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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01077128
First received: February 25, 2010
Last updated: February 19, 2014
Last verified: February 2014
  Purpose

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.

Condition
Psoriasis

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: [E S] A Greek, Post-marketing, Observational Study of the quAlity of Life in Patients With Psoriasis Treated With Adalimumab - GOAL Study

Resource links provided by NLM:


Further study details as provided by AbbVie:

Primary Outcome Measures:
  • Mean Change of Dermatology Life Quality Index (DLQI) Scores [ Time Frame: 12-month period, (Month 0, Month 1, Month 4, Month 8, Month 12) ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
    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.

  • 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) ] [ Designated as safety issue: No ]
    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.

  • 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) ] [ Designated as safety issue: No ]

    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.

  • 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) ] [ Designated as safety issue: No ]

    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.

  • 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) ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 500
Study Start Date: September 2009
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Patients with psoriasis
All eligible patients with psoriasis treated with Adalimumab

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01077128

  Hide Study Locations
Locations
Greece
Site Reference ID/Investigator# 43746
Agrinio, Greece, 301 00
Site Reference ID/Investigator# 30197
Amaliada, Greece
Site Reference ID/Investigator# 30039
Argos, Greece, 21200
Site Reference ID/Investigator# 29903
Argyroupoli, Greece
Site Reference ID/Investigator# 29819
Athens, Greece, 10673
Site Reference ID/Investigator# 22385
Athens, Greece
Site Reference ID/Investigator# 29826
Athens, Greece
Site Reference ID/Investigator# 30181
Athens, Greece
Site Reference ID/Investigator# 30107
Athens, Greece
Site Reference ID/Investigator# 30106
Athens, Greece
Site Reference ID/Investigator# 30806
Athens, Greece, 16121
Site Reference ID/Investigator# 29949
Athens, Greece, 11526
Site Reference ID/Investigator# 29966
Athens, Greece
Site Reference ID/Investigator# 30804
Athens, Greece, 16121
Site Reference ID/Investigator# 38324
Athens, Greece, 16121
Site Reference ID/Investigator# 30470
Athens, Greece
Site Reference ID/Investigator# 29991
Athens, Greece
Site Reference ID/Investigator# 30086
Chania, Crete, Greece, 73136
Site Reference ID/Investigator# 43744
Chania, Crete, Greece
Site Reference ID/Investigator# 29959
Crete, Greece
Site Reference ID/Investigator# 29969
Crete, Greece
Site Reference ID/Investigator# 29937
Crete, Greece
Site Reference ID/Investigator# 30794
Crete, Greece, 71409
Site Reference ID/Investigator# 38334
Drama, Greece
Site Reference ID/Investigator# 30801
Florina, Greece, 53100
Site Reference ID/Investigator# 30202
Giannitsa, Greece
Site Reference ID/Investigator# 29919
Giannitsa, Greece, 58100
Site Reference ID/Investigator# 29823
Glyfada, Greece
Site Reference ID/Investigator# 30013
Glyfada, Greece, 16675
Site Reference ID/Investigator# 29970
Glyfada, Greece, 16675
Site Reference ID/Investigator# 30193
Halandri, Greece
Site Reference ID/Investigator# 30083
Kalamaria, Greece
Site Reference ID/Investigator# 30143
Kallithea, Greece, 17672
Site Reference ID/Investigator# 47262
Katerini, Greece, 60100
Site Reference ID/Investigator# 38329
Keratsini, Greece
Site Reference ID/Investigator# 30108
Kolonaki, Greece, 10675
Site Reference ID/Investigator# 30009
Kosmos, Greece
Site Reference ID/Investigator# 38323
Larissa, Greece, 41100
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# 30469
Mitilini, Greece
Site Reference ID/Investigator# 29834
Mitilini, Greece
Site Reference ID/Investigator# 38326
N.Heraklion, Greece
Site Reference ID/Investigator# 30032
Neapoli, Greece
Site Reference ID/Investigator# 30104
Pagkrati, Greece, 11634
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# 30769
Thessaloniki, Greece, 564 29
Site Reference ID/Investigator# 38332
Thessaloniki, Greece
Site Reference ID/Investigator# 38333
Thessaloniki, Greece
Site Reference ID/Investigator# 30170
Thessaloniki, Greece
Site Reference ID/Investigator# 38335
Thessaloniki, Greece
Site Reference ID/Investigator# 38337
Thessaloniki, Greece
Site Reference ID/Investigator# 38331
Thessaloniki, Greece
Site Reference ID/Investigator# 38325
Thessaloniki, Greece, 54643
Site Reference ID/Investigator# 30203
Vari, Greece, 16672
Site Reference ID/Investigator# 29921
Volos, Greece
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Investigators
Study Chair: Athina Katsavou, MD AbbVie Pharmaceuticals S.A.
  More Information

Additional Information:
No publications provided

Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT01077128     History of Changes
Other Study ID Numbers: P11-984
Study First Received: February 25, 2010
Results First Received: September 13, 2013
Last Updated: February 19, 2014
Health Authority: Greece: National Organization of Medicines

Keywords provided by AbbVie:
Psoriasis
Quality of life

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Adalimumab
Antirheumatic Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on July 26, 2014