Clinical trial NCT01077128: Greek Study of the Quality of Life in Patients With Psoriasis Treated With Adalimumab
Official title: [E S] A Greek, Post-marketing, Observational Study of the quAlity of Life in Patients With Psoriasis Treated With Adalimumab - GOAL Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Psoriasis
Keywords: Psoriasis
Quality of life
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2010-02-26
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients treated with Adalimumab according to routine medical practice from hospital and private physicians.

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Mean Change of Dermatology Life Quality Index (DLQI) Scores
timeFrame: 12-month period, (Month 0, Month 1, Month 4, Month 8, Month 12)
Secondary outcomes:
measure: Percentage of Patients Who Experienced an Improvement in Disease Severity as Determined by the Physician's Global Assessment of Disease Severity (PGA) Scores
timeFrame: 12-month period (Month 0, Month 1, Month 4, Month 8, Month 12)
measure: 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
timeFrame: 12-month period (Month 0, Month 1, Month 4, Month 8, Month 12)
measure: Percentage of Patients Reporting "No Problem" on the European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D)
timeFrame: 12-month period (Month 0, Month 1, Month 4, Month 8, Month 12)
measure: Mean Change From Baseline of European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Visual Analogue Scale (VAS) Scores
timeFrame: 12-month period (Month 0, Month 1, Month 4, Month 8, Month 12)
measure: 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
timeFrame: 12-month period (Month 0, Month 1, Month 4, Month 8, Month 12)
Other outcomes:
Locations:
city: Agrinio
country: Greece
facility: Site Reference ID/Investigator# 43746
city: Amaliada
country: Greece
facility: Site Reference ID/Investigator# 30197
city: Argos
country: Greece
facility: Site Reference ID/Investigator# 30039
city: Argyroupoli
country: Greece
facility: Site Reference ID/Investigator# 29903
city: Athens
country: Greece
facility: Site Reference ID/Investigator# 29819
city: Athens
country: Greece
facility: Site Reference ID/Investigator# 29949
city: Athens
country: Greece
facility: Site Reference ID/Investigator# 30804
city: Athens
country: Greece
facility: Site Reference ID/Investigator# 30806
city: Athens
country: Greece
facility: Site Reference ID/Investigator# 38324
city: Athens
country: Greece
facility: Site Reference ID/Investigator# 22385
city: Athens
country: Greece
facility: Site Reference ID/Investigator# 29826
city: Athens
country: Greece
facility: Site Reference ID/Investigator# 29966
city: Athens
country: Greece
facility: Site Reference ID/Investigator# 29991
city: Athens
country: Greece
facility: Site Reference ID/Investigator# 30106
city: Athens
country: Greece
facility: Site Reference ID/Investigator# 30107
city: Athens
country: Greece
facility: Site Reference ID/Investigator# 30181
city: Athens
country: Greece
facility: Site Reference ID/Investigator# 30470
city: Chania, Crete
country: Greece
facility: Site Reference ID/Investigator# 30086
city: Chania, Crete
country: Greece
facility: Site Reference ID/Investigator# 43744
city: Crete
country: Greece
facility: Site Reference ID/Investigator# 30794
city: Crete
country: Greece
facility: Site Reference ID/Investigator# 29937
city: Crete
country: Greece
facility: Site Reference ID/Investigator# 29959
city: Crete
country: Greece
facility: Site Reference ID/Investigator# 29969
city: Drama
country: Greece
facility: Site Reference ID/Investigator# 38334
city: Florina
country: Greece
facility: Site Reference ID/Investigator# 30801
city: Giannitsa
country: Greece
facility: Site Reference ID/Investigator# 29919
city: Giannitsa
country: Greece
facility: Site Reference ID/Investigator# 30202
city: Glyfada
country: Greece
facility: Site Reference ID/Investigator# 29970
city: Glyfada
country: Greece
facility: Site Reference ID/Investigator# 30013
city: Glyfada
country: Greece
facility: Site Reference ID/Investigator# 29823
city: Halandri
country: Greece
facility: Site Reference ID/Investigator# 30193
city: Kalamaria
country: Greece
facility: Site Reference ID/Investigator# 30083
city: Kallithea
country: Greece
facility: Site Reference ID/Investigator# 30143
city: Katerini
country: Greece
facility: Site Reference ID/Investigator# 47262
city: Keratsini
country: Greece
facility: Site Reference ID/Investigator# 38329
city: Kolonaki
country: Greece
facility: Site Reference ID/Investigator# 30108
city: Kosmos
country: Greece
facility: Site Reference ID/Investigator# 30009
city: Larissa
country: Greece
facility: Site Reference ID/Investigator# 38323
city: Larissa
country: Greece
facility: Site Reference ID/Investigator# 38340
city: Livadeia
country: Greece
facility: Site Reference ID/Investigator# 29822
city: Makri
country: Greece
facility: Site Reference ID/Investigator# 30180
city: Mitilini
country: Greece
facility: Site Reference ID/Investigator# 29834
city: Mitilini
country: Greece
facility: Site Reference ID/Investigator# 30469
city: N.Heraklion
country: Greece
facility: Site Reference ID/Investigator# 38326
city: Neapoli
country: Greece
facility: Site Reference ID/Investigator# 30032
city: Pagkrati
country: Greece
facility: Site Reference ID/Investigator# 30104
city: Patras
country: Greece
facility: Site Reference ID/Investigator# 29817
city: Peiraius
country: Greece
facility: Site Reference ID/Investigator# 29967
city: Peristeri
country: Greece
facility: Site Reference ID/Investigator# 38327
city: Petralona
country: Greece
facility: Site Reference ID/Investigator# 30109
city: Smyrni
country: Greece
facility: Site Reference ID/Investigator# 29824
city: Thessaloniki
country: Greece
facility: Site Reference ID/Investigator# 38325
city: Thessaloniki
country: Greece
facility: Site Reference ID/Investigator# 30769
city: Thessaloniki
country: Greece
facility: Site Reference ID/Investigator# 30170
city: Thessaloniki
country: Greece
facility: Site Reference ID/Investigator# 38331
city: Thessaloniki
country: Greece
facility: Site Reference ID/Investigator# 38332
city: Thessaloniki
country: Greece
facility: Site Reference ID/Investigator# 38333
city: Thessaloniki
country: Greece
facility: Site Reference ID/Investigator# 38335
city: Thessaloniki
country: Greece
facility: Site Reference ID/Investigator# 38337
city: Vari
country: Greece
facility: Site Reference ID/Investigator# 30203
city: Volos
country: Greece
facility: Site Reference ID/Investigator# 29921
Study officials:
affiliation: AbbVie Pharmaceuticals S.A.
name: Athina Katsavou, MD
role: STUDY_CHAIR
References: