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

May 1, 2024 updated by: Ampel BioSolutions, LLC

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)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85032
        • Not yet recruiting
        • Arizona Arthritis & Rheumatology Research, PLLC
        • Contact:
        • Principal Investigator:
          • Hani Rashid
    • California
      • Los Angeles, California, United States, 90048
        • Recruiting
        • Cedars-Sinai Medical Center
        • Principal Investigator:
          • Daniel Wallace
        • Contact:
      • Santa Monica, California, United States, 90404
        • Not yet recruiting
        • Providence St. John's Health Center - Rheumatology
        • Principal Investigator:
          • Orrin Troum
        • Contact:
    • Connecticut
      • New Haven, Connecticut, United States, 06519
        • Not yet recruiting
        • Yale School of Medicine
        • Contact:
        • Principal Investigator:
          • Fotios Koumpouras
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Not yet recruiting
        • Rush University Medical Center
        • Principal Investigator:
          • Meenakshi Jolly
        • Contact:
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Not yet recruiting
        • University of Maryland School of Medicine
        • Principal Investigator:
          • Violeta Rus
        • Contact:
    • Minnesota
      • Rochester, Minnesota, United States, 55096
        • Not yet recruiting
        • Mayo Clinic
        • Contact:
        • Principal Investigator:
          • Uma Thanarajasingam
    • New York
      • Manhasset, New York, United States, 11030
        • Recruiting
        • Feinstein Institute for Medical Research
        • Principal Investigator:
          • Cynthia Aranow
        • Contact:
      • New York, New York, United States, 10021
        • Not yet recruiting
        • The Hospital for Special Surgery
        • Contact:
          • Emily Wu
          • Phone Number: 212-774-2967
          • Email: WuE@HSS.edu
        • Principal Investigator:
          • Kyriakos Kirou
    • North Carolina
      • Charlotte, North Carolina, United States, 28207
        • Recruiting
        • Arthritis and Osteoporosis Consultants of the Carolinas
        • Contact:
        • Principal Investigator:
          • Gordon Lam
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Not yet recruiting
        • Cleveland Clinic
        • Contact:
        • Principal Investigator:
          • Emily Littlejohn

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.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
LuGENE clinical decision support relative to clinical disease activity
Time Frame: 16 months
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
Time Frame: 16 months
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
Time Frame: 16 months
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:
Time Frame: 16 months
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:
Time Frame: 16 months
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:
Time Frame: 16 months
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:
Time Frame: 16 months
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:
Time Frame: 16 months
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:
Time Frame: 16 months
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:
Time Frame: 16 months
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:
Time Frame: 16 months
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:
Time Frame: 16 months
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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physician use and satisfaction
Time Frame: 16 months
Evaluate the patterns of physician use and opinion of value of LuGENE® using a focused questionnaire created for this trial
16 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ampel BioSolutions, LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 19, 2023

Primary Completion (Estimated)

December 10, 2024

Study Completion (Estimated)

March 5, 2025

Study Registration Dates

First Submitted

April 4, 2023

First Submitted That Met QC Criteria

April 25, 2023

First Posted (Actual)

May 6, 2023

Study Record Updates

Last Update Posted (Actual)

May 3, 2024

Last Update Submitted That Met QC Criteria

May 1, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AMP-005

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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