このページは自動翻訳されたものであり、翻訳の正確性は保証されていません。を参照してください。 英語版 ソーステキスト用。

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.

調査の概要

状態

完了

条件

詳細な説明

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.

研究の種類

観察的

入学 (実際)

500

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

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

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

サンプリング方法

非確率サンプル

調査対象母集団

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

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

コホートと介入

グループ/コホート
Patients with psoriasis
All eligible patients with psoriasis treated with Adalimumab

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Mean Change of Dermatology Life Quality Index (DLQI) Scores
時間枠：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)

二次結果の測定

結果測定
メジャーの説明
時間枠
Percentage of Patients Who Experienced an Improvement in Disease Severity as Determined by the Physician's Global Assessment of Disease Severity (PGA) Scores
時間枠：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
時間枠：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)
時間枠：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:

  1. the EQ-5D descriptive system (i.e., the EQ-5D Index Score, comprised of five items), and
  2. 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
時間枠：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:

  1. the EQ-5D descriptive system (i.e., the EQ-5D Index Score, comprised of five items), and
  2. 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
時間枠：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)

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

AbbVie (prior sponsor, Abbott)

捜査官

  • スタディチェア：Athina Katsavou, MD、AbbVie Pharmaceuticals S.A.

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

便利なリンク

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始

2009年9月1日

一次修了 (実際)

2012年9月1日

研究の完了 (実際)

2012年9月1日

試験登録日

最初に提出

2010年2月25日

QC基準を満たした最初の提出物

2010年2月25日

最初の投稿 (見積もり)

2010年2月26日

学習記録の更新

投稿された最後の更新 (見積もり)

2014年2月21日

QC基準を満たした最後の更新が送信されました

2014年2月19日

最終確認日

2014年2月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • P11-984

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

購読する