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

February 19, 2014 updated by: 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.

Study Overview

Status

Completed

Conditions

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Patients with psoriasis
All eligible patients with psoriasis treated with Adalimumab

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Change of Dermatology Life Quality Index (DLQI) Scores
Time Frame: 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)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Patients Who Experienced an Improvement in Disease Severity as Determined by the Physician's Global Assessment of Disease Severity (PGA) Scores
Time Frame: 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
Time Frame: 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)
Time Frame: 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
Time Frame: 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
Time Frame: 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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AbbVie (prior sponsor, Abbott)

Investigators

  • Study Chair: Athina Katsavou, MD, AbbVie Pharmaceuticals S.A.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (Actual)

September 1, 2012

Study Completion (Actual)

September 1, 2012

Study Registration Dates

First Submitted

February 25, 2010

First Submitted That Met QC Criteria

February 25, 2010

First Posted (Estimate)

February 26, 2010

Study Record Updates

Last Update Posted (Estimate)

February 21, 2014

Last Update Submitted That Met QC Criteria

February 19, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P11-984

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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