Quality of Life and Psychosocial Factors Associated With Severe Psoriasis Following Treatment With Adalimumab (Body Image)
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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. |
- 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.
- 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)
| Estimated Enrollment: | 150 |
| Study Start Date: | May 2011 |
| Estimated Study Completion Date: | April 2014 |
| Estimated Primary Completion Date: | April 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 |
Secondary Care Outpatients
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| Contact: Jill Boorman | jill.boorman@abbvie.com | |
| Contact: Virginia Holmes | +44 1628 644340 | virginia.holmes@abbvie.com |
| United Kingdom | |
| Site Reference ID/Investigator# 52230 | Recruiting |
| Cambridge, United Kingdom, CB2 0QQ | |
| Principal Investigator: Site Reference ID/Investigator# 52230 | |
| Site Reference ID/Investigator# 52227 | Recruiting |
| Cannock, United Kingdom, WS11 5XY | |
| Principal Investigator: Site Reference ID/Investigator# 52227 | |
| Site Reference ID/Investigator# 51727 | Recruiting |
| Chester, United Kingdom, CH2 1UL | |
| Principal Investigator: Site Reference ID/Investigator# 51727 | |
| Site Reference ID/Investigator# 60322 | Recruiting |
| Crewe, United Kingdom, CW1 4QJ | |
| Principal Investigator: Site Reference ID/Investigator# 60322 | |
| Site Reference ID/Investigator# 52222 | Recruiting |
| Exeter, United Kingdom, EX1 2ED | |
| Principal Investigator: Site Reference ID/Investigator# 52222 | |
| Site Reference ID/Investigator# 52224 | Recruiting |
| Harrogate, United Kingdom, HG2 5SX | |
| Principal Investigator: Site Reference ID/Investigator# 52224 | |
| Site Reference ID/Investigator# 51723 | Recruiting |
| Hull, United Kingdom, HU8 9HE | |
| Principal Investigator: Site Reference ID/Investigator# 51723 | |
| Site Reference ID/Investigator# 52226 | Recruiting |
| London, United Kingdom, E1 1BB | |
| Principal Investigator: Site Reference ID/Investigator# 52226 | |
| Site Reference ID/Investigator# 44285 | Recruiting |
| London, United Kingdom, E11 1NR | |
| Principal Investigator: Site Reference ID/Investigator# 44285 | |
| Site Reference ID/Investigator# 74093 | Recruiting |
| London, United Kingdom, SW17 0QT | |
| Principal Investigator: Site Reference ID/Investigator# 74093 | |
| Site Reference ID/Investigator# 52225 | Recruiting |
| London, United Kingdom, NW3 2QG | |
| Principal Investigator: Site Reference ID/Investigator# 52225 | |
| Site Reference ID/Investigator# 66063 | Recruiting |
| London, United Kingdom, W2 1NY | |
| Principal Investigator: Site Reference ID/Investigator# 66063 | |
| Site Reference ID/Investigator# 66062 | Recruiting |
| London, United Kingdom, E9 6SR | |
| Principal Investigator: Site Reference ID/Investigator# 66062 | |
| Site Reference ID/Investigator# 51724 | Recruiting |
| Newport, United Kingdom, NP20 4SZ | |
| Principal Investigator: Site Reference ID/Investigator# 51724 | |
| Site Reference ID/Investigator# 51722 | Recruiting |
| Portsmouth, United Kingdom, PO3 6AD | |
| Principal Investigator: Site Reference ID/Investigator# 51722 | |
| Site Reference ID/Investigator# 52229 | Recruiting |
| Redhill, United Kingdom, RH1 5RH | |
| Principal Investigator: Site Reference ID/Investigator# 52229 | |
| Site Reference ID/Investigator# 52223 | Recruiting |
| Truro, United Kingdom, TR1 3LJ | |
| Principal Investigator: Site Reference ID/Investigator# 52223 | |
| 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: | May 6, 2013 |
| 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 |
Antirheumatic Agents Therapeutic Uses Pharmacologic Actions Anti-Inflammatory Agents |
ClinicalTrials.gov processed this record on May 16, 2013