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

NCT ID: NCT01077128

Last Updated: 2014-02-21

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-09-30
• Study Completion Date: 2012-09-30

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.

Conditions

Psoriasis

Study Design

• Study Time Perspective: PROSPECTIVE

Study Groups

Patients with psoriasis

All eligible patients with psoriasis treated with Adalimumab

No interventions assigned to this group

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AbbVie (prior sponsor, Abbott)

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Athina Katsavou, MD

Role: STUDY_CHAIR

AbbVie Pharmaceuticals S.A.

Locations

Site Reference ID/Investigator# 43746

Agrinio, , Greece

Site Reference ID/Investigator# 30197

Amaliáda, , Greece

Site Reference ID/Investigator# 30039

Argos, , Greece

Site Reference ID/Investigator# 29903

Argyroúpoli, , Greece

Site Reference ID/Investigator# 29819

Athens, , Greece

Site Reference ID/Investigator# 29949

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# 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

Athens, , Greece

Site Reference ID/Investigator# 30086

Chania, Crete, , Greece

Site Reference ID/Investigator# 43744

Chania, Crete, , Greece

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

Crete, , Greece

Site Reference ID/Investigator# 38334

Drama, , Greece

Site Reference ID/Investigator# 30801

Florina, , Greece

Site Reference ID/Investigator# 29919

Giannitsá, , Greece

Site Reference ID/Investigator# 30202

Giannitsá, , Greece

Site Reference ID/Investigator# 29970

Glyfada, , Greece

Site Reference ID/Investigator# 30013

Glyfada, , Greece

Site Reference ID/Investigator# 29823

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

Mytilene, , Greece

Site Reference ID/Investigator# 30469

Mytilene, , Greece

Site Reference ID/Investigator# 38326

N.Heraklion, , Greece

Site Reference ID/Investigator# 30032

Neapoli, , Greece

Site Reference ID/Investigator# 30104

Pagkráti, , Greece

Site Reference ID/Investigator# 29817

Pátrai, , 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# 38325

Thessaloniki, , Greece

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

Thessaloniki, , Greece

Site Reference ID/Investigator# 30203

Vári, , Greece

Site Reference ID/Investigator# 29921

Volos, , Greece

Countries

Greece

Related Links

http://rxabbvie.com

Related Info

Other Identifiers

P11-984

Identifier Type: -

Identifier Source: org_study_id