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

This study has been completed.
Sponsor:
Collaborator:
pH Associates
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01328366
First received: April 1, 2011
Last updated: June 2, 2014
Last verified: June 2014
  Purpose

Psoriasis affects around 1.5% of the UK population with 20- 30% of these patients having severe psoriasis managed by National Health Service's secondary and tertiary care centres. Secondary care initiated therapies include light therapy, systemic agents such as ciclosporin and methotrexate and ultimately if no response is seen with these agents a biologic therapy may be initiated. Aside from the management of dermatological symptoms of the disease, the disorder is also associated with significant emotional and social dysfunction. It has been shown that patients with psoriasis have a greater prevalence of depressive symptoms, mood disturbances, anxiety and even suicidal tendencies. The aim of this study is to assess the impact that treatment of psoriasis with adalimumab (a biologic agent) has on quality of life, body image and psychosocial factors. The main outcome measure will be the proportion of 'responders' (having a 5 or more point drop in their score on the Dermatology Life Quality Index DLQI) after 16 weeks of adalimumab treatment.

The study will involve collecting some information from clinical records and administering a series of patient reported questionnaires on 4 occasions (once just before and 3 times after initiation of adalimumab). The decision to prescribe adalimumab will be outside the study and will be made by the consultant according to his / her own clinical judgment, together with the patient. Any consenting adult patient being initiated on adalimumab as their first biologic for psoriasis will be eligible to participate in the study. There will be no change to the patient's management for the study. The patient will be asked to complete the questionnaires at the time of initiation of therapy and then after approximately 4 weeks, 16 weeks and 6 months of treatment as and when the patient attends the clinic for routine appointments.


Condition
Psoriasis

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by AbbVie:

Primary Outcome Measures:
  • Change in patient reported Dermatology Life Quality Index (DLQI) measurement [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    The proportion of "responders" at week 16, where a "responder" is defined as a patient reporting at least a 5 point reduction in DLQI score after 16 weeks of treatment with adalimumab.


Secondary Outcome Measures:
  • Patient reported factors relating to body image [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]

    Using the following questionnaires:

    • Self administered psoriasis area and severity index (SAPASI)
    • Cutaneous body image scale

  • Change in Quality of Life [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    Using the Short Form-12 (SF-12)

  • Patient reported factors relating to sexual function [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]

    Using the following questionnaires relating to sexual function:

    • Female sexual function index (FSFI) (for females only)
    • International index of erectile function (IIEF) (for males only)

  • Patient reported factors relating to anxiety and depression [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    Using the Hospital Anxiety and Depression Scale (HADS)

  • Change in quality of life [ Time Frame: 4 weeks and 6 months ] [ Designated as safety issue: No ]
    Dermatology Life Quality Index (DLQI) measurement

  • Patient reported factors relating to body image [ Time Frame: 4 weeks, and 6 months ] [ Designated as safety issue: No ]

    Using the following questionnaires:

    • Self administered psoriasis area and severity index (SAPASI)
    • Cutaneous body image scale

  • Change in Quality of Life [ Time Frame: 4 weeks and 6 months ] [ Designated as safety issue: No ]
    Using the Short Form-12 (SF-12)

  • Patient reported factors relating to sexual function [ Time Frame: 4 weeks and 6 months ] [ Designated as safety issue: No ]

    Using the following questionnaires relating to sexual function:

    • Female sexual function index (FSFI) (for females only)
    • International index of erectile function (IIEF) (for males only)

  • Patient reported factors relating to anxiety and depression [ Time Frame: 4 weeks and 6 months ] [ Designated as safety issue: No ]
    Using the Hospital Anxiety and Depression Scale (HADS)


Enrollment: 152
Study Start Date: May 2011
Study Completion Date: May 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Psoriasis

The disease is severe 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.

The psoriasis has not responded to standard systemic therapies including ciclosporin, methotrexate and PUVA (psoralen and long-wave ultraviolet radiation); or the person is intolerant of, or has a contraindication to, these treatments.


  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Secondary Care Outpatients

Criteria

Inclusion Criteria:

  • Patients aged 18 or over at date of consent / approach for consent
  • Patients eligible for and due to commence adalimumab as determined by National Institute for Health and Clinical Excellence (NICE) criteria
  • The disease is severe 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
  • The psoriasis has not responded to standard systemic therapies including ciclosporin, methotrexate and PUVA (psoralen and long-wave ultraviolet radiation); or the person is intolerant of, or has a contraindication to, these treatments

Exclusion Criteria:

  • Patients previously treated with another biologic therapy
  • Patients declining to consent to taking part in the study
  • Patients who are unable or unwilling to complete the study questionnaires
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01328366

Locations
United Kingdom
Site Reference ID/Investigator# 97456
Birmingham, United Kingdom, B15 2TH
Site Reference ID/Investigator# 52230
Cambridge, United Kingdom, CB2 0QQ
Site Reference ID/Investigator# 52227
Cannock, United Kingdom, WS11 5XY
Site Reference ID/Investigator# 51727
Chester, United Kingdom, CH2 1UL
Site Reference ID/Investigator# 60322
Crewe, United Kingdom, CW1 4QJ
Site Reference ID/Investigator# 52222
Exeter, United Kingdom, EX1 2ED
Site Reference ID/Investigator# 97455
Glasgow, United Kingdom, G11 6NT
Site Reference ID/Investigator# 52224
Harrogate, United Kingdom, HG2 5SX
Site Reference ID/Investigator# 51723
Hull, United Kingdom, HU8 9HE
Site Reference ID/Investigator# 60323
Leeds, United Kingdom, LS1 3EX
Site Reference ID/Investigator# 66062
London, United Kingdom, E9 6SR
Site Reference ID/Investigator# 52225
London, United Kingdom, NW3 2QG
Site Reference ID/Investigator# 74093
London, United Kingdom, SW17 0QT
Site Reference ID/Investigator# 66063
London, United Kingdom, W2 1NY
Site Reference ID/Investigator# 52226
London, United Kingdom, E1 1BB
Site Reference ID/Investigator# 44285
London, United Kingdom, E11 1NR
Site Reference ID/Investigator# 51724
Newport, United Kingdom, NP20 4SZ
Site Reference ID/Investigator# 51722
Portsmouth, United Kingdom, PO3 6AD
Site Reference ID/Investigator# 52229
Redhill, United Kingdom, RH1 5RH
Site Reference ID/Investigator# 52223
Truro, United Kingdom, TR1 3LJ
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
pH Associates
Investigators
Study Director: Jon Ryland, MD AbbVie
  More Information

Additional Information:
No publications provided

Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT01328366     History of Changes
Other Study ID Numbers: P12-627
Study First Received: April 1, 2011
Last Updated: June 2, 2014
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by AbbVie:
Quality of Life
Psychosocial factors

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

ClinicalTrials.gov processed this record on September 15, 2014