Quality of Life in Adalimumab Treated Psoriasis Patients Failing Other Biologic Disease Modifying Anti-rheumatic Drugs (QUALITY)
25. juni 2012 oppdatert av: 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.
Studieoversikt
Status
Fullført
Forhold
Detaljert beskrivelse
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
Observasjonsmessig
Registrering (Faktiske)
46
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
-
Feldkirch, Østerrike, 6807
- Site Reference ID/Investigator# 27435
-
Graz, Østerrike, 8010
- Site Reference ID/Investigator# 27436
-
Graz, Østerrike, 8036
- Site Reference ID/Investigator# 38445
-
Linz, Østerrike, 4020
- Site Reference ID/Investigator# 27443
-
Vienna, Østerrike, 1030
- Site Reference ID/Investigator# 27442
-
Vienna, Østerrike, 1130
- Site Reference ID/Investigator# 27440
-
Vienna, Østerrike, 1160
- Site Reference ID/Investigator# 27437
-
Vienna, Østerrike, A-1090
- Site Reference ID/Investigator# 27439
-
Wels, Østerrike, 4600
- Site Reference ID/Investigator# 23309
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
Hospital, Dermatology
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
|---|
|
Adalimumab
Participants with moderate to severe chronic plaque psoriasis treated with adalimumab after biologic disease modifying anti-rheumatic drug (BDMARD) failure
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Psoriasis Area and Severity Index (PASI) Score
Tidsramme: 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)
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Dermatology Life Quality Index (DLQI) Score
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- Studieleder: Astrid Dworan-Timler, MD, Abbott Austria
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. november 2008
Primær fullføring (Faktiske)
1. april 2011
Studiet fullført (Faktiske)
1. april 2011
Datoer for studieregistrering
Først innsendt
28. februar 2010
Først innsendt som oppfylte QC-kriteriene
9. mars 2010
Først lagt ut (Anslag)
10. mars 2010
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
29. juni 2012
Siste oppdatering sendt inn som oppfylte QC-kriteriene
25. juni 2012
Sist bekreftet
1. juni 2012
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- P10-708
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .