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

February 25, 2010
February 19, 2014
September 2009
September 2012   (final data collection date for primary outcome measure)
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.
Mean change of Dermatology Life Quality Index (DLQI) scores [ Time Frame: 12 months period, (Month 0, Month 1, Month 4, Month 8, Month 12) ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01077128 on ClinicalTrials.gov Archive Site
  • 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.
  • Percent of patients improving the physician's global assessment of disease severity (PGA) scores [ Time Frame: 12 months period, (Month 0, Month 1, Month 4, Month 8, Month 12) ] [ Designated as safety issue: No ]
  • Mean change in DLQI score by PGA response groups and by geographical region [ Time Frame: 12 months period, (Month 0, Month 1, Month 4, Month 8, Month 12) ] [ Designated as safety issue: No ]
  • Mean change of EQ-5D [ Time Frame: 12 months period, (Month 0, Month 1, Month 4, Month 8, Month 12) ] [ Designated as safety issue: No ]
  • 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 months period, (Month 0, Month 1, Month 4, Month 8, Month 12) ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Greek Study of the Quality of Life in Patients With Psoriasis Treated With Adalimumab
[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.

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.

Observational
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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

Psoriasis
Not Provided
Patients with psoriasis
All eligible patients with psoriasis treated with Adalimumab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
500
September 2012
September 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Greece
 
NCT01077128
P11-984
No
AbbVie ( AbbVie (prior sponsor, Abbott) )
AbbVie (prior sponsor, Abbott)
Not Provided
Study Chair: Athina Katsavou, MD AbbVie Pharmaceuticals S.A.
AbbVie
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP