Effect of Apremilast in Psoriatic Arthritis on Work Related Disability
Research type
Research Study
Full title
EMPOWER - Effect of Apremilast in Psoriatic Arthritis on Worker Related Disability
IRAS ID
216399
Contact name
Bashaar Boyce
Contact email
Sponsor organisation
Royal United Hospitals Bath NHS FT
Duration of Study in the UK
2 years, 0 months, 0 days
Research summary
Psoriatic Arthritis (PsA) is an inflammatory arthritis occurring in up to 30% of patients with skin psoriasis. Patients can develop inflammation in joints, tendons, spine, skin, nails and eyes causing stiffness, pain and fatigue. Left untreated the inflammation results in damage causing further pain and restricted movement. Cohort studies have demonstrated progression of joint destruction, deteriorating functional status and a negative impact on quality of life and ability to work. There are high levels of work disability in patients with PsA.
Work disability is an important patient centred outcome measure. It captures how the disease affects patients more holistically than focussing solely on articular manifestations, which historically have often been the primary outcome measure. It also provides information on the economic impact of the disease on a wider scale.
Apremilast is a novel therapeutic agent that has proven efficacy in ameliorating disease activity in Psoriasis and PsA. However, there have been no studies to date demonstrating whether Apremilast reduces work disability.
This study will investigate the effect of Apremilast on various measures of work disability in a cohort of patients with PsA. Work disability can be assessed using specific questionnaires designed to capture this information. Adult patients with evidence of active PsA who are starting Apremilast will be invited to participate during their routine clinical appointments. A combination of clinical assessments and questionnaires over a 6 month period will be used in the study. Patients will be recruited from the base hospital and other UK Rheumatology centres. The study will run for 2 years funded by Celgene Pharmaceuticals.
REC name
London - Brent Research Ethics Committee
REC reference
17/LO/0837
Date of REC Opinion
23 Jun 2017
REC opinion
Further Information Favourable Opinion