Quality of Life in Adalimumab Treated Psoriasis Patients Failing Other Biologic Disease Modifying Anti-rheumatic Drugs (QUALITY)
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|ClinicalTrials.gov Identifier: NCT01084668|
Recruitment Status : Completed
First Posted : March 10, 2010
Results First Posted : May 30, 2012
Last Update Posted : June 29, 2012
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||46 participants|
|Official Title:||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)|
|Study Start Date :||November 2008|
|Actual Primary Completion Date :||April 2011|
|Actual Study Completion Date :||April 2011|
Participants with moderate to severe chronic plaque psoriasis treated with adalimumab after biologic disease modifying anti-rheumatic drug (BDMARD) failure
- Psoriasis Area and Severity Index (PASI) Score [ Time Frame: 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).
- Reduction in Psoriasis Area and Severity Index Score of at Least 75% (PASI75) [ Time Frame: 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).
- Dermatology Life Quality Index (DLQI) Score [ Time Frame: 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).
- Nail Psoriasis Severity Index (NAPSI) Score [ Time Frame: 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).
- Tolerability and Safety Assessed by Collection and Classification of Adverse Reactions [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01084668
|Site Reference ID/Investigator# 27435|
|Feldkirch, Austria, 6807|
|Site Reference ID/Investigator# 27436|
|Graz, Austria, 8010|
|Site Reference ID/Investigator# 38445|
|Graz, Austria, 8036|
|Site Reference ID/Investigator# 27443|
|Linz, Austria, 4020|
|Site Reference ID/Investigator# 27442|
|Vienna, Austria, 1030|
|Site Reference ID/Investigator# 27440|
|Vienna, Austria, 1130|
|Site Reference ID/Investigator# 27437|
|Vienna, Austria, 1160|
|Site Reference ID/Investigator# 27439|
|Vienna, Austria, A-1090|
|Site Reference ID/Investigator# 23309|
|Wels, Austria, 4600|
|Study Director:||Astrid Dworan-Timler, MD||Abbott Austria|