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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-12-19

Study Completion Date

2025-03-05

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.

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Detailed Description

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Conditions

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Lupus Erythematosus, Systemic

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Group 1

Adult male and female patients with a clinical diagnosis of SLE or incomplete lupus

Decision Support Test

Intervention Type OTHER

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

Interventions

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Decision Support Test

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

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Locations

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