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Quality of Life in Adalimumab Treated Psoriasis Patients Failing Other Biologic Disease Modifying Anti-rheumatic Drugs (QUALITY)

2012年6月25日更新者：Abbott

A Post-marketing Observational Study of the Quality of Life in Adalimumab Treated Psoriasis Patients Failing Other Biologic DMARDs Over a Period of 1 Year (QUALITY)

The aim of this post-marketing observational study (PMOS) was to obtain further data on long-term safety, efficacy, and quality of life outcomes for adalimumab in routine clinical use in participants with moderate to severe chronic plaque psoriasis after unsustainable clinical response to other biologic disease modifying anti-rheumatic drugs (BDMARDs). There are few data so far showing the effects of switching from other BDMARDs to adalimumab in patients with moderate to severe chronic plaque psoriasis. This study was designed to evaluate the long-term effectiveness of adalimumab in participants with moderate to severe chronic plaque psoriasis using the Psoriasis Area and Severity Index (PASI) in participants previously treated with efalizumab, infliximab, or etanercept and who either never achieved satisfactory response, achieved satisfactory response initially but lost it over time, or discontinued treatment due to intolerance/side effect(s) or other reasons, for example after regular stop of etanercept.

研究概览

地位

完全的

条件

慢性银屑病

详细说明

This was a non-interventional PMOS conducted in a prospective, single-country, multicenter format to assess the quality of life of psoriasis patients taking adalimumab as prescribed by their physician in accordance with the terms of the local marketing authorization with regard to dose, population, and indication. The prescription of adalimumab was clearly separated from the decision to include the participant in this study. No procedures other than standard of care were to have been performed. Visits were non-interventional and timing of participant appointments was left to each physician. After therapy initiation, visits occurred over 12 months usually close to Weeks 4, 12, 24, 36, and 52 for a total of 6 visits (Visits 1 through 6 including Screening). Because participant visits were left to the physician, participant failure to meet the suggested visit weeks did not constitute a breach of the protocol.

研究类型

观察性的

注册 (实际的)

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

奥地利
- - Feldkirch、奥地利、6807
    - Site Reference ID/Investigator# 27435
  - Graz、奥地利、8010
    - Site Reference ID/Investigator# 27436
  - Graz、奥地利、8036
    - Site Reference ID/Investigator# 38445
  - Linz、奥地利、4020
    - Site Reference ID/Investigator# 27443
  - Vienna、奥地利、1030
    - Site Reference ID/Investigator# 27442
  - Vienna、奥地利、1130
    - Site Reference ID/Investigator# 27440
  - Vienna、奥地利、1160
    - Site Reference ID/Investigator# 27437
  - Vienna、奥地利、A-1090
    - Site Reference ID/Investigator# 27439
  - Wels、奥地利、4600
    - Site Reference ID/Investigator# 23309

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

Hospital, Dermatology

描述

Inclusion Criteria:

Patients for whom adalimumab therapy is indicated and has been prescribed according to the product label
Patients aged 18 years and older
Unsatisfactory response to prior BDMARDS (efalizumab, infliximab, etanercept) in patients with moderate to severe chronic plaque psoriasis or achievement of satisfactory response initially, but loss over time or discontinuation of treatment due to intolerance/side effects(s) or other reasons e.g. restart after regular stop of etanercept
Patients must fulfill Austrian Treatment Recommendations for use of BDMARD in psoriasis (chest X-ray and purified protein derivative [PPD] skin test negative for tuberculosis)
Patient is willing to consent to data being collected and provided to Abbott
Patient must be able and willing to self-administer Pen injections or have a qualified person available to administer Pen injections

Exclusion Criteria:

Patients who meet contraindications as outlined in the latest version of the Humira-Pen Summary of Product Characteristics (SPC)
Patients who do not meet the criteria for the use of BDMARDs of the Austrian Treatment Recommendations
Patients participating in another study or clinical trial

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
Adalimumab Participants with moderate to severe chronic plaque psoriasis treated with adalimumab after biologic disease modifying anti-rheumatic drug (BDMARD) failure

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
Psoriasis Area and Severity Index (PASI) Score 大体时间：Inclusion visit (Week 0), Week 4, Week 36, Week 52	Psoriasis Area and Severity Index (PASI) score is based on assessment of erythema (reddening), induration (plaque thickness), desquamation (scaling), and area affected as observed on the day of examination. The score ranges from 0 (best outcome) to 72 (worst outcome).	Inclusion visit (Week 0), Week 4, Week 36, Week 52
Reduction in Psoriasis Area and Severity Index Score of at Least 75% (PASI75) 大体时间：Inclusion visit (Week 0) to Week 52	PASI75 is the number of participants who achieved at least a 75% reduction (improvement) from baseline in PASI score at Week 52 (final visit). PASI score is based on assessment of erythema (reddening), induration (plaque thickness), desquamation (scaling), and area affected as observed on the day of examination. The score ranges from 0 (best outcome) to 72 (worst outcome).	Inclusion visit (Week 0) to Week 52

次要结果测量

结果测量	措施说明	大体时间
Dermatology Life Quality Index (DLQI) Score 大体时间：Inclusion visit (Week 0), Week 4, Week 36, Week 52	Dermatology Life Quality Index (DLQI) Score is a participant-reported outcome consisting of a set of 10 questions regarding the degree to which the participant's skin has affected certain behaviors and quality of life over the last week. Responses to each are: very much, a lot, a little, or not at all. The DLQI score ranges from 0 (best) to 30 (worst).	Inclusion visit (Week 0), Week 4, Week 36, Week 52
Nail Psoriasis Severity Index (NAPSI) Score 大体时间：Inclusion visit (Week 0), Week 4, Week 36, and Week 52	The nails are graded for nail matrix psoriasis and nail bed psoriasis. The sum of these two scores is the total score for that nail. Per nail, the NAPSI score ranges from 0 (no nail psoriasis) to 4 (most severe nail psoriasis).	Inclusion visit (Week 0), Week 4, Week 36, and Week 52
Tolerability and Safety Assessed by Collection and Classification of Adverse Reactions 大体时间：From the time of participant consent until 70 days after last dose of study drug	Tolerability and safety were assessed by collecting adverse events during the course of the study up to 70 days following the last dose of physician-prescribed adalimumab. The number of participants experiencing a serious or non-serious adverse event is summarized. See the Reported Adverse Event section for details.	From the time of participant consent until 70 days after last dose of study drug

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

Abbott

合作者

Assign Data Management and Biostatistics GmbH

调查人员

研究主任：Astrid Dworan-Timler, MD、Abbott Austria

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

2008年11月1日

初级完成 (实际的)

2011年4月1日

研究完成 (实际的)

2011年4月1日

研究注册日期

首次提交

2010年2月28日

首先提交符合 QC 标准的

2010年3月9日

首次发布 (估计)

2010年3月10日

研究记录更新

最后更新发布 (估计)

2012年6月29日

上次提交的符合 QC 标准的更新

2012年6月25日

最后验证

2012年6月1日