Prediction of Lupus treAtment respoNse Study (PLANS)
Research type
Research Study
Full title
An open label observational study to identify predictors of response to rituximab and mycophenolate in patients with systemic lupus erythematosus including cutaneous or renal manifestations
IRAS ID
198463
Contact name
Ian N Bruce
Contact email
Sponsor organisation
The University of Manchester
Duration of Study in the UK
2 years, 9 months, 14 days
Research summary
Patients with Systemic Lupus Erythematosus (SLE; lupus) differ in the parts of the body affected by their lupus and how well they respond to different therapies. Overall, only 40-60% of patients respond well to each drug and a smaller proportion achieves remission. Poor responders may try several other treatments until their SLE is controlled. The PLANS observational study aims to identify differences in the genes and components of blood, urine and tissues of patients who respond well or less well to two drugs (mycophenolate and rituximab). If we can identify single factors or combinations of factors that predict who will respond well to different drugs, we plan to test the clinical utility of these predictive factors in future proof of concept trials. We aim to take an early view on the potential health economic implications of such tests.\n\n240 patients aged 12 - 80 will be recruited from UK hospital rheumatology clinics. They will have SLE with active skin and/or kidney disease and their hospital physician will already have decided to prescribe mycophenolate or rituximab as part of routine clinical care. All patients will provide blood, urine and clinical data. If they have skin disease, they will have skin biopsies, epidermal sampling and skin photographs. Patients with kidney disease will be already scheduled to have a kidney biopsy as part of their standard care, and an additional kidney sample will be taken at the same time. Patients will also complete questionnaires during their visit or later at home. Each patient will attend up to eight hospital appointments over a one year period for PLANS, with possible additional visits if they have a lupus flare. PLANS visits will take place at the same time as routine clinical appointments. \n\n
REC name
North West - Preston Research Ethics Committee
REC reference
16/NW/0546
Date of REC Opinion
27 Jul 2016
REC opinion
Favourable Opinion