[E S] A Greek, Post-marketing, Observational Study of the quAlity of Life in Patients With Psoriasis Treated With Adalimumab - GOAL Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 500
- 试验地点
- 61
- 主要终点
- Mean Change of Dermatology Life Quality Index (DLQI) Scores
研究概览
简要总结
Primary objective
- To evaluate the quality of life of Adalimumab treated patients over a period of 12 months
Secondary objectives
- To evaluate the long-term efficacy of Adalimumab in patients with moderate to severe chronic plaque psoriasis as prescribed by the dermatologists in day-to-day clinical practice and in accordance with the terms of the European marketing authorization.
- To evaluate changes in patients quality of life according to treatment response over a 12-month period
- To observe and assess the long term use and safety of Adalimumab as prescribed by the dermatologist in a normal clinical setting and in accordance with the terms of the European marketing authorization.
详细描述
The aim of this post-marketing observational study in adult patients with moderate to severe chronic plaque psoriasis is to obtain further data on patient's Quality of Life and assess the impact of Adalimumab treatment on patient's quality of life in conditions of day-to-day clinical practice in Greece. This study will further assess the relationship between clinical outcomes and patient-reported outcomes. As this is an observational study, Abbott will not provide the study drug. Humira will be prescribed according to the routine medical practice. The participating physicians are free to determine the appropriate therapy for each patient and make treatment choices as deemed clinically necessary.
The Dermatology Life Quality Index (DLQI) will be used to assess patient quality of life. The Dermatology Life Quality Index (DLQI) total scores range from 0 to 30, with 0 corresponding to the best quality of life and 30 to the worst. The Dermatology Life Quality Index (DLQI) has well-established reliability and validity as determined in several studies. Moreover, it is frequently used in clinical trials of psoriasis.
The physician's global assessment of disease severity (PGA) will be used to measure patients' disease status at the time of assessment. It is a 6-point scale measuring the degree of overall psoriatic lesion severity, and scores range from 0 (clear) to 5 (very severe).
Complementary, European Quality of Life-5 Dimensions health questionnaire (EQ5D) will be used as a measure of health outcome. This is applicable to a wide range of health conditions and treatments and it provides a simple descriptive profile and a single index value for health status. Health economic data will be collected by using European Quality of Life-5 Dimensions health questionnaire (EQ5D) questionnaire and data regarding patients hospitalisation due to psoriasis. Hospitalisation data will be collected 6 months before the period and throughout the observation period.
Moreover, this study will observe the current medical practice in prescribing Adalimumab in Greece and more detailed data on prescription behavior will be collected. Guidelines have been developed in order to ensure that the new class of therapy (biologic agents) is introduced in a systematic and planned way to achieve the greatest possible benefit to people with psoriasis and to facilitate safe and effective prescribing. However, many issues are not fully addressed, such as recommendation regarding the amount of time for wash out of previous antipsoriatic drugs and combination therapies. Such issues remain at the discretion of the healthcare professional. Since this is an observational study the patient will be treated in accordance with the physician's usual and customary medical practice. Thus, the following information regarding the use of Adalimumab will be collected
研究设计
- 研究类型
- Observational
- 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
- •Patients with moderate to severe chronic plaque psoriasis who are newly prescribed Humira (adalimumab) therapy (have never been treated with adalimumab before) and for whom the treating physician has made the decision that they are eligible for treatment with adalimumab in accordance with the terms of the local marketing authorization
- •Patients with moderate to severe chronic plaque psoriasis for whom Adalimumab is indicated and has been prescribed according to the current approved local SPC as long as the first administration of adalimumab is not older than two months and they have not had dose interruptions since the initiation of adalimumab, and the Investigator can provide all the needed source documentation including a completed DLQI questionnaire at the start of Adalimumab treatment.
- •Patient age ≥ 18
- •Patient is willing to consent to data being collected and provided to Abbott
排除标准
- •Patients who meet contraindications as outlined in the latest version of the local approved SPC
- •Patients who participate in another clinical/observational study
- •Patients who are not willing to sign an Informed Consent Form
结局指标
主要结局
Mean Change of Dermatology Life Quality Index (DLQI) Scores
时间窗: 12-month period, (Month 0, Month 1, Month 4, Month 8, Month 12)
DLQI (Dermatology Life Quality Index) assesses symptoms and impacts of dermatologic diseases on quality of life. DLQI scores range from 0 to 30, with a higher score indicating a more impaired quality of life.
次要结局
- Assessment of Long Term Use and Safety of Adalimumab as Prescribed by the Dermatologist in a Normal Clinical Setting and in Accordance With the Terms of the European Marketing Authorization(12-month period (Month 0, Month 1, Month 4, Month 8, Month 12))
- Percentage of Patients Who Experienced an Improvement in Disease Severity as Determined by the Physician's Global Assessment of Disease Severity (PGA) Scores(12-month period (Month 0, Month 1, Month 4, Month 8, Month 12))
- Mean Change in the Dermatology Life Quality Index (DLQI) Score by Physician's Global Assessment of Disease Severity (PGA) Response Groups and by Geographical Region(12-month period (Month 0, Month 1, Month 4, Month 8, Month 12))
- Percentage of Patients Reporting "No Problem" on the European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D)(12-month period (Month 0, Month 1, Month 4, Month 8, Month 12))
- Mean Change From Baseline of European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Visual Analogue Scale (VAS) Scores(12-month period (Month 0, Month 1, Month 4, Month 8, Month 12))