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

Psoriasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01077128
• Other study ID #: P11-984
• Status: Completed
• Phase: N/A
• First received: February 25, 2010
• Last updated: February 19, 2014
• Start date: September 2009
• Est. completion date: September 2012

Study information

• Verified date: February 2014
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: National Organization of Medicines
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Psoriasis

Locations

Country	Name	City	State
Greece	Site Reference ID/Investigator# 43746	Agrinio
Greece	Site Reference ID/Investigator# 30197	Amaliada
Greece	Site Reference ID/Investigator# 30039	Argos
Greece	Site Reference ID/Investigator# 29903	Argyroupoli
Greece	Site Reference ID/Investigator# 22385	Athens
Greece	Site Reference ID/Investigator# 29819	Athens
Greece	Site Reference ID/Investigator# 29826	Athens
Greece	Site Reference ID/Investigator# 29949	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	Athens
Greece	Site Reference ID/Investigator# 30804	Athens
Greece	Site Reference ID/Investigator# 30806	Athens
Greece	Site Reference ID/Investigator# 38324	Athens
Greece	Site Reference ID/Investigator# 30086	Chania, Crete
Greece	Site Reference ID/Investigator# 43744	Chania, Crete
Greece	Site Reference ID/Investigator# 29937	Crete
Greece	Site Reference ID/Investigator# 29959	Crete
Greece	Site Reference ID/Investigator# 29969	Crete
Greece	Site Reference ID/Investigator# 30794	Crete
Greece	Site Reference ID/Investigator# 38334	Drama
Greece	Site Reference ID/Investigator# 30801	Florina
Greece	Site Reference ID/Investigator# 29919	Giannitsa
Greece	Site Reference ID/Investigator# 30202	Giannitsa
Greece	Site Reference ID/Investigator# 29823	Glyfada
Greece	Site Reference ID/Investigator# 29970	Glyfada
Greece	Site Reference ID/Investigator# 30013	Glyfada
Greece	Site Reference ID/Investigator# 30193	Halandri
Greece	Site Reference ID/Investigator# 30083	Kalamaria
Greece	Site Reference ID/Investigator# 30143	Kallithea
Greece	Site Reference ID/Investigator# 47262	Katerini
Greece	Site Reference ID/Investigator# 38329	Keratsini
Greece	Site Reference ID/Investigator# 30108	Kolonaki
Greece	Site Reference ID/Investigator# 30009	Kosmos
Greece	Site Reference ID/Investigator# 38323	Larissa
Greece	Site Reference ID/Investigator# 38340	Larissa
Greece	Site Reference ID/Investigator# 29822	Livadeia
Greece	Site Reference ID/Investigator# 30180	Makri
Greece	Site Reference ID/Investigator# 29834	Mitilini
Greece	Site Reference ID/Investigator# 30469	Mitilini
Greece	Site Reference ID/Investigator# 38326	N.Heraklion
Greece	Site Reference ID/Investigator# 30032	Neapoli
Greece	Site Reference ID/Investigator# 30104	Pagkrati
Greece	Site Reference ID/Investigator# 29817	Patras
Greece	Site Reference ID/Investigator# 29967	Peiraius
Greece	Site Reference ID/Investigator# 38327	Peristeri
Greece	Site Reference ID/Investigator# 30109	Petralona
Greece	Site Reference ID/Investigator# 29824	Smyrni
Greece	Site Reference ID/Investigator# 30170	Thessaloniki
Greece	Site Reference ID/Investigator# 30769	Thessaloniki
Greece	Site Reference ID/Investigator# 38325	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	Thessaloniki
Greece	Site Reference ID/Investigator# 30203	Vari
Greece	Site Reference ID/Investigator# 29921	Volos

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie (prior sponsor, Abbott)

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Change of Dermatology Life Quality Index (DLQI) Scores	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)	No
Secondary	Percentage of Patients Who Experienced an Improvement in Disease Severity as Determined by the Physician's Global Assessment of Disease Severity (PGA) Scores	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)	No
Secondary	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	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)	No
Secondary	Percentage of Patients Reporting "No Problem" on the European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D)	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)	No
Secondary	Mean Change From Baseline of European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Visual Analogue Scale (VAS) Scores	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)	No
Secondary	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	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)	Yes

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