- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01328366
Quality of Life and Psychosocial Factors Associated With Severe Psoriasis Following Treatment With Adalimumab (Body Image)
June 11, 2015 updated by: AbbVie (prior sponsor, Abbott)
A Real World Observational Study to Evaluate the Impact of Adalimumab Therapy on Quality of Life and Psychological Factors Associated With Severe Psoriasis
The impact of psoriasis on an individual's emotional and social well-being goes beyond skin symptoms of the disease.
Data suggests patients with severe psoriasis experience a greater prevalence of depressive symptoms, mood disturbances, anxiety and even suicidal ideation.
Given the nature of the disease and the treatment failures which are required before a patient commences a biologic therapy such as adalimumab, the patient's mental health at initiation of biologics is an important consideration for clinicians.
This study seeks to explore if adalimumab treatment of psoriasis leads to a positive impact on psychosocial factors and disease-related quality of life.
Study Overview
Status
Completed
Conditions
Detailed Description
This was a multi-center, prospective, post-marketing observational study of participants with severe chronic plaque psoriasis who began adalimumab therapy in the United Kingdom.
Although 153 participants enrolled in the study, data was only analyzed on 143 individuals and there were no interventions or changes to participant management for the study.
Prior to initiating adalimumab therapy (baseline), the Dermatology Life Quality Index (DLQI), Self-Administered Psoriasis Area Severity Index (SAPASI), Hospital Anxiety and Depression Scale (HADS), Cutaneous Body Image (CBI) scale, Short Form 12 (SF-12) Health Survey, Female Sexual Function Index (FSFI) (female participants) and International Index of Erectile Function (IIEF) (male participants) questionnaires were completed by participants and at 4 weeks, 16 weeks and 6 months following initiation.
Study Type
Observational
Enrollment (Actual)
153
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
Secondary Care Outpatients
Description
Inclusion Criteria:
- Participants were eligible for adalimumab as determined by the National Institute for Health and Clinical Excellence (NICE) criteria
- Participants had severe psoriasis as defined by a Psoriasis Area Severity Index (PASI) of 10 or more and a Dermatology Life Quality Index (DLQI) of more than 10
- Participant's psoriasis did not respond to standard systemic therapies, to include: ciclosporin, methotrexate, and psoralen and long-wave ultraviolet radiation; or the participant was intolerant of or had a contraindication to these treatments
Exclusion Criteria:
- Participants were previously treated with another biologic therapy
- Participants were unable or unwilling to complete the study questionnaires
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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Participants with severe psoriasis
The participants had severe disease as defined by a total Psoriasis Area Severity Index (PASI) of 10 or more and a Dermatology Life Quality Index (DLQI) of more than 10 and had not responded to standard systemic therapies.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Dermatology Life Quality Index (DLQI) Scores
Time Frame: Baseline; 4 weeks, 16 weeks, and 6 months following adalimumab initiation
|
The Dermatology Life Quality Index (DLQI) was a participant-reported questionnaire used to measure the health-related quality of life (QOL) of adults suffering from a skin disease.
Scores ranged from 0-30, a higher score indicating a greater impact on a participant's QOL.
Data are reported as the mean DLQI score ± standard deviation.
|
Baseline; 4 weeks, 16 weeks, and 6 months following adalimumab initiation
|
Mean Change in Dermatology Life Quality Index (DLQI) Scores From Baseline
Time Frame: 4 weeks, 16 weeks, and 6 months following adalimumab initiation
|
The Dermatology Life Quality Index (DLQI) was a participant-reported questionnaire used to measure the health-related quality of life (QOL) of adults suffering from a skin disease.
Scores ranged from 0-30, a higher score indicated a greater impact on a participant's QOL.
"Responders" to adalimumab had a ≥5 point reduction in DLQI scores or DLQI score of 0. Data are reported as the mean DLQI score ± standard deviation.
|
4 weeks, 16 weeks, and 6 months following adalimumab initiation
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Self-assessed Psoriasis Area and Severity Index (SAPASI) Scores
Time Frame: Baseline; 4 weeks, 16 weeks, and 6 months following adalimumab initiation
|
The Self-assessed Psoriasis Area and Severity Index (SAPASI) questionnaire was used to objectively measure the severity of a participant's psoriasis, taking into account the area of psoriasis legions on the body and the characteristics of these legions (redness, thickness, scaliness).
Scores ranged from 0-72, a higher score indicated more severe psoriasis.
Data are reported as the mean SAPASI score ± standard deviation.
|
Baseline; 4 weeks, 16 weeks, and 6 months following adalimumab initiation
|
Mean Change in Self-assessed Psoriasis Area and Severity Index (SAPASI) Scores From Baseline
Time Frame: 4 weeks, 16 weeks, and 6 months after adalimumab initiation
|
The Self-assessed Psoriasis Area and Severity Index (SAPASI) questionnaire was used to objectively measure the severity of a participant's psoriasis, taking into account the area of psoriasis legions on the body and the characteristics of these legions (redness, thickness, scaliness).
Scores ranged from 0-72, a higher score indicated more severe psoriasis.
Data are reported as the mean change in SAPASI score ± standard deviation.
|
4 weeks, 16 weeks, and 6 months after adalimumab initiation
|
Psoriasis Area and Severity Index (PASI) Scores
Time Frame: Baseline; 4 weeks, 16 weeks, and 6 months following adalimumab initiation
|
The Psoriasis Area and Severity Index (PASI) questionnaire was used by the clinical staff to measure the severity of a participant's psoriasis, taking into account the area of psoriasis legions on the body and the characteristics of these legions (redness, thickness, scaliness).
Scores ranged from 0-72, a higher score indicated more severe psoriasis.
Data are reported as the mean PASI score ± standard deviation.
|
Baseline; 4 weeks, 16 weeks, and 6 months following adalimumab initiation
|
Mean Change in Psoriasis Area and Severity Index (PASI) Scores From Baseline
Time Frame: 4 weeks, 16 weeks, and 6 months following adalimumab initiation
|
The Psoriasis Area and Severity Index (PASI) questionnaire was used by the clinical staff to measure the severity of a participant's psoriasis, taking into account the area of psoriasis legions on the body and the characteristics of these legions (redness, thickness, scaliness).
Scores range from 0-72, a higher score indicating more severe psoriasis.
Data are reported as the mean change in PASI score ± standard deviation.
|
4 weeks, 16 weeks, and 6 months following adalimumab initiation
|
Hospital Anxiety and Depression Scale (HADS) Scores
Time Frame: Baseline; 4 weeks, 16 weeks, and 6 months following adalimumab initiation
|
The Hospital Anxiety and Depression Scale (HADS) was a patient-reported questionnaire used to assess the level of anxiety and depression in the setting of a hospital medical outpatient clinic.
The anxiety and depression subscales each have a range from 0-21, higher scores indicated higher levels of anxiety and depression, respectively.
Data are reported as the mean anxiety or depression score ± standard deviation.
|
Baseline; 4 weeks, 16 weeks, and 6 months following adalimumab initiation
|
Mean Change in Hospital Anxiety and Depression Scale (HADS) Scores From Baseline
Time Frame: 4 weeks, 16 weeks, and 6 months following adalimumab initiation
|
The Hospital Anxiety and Depression Scale (HADS) was a patient-reported questionnaire used to assess the level of anxiety and depression in the setting of a hospital medical outpatient clinic.
The anxiety and depression subscales each have a range from 0-21, higher scores indicated higher levels of anxiety and depression, respectively.
Data are reported as the mean change in anxiety or depression score ± standard deviation.
|
4 weeks, 16 weeks, and 6 months following adalimumab initiation
|
Cutaneous Body Image Scale (CBI) Scores
Time Frame: Baseline; 4 weeks, 16 weeks, and 6 months following adalimumab initiation
|
The Cutaneous Body Image (CBI) Scale was a participant-reported questionnaire used to measure a participant's satisfaction with their hair, nails, and skin.
Scores range from 0-9, higher scores indicated a higher level of satisfaction.
Data are reported as the mean CBI score ± standard deviation.
|
Baseline; 4 weeks, 16 weeks, and 6 months following adalimumab initiation
|
Mean Change in Cutaneous Body Image (CBI) Scale Scores From Baseline
Time Frame: 4 weeks, 16 weeks, and 6 months following adalimumab initiation
|
The Cutaneous Body Image (CBI) Scale was a participant-reported questionnaire used to measure a participant's satisfaction with their hair, nails, and skin.
Scores range from 0-9, higher scores indicated a higher level of satisfaction.
Data are reported as the mean change in CBI score ± standard deviation.
|
4 weeks, 16 weeks, and 6 months following adalimumab initiation
|
12-item Short Form Survey (SF-12) Score
Time Frame: Baseline; 4 weeks, 16 weeks, and 6 months following adalimumab initiation
|
The 12-item Short Form Survey (SF-12) was a participant-reported questionnaire use to measure the functional health and well-being of a participant to include both physical and mental health domains.
Scores range from 0-100 for each domain, higher scores indicated better physical or mental health.
Data are reported as the mean SF-12 score physical or mental ± standard deviation.
|
Baseline; 4 weeks, 16 weeks, and 6 months following adalimumab initiation
|
Change in 12-item Short Form Survey (SF-12) Score From Baseline
Time Frame: 4 weeks, 16 weeks, and 6 months following adalimumab initiation
|
The 12-item Short Form Survey (SF-12) was a participant-reported questionnaire use to measure the functional health and well-being of a participant to include both physical and mental health domains.
Scores range from 0-100 for each domain, higher scores indicated better physical or mental health.
Data are reported as the mean change SF-12 score physical or mental ± standard deviation.
|
4 weeks, 16 weeks, and 6 months following adalimumab initiation
|
Female Sexual Function Index (FSFI) Score
Time Frame: Baseline; 16 weeks, and 6 months following adalimumab initiation
|
The Female Sexual Function Index (FSFI) was a participant-reported questionnaire used to measure a female's sexual function.
Scores range from 2-36, higher scores indicated better sexual function.
Data are reported as the mean FSFI score ± standard deviation.
|
Baseline; 16 weeks, and 6 months following adalimumab initiation
|
Mean Change in Female Sexual Function Index (FSFI) Score From Baseline
Time Frame: 4 week, 16 weeks, and 6 months following adalimumab initiation
|
The Female Sexual Function Index was a participant-reported questionnaire used to measure a female's sexual function.
Scores range from 2-36, higher scores indicated better sexual function.
Data are reported as the mean change in FSFI score ± standard deviation.
|
4 week, 16 weeks, and 6 months following adalimumab initiation
|
International Index of Erectile Function Score
Time Frame: Baseline; 4 weeks, 16 weeks, and 6 months following adalimumab initiation
|
The International Index of Erectile Function (IIEF) was a participant-reported questionnaire used to measure a male's erection function.
Scores range from 5-75, higher scores indicated better erection quality.
Data are reported as the mean IIEF score ± standard deviation.
|
Baseline; 4 weeks, 16 weeks, and 6 months following adalimumab initiation
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: Neil Pumford, MD, AbbVie
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
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
May 1, 2011
Primary Completion (Actual)
May 1, 2014
Study Completion (Actual)
May 1, 2014
Study Registration Dates
First Submitted
April 1, 2011
First Submitted That Met QC Criteria
April 1, 2011
First Posted (Estimate)
April 4, 2011
Study Record Updates
Last Update Posted (Estimate)
July 9, 2015
Last Update Submitted That Met QC Criteria
June 11, 2015
Last Verified
June 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- P12-627
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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