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)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 11
- 主要终点
- LuGENE clinical decision support relative to lab measures
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female aged at least 18 years old.
- •Capable of giving written consent on an IRB-approved Informed Consent Form prior to any study-specific evaluation
- •Have a clinical diagnosis of SLE determined by the examining physician or a diagnosis of incomplete lupus determined by the examining physician
- •On a stable SLE treatment regimen consisting of a stable dosage of medications for a period of at least 30 days prior to testing
排除标准
- •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
- •Have received intravenous glucocorticoids at a dosage of ≥ 500 mg daily within the past month
- •Have current drug or alcohol abuse or dependence, or a history of drug or alcohol abuse or dependence within 364 days prior to Baseline
- •Pregnant or lactating.
- •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
- •Any condition that in the opinion of the treating physician might interfere with the performance of the LuGENE® test
结局指标
主要结局
LuGENE clinical decision support relative to lab measures
时间窗: 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)
LuGENE clinical decision support relative to PROs
时间窗: 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.
LuGENE clinical decision support relative to clinical disease activity
时间窗: 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).
次要结局
- LuGENE score correlation to Clinical Feature endpoint:(16 months)
- LuGENE profile correlation to Clinical Feature endpoint:(16 months)
- LuGENE score correlation to Quality of Life PROs endpoint:(16 months)
- LuGENE subset membership correlation to Immune Function with Biomarker endpoint:(16 months)
- LuGENE score correlation to Immune Function with Biomarker endpoint:(16 months)
- LuGENE subset membership correlation to Clinical Feature endpoint:(16 months)
- LuGENE subset membership correlation to Quality of Life PROs endpoint:(16 months)
- LuGENE profile correlation to Immune Function with Biomarker endpoint:(16 months)
- LuGENE profile correlation to Quality of Life PROs endpoint:(16 months)