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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)
NCT05845593 · Ampel BioSolutions, LLC
In plain English
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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)
About this study
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
Study design
Enrollment target: 200 participants
Age groups: adult, older_adult
Timeline
Starts: 2023-12-19
Estimated completion: 2025-03-05
Last updated: 2024-05-03
Interventions
Other: Decision Support Test
Primary outcomes
- • LuGENE clinical decision support relative to clinical disease activity (16 months)
- • LuGENE clinical decision support relative to lab measures (16 months)
- • LuGENE clinical decision support relative to PROs (16 months)
Sponsor
Ampel BioSolutions, LLC · industry
Contacts & investigators
ContactClaire Dykas · contact · claire.dykas@ampelbiosolutions.com · 434-296-2675
All locations (11)
Arizona Arthritis & Rheumatology Research, PLLCNot Yet Recruiting
Phoenix, Arizona, United States
Cedars-Sinai Medical CenterRecruiting
Los Angeles, California, United States
Providence St. John's Health Center - RheumatologyNot Yet Recruiting
Santa Monica, California, United States
Yale School of MedicineNot Yet Recruiting
New Haven, Connecticut, United States
Rush University Medical CenterNot Yet Recruiting
Chicago, Illinois, United States
University of Maryland School of MedicineNot Yet Recruiting
Baltimore, Maryland, United States
Mayo ClinicNot Yet Recruiting
Rochester, Minnesota, United States
Feinstein Institute for Medical ResearchRecruiting
Manhasset, New York, United States
The Hospital for Special SurgeryNot Yet Recruiting
New York, New York, United States
Arthritis and Osteoporosis Consultants of the CarolinasRecruiting
Charlotte, North Carolina, United States
Cleveland ClinicNot Yet Recruiting
Cleveland, Ohio, United States