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

Last updated: May 1, 2024
Sponsor: Ampel BioSolutions, LLC
Overall Status: Active - Recruiting

Phase

N/A

Condition

Lupus

Cutaneous Lupus Erythematosus

Systemic Lupus Erythematosus

Treatment

Decision Support Test

Clinical Study ID

NCT05845593
AMP-005
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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 toany study-specific evaluation
  3. Have a clinical diagnosis of SLE determined by the examining physician or a diagnosisof incomplete lupus determined by the examining physician
  4. On a stable SLE treatment regimen consisting of a stable dosage of medications for aperiod of at least 30 days prior to testing

Exclusion

Exclusion Criteria:

  1. Have clinical evidence of significant unstable or uncontrolled acute or chronicdiseases not related to SLE (i.e., diabetes, cardiovascular, pulmonary, hematologic,gastrointestinal, neurological, or infectious) which, in the opinion of the treatingphysician, 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 thepast month
  3. Have current drug or alcohol abuse or dependence, or a history of drug or alcoholabuse 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 6weeks, 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 theperformance of the LuGENE® test

Study Design

Total Participants: 200
Treatment Group(s): 1
Primary Treatment: Decision Support Test
Phase:
Study Start date:
December 19, 2023
Estimated Completion Date:
March 05, 2025

Connect with a study center

  • Arizona Arthritis & Rheumatology Research, PLLC

    Phoenix, Arizona 85032
    United States

    Site Not Available

  • Cedars-Sinai Medical Center

    Los Angeles, California 90048
    United States

    Active - Recruiting

  • Providence St. John's Health Center - Rheumatology

    Santa Monica, California 90404
    United States

    Site Not Available

  • Yale School of Medicine

    New Haven, Connecticut 06519
    United States

    Site Not Available

  • Rush University Medical Center

    Chicago, Illinois 60612
    United States

    Site Not Available

  • University of Maryland School of Medicine

    Baltimore, Maryland 21201
    United States

    Site Not Available

  • UMASS Memorial Medical Center-Memorial Campus

    Worcester, Massachusetts 01605
    United States

    Site Not Available

  • Mayo Clinic

    Rochester, Minnesota 55096
    United States

    Site Not Available

  • Feinstein Institute for Medical Research

    Manhasset, New York 11030
    United States

    Active - Recruiting

  • The Hospital for Special Surgery

    New York, New York 10021
    United States

    Site Not Available

  • Arthritis and Osteoporosis Consultants of the Carolinas

    Charlotte, North Carolina 28207
    United States

    Active - Recruiting

  • Cleveland Clinic

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • Temple University

    Philadelphia, Pennsylvania 19140
    United States

    Site Not Available

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