Quality of Life in Adalimumab Treated Psoriasis Patients Failing Other Biologic Disease Modifying Anti-rheumatic Drugs (QUALITY)
25 juni 2012 uppdaterad 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.
Studieöversikt
Status
Avslutad
Betingelser
Detaljerad beskrivning
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.
Studietyp
Observationell
Inskrivning (Faktisk)
46
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
-
Feldkirch, Österrike, 6807
- Site Reference ID/Investigator# 27435
-
Graz, Österrike, 8010
- Site Reference ID/Investigator# 27436
-
Graz, Österrike, 8036
- Site Reference ID/Investigator# 38445
-
Linz, Österrike, 4020
- Site Reference ID/Investigator# 27443
-
Vienna, Österrike, 1030
- Site Reference ID/Investigator# 27442
-
Vienna, Österrike, 1130
- Site Reference ID/Investigator# 27440
-
Vienna, Österrike, 1160
- Site Reference ID/Investigator# 27437
-
Vienna, Österrike, A-1090
- Site Reference ID/Investigator# 27439
-
Wels, Österrike, 4600
- Site Reference ID/Investigator# 23309
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Testmetod
Icke-sannolikhetsprov
Studera befolkning
Hospital, Dermatology
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
|---|
|
Adalimumab
Participants with moderate to severe chronic plaque psoriasis treated with adalimumab after biologic disease modifying anti-rheumatic drug (BDMARD) failure
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Psoriasis Area and Severity Index (PASI) Score
Tidsram: 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)
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Dermatology Life Quality Index (DLQI) Score
Tidsram: 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
Tidsram: 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
Tidsram: 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
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Samarbetspartners
Utredare
- Studierektor: Astrid Dworan-Timler, MD, Abbott Austria
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 november 2008
Primärt slutförande (Faktisk)
1 april 2011
Avslutad studie (Faktisk)
1 april 2011
Studieregistreringsdatum
Först inskickad
28 februari 2010
Först inskickad som uppfyllde QC-kriterierna
9 mars 2010
Första postat (Uppskatta)
10 mars 2010
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
29 juni 2012
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
25 juni 2012
Senast verifierad
1 juni 2012
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- P10-708
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .