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Greek Study of the Quality of Life in Patients With Psoriasis Treated With Adalimumab

2014年2月19日更新者：AbbVie (prior sponsor, Abbott)

[E S] A Greek, Post-marketing, Observational Study of the quAlity of Life in Patients With Psoriasis Treated With Adalimumab - GOAL Study

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.

研究概览

地位

完全的

条件

银屑病

详细说明

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

the previous systemic treatment history will be recorded including previous biological therapies that patient received, if any,
wash out periods prior to initiating Adalimumab therapy, if any
reasons for stopping previous treatment,
combination of Adalimumab with other topical or systemic antipsoriatic agents, if applicable

Furthermore, demographic data of patients suffering from psoriasis in Greece will be collected (age, gender, ethnicity) and disease data such as duration of the disease, involvement of nails or joints, geographic distribution of the disease in Greece will be collected.

研究类型

观察性的

注册 (实际的)

500

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

希腊
- - Agrinio、希腊、301 00
    - Site Reference ID/Investigator# 43746
  - Amaliada、希腊
    - Site Reference ID/Investigator# 30197
  - Argos、希腊、21200
    - Site Reference ID/Investigator# 30039
  - Argyroupoli、希腊
    - Site Reference ID/Investigator# 29903
  - Athens、希腊、10673
    - Site Reference ID/Investigator# 29819
  - Athens、希腊、11526
    - Site Reference ID/Investigator# 29949
  - Athens、希腊、16121
    - Site Reference ID/Investigator# 30804
  - Athens、希腊、16121
    - Site Reference ID/Investigator# 30806
  - Athens、希腊、16121
    - Site Reference ID/Investigator# 38324
  - Athens、希腊
    - Site Reference ID/Investigator# 22385
  - Athens、希腊
    - Site Reference ID/Investigator# 29826
  - Athens、希腊
    - Site Reference ID/Investigator# 29966
  - Athens、希腊
    - Site Reference ID/Investigator# 29991
  - Athens、希腊
    - Site Reference ID/Investigator# 30106
  - Athens、希腊
    - Site Reference ID/Investigator# 30107
  - Athens、希腊
    - Site Reference ID/Investigator# 30181
  - Athens、希腊
    - Site Reference ID/Investigator# 30470
  - Chania, Crete、希腊、73136
    - Site Reference ID/Investigator# 30086
  - Chania, Crete、希腊
    - Site Reference ID/Investigator# 43744
  - Crete、希腊、71409
    - Site Reference ID/Investigator# 30794
  - Crete、希腊
    - Site Reference ID/Investigator# 29937
  - Crete、希腊
    - Site Reference ID/Investigator# 29959
  - Crete、希腊
    - Site Reference ID/Investigator# 29969
  - Drama、希腊
    - Site Reference ID/Investigator# 38334
  - Florina、希腊、53100
    - Site Reference ID/Investigator# 30801
  - Giannitsa、希腊、58100
    - Site Reference ID/Investigator# 29919
  - Giannitsa、希腊
    - Site Reference ID/Investigator# 30202
  - Glyfada、希腊、16675
    - Site Reference ID/Investigator# 29970
  - Glyfada、希腊、16675
    - Site Reference ID/Investigator# 30013
  - Glyfada、希腊
    - Site Reference ID/Investigator# 29823
  - Halandri、希腊
    - Site Reference ID/Investigator# 30193
  - Kalamaria、希腊
    - Site Reference ID/Investigator# 30083
  - Kallithea、希腊、17672
    - Site Reference ID/Investigator# 30143
  - Katerini、希腊、60100
    - Site Reference ID/Investigator# 47262
  - Keratsini、希腊
    - Site Reference ID/Investigator# 38329
  - Kolonaki、希腊、10675
    - Site Reference ID/Investigator# 30108
  - Kosmos、希腊
    - Site Reference ID/Investigator# 30009
  - Larissa、希腊、41100
    - Site Reference ID/Investigator# 38323
  - Larissa、希腊
    - Site Reference ID/Investigator# 38340
  - Livadeia、希腊
    - Site Reference ID/Investigator# 29822
  - Makri、希腊
    - Site Reference ID/Investigator# 30180
  - Mitilini、希腊
    - Site Reference ID/Investigator# 29834
  - Mitilini、希腊
    - Site Reference ID/Investigator# 30469
  - N.Heraklion、希腊
    - Site Reference ID/Investigator# 38326
  - Neapoli、希腊
    - Site Reference ID/Investigator# 30032
  - Pagkrati、希腊、11634
    - Site Reference ID/Investigator# 30104
  - Patras、希腊
    - Site Reference ID/Investigator# 29817
  - Peiraius、希腊
    - Site Reference ID/Investigator# 29967
  - Peristeri、希腊
    - Site Reference ID/Investigator# 38327
  - Petralona、希腊
    - Site Reference ID/Investigator# 30109
  - Smyrni、希腊
    - Site Reference ID/Investigator# 29824
  - Thessaloniki、希腊、54643
    - Site Reference ID/Investigator# 38325
  - Thessaloniki、希腊、564 29
    - Site Reference ID/Investigator# 30769
  - Thessaloniki、希腊
    - Site Reference ID/Investigator# 30170
  - Thessaloniki、希腊
    - Site Reference ID/Investigator# 38331
  - Thessaloniki、希腊
    - Site Reference ID/Investigator# 38332
  - Thessaloniki、希腊
    - Site Reference ID/Investigator# 38333
  - Thessaloniki、希腊
    - Site Reference ID/Investigator# 38335
  - Thessaloniki、希腊
    - Site Reference ID/Investigator# 38337
  - Vari、希腊、16672
    - Site Reference ID/Investigator# 30203
  - Volos、希腊
    - Site Reference ID/Investigator# 29921

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

非概率样本

研究人群

Patients treated with Adalimumab according to routine medical practice from hospital and private physicians.

描述

Inclusion Criteria:

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

Exclusion Criteria:

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

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

团体/队列数

队列和干预

团体/队列
Patients with psoriasis All eligible patients with psoriasis treated with Adalimumab

研究衡量的是什么？

主要结果指标

结果测量	措施说明	大体时间
Mean Change of Dermatology Life Quality Index (DLQI) Scores 大体时间：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.	12-month period, (Month 0, Month 1, Month 4, Month 8, Month 12)

次要结果测量

结果测量	措施说明	大体时间
Percentage of Patients Who Experienced an Improvement in Disease Severity as Determined by the Physician's Global Assessment of Disease Severity (PGA) Scores 大体时间：12-month period (Month 0, Month 1, Month 4, Month 8, Month 12)	The Physician's Global Assessment of disease severity (PGA) was used to measure participants' disease status at the time of assessment. This tool is a horizontal visual analogue 6-point scale measuring the degree of overall psoriatic lesion severity, and scores range from 0 (clear) to 5 (very severe). The percentage of patients who showed an improvement from baseline in their PGA scores was recorded.	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 大体时间：12-month period (Month 0, Month 1, Month 4, Month 8, Month 12)	The average change in the Dermatology Life Quality Index (DLQI) score during the 12-month study was analyzed by the Physician's Global Assessment of disease severity (PGA) response and also by geographical location of study participants. DLQI scores range from 0 to 30, with a higher score indicating a more impaired quality of life. . In this table, a higher number means a greater improvement in the participants' quality of life.	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) 大体时间：12-month period (Month 0, Month 1, Month 4, Month 8, Month 12)	EQ-5D (European Quality of Life - 5 Dimensions Questionnaire) is a standardized instrument for use as a measure of health outcome. It has two components: the EQ-5D descriptive system (i.e., the EQ-5D Index Score, comprised of five items), and the EQ-5D VAS. The EQ-5D Index Score has five dimensions of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Patients reported either "problem" or "no problem" with each of the five dimensions of health. The EQ-5D VAS is a 20-cm scale with endpoints labeled "best imaginable health" and "worst imaginable health" anchored at 100 and 0, respectively.	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 大体时间：12-month period (Month 0, Month 1, Month 4, Month 8, Month 12)	EQ-5D (European Quality of Life - 5 Dimensions Questionnaire) is a standardized instrument for use as a measure of health outcome. It has two components: the EQ-5D descriptive system (i.e., the EQ-5D Index Score, comprised of five items), and the EQ-5D VAS. EQ-5D Index Score has five dimensions of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Patients reported either "problem" or "no problem" with each of the five dimensions of health. The EQ-5D VAS is a 20-cm scale with endpoints labeled "best imaginable health" and "worst imaginable health" anchored at 100 and 0, respectively.	12-month period (Month 0, Month 1, Month 4, Month 8, Month 12)
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 大体时间：12-month period (Month 0, Month 1, Month 4, Month 8, Month 12)	An adverse event (AE) was defined as any untoward medical occurrence in a participant, which did not necessarily have a causal relationship with their treatment. Any worsening of a pre-existing condition or illness was considered an adverse event.	12-month period (Month 0, Month 1, Month 4, Month 8, Month 12)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

AbbVie (prior sponsor, Abbott)

调查人员

学习椅：Athina Katsavou, MD、AbbVie Pharmaceuticals S.A.

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

有用的网址

Related Info

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2009年9月1日

初级完成 (实际的)

2012年9月1日

研究完成 (实际的)

2012年9月1日

研究注册日期

首次提交

2010年2月25日

首先提交符合 QC 标准的