At 24 months)
- Safety and tolerability of Humira - treatment for patient groups with frequent concommitant diseases, especially diabetes type I and II, cardio-vascular and liver and kidney functional impairment and respective concommitant medication.(At 24, 48 and 60 months)
- Patients' assessment on Humira treatment.(At 24, 48 and 60 months)
- Itch Visual Analogue Scale (Itch VAS).(At 24 months)
- Palmoplantar Psoriasis Area Severity Index (pPASI).(At 24 months)