Sophos study is now closed please follow the link below for a summary of results and any publications arising.
Study Title: ScOttish Psoriatic arthritis Observational Study and biobank (SOPHOS)
Study Summary
This study, funded by Chief Scientist’s Office (Scotland) and UCB Pharma, is a pan-Scottish study which aims to create a biobank of epidemiological, clinical, serological data and of biological samples in patients with newly diagnosed and established psoriatic arthritis.
What does the study involve?
The study is designed to be able to answer a number of different research questions, the precise analysis will depend on the specific question being asked but is likely to include identifying predictors of prognosis (good and bad outcomes) and treatment response. The data collected will also allow assessment of the burden of disease and treatment in patients with this chronic disease.
This study records information about each participant, including age, gender, BMI, blood pressure, current treatment and changes in treatment, employment status, past medical history and past test results relevant to psoriatic arthritis (ESR, CRP, rheumatoid factor). Participants receive usual standard care and treatment, with no study-specific treatments.
A series of questionnaires are completed at six monthly intervals recording how psoriatic arthritis affects patients’ quality of life. These questionnaires include (PROMIS-Fatigue 8A, Dermatology Life Quality Index (DLQI), HAQ-DI, EQ-5D, HAD, Perceived Stress Scale, Patient Experience with Treatment and Self-management (PETS), Work Productivity and Activity Impairment (WPAI), Psoriatic Arthritis Impact of Disease (PSAID-12)). The following assessments will be performed at each study visit and includes assessment of swollen and tender joint (66/68), assessment of enthesitis, dactylitis and psoriasis body surface area. Study nurses will record patient global VAS, pain and fatigue, physician global assessment, results from standard laboratory tests. and change in treatment. Imaging (conventional radiographs hands and feet), will be collected at baseline and at 12 months. No further study specific imaging would be performed, but dates of other routine imaging would be collected.
At the first three study visits, 55ml (8 teaspoons) of blood and a sample of urine are taken with the intention to be used for future studies to understand aspects of psoriatic arthritis, inflammation, genetics and potential biomarker discovery. It is planned to use the biobank as the basis for future clinical research. However, such studies will be the subject of separate requests for approvals, with distinct protocols.
The study is now closed to recruitment and follow up. A summary of findings can be found on the Chief Scientist Office website https://www.cso.scot.nhs.uk/wp-content/uploads/ETM.414-Final-Report.pdf
Study contacts for further information
Ms Caron Paterson, Lead Rheumatology Project Manager
Caron.Paterson@glasgow.ac.uk
Professor Stefan Siebert, Professor of Inflammation Medicine and Rheumatology
Stefan.Siebert@glasgow.ac.uk