Disease Outcomes and Biomarkers across SARDS V1
Research type
Research Study
Full title
Disease Outcomes and Biomarkers across systemic autoimmune rheumatic diseases: An observational study
IRAS ID
301771
Contact name
Anastasia-Vasiliki Madenidou
Contact email
Sponsor organisation
The University of Manchester
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
4 years, 0 months, 0 days
Research summary
Systemic Autoimmune Rheumatic Diseases (SARDs) are a group of multisystem autoimmune disorders with overlapping clinical and serological manifestations, including systemic lupus erythematosus (SLE), Sjögren’s syndrome (pSS), idiopathic inflammatory myopathies (IIM) and systemic sclerosis (SSc). Patients may transition between clinical disease categories over time; some evolve from an undifferentiated connective tissue disease (UCTD) to a specific disease type, whilst others develop an overlap syndrome. The commonality in clinical features and autoantibody profiles between conditions suggests shared molecular pathways, whilst within a single-disease, significant molecular heterogeneity has been described.
This study will take place at Manchester Foundation Trust rheumatology departments (Manchester Royal Infirmary and University Hospital South Manchester). This study aims to recruit 80 patients from across the SARD spectrum of disease who are positive for either the anti-Ro (anti-SSA) and/ or the anti-RNP (anti-U1-snRNP) antibodies. Patients will be reviewed 6 monthly 18 months (total 4 visits). If a patient reports a flare, or progression of their disease to the clinical team, an optional additional ‘ad hoc’ research follow-up will be offered during the same appointment.
The aim of this study is monitor disease activity over time to inform which outcome measures or scores are useful to track disease activity outcomes across multiple diseases. Patients will be invited to complete questionnaires focusing on their symptoms and have objective measures of activity measured by a healthcare professional including disease activity scores, attention using a computer application (‘app’) and saliva and tear flow rates. The secondary aim is to investigate clinical, serological and immune biomarkers common across diseases which can be used to re-stratify patients. We will collect research blood, tear and saliva samples to research novel biomarkers of disease phenotype, and investigate how these change over time. Optional nailfold capillaroscopy and a skin biopsy or skin tapping may also be offered.REC name
West Midlands - South Birmingham Research Ethics Committee
REC reference
21/WM/0235
Date of REC Opinion
29 Nov 2021
REC opinion
Further Information Favourable Opinion