3TR SLE
Research type
Research Study
Full title
3TR - Taxonomy, Treatment, Targets and Remission Identification of the Molecular Mechanisms of non-response to Treatments, Relapses and Remission in Autoimmune, Inflammatory, and Allergic Conditions SLE Study
IRAS ID
317894
Contact name
Ian Bruce
Contact email
Sponsor organisation
The University of Manchester
Duration of Study in the UK
3 years, 2 months, 31 days
Research summary
A large proportion of lupus patients respond inefficiently or do not respond to therapy given to reduce the degree of inflammation and prevent the accumulation of irreversible organ damage. The disease is quite heterogeneous which means different between individuals in terms of which organs are involved and its severity. This is one of the major reasons why different individuals respond differently to different medications. With this background, the objective with the 3TR SLE study is to identify mechanisms causing disease, understand the causes of this heterogeneity and the mechanisms of response or non-response to therapies, understand how this heterogeneity relates to accumulation of tissue damage and predict when and why a patient will develop a flare. This will help us prevent flares and accumulation of irreversible organ damage, as well as determine which is the right treatment for each patient at the time of a flare. The planned study consists of two stages. In the first stage, lupus patients with quiescent disease will be observed during 24 months. This stage is known as T-1. Patients with lupus will be sampled for blood, urine, saliva and stools. When a patient from T-1 flares, or when a new flaring case appears, the individual will be included in the longitudinal observational study (T-2) following standard of care for 6, 12, 24 and 52 weeks, times when the patient will be sampled for blood, urine, saliva, and stools. If a patient does not respond to treatment by week 52 (early termination), new standard-of-care therapy will be provided and followed 3 times, week 26 and 52. Patient recruitments will be undertaken in Manchester Royal Infirmary (University of Manchester), University College London Hospitals (University College London), and Cambridge University Hospitals (University of Cambridge).
REC name
North West - Liverpool Central Research Ethics Committee
REC reference
23/NW/0174
Date of REC Opinion
20 Jun 2023
REC opinion
Further Information Favourable Opinion