ELEVATE - (Empower Lupus Erythematosus Patients Via Allowing RemoTe Evaluation)

Study Overview
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Brief Summary
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To explore the potential for use of DxTerity's AIP IFN-1 test as personalized guided care and monitoring module in patients with Systemic lupus erythematosus(SLE) using consented patient health information

Detailed Description
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Explore and demonstrate concordance between self-collected samples and traditional phlebotomist venous draw for DxTerity AIP module and biomarkers like C3, C4, anti dsDNA and CRP in SLE participants with self-reported outcomes and medical record data. The study will collect blood samples and self-reported information for SLE subjects, up to 5000 participants in Phase I, with a subset of 1000 continuing to Phase II with Medical records. Study participants will be recruited using a combination of digital media (including social media, advertising, bloggers, emails). Enrollment and qualification will be done along with consented retrieval of medical records using a study specific mobile app.

Official Title
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ELEVATE - (Empower Lupus Erythematosus Patients Via Allowing RemoTe Evaluation)

Conditions
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Systemic Lupus Erythematosus

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: (PHASE I) Individuals aged 18 years or older. Must reside in United States Have a clinical diagnosis of SLE Willingness to consent to provide electronic medical records (EMR) Provide written informed consent and comply with the study procedures. (PHASE II) Verified diagnosis (Medical records or /and Physician Questionnaire) for SLE Report one or more of the following (record all that apply): Worsening or changes in symptoms or flare Changes in treatment regimen On standard of care treatment On biologics Exclusion Criteria: 1. Participants unable to complete study requirements

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Standard of Care<br>Cohort(1) of the study will collect longitudinal blood samples from participants who are on the standard of care treatment for Systemic lupus erythematosus (SLE) based on Cohort specific inclusion criteria | |
| Biologics<br>Cohort(2) of the study will collect longitudinal blood samples from participants who are on biologics treatment for Systemic lupus erythematosus (SLE) based on Cohort specific inclusion criteria | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concordance between self collected samples and traditional venous draws | Percentage of participants with concordant IFN-1 status as assessed by the DxTerity AIP IFN-1 module, concordance between phlebotomy draw and self-collected blood samples. | 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Longitudinal monitoring | Percentage of participants with correlation between IFN-1 high status and increased flares by SAF36 and medical records. | 36 months |