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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
Sponsor:
Collaborator:
Assign Data Management and Biostatistics GmbH
Information provided by (Responsible Party):
Abbott

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Condition Psoriasis Chronic
Enrollment 46
Recruitment Details A total of 46 participants were screened for this PMOS at 9 study sites in Austria. One participant did not meet entry criteria (screening failure), and 45 participants were enrolled and received treatment with adalimumab in the study.
Pre-assignment Details Three participants were excluded from the database because they had been treated with adalimumab prior to their Visit 1. Statistical analysis has been performed for the 42 participants included in the All Treated population.
Arm/Group Title Adalimumab
Hide Arm/Group Description Participants with moderate to severe chronic plaque psoriasis treated with adalimumab after biologic disease modifying anti-rheumatic drug (BDMARD) failure
Period Title: Overall Study
Started 42 [1]
Completed 33
Not Completed 9
Reason Not Completed
Lack of Efficacy             5
Withdrawal by Subject             2
Pregnancy             1
Non-compliance             1
[1]
Three participants who took Humira prior to study entry have been excluded from the database.
Arm/Group Title Adalimumab
Hide Arm/Group Description Participants with moderate to severe chronic plaque psoriasis treated with adalimumab after biologic disease modifying anti-rheumatic drug (BDMARD) failure
Overall Number of Baseline Participants 42
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 42 participants
47.1  (11.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 42 participants
Female
15
  35.7%
Male
27
  64.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Austria Number Analyzed 42 participants
42
1.Primary Outcome
Title Psoriasis Area and Severity Index (PASI) Score
Hide Description 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).
Time Frame Inclusion visit (Week 0), Week 4, Week 36, Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the All Treated population using an observed case approach. PASI score was assessed at Weeks 0, 4, 36, and 52 in 41, 36, 28, and 27 participants, respectively.
Arm/Group Title All Treated
Hide Arm/Group Description:
Participants with moderate to severe chronic plaque psoriasis treated with adalimumab after biologic disease modifying anti-rheumatic drug (BDMARD) failure
Overall Number of Participants Analyzed 42
Mean (Standard Deviation)
Unit of Measure: units on a scale
Week 0 15.5  (11.4)
Week 4 7.6  (4.5)
Week 36 2.5  (5.2)
Week 52 2.0  (4.9)
2.Primary Outcome
Title Reduction in Psoriasis Area and Severity Index Score of at Least 75% (PASI75)
Hide Description 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).
Time Frame Inclusion visit (Week 0) to Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the All Treated population using an observed case approach. PASI response was assessed in 26 participants at Week 52.
Arm/Group Title All Treated
Hide Arm/Group Description:
Participants with moderate to severe chronic plaque psoriasis treated with adalimumab after biologic disease modifying anti-rheumatic drug (BDMARD) failure
Overall Number of Participants Analyzed 26
Measure Type: Number
Unit of Measure: participants
23
3.Secondary Outcome
Title Dermatology Life Quality Index (DLQI) Score
Hide Description 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).
Time Frame Inclusion visit (Week 0), Week 4, Week 36, Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the All Treated population using an observed case approach. DLQI score was assessed at Weeks 0, 4, 36, and 52 in 36, 34, 26, and 27 participants, respectively.
Arm/Group Title All Treated
Hide Arm/Group Description:
Participants with moderate to severe chronic plaque psoriasis treated with adalimumab after biologic disease modifying anti-rheumatoid drug (BDMARD) failure
Overall Number of Participants Analyzed 42
Mean (Standard Deviation)
Unit of Measure: units on a scale
Week 0 13.8  (8.3)
Week 4 7.2  (5.6)
Week 36 2.2  (3.4)
Week 52 2.2  (4.8)
4.Secondary Outcome
Title Nail Psoriasis Severity Index (NAPSI) Score
Hide Description 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).
Time Frame Inclusion visit (Week 0), Week 4, Week 36, and Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed using an observed case approach. For the All Treated population, NAPSI was assessed at Weeks 0, 4, 36, and 52 in 34, 30, 24, and 25 participants, respectively. For the Subgroup with nail psoriasis, NAPSI was assessed at Weeks 0, 4, 36, and 52 in 18, 16, 12, and 13 participants, respectively.
Arm/Group Title All Treated Subgroup With Nail Psoriasis
Hide Arm/Group Description:
Participants with moderate to severe chronic plaque psoriasis treated with adalimumab after biologic disease modifying anti-rheumatoid drug (BDMARD) failure
Subgroup of participants with nail psoriasis and a NAPSI score greater than 0 for at least 1 study visit
Overall Number of Participants Analyzed 42 18
Mean (Standard Deviation)
Unit of Measure: units on a scale
Week 0 15.4  (24.0) 29.0  (26.5)
Week 4 14.9  (22.9) 28.0  (25.0)
Week 36 4.0  (9.6) 7.9  (12.6)
Week 52 4.0  (7.8) 7.7  (9.5)
5.Secondary Outcome
Title Tolerability and Safety Assessed by Collection and Classification of Adverse Reactions
Hide Description 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.
Time Frame From the time of participant consent until 70 days after last dose of study drug
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the All Treated population.
Arm/Group Title All Treated
Hide Arm/Group Description:
Participants with moderate to severe chronic plaque psoriasis treated with adalimumab after biologic disease modifying anti-rheumatoid drug (BDMARD) failure
Overall Number of Participants Analyzed 42
Measure Type: Number
Unit of Measure: participants
Non-serious adverse events 8
Serious adverse events 1
Time Frame Up to 1 year (from the time of participant consent through the final Week 52 visit) plus 70 days following administration of the last dose of physician-prescribed study treatment.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Adalimumab
Hide Arm/Group Description Participants with moderate to severe chronic plaque psoriasis treated with adalimumab after biologic disease modifying anti-rheumatic drug (BDMARD) failure
All-Cause Mortality
Adalimumab
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Adalimumab
Affected / at Risk (%) # Events
Total   1/42 (2.38%)    
Injury, poisoning and procedural complications   
Ligament rupture * 1  1/42 (2.38%)  2
Surgical and medical procedures   
Arthroscopic surgery * 1  1/42 (2.38%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 14.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Adalimumab
Affected / at Risk (%) # Events
Total   8/42 (19.05%)    
Gastrointestinal disorders   
Nausea * 1  1/42 (2.38%) 
General disorders   
Injection site pain * 1  1/42 (2.38%) 
Injection site reaction * 1  1/42 (2.38%) 
Injection site urticaria * 1  1/42 (2.38%) 
Infections and infestations   
Acute tonsillitis * 1  2/42 (4.76%) 
Nasopharyngitis * 1  2/42 (4.76%) 
Injury, poisoning and procedural complications   
Tooth fracture * 1  1/42 (2.38%) 
Skin and subcutaneous tissue disorders   
Pruritus * 1  1/42 (2.38%) 
Psoriasis * 1  1/42 (2.38%) 
Vascular disorders   
Hypertension * 1  1/42 (2.38%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 14.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Abbott requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. Abbott requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if Abbott needs to secure patent or proprietary protection.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Global Medical Services
Organization: Abbott
Phone: 800-633-9110
Layout table for additonal information
Responsible Party: Abbott
ClinicalTrials.gov Identifier: NCT01084668     History of Changes
Other Study ID Numbers: P10-708
First Submitted: February 28, 2010
First Posted: March 10, 2010
Results First Submitted: April 26, 2012
Results First Posted: May 30, 2012
Last Update Posted: June 29, 2012