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

Lupus Erythematosus, Systemic Clinical Trial

— ReLATE  

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05845593
• Other study ID #: AMP-005
• Status: Recruiting
• Start date: December 19, 2023
• Est. completion date: March 5, 2025

Study information

• Verified date: May 2024
• Source: Ampel BioSolutions, LLC
• Contact: Claire Dykas
• Phone: 434-296-2675
• Email: claire.dykas[@]ampelbiosolutions.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: March 5, 2025
• Est. primary completion date: December 10, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic

Intervention

Other:
• Decision Support Test
LuGENE®, a transcriptomic-based LDT, with standard evaluation of patients diagnosed with SLE

Locations

Country	Name	City	State
United States	University of Maryland School of Medicine	Baltimore	Maryland
United States	Arthritis and Osteoporosis Consultants of the Carolinas	Charlotte	North Carolina
United States	Rush University Medical Center	Chicago	Illinois
United States	Cleveland Clinic	Cleveland	Ohio
United States	Cedars-Sinai Medical Center	Los Angeles	California
United States	Feinstein Institute for Medical Research	Manhasset	New York
United States	Yale School of Medicine	New Haven	Connecticut
United States	The Hospital for Special Surgery	New York	New York
United States	Arizona Arthritis & Rheumatology Research, PLLC	Phoenix	Arizona
United States	Mayo Clinic	Rochester	Minnesota
United States	Providence St. John's Health Center - Rheumatology	Santa Monica	California

Sponsors (1)

Lead Sponsor	Collaborator
Ampel BioSolutions, LLC

Country where clinical trial is conducted

United States, 

References & 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. Erratum In: Genome Med. 2023 Dec 13;15(1):113. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Physician use and satisfaction	Evaluate the patterns of physician use and opinion of value of LuGENE® using a focused questionnaire created for this trial	16 months
Primary	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
Primary	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
Primary	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	LuGENE score correlation to Immune Function with Biomarker endpoint:	The association of the LuGENE Score with Immune function in SLE patients using Biomarkers (Anti-DNA, anti-RNP, Complement C3/C4 levels).	16 months
Secondary	LuGENE score correlation to Clinical Feature endpoint:	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
Secondary	LuGENE score correlation to Quality of Life PROs endpoint:	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
Secondary	LuGENE subset membership correlation to Immune Function with Biomarker endpoint:	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
Secondary	LuGENE subset membership correlation to Clinical Feature endpoint:	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
Secondary	LuGENE subset membership correlation to Quality of Life PROs endpoint:	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
Secondary	LuGENE profile correlation to Immune Function with Biomarker endpoint:	The association of the LuGENE® profile with Immune function in SLE patients using Biomarkers (Anti-DNA, anti-RNP, Complement C3/C4 levels).	16 months
Secondary	LuGENE profile correlation to Clinical Feature endpoint:	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
Secondary	LuGENE profile correlation to Quality of Life PROs endpoint:	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

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