BODYCOPA

• Research type

  Research Study

• Full title

  BODYCOPA: Body composition in psoriatic disease and arthritis; exploration of the effects on body composition and metabolic profiles in patients with psoriatic disease.

• IRAS ID

  273889

• Contact name

  Tim Blake

• Contact email

  tim.blake@uhcw.nhs.uk

• Sponsor organisation

  University Hospitals Coventry and Warwickshire NHS Trust

• Clinicaltrials.gov Identifier

  N/A, N/A

• Duration of Study in the UK

  1 years, 6 months, 1 days

• Research summary

  Background: Patients with psoriatic disease (including psoriasis and psoriatic arthritis) are found to have altered body compositions and a significantly higher prevalence of metabolic syndrome compared with the general population. Currently, we have a plethora of treatments available for the management of psoriatic disease including newer targeted high cost biological therapies; however, clinicians are not able to practise precision medicine and tailor the right biological drug for the right patient, which often results in suboptimal response or intolerance. There are emerging data that the more traditional 'anti-TNF' biological drugs can lead to weight gain.

  Aim/rationale: We aim to investigate the influence of obesity on disease activity and outcomes in PsA patients, and the effects of body composition in routine care. We postulate that individualised treatment strategies based on insight into prognostic profiles and response-modifying factors could improve outcomes and overall care of psoriatic patients. We are particularly interested in the application of magnetic resonance imaging (MRI) in body composition, something that is now widely available and more cost-effective, though not yet been validated.

  The central aims and objectives of this pilot study are:

  • To compare demographics, lifestyle and disease characteristics in Pso and PsA according to body composition phenotypes:
  • To compare the anthropometric, biochemical and radiological measures of body composition in men and women with Pso and PsA vs healthy controls
  • To develop MRI protocols for the delineation of body fat distribution and compare these to BodPod analysis

  We anticipate that a future phase II of the study would compare the anthropometric, biochemical and radiological data between assessments performed at baseline and following treatments, including conventional synthetic DMARDs (csDMARDs) and biologic DMARDs, as part of patients’ routine clinical care.

  Methodology: We intend to recruit 30 adult participants with confirmed psoriatic disease (including psoriasis and psoriatic arthritis) and 30 matched healthy controls. Participants would be recruited from Coventry and Rugby hospitals. They would firstly undergo a full metabolic assessment in the Human Metabolism Research Unit (HMRU) in Coventry.

• REC name

  East of England - Cambridge South Research Ethics Committee

• REC reference

  21/EE/0102

• Date of REC Opinion

  24 May 2021

• REC opinion

  Further Information Favourable Opinion