Quality of Life and Psychosocial Factors Associated With Severe Psoriasis Following Treatment With Adalimumab

NCT01328366 | Completed Results

• 1 other identifier: P12-627
• Study Type: observational
• Target: 153
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Psoriasis

Keywords

Quality of Life; Psychosocial factors

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  4 weeks, 16 weeks, and 6 months following adalimumab initiation

Secondary Outcomes (13)

• Self-assessed Psoriasis Area and Severity Index (SAPASI) Scores

  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

  4 weeks, 16 weeks, and 6 months after adalimumab initiation

• Psoriasis Area and Severity Index (PASI) Scores

  Baseline; 4 weeks, 16 weeks, and 6 months following adalimumab initiation

• Mean Change in Psoriasis Area and Severity Index (PASI) Scores From Baseline

  4 weeks, 16 weeks, and 6 months following adalimumab initiation

• Hospital Anxiety and Depression Scale (HADS) Scores

  Baseline; 4 weeks, 16 weeks, and 6 months following adalimumab initiation

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Secondary Care Outpatients

You may qualify if:

• 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

You may not qualify if:

• Participants were previously treated with another biologic therapy
• Participants were unable or unwilling to complete the study questionnaires

Sponsors & Collaborators

• AbbVie (prior sponsor, Abbott): lead
• pH Associates: collaborator

Related Links

• Related Info

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Global Medical Information
• Organization: AbbVie (prior sponsor, Abbott)

800-633-9110

Study Officials

• Neil Pumford, MD

  AbbVie

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2011
• First Posted: April 4, 2011
• Study Start: May 1, 2011
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: July 9, 2015
• Results First Posted: June 11, 2015

Record last verified: 2015-06