Clinical trial NCT05845593: Relationship Between Data Obtained With the LuGENE® Multiparameter Transcriptomics Blood Test and Clinical and Standard Laboratory Features of Patients With SLE (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)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lupus Erythematosus, Systemic
Lead sponsor: Ampel BioSolutions, LLC
Sponsor class: INDUSTRY
First posted: 2023-05-06
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult male and female patients with a clinical diagnosis of SLE or incomplete lupus

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.


Eligibility 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

Primary outcomes:
measure: LuGENE clinical decision support relative to clinical disease activity
timeFrame: 16 months
measure: LuGENE clinical decision support relative to lab measures
timeFrame: 16 months
measure: LuGENE clinical decision support relative to PROs
timeFrame: 16 months
Secondary outcomes:
measure: LuGENE score correlation to Immune Function with Biomarker endpoint:
timeFrame: 16 months
measure: LuGENE score correlation to Clinical Feature endpoint:
timeFrame: 16 months
measure: LuGENE score correlation to Quality of Life PROs endpoint:
timeFrame: 16 months
measure: LuGENE subset membership correlation to Immune Function with Biomarker endpoint:
timeFrame: 16 months
measure: LuGENE subset membership correlation to Clinical Feature endpoint:
timeFrame: 16 months
measure: LuGENE subset membership correlation to Quality of Life PROs endpoint:
timeFrame: 16 months
measure: LuGENE profile correlation to Immune Function with Biomarker endpoint:
timeFrame: 16 months
measure: LuGENE profile correlation to Clinical Feature endpoint:
timeFrame: 16 months
measure: LuGENE profile correlation to Quality of Life PROs endpoint:
timeFrame: 16 months
Other outcomes:
measure: Physician use and satisfaction
timeFrame: 16 months
Locations:
city: Phoenix
country: United States
facility: Arizona Arthritis & Rheumatology Research, PLLC
state: Arizona
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: Santa Monica
country: United States
facility: Providence St. John's Health Center - Rheumatology
state: California
city: New Haven
country: United States
facility: Yale School of Medicine
state: Connecticut
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Baltimore
country: United States
facility: University of Maryland School of Medicine
state: Maryland
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Manhasset
country: United States
facility: Feinstein Institute for Medical Research
state: New York
city: New York
country: United States
facility: The Hospital for Special Surgery
state: New York
city: Charlotte
country: United States
facility: Arthritis and Osteoporosis Consultants of the Carolinas
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
References:
citation: 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.