- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01084668
Quality of Life in Adalimumab Treated Psoriasis Patients Failing Other Biologic Disease Modifying Anti-rheumatic Drugs (QUALITY)
June 25, 2012 updated by: 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.
Study Overview
Status
Completed
Conditions
Detailed Description
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.
Study Type
Observational
Enrollment (Actual)
46
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Feldkirch, Austria, 6807
- Site Reference ID/Investigator# 27435
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Graz, Austria, 8010
- Site Reference ID/Investigator# 27436
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Graz, Austria, 8036
- Site Reference ID/Investigator# 38445
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Linz, Austria, 4020
- Site Reference ID/Investigator# 27443
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Vienna, Austria, 1030
- Site Reference ID/Investigator# 27442
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Vienna, Austria, 1130
- Site Reference ID/Investigator# 27440
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Vienna, Austria, 1160
- Site Reference ID/Investigator# 27437
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Vienna, Austria, A-1090
- Site Reference ID/Investigator# 27439
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Wels, Austria, 4600
- Site Reference ID/Investigator# 23309
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Hospital, Dermatology
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Adalimumab
Participants with moderate to severe chronic plaque psoriasis treated with adalimumab after biologic disease modifying anti-rheumatic drug (BDMARD) failure
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Psoriasis Area and Severity Index (PASI) Score
Time Frame: Inclusion visit (Week 0), Week 4, Week 36, Week 52
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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).
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Inclusion visit (Week 0), Week 4, Week 36, Week 52
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Reduction in Psoriasis Area and Severity Index Score of at Least 75% (PASI75)
Time Frame: Inclusion visit (Week 0) to Week 52
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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).
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Inclusion visit (Week 0) to Week 52
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Dermatology Life Quality Index (DLQI) Score
Time Frame: Inclusion visit (Week 0), Week 4, Week 36, Week 52
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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).
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Inclusion visit (Week 0), Week 4, Week 36, Week 52
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Nail Psoriasis Severity Index (NAPSI) Score
Time Frame: Inclusion visit (Week 0), Week 4, Week 36, and Week 52
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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).
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Inclusion visit (Week 0), Week 4, Week 36, and Week 52
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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
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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.
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From the time of participant consent until 70 days after last dose of study drug
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: Astrid Dworan-Timler, MD, Abbott Austria
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2008
Primary Completion (Actual)
April 1, 2011
Study Completion (Actual)
April 1, 2011
Study Registration Dates
First Submitted
February 28, 2010
First Submitted That Met QC Criteria
March 9, 2010
First Posted (Estimate)
March 10, 2010
Study Record Updates
Last Update Posted (Estimate)
June 29, 2012
Last Update Submitted That Met QC Criteria
June 25, 2012
Last Verified
June 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- P10-708
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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