The 3TR Systemic lupus erythematosus (SLE) studies are two of the six prospective clinical studies foreseen within the 3TR project. The SLE studies comprise on the one hand the “flare biomarker study” that recruits patients at the time of quiescent disease and follows them for 24 months or until they develop a disease flare, with the aim of identifying biomarkers of flare development. On the other hand, the “response biomarker study” recruits patients at the time of active disease and follows them longitudinally with multiple assessments and sampling of biological material for one year. The aim here is to determine biomarkers of response or non-response to standard therapy according to current recommendations.
Following a unique integrative analysis approach, data generated within these trials will be studied across the different 3TR diseases and will be complemented by analysis of academic study collections as well as industry-driven clinical trial data.
Enrolment in the 3TR SLE studies started in January 2022 with the first three patients from the Örebro University Hospital (PI: Associate Professor Ioannis Parodis). The target is to include 1,000 patients in the flare biomarker study and 330 patients in the response biomarker study from more than 20 European centres of excellence in the care of patients with SLE. The 3TR studies are expected to increase the current understanding of the immune mechanisms underlying the different manifestations of the complex inflammatory autoimmune disease SLE. Those are mechanisms preceding flares and mechanisms that are associated with response or non-response to therapies. The ultimate target is personalised therapeutic approaches based on individual molecular portraits.
Similar clinical studies within the 3TR project focusing on patients with rheumatoid arthritis, inflammatory bowel diseases, multiple sclerosis, asthma and chronic obstructive pulmonary disease will be conducted in the future or are already underway.