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Quality of Life in Adalimumab Treated Psoriasis Patients Failing Other Biologic Disease Modifying Anti-rheumatic Drugs (QUALITY)

25 giugno 2012 aggiornato da: Abbott

A Post-marketing Observational Study of the Quality of Life in Adalimumab Treated Psoriasis Patients Failing Other Biologic DMARDs Over a Period of 1 Year (QUALITY)

The aim of this post-marketing observational study (PMOS) was to obtain further data on long-term safety, efficacy, and quality of life outcomes for adalimumab in routine clinical use in participants with moderate to severe chronic plaque psoriasis after unsustainable clinical response to other biologic disease modifying anti-rheumatic drugs (BDMARDs). There are few data so far showing the effects of switching from other BDMARDs to adalimumab in patients with moderate to severe chronic plaque psoriasis. This study was designed to evaluate the long-term effectiveness of adalimumab in participants with moderate to severe chronic plaque psoriasis using the Psoriasis Area and Severity Index (PASI) in participants previously treated with efalizumab, infliximab, or etanercept and who either never achieved satisfactory response, achieved satisfactory response initially but lost it over time, or discontinued treatment due to intolerance/side effect(s) or other reasons, for example after regular stop of etanercept.

Panoramica dello studio

Stato

Completato

Condizioni

Descrizione dettagliata

This was a non-interventional PMOS conducted in a prospective, single-country, multicenter format to assess the quality of life of psoriasis patients taking adalimumab as prescribed by their physician in accordance with the terms of the local marketing authorization with regard to dose, population, and indication. The prescription of adalimumab was clearly separated from the decision to include the participant in this study. No procedures other than standard of care were to have been performed. Visits were non-interventional and timing of participant appointments was left to each physician. After therapy initiation, visits occurred over 12 months usually close to Weeks 4, 12, 24, 36, and 52 for a total of 6 visits (Visits 1 through 6 including Screening). Because participant visits were left to the physician, participant failure to meet the suggested visit weeks did not constitute a breach of the protocol.

Tipo di studio

Osservativo

Iscrizione (Effettivo)

46

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Austria
      • Feldkirch, Austria, 6807
        • Site Reference ID/Investigator# 27435
      • Graz, Austria, 8010
        • Site Reference ID/Investigator# 27436
      • Graz, Austria, 8036
        • Site Reference ID/Investigator# 38445
      • Linz, Austria, 4020
        • Site Reference ID/Investigator# 27443
      • Vienna, Austria, 1030
        • Site Reference ID/Investigator# 27442
      • Vienna, Austria, 1130
        • Site Reference ID/Investigator# 27440
      • Vienna, Austria, 1160
        • Site Reference ID/Investigator# 27437
      • Vienna, Austria, A-1090
        • Site Reference ID/Investigator# 27439
      • Wels, Austria, 4600
        • Site Reference ID/Investigator# 23309

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

Hospital, Dermatology

Descrizione

Inclusion Criteria:

  • Patients for whom adalimumab therapy is indicated and has been prescribed according to the product label
  • Patients aged 18 years and older
  • Unsatisfactory response to prior BDMARDS (efalizumab, infliximab, etanercept) in patients with moderate to severe chronic plaque psoriasis or achievement of satisfactory response initially, but loss over time or discontinuation of treatment due to intolerance/side effects(s) or other reasons e.g. restart after regular stop of etanercept
  • Patients must fulfill Austrian Treatment Recommendations for use of BDMARD in psoriasis (chest X-ray and purified protein derivative [PPD] skin test negative for tuberculosis)
  • Patient is willing to consent to data being collected and provided to Abbott
  • Patient must be able and willing to self-administer Pen injections or have a qualified person available to administer Pen injections

Exclusion Criteria:

  • Patients who meet contraindications as outlined in the latest version of the Humira-Pen Summary of Product Characteristics (SPC)
  • Patients who do not meet the criteria for the use of BDMARDs of the Austrian Treatment Recommendations
  • Patients participating in another study or clinical trial

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Coorti e interventi

Gruppo / Coorte
Adalimumab
Participants with moderate to severe chronic plaque psoriasis treated with adalimumab after biologic disease modifying anti-rheumatic drug (BDMARD) failure

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Psoriasis Area and Severity Index (PASI) Score
Lasso di tempo: Inclusion visit (Week 0), Week 4, Week 36, Week 52
Psoriasis Area and Severity Index (PASI) score is based on assessment of erythema (reddening), induration (plaque thickness), desquamation (scaling), and area affected as observed on the day of examination. The score ranges from 0 (best outcome) to 72 (worst outcome).
Inclusion visit (Week 0), Week 4, Week 36, Week 52
Reduction in Psoriasis Area and Severity Index Score of at Least 75% (PASI75)
Lasso di tempo: Inclusion visit (Week 0) to Week 52
PASI75 is the number of participants who achieved at least a 75% reduction (improvement) from baseline in PASI score at Week 52 (final visit). PASI score is based on assessment of erythema (reddening), induration (plaque thickness), desquamation (scaling), and area affected as observed on the day of examination. The score ranges from 0 (best outcome) to 72 (worst outcome).
Inclusion visit (Week 0) to Week 52

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Dermatology Life Quality Index (DLQI) Score
Lasso di tempo: Inclusion visit (Week 0), Week 4, Week 36, Week 52
Dermatology Life Quality Index (DLQI) Score is a participant-reported outcome consisting of a set of 10 questions regarding the degree to which the participant's skin has affected certain behaviors and quality of life over the last week. Responses to each are: very much, a lot, a little, or not at all. The DLQI score ranges from 0 (best) to 30 (worst).
Inclusion visit (Week 0), Week 4, Week 36, Week 52
Nail Psoriasis Severity Index (NAPSI) Score
Lasso di tempo: Inclusion visit (Week 0), Week 4, Week 36, and Week 52
The nails are graded for nail matrix psoriasis and nail bed psoriasis. The sum of these two scores is the total score for that nail. Per nail, the NAPSI score ranges from 0 (no nail psoriasis) to 4 (most severe nail psoriasis).
Inclusion visit (Week 0), Week 4, Week 36, and Week 52
Tolerability and Safety Assessed by Collection and Classification of Adverse Reactions
Lasso di tempo: From the time of participant consent until 70 days after last dose of study drug
Tolerability and safety were assessed by collecting adverse events during the course of the study up to 70 days following the last dose of physician-prescribed adalimumab. The number of participants experiencing a serious or non-serious adverse event is summarized. See the Reported Adverse Event section for details.
From the time of participant consent until 70 days after last dose of study drug

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Abbott

Collaboratori

Assign Data Management and Biostatistics GmbH

Investigatori

  • Direttore dello studio: Astrid Dworan-Timler, MD, Abbott Austria

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 novembre 2008

Completamento primario (Effettivo)

1 aprile 2011

Completamento dello studio (Effettivo)

1 aprile 2011

Date di iscrizione allo studio

Primo inviato

28 febbraio 2010

Primo inviato che soddisfa i criteri di controllo qualità

9 marzo 2010

Primo Inserito (Stima)

10 marzo 2010

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

29 giugno 2012

Ultimo aggiornamento inviato che soddisfa i criteri QC

25 giugno 2012

Ultimo verificato

1 giugno 2012

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • P10-708

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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