Study Status: RECRUITING
Recruit Status: RECRUITING
Study Type: OBSERVATIONAL
Official Title: An Open Label Multicenter Study to Assess the Relationship Between Data Obtained With the LuGENE� Multiparameter Transcriptomics Blood Test and Clinical and Standard Laboratory Features of Patients Wi
Brief Summary: This is an open label study to determine the association of the data obtained with LuGENE�, a transcriptomic-based LDT, with standard evaluation of patients diagnosed with SLE, including clinical involvement, SLEDAI score, Physician Global Assessment (PGA) and standard laboratory measures, including ANA, anti-DNA, anti-RNP and complement components C3 and C4, as well as Patient Reported Outcomes capturing pain, fatigue and Health-Related Quality of Life.
The test will be administered on one occasion to patients with a clinical diagnosis of lupus or incomplete lupus and clinical and laboratory features evaluated contemporaneously.
This trial includes a pilot study of approximately 10 subjects from 2-3 sites to assess whether the delivery times of LuGENE� laboratory results do not exceed more than 7 business days.