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

Description

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.

Conditions

Lupus Erythematosus, Systemic

Study Overview

Study Details

Study overview

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.

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)

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

Condition
Lupus Erythematosus, Systemic
Intervention / Treatment

-

Contacts and Locations

Phoenix

Arizona Arthritis & Rheumatology Research, PLLC, Phoenix, Arizona, United States, 85032

Los Angeles

Cedars-Sinai Medical Center, Los Angeles, California, United States, 90048

Santa Monica

Providence St. John's Health Center - Rheumatology, Santa Monica, California, United States, 90404

New Haven

Yale School of Medicine, New Haven, Connecticut, United States, 06519

Chicago

Rush University Medical Center, Chicago, Illinois, United States, 60612

Baltimore

University of Maryland School of Medicine, Baltimore, Maryland, United States, 21201

Rochester

Mayo Clinic, Rochester, Minnesota, United States, 55096

Manhasset

Feinstein Institute for Medical Research, Manhasset, New York, United States, 11030

New York

The Hospital for Special Surgery, New York, New York, United States, 10021

Charlotte

Arthritis and Osteoporosis Consultants of the Carolinas, Charlotte, North Carolina, United States, 28207

Participation Criteria

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.

Eligibility 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
  • 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Ampel BioSolutions, LLC,

Study Record Dates

2025-03-05