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

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ClinicalTrials.gov Identifier: NCT05845593
Recruitment Status : Recruiting
First Posted : May 6, 2023
Last Update Posted : March 26, 2024
Sponsor:
Information provided by (Responsible Party):
Ampel BioSolutions, LLC

Study Description
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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.

Condition or disease Intervention/treatment
Lupus Erythematosus, Systemic Other: Decision Support Test

Study Design
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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: 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)
Actual Study Start Date : December 19, 2023
Estimated Primary Completion Date : December 10, 2024
Estimated Study Completion Date : March 5, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lupus

Groups and Cohorts
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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).

  2. 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)

  3. 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.


Secondary Outcome Measures :
  1. 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).

  2. 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)

  3. 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))

  4. 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).

  5. 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)

  6. 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))

  7. 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).

  8. 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)

  9. 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))


Other Outcome Measures:
  1. 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


Biospecimen Retention:   Samples With DNA
Future Research Plasma

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05845593


Contacts
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Contact: Claire Dykas 434-296-2675 claire.dykas@ampelbiosolutions.com

Locations
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United States, Arizona
Arizona Arthritis & Rheumatology Research, PLLC Not yet recruiting
Phoenix, Arizona, United States, 85032
Contact: Rebecca Martinez    480-350-7655    rebecca.martinez@azarthritis.com   
Principal Investigator: Hani Rashid         
United States, California
Cedars-Sinai Medical Center Recruiting
Los Angeles, California, United States, 90048
Contact: Carla Martinez    310-360-9197    carla@walleemed.com   
Principal Investigator: Daniel Wallace         
Providence St. John's Health Center - Rheumatology Not yet recruiting
Santa Monica, California, United States, 90404
Contact: Olga Pimienta    310-449-1999    olga.pimienta@providence.org   
Principal Investigator: Orrin Troum         
United States, Connecticut
Yale School of Medicine Not yet recruiting
New Haven, Connecticut, United States, 06519
Contact: Julie Heffernan    203-785-6631    julie.heffernan@yale.edu   
Principal Investigator: Fotios Koumpouras         
United States, Illinois
Rush University Medical Center Not yet recruiting
Chicago, Illinois, United States, 60612
Contact: Joshlean Fair    312-942-8268    Joshlean_Fair@rush.edu   
Principal Investigator: Meenakshi Jolly         
United States, Maryland
University of Maryland School of Medicine Not yet recruiting
Baltimore, Maryland, United States, 21201
Contact: Vinh Nguyen    410-706-6474    BSIATON@SOM.UMARYLAND.EDU   
Principal Investigator: Violeta Rus         
United States, Minnesota
Mayo Clinic Not yet recruiting
Rochester, Minnesota, United States, 55096
Contact: Amber Woltzen    507-422-6732    woltzen.amber@mayo.edu   
Principal Investigator: Uma Thanarajasingam         
United States, New York
Feinstein Institute for Medical Research Not yet recruiting
Manhasset, New York, United States, 11030
Contact: Sanita Kandasami    516-562-2401    skandasami@northwell.edu   
Principal Investigator: Cynthia Aranow         
The Hospital for Special Surgery Not yet recruiting
New York, New York, United States, 10021
Contact: Emily Wu    212-774-2967    wue@hss.edu   
Principal Investigator: Kyriakos Kirou         
United States, North Carolina
Arthritis and Osteoporosis Consultants of the Carolinas Recruiting
Charlotte, North Carolina, United States, 28207
Contact: Audrey Droppelman    704-631-3342 ext 1170    adroppelman@aocc.md   
Principal Investigator: Gordon Lam         
United States, Ohio
Cleveland Clinic Not yet recruiting
Cleveland, Ohio, United States, 44195
Contact: Sandra Hodnick    216-444-6039    hodnics@ccf.org   
Principal Investigator: Emily Littlejohn         
Sponsors and Collaborators
Ampel BioSolutions, LLC
More Information
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Additional Information:

Publications:

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Responsible Party: Ampel BioSolutions, LLC
ClinicalTrials.gov Identifier: NCT05845593    
Other Study ID Numbers: AMP-005
First Posted: May 6, 2023    Key Record Dates
Last Update Posted: March 26, 2024
Last Verified: March 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases