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

Study Overview
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Brief Summary
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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.

Official Title
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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)

Conditions
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Lupus Erythematosus, Systemic

Intervention / Treatment
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* Other: Decision Support Test


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female aged at least 18 years old. Capable of giving written consent on an IRB-approved Informed Consent Form prior to any study-specific evaluation Have a clinical diagnosis of SLE determined by the examining physician or a diagnosis of incomplete lupus determined by the examining physician 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: 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 Have received intravenous glucocorticoids at a dosage of ≥ 500 mg daily within the past month Have current drug or alcohol abuse or dependence, or a history of drug or alcohol abuse or dependence within 364 days prior to Baseline Pregnant or lactating. 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 Any condition that in the opinion of the treating physician might interfere with the performance of the LuGENE® test

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1<br>Adult male and female patients with a clinical diagnosis of SLE or incomplete lupus | Other: Decision Support Test<br>* LuGENE®, a transcriptomic-based LDT, with standard evaluation of patients diagnosed with SLE<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LuGENE clinical decision support relative to clinical disease activity | The primary endpoint is to determine the capacity of LuGENE® to support clinical decision making by Health Care Professionals (HCPs) providing care to lupus patients. This will be determined by comparing the data obtained with LuGENE®, a transcriptomic-based LDT, with standard evaluation of patients diagnosed with SLE, including clinical activity (SLEDAI score) Physician Global Assessment (PGA). | 16 months | 
| LuGENE clinical decision support relative to lab measures | The co-primary endpoint is to determine the capacity of LuGENE® to support clinical decision making by Health Care Professionals (HCPs) providing care to lupus patients. This will be determined by comparing the data obtained with LuGENE® with standard laboratory measures of lupus (ANA, anti-DNA, anti-RNP and complement components C3 and C4) | 16 months | 
| LuGENE clinical decision support relative to PROs | The co-primary endpoint is to determine the capacity of LuGENE® to support clinical decision making by Health Care Professionals (HCPs) providing care to lupus patients. This will be determined by comparing the data obtained with LuGENE with standard evaluation of patient reported outcomes using standard instruments capturing pain, fatigue and Health-Related Quality of Life. | 16 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LuGENE score correlation to Immune Function with Biomarker endpoint: | The association of the LuGENE Score with Immune function in SLE patients using Biomarkers (Anti-DNA, anti-RNP, Complement C3/C4 levels). | 16 months | 
| LuGENE score correlation to Clinical Feature endpoint: | The association of the LuGENE Score with Clinical features of SLE using SLEDAI-2K with sub-domains, ACR/EULAR Lupus diagnostic criteria, Physician Global Assessment (PGA) | 16 months | 
| LuGENE score correlation to Quality of Life PROs endpoint: | The association of the LuGENE Score with Quality of Life measures using validated patient PROs (SF-36, fatigue by FACIT-F, Fatigue VAS, Pain VAS, Patient Global Assessment (PtGA)) | 16 months | 
| LuGENE subset membership correlation to Immune Function with Biomarker endpoint: | The association of the LuGENE® determined subset membership with Immune function in SLE patients using Biomarkers (Anti-DNA, anti-RNP, Complement C3/C4 levels). | 16 months | 
| LuGENE subset membership correlation to Clinical Feature endpoint: | The association of the LuGENE® determined subset membership with Clinical features of SLE using SLEDAI-2K with sub-domains, ACR/EULAR Lupus diagnostic criteria, Physician Global Assessment (PGA) | 16 months | 
| LuGENE subset membership correlation to Quality of Life PROs endpoint: | The association of the LuGENE® determined subset membership with Quality of Life measures using validated patient PROs (SF-36, fatigue by FACIT-F, Fatigue VAS, Pain VAS, Patient Global Assessment (PtGA)) | 16 months | 
| LuGENE profile correlation to Immune Function with Biomarker endpoint: | The association of the LuGENE® profile with Immune function in SLE patients using Biomarkers (Anti-DNA, anti-RNP, Complement C3/C4 levels). | 16 months | 
| LuGENE profile correlation to Clinical Feature endpoint: | The association of the LuGENE® profile with Clinical features of SLE using SLEDAI-2K with sub-domains, ACR/EULAR Lupus diagnostic criteria, Physician Global Assessment (PGA) | 16 months | 
| LuGENE profile correlation to Quality of Life PROs endpoint: | The association of the LuGENE® profile with Quality of Life measures using validated patient PROs (SF-36, fatigue by FACIT-F, Fatigue VAS, Pain VAS, Patient Global Assessment (PtGA)) | 16 months |