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RECRUITINGOBSERVATIONAL

Relationship Between Data Obtained With the LuGENE® Multiparameter Transcriptomics Blood Test and Clinical and Standard Laboratory Features of Patients With SLE (ReLATE)

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 With Systemic Lupus Erythematosus (SLE)

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Male or female aged at least 18 years old. 2. Capable of giving written consent on an IRB-approved willing to sign a consent form Form prior to any study-specific evaluation 3. Have a clinical diagnosis of SLE determined by the examining physician or a diagnosis of incomplete lupus determined by the examining physician 4. On a stable SLE treatment regimen consisting of a stable dosage of medications for a period of at least 30 days prior to testing Who Should NOT Join This Trial: 1. Have clinical evidence of significant unstable or uncontrolled acute or chronic diseases not related to SLE (i.e., diabetes, cardiovascular, pulmonary, hematologic, gastrointestinal, neurological, or infectious) which, in the opinion of the treating physician, could confound the results of the study or put the patient at undue risk 2. Have received intravenous glucocorticoids at a dosage of ≥ 500 mg daily within the past month 3. Have current drug or alcohol abuse or dependence, or a history of drug or alcohol abuse or dependence within 364 days prior to Baseline 4. Pregnant or lactating. 5. Recent participation in a clinical trial with an experimental agent in the past 6 weeks, or 5 half-lives of the study drug, whichever is longer 6. Any condition that in the opinion of the treating physician might interfere with the performance of the LuGENE® test Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: 1. Male or female aged at least 18 years old. 2. Capable of giving written consent on an IRB-approved Informed Consent Form prior to any study-specific evaluation 3. Have a clinical diagnosis of SLE determined by the examining physician or a diagnosis of incomplete lupus determined by the examining physician 4. On a stable SLE treatment regimen consisting of a stable dosage of medications for a period of at least 30 days prior to testing Exclusion Criteria: 1. Have clinical evidence of significant unstable or uncontrolled acute or chronic diseases not related to SLE (i.e., diabetes, cardiovascular, pulmonary, hematologic, gastrointestinal, neurological, or infectious) which, in the opinion of the treating physician, could confound the results of the study or put the patient at undue risk 2. Have received intravenous glucocorticoids at a dosage of ≥ 500 mg daily within the past month 3. Have current drug or alcohol abuse or dependence, or a history of drug or alcohol abuse or dependence within 364 days prior to Baseline 4. Pregnant or lactating. 5. Recent participation in a clinical trial with an experimental agent in the past 6 weeks, or 5 half-lives of the study drug, whichever is longer 6. Any condition that in the opinion of the treating physician might interfere with the performance of the LuGENE® test

Treatments Being Tested

OTHER

Decision Support Test

LuGENE®, a transcriptomic-based LDT, with standard evaluation of patients diagnosed with SLE

Locations (11)

Arizona Arthritis & Rheumatology Research, PLLC
Phoenix, Arizona, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
Providence St. John's Health Center - Rheumatology
Santa Monica, California, United States
Yale School of Medicine
New Haven, Connecticut, United States
Rush University Medical Center
Chicago, Illinois, United States
University of Maryland School of Medicine
Baltimore, Maryland, United States
Mayo Clinic
Rochester, Minnesota, United States
Feinstein Institute for Medical Research
Manhasset, New York, United States
The Hospital for Special Surgery
New York, New York, United States
Arthritis and Osteoporosis Consultants of the Carolinas
Charlotte, North Carolina, United States
Cleveland Clinic
Cleveland, Ohio, United States