PsoriasisBody ImageNCT01328366
Quality of Life and Psychosocial Factors Associated With Severe Psoriasis Following Treatment With Adalimumab
An observational study of Psoriasis, run by AbbVie (prior sponsor, Abbott).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriasis
- How many people
- 153 participants
- Where
- No sites listed yet
- Study dates
- May 2011to May 2014
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Secondary Care Outpatients
Who may be able to join
- 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
Who cannot join
- Participants were previously treated with another biologic therapy
- Participants were unable or unwilling to complete the study questionnaires
About this study
Official title: 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.
Read the 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.
- Conditions
- Psoriasis
- Keywords
- Quality of Life, Psychosocial factors
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Dermatology Life Quality Index (DLQI) Scores
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.
Measured: Baseline; 4 weeks, 16 weeks, and 6 months following adalimumab initiation
Mean Change in Dermatology Life Quality Index (DLQI) Scores From Baseline
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.
Measured: 4 weeks, 16 weeks, and 6 months following adalimumab initiation
Secondary outcomes (13)
Self-assessed Psoriasis Area and Severity Index (SAPASI) Scores
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.
Measured: 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
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.
Measured: 4 weeks, 16 weeks, and 6 months after adalimumab initiation
Psoriasis Area and Severity Index (PASI) Scores
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.
Measured: Baseline; 4 weeks, 16 weeks, and 6 months following adalimumab initiation
Mean Change in Psoriasis Area and Severity Index (PASI) Scores From Baseline
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.
Measured: 4 weeks, 16 weeks, and 6 months following adalimumab initiation
Hospital Anxiety and Depression Scale (HADS) Scores
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.
Measured: Baseline; 4 weeks, 16 weeks, and 6 months following adalimumab initiation
Mean Change in Hospital Anxiety and Depression Scale (HADS) Scores From Baseline
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.
Measured: 4 weeks, 16 weeks, and 6 months following adalimumab initiation
Cutaneous Body Image Scale (CBI) Scores
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.
Measured: Baseline; 4 weeks, 16 weeks, and 6 months following adalimumab initiation
Mean Change in Cutaneous Body Image (CBI) Scale Scores From Baseline
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.
Measured: 4 weeks, 16 weeks, and 6 months following adalimumab initiation
12-item Short Form Survey (SF-12) Score
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.
Measured: Baseline; 4 weeks, 16 weeks, and 6 months following adalimumab initiation
Change in 12-item Short Form Survey (SF-12) Score From Baseline
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.
Measured: 4 weeks, 16 weeks, and 6 months following adalimumab initiation
Female Sexual Function Index (FSFI) Score
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.
Measured: Baseline; 16 weeks, and 6 months following adalimumab initiation
Mean Change in Female Sexual Function Index (FSFI) Score From Baseline
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.
Measured: 4 week, 16 weeks, and 6 months following adalimumab initiation
International Index of Erectile Function Score
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.
Measured: Baseline; 4 weeks, 16 weeks, and 6 months following adalimumab initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2011 (estimated)
- Study startMay 2011
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 153 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie (prior sponsor, Abbott)
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- pH Associates
- Responsible party
- Sponsor
- Investigators
- Neil Pumford, MD, Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01328366
- Sponsor's protocol ID
- P12-627
- Acronym
- Body Image
- Status last verified
- Jun 2015
- First submitted
- 1 Apr 2011
- Last updated
- 9 Jul 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Real World Observational Study to Evaluate the Impact of Adalimumab Therapy on Quality of Life and Psychological Factors Associated With Severe Psoriasis
- ClinicalTrials.gov ID
- NCT01328366
- Acronym / sponsor ID
- Body Image / P12-627
- Conditions
- Psoriasis
- Keywords
- Quality of Life, Psychosocial factors
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 153 participants (actual)
- Lead sponsor
- AbbVie (prior sponsor, Abbott)Industry (pharma, biotech, devices)
- Collaborators
- pH Associates
- Study start
- May 2011
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 4 Apr 2011 (estimated)
- Results
- Posted 11 Jun 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Secondary Care Outpatients
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Participants were previously treated with another biologic therapy
- Participants were unable or unwilling to complete the study questionnaires
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
13 secondary outcomes
Self-assessed Psoriasis Area and Severity Index (SAPASI) Scores
Time frame: 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
Psoriasis Area and Severity Index (PASI) Scores
Time frame: 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
Hospital Anxiety and Depression Scale (HADS) Scores
Time frame: 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
Cutaneous Body Image Scale (CBI) Scores
Time frame: 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
12-item Short Form Survey (SF-12) Score
Time frame: 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
Female Sexual Function Index (FSFI) Score
Time frame: 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
International Index of Erectile Function Score
Time frame: Baseline; 4 weeks, 16 weeks, and 6 months following adalimumab initiation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Neil Pumford, MD study director
AbbVie
Questions about this trial
What is this clinical trial studying?
An observational study of Psoriasis, run by AbbVie (prior sponsor, Abbott).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Jun 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dermatology Life Quality Index (DLQI) Scores (time frame: Baseline; 4 weeks, 16 weeks, and 6 months following adalimumab initiation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2015.