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Quality of Life and Psychosocial Factors Associated With Severe Psoriasis Following Treatment With Adalimumab (Body Image)

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ClinicalTrials.gov Identifier: NCT01328366
Recruitment Status : Completed
First Posted : April 4, 2011
Results First Posted : June 11, 2015
Last Update Posted : July 9, 2015
Sponsor:
Collaborator:
pH Associates
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )

Study Description
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief 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. 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.

Condition or disease
Psoriasis

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
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Study Type : Observational
Actual Enrollment : 153 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Study Start Date : May 2011
Actual Primary Completion Date : May 2014
Actual Study Completion Date : May 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis
Drug Information available for: Adalimumab
U.S. FDA Resources

Groups and Cohorts
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Group/Cohort
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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Secondary Care Outpatients
Criteria

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
Contacts and Locations
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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): NCT01328366


Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
pH Associates
Investigators
Study Director: Neil Pumford, MD AbbVie
More Information
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

Responsible Party: AbbVie (prior sponsor, Abbott)
ClinicalTrials.gov Identifier: NCT01328366     History of Changes
Other Study ID Numbers: P12-627
First Posted: April 4, 2011    Key Record Dates
Results First Posted: June 11, 2015
Last Update Posted: July 9, 2015
Last Verified: June 2015

Keywords provided by AbbVie ( AbbVie (prior sponsor, Abbott) ):
Quality of Life
Psychosocial factors

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
 Adalimumab
Anti-Inflammatory Agents
Antirheumatic Agents