FOREUM Stratified Medicine in Primary Sjogren’s Syndrome
Research type
Research Study
Full title
Foreum\n\nStratified Medicine in Primary Sjogren’s Syndrome\n\nA mixed methods quantitative/qualitative study to develop a patient reported questionnaire looking at disease burden within the Primary Sjogren’s Syndrome subtypes\n
IRAS ID
264215
Contact name
Wan-Fai Ng
Contact email
Sponsor organisation
The Newcastle upon Tyne Hospitals NHS Foundation Trust
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
Primary Sjögren’s syndrome (PSS) is a chronic, complex immune-mediated disease with no effective treatment available. The effects vary greatly among PSS sufferers with some reporting disabling fatigue, some unbearable pain and dryness, while others report fewer symptoms. Some PSS patients develop lymphoma or major extra-glandular organ damage while some have disease confined to the exocrine glands. Although many biological abnormalities have been described in PSS, their relationships with specific clinical manifestations remain unclear. This creates challenges in finding appropriate ways of measuring the effectiveness of therapies and burden of disease. \n\nUsing detailed clinical data from 600 PSS patients from the UK, we have identified 4 clinical PSS subtypes which differ in characteristics. The data suggests that outcome and response to therapies may differ depending on the patient’s subtype. \n\nThe aim of the project is to develop a PSS specific patient reported questionnaire that captures the disease burden/impact in each of the PSS subtypes. We will work with patients and clinicians across Europe; Sweden, Norway and France to develop the questionnaire and pilot it in established PSS registries. 600 patients in total(150 in each subtype) will be asked to complete the questionnaire at baseline and follow-up.
REC name
East of England - Cambridge East Research Ethics Committee
REC reference
21/EE/0069
Date of REC Opinion
9 Apr 2021
REC opinion
Further Information Favourable Opinion