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

19 février 2014 mis à jour par: AbbVie (prior sponsor, Abbott)

[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.

Aperçu de l'étude

Statut

Complété

Les conditions

Description détaillée

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.

Type d'étude

Observationnel

Inscription (Réel)

500

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • Grèce
      • Agrinio, Grèce, 301 00
        • Site Reference ID/Investigator# 43746
      • Amaliada, Grèce
        • Site Reference ID/Investigator# 30197
      • Argos, Grèce, 21200
        • Site Reference ID/Investigator# 30039
      • Argyroupoli, Grèce
        • Site Reference ID/Investigator# 29903
      • Athens, Grèce, 10673
        • Site Reference ID/Investigator# 29819
      • Athens, Grèce, 11526
        • Site Reference ID/Investigator# 29949
      • Athens, Grèce, 16121
        • Site Reference ID/Investigator# 30804
      • Athens, Grèce, 16121
        • Site Reference ID/Investigator# 30806
      • Athens, Grèce, 16121
        • Site Reference ID/Investigator# 38324
      • Athens, Grèce
        • Site Reference ID/Investigator# 22385
      • Athens, Grèce
        • Site Reference ID/Investigator# 29826
      • Athens, Grèce
        • Site Reference ID/Investigator# 29966
      • Athens, Grèce
        • Site Reference ID/Investigator# 29991
      • Athens, Grèce
        • Site Reference ID/Investigator# 30106
      • Athens, Grèce
        • Site Reference ID/Investigator# 30107
      • Athens, Grèce
        • Site Reference ID/Investigator# 30181
      • Athens, Grèce
        • Site Reference ID/Investigator# 30470
      • Chania, Crete, Grèce, 73136
        • Site Reference ID/Investigator# 30086
      • Chania, Crete, Grèce
        • Site Reference ID/Investigator# 43744
      • Crete, Grèce, 71409
        • Site Reference ID/Investigator# 30794
      • Crete, Grèce
        • Site Reference ID/Investigator# 29937
      • Crete, Grèce
        • Site Reference ID/Investigator# 29959
      • Crete, Grèce
        • Site Reference ID/Investigator# 29969
      • Drama, Grèce
        • Site Reference ID/Investigator# 38334
      • Florina, Grèce, 53100
        • Site Reference ID/Investigator# 30801
      • Giannitsa, Grèce, 58100
        • Site Reference ID/Investigator# 29919
      • Giannitsa, Grèce
        • Site Reference ID/Investigator# 30202
      • Glyfada, Grèce, 16675
        • Site Reference ID/Investigator# 29970
      • Glyfada, Grèce, 16675
        • Site Reference ID/Investigator# 30013
      • Glyfada, Grèce
        • Site Reference ID/Investigator# 29823
      • Halandri, Grèce
        • Site Reference ID/Investigator# 30193
      • Kalamaria, Grèce
        • Site Reference ID/Investigator# 30083
      • Kallithea, Grèce, 17672
        • Site Reference ID/Investigator# 30143
      • Katerini, Grèce, 60100
        • Site Reference ID/Investigator# 47262
      • Keratsini, Grèce
        • Site Reference ID/Investigator# 38329
      • Kolonaki, Grèce, 10675
        • Site Reference ID/Investigator# 30108
      • Kosmos, Grèce
        • Site Reference ID/Investigator# 30009
      • Larissa, Grèce, 41100
        • Site Reference ID/Investigator# 38323
      • Larissa, Grèce
        • Site Reference ID/Investigator# 38340
      • Livadeia, Grèce
        • Site Reference ID/Investigator# 29822
      • Makri, Grèce
        • Site Reference ID/Investigator# 30180
      • Mitilini, Grèce
        • Site Reference ID/Investigator# 29834
      • Mitilini, Grèce
        • Site Reference ID/Investigator# 30469
      • N.Heraklion, Grèce
        • Site Reference ID/Investigator# 38326
      • Neapoli, Grèce
        • Site Reference ID/Investigator# 30032
      • Pagkrati, Grèce, 11634
        • Site Reference ID/Investigator# 30104
      • Patras, Grèce
        • Site Reference ID/Investigator# 29817
      • Peiraius, Grèce
        • Site Reference ID/Investigator# 29967
      • Peristeri, Grèce
        • Site Reference ID/Investigator# 38327
      • Petralona, Grèce
        • Site Reference ID/Investigator# 30109
      • Smyrni, Grèce
        • Site Reference ID/Investigator# 29824
      • Thessaloniki, Grèce, 54643
        • Site Reference ID/Investigator# 38325
      • Thessaloniki, Grèce, 564 29
        • Site Reference ID/Investigator# 30769
      • Thessaloniki, Grèce
        • Site Reference ID/Investigator# 30170
      • Thessaloniki, Grèce
        • Site Reference ID/Investigator# 38331
      • Thessaloniki, Grèce
        • Site Reference ID/Investigator# 38332
      • Thessaloniki, Grèce
        • Site Reference ID/Investigator# 38333
      • Thessaloniki, Grèce
        • Site Reference ID/Investigator# 38335
      • Thessaloniki, Grèce
        • Site Reference ID/Investigator# 38337
      • Vari, Grèce, 16672
        • Site Reference ID/Investigator# 30203
      • Volos, Grèce
        • Site Reference ID/Investigator# 29921

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

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

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Cohortes et interventions

Groupe / Cohorte
Patients with psoriasis
All eligible patients with psoriasis treated with Adalimumab

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Mean Change of Dermatology Life Quality Index (DLQI) Scores
Délai: 12-month period, (Month 0, Month 1, Month 4, Month 8, Month 12)
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)

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Percentage of Patients Who Experienced an Improvement in Disease Severity as Determined by the Physician's Global Assessment of Disease Severity (PGA) Scores
Délai: 12-month period (Month 0, Month 1, Month 4, Month 8, Month 12)
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)
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
Délai: 12-month period (Month 0, Month 1, Month 4, Month 8, Month 12)
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)
Percentage of Patients Reporting "No Problem" on the European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D)
Délai: 12-month period (Month 0, Month 1, Month 4, Month 8, Month 12)

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.
12-month period (Month 0, Month 1, Month 4, Month 8, Month 12)
Mean Change From Baseline of European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Visual Analogue Scale (VAS) Scores
Délai: 12-month period (Month 0, Month 1, Month 4, Month 8, Month 12)

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.
12-month period (Month 0, Month 1, Month 4, Month 8, Month 12)
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
Délai: 12-month period (Month 0, Month 1, Month 4, Month 8, Month 12)
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)

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

AbbVie (prior sponsor, Abbott)

Les enquêteurs

  • Chaise d'étude: Athina Katsavou, MD, AbbVie Pharmaceuticals S.A.

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Liens utiles

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 septembre 2009

Achèvement primaire (Réel)

1 septembre 2012

Achèvement de l'étude (Réel)

1 septembre 2012

Dates d'inscription aux études

Première soumission

25 février 2010

Première soumission répondant aux critères de contrôle qualité

25 février 2010

Première publication (Estimation)

26 février 2010

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Estimation)

21 février 2014

Dernière mise à jour soumise répondant aux critères de contrôle qualité

19 février 2014

Dernière vérification

1 février 2014

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • P11-984

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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