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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

April 1, 2011
June 2, 2014
May 2011
May 2014   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01328366 on ClinicalTrials.gov Archive Site
  • 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)
Same as current
Not Provided
Not Provided
 
Quality of Life and Psychosocial Factors Associated With Severe Psoriasis Following Treatment With Adalimumab
A Real World Observational Study to Evaluate the Impact of Adalimumab Therapy on Quality of Life and Psychological Factors Associated With Severe Psoriasis

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Secondary Care Outpatients

Psoriasis
Not Provided
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.

Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
152
May 2014
May 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT01328366
P12-627
No
AbbVie ( AbbVie (prior sponsor, Abbott) )
AbbVie (prior sponsor, Abbott)
pH Associates
Study Director: Jon Ryland, MD AbbVie
AbbVie
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP