Biomarkers of treatment response in patients with SLE. V1
Research type
Research Study
Full title
Statistical and biomarker approaches to identifying trajectories of response in patients with SLE: an observational study
IRAS ID
294791
Contact name
Mia Rodziewicz
Contact email
Sponsor organisation
University of Manchester
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
3 years, 4 months, 28 days
Research summary
Systemic lupus erythematous (SLE) or lupus is an incurable disease of the immune system that most commonly affects women of childbearing age. The medications used to treat lupus have not been well studied in lupus and can cause significant side effects. The variety of symptoms and the relative rarity of the disease make it difficult to study and because of this, there has only been one drug licensed to treat it in the past 50 years. The aim of this project is to find markers in the blood and urine to help predict which patients will not respond to standard treatments and those who are more likely to suffer side effects. This will help guide the choice of the best treatments for patients and the development of new drugs in in the future.
This study will take place at Manchester Foundation Trust rheumatology departments (Manchester Royal Infirmary and Wythenshawe Hospital) and aims to recruit 40 lupus patients who require a change in their medication due to active disease. Clinical information relating to lupus activity will be regularly recorded and participants will be invited to complete questionnaires about quality of life, mental wellbeing and attitudes to treatment, at their usual clinic appointments. Patients will be followed for up to 3 years. Additional blood and urine samples will be taken only at times when samples are needed for patients' usual care. The extra samples will be tested for to look for novel markers of how disease activity changes over time.
REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
21/EM/0096
Date of REC Opinion
13 Apr 2021
REC opinion
Favourable Opinion