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.
Lupus Erythematosus, Systemic
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.
Relationship Between Data Obtained With the LuGENE® Multiparameter Transcriptomics Blood Test and Clinical and Standard Laboratory Features of Patients With SLE (ReLATE)
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Arizona Arthritis & Rheumatology Research, PLLC, Phoenix, Arizona, United States, 85032
Cedars-Sinai Medical Center, Los Angeles, California, United States, 90048
Providence St. John's Health Center - Rheumatology, Santa Monica, California, United States, 90404
Yale School of Medicine, New Haven, Connecticut, United States, 06519
Rush University Medical Center, Chicago, Illinois, United States, 60612
University of Maryland School of Medicine, Baltimore, Maryland, United States, 21201
Mayo Clinic, Rochester, Minnesota, United States, 55096
Feinstein Institute for Medical Research, Manhasset, New York, United States, 11030
The Hospital for Special Surgery, New York, New York, United States, 10021
Arthritis and Osteoporosis Consultants of the Carolinas, Charlotte, North Carolina, United States, 28207
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
For general information about clinical research, read Learn About Studies.
18 Years to
ALL
No
Ampel BioSolutions, LLC,
2025-03-05