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

25 juni 2012 bijgewerkt door: 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.

Studie Overzicht

Toestand

Voltooid

Conditie

Gedetailleerde beschrijving

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.

Studietype

Observationeel

Inschrijving (Werkelijk)

46

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

Hospital, Dermatology

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Cohorten en interventies

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

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Psoriasis Area and Severity Index (PASI) Score
Tijdsspanne: 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)
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Dermatology Life Quality Index (DLQI) Score
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Abbott

Medewerkers

Assign Data Management and Biostatistics GmbH

Onderzoekers

  • Studie directeur: Astrid Dworan-Timler, MD, Abbott Austria

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 november 2008

Primaire voltooiing (Werkelijk)

1 april 2011

Studie voltooiing (Werkelijk)

1 april 2011

Studieregistratiedata

Eerst ingediend

28 februari 2010

Eerst ingediend dat voldeed aan de QC-criteria

9 maart 2010

Eerst geplaatst (Schatting)

10 maart 2010

Updates van studierecords

Laatste update geplaatst (Schatting)

29 juni 2012

Laatste update ingediend die voldeed aan QC-criteria

25 juni 2012

Laatst geverifieerd

1 juni 2012

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • P10-708

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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