Relationship Between Data Obtained With the LuGENE® Multiparameter Transcriptomics Blood Test and Clinical and Standard Laboratory Features of Patients With SLE (ReLATE)
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)
1 other identifier
observational
200
1 country
11
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2023
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 4, 2023
CompletedFirst Posted
Study publicly available on registry
May 6, 2023
CompletedStudy Start
First participant enrolled
December 19, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 10, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
March 5, 2025
CompletedMay 3, 2024
May 1, 2024
12 months
April 4, 2023
May 1, 2024
Conditions
Outcome Measures
Primary Outcomes (3)
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 Outcomes (9)
LuGENE score correlation to Immune Function with Biomarker endpoint:
16 months
LuGENE score correlation to Clinical Feature endpoint:
16 months
LuGENE score correlation to Quality of Life PROs endpoint:
16 months
LuGENE subset membership correlation to Immune Function with Biomarker endpoint:
16 months
LuGENE subset membership correlation to Clinical Feature endpoint:
16 months
- +4 more secondary outcomes
Other Outcomes (1)
Physician use and satisfaction
16 months
Study Arms (1)
Group 1
Adult male and female patients with a clinical diagnosis of SLE or incomplete lupus
Interventions
LuGENE®, a transcriptomic-based LDT, with standard evaluation of patients diagnosed with SLE
Eligibility Criteria
Adult male and female patients with a clinical diagnosis of SLE or incomplete lupus
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (11)
Arizona Arthritis & Rheumatology Research, PLLC
Phoenix, Arizona, 85032, United States
Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
Providence St. John's Health Center - Rheumatology
Santa Monica, California, 90404, United States
Yale School of Medicine
New Haven, Connecticut, 06519, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
University of Maryland School of Medicine
Baltimore, Maryland, 21201, United States
Mayo Clinic
Rochester, Minnesota, 55096, United States
Feinstein Institute for Medical Research
Manhasset, New York, 11030, United States
The Hospital for Special Surgery
New York, New York, 10021, United States
Arthritis and Osteoporosis Consultants of the Carolinas
Charlotte, North Carolina, 28207, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
Related Publications (1)
Hubbard EL, Bachali P, Kingsmore KM, He Y, Catalina MD, Grammer AC, Lipsky PE. Analysis of transcriptomic features reveals molecular endotypes of SLE with clinical implications. Genome Med. 2023 Oct 16;15(1):84. doi: 10.1186/s13073-023-01237-9.
PMID: 37845772BACKGROUND
Related Links
Biospecimen
Future Research Plasma
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 4, 2023
First Posted
May 6, 2023
Study Start
December 19, 2023
Primary Completion
December 10, 2024
Study Completion
March 5, 2025
Last Updated
May 3, 2024
Record last verified: 2024-05
Data Sharing
- IPD Sharing
- Will not share