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

DxTerity Diagnostics423 enrolled

Overview

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

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.

Study Type

OBSERVATIONAL

Enrollment

423

Conditions

Systemic Lupus Erythematosus

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: (PHASE I) 1. Individuals aged 18 years or older. 2. Must reside in United States 3. Have a clinical diagnosis of SLE 4. Willingness to consent to provide electronic medical records (EMR) 5. Provide written informed consent and comply with the study procedures. (PHASE II) 1. Verified diagnosis (Medical records or /and Physician Questionnaire) for SLE 2. Report one or more of the following (record all that apply): 1. Worsening or changes in symptoms or flare 2. Changes in treatment regimen 3. On standard of care treatment 4. On biologics Exclusion Criteria: 1\. Participants unable to complete study requirements

Locations (1)

DxTerity Diagnostics, Inc.

Compton, California, United States

Outcomes

Primary Outcomes

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.

Time frame: 36 months

Secondary Outcomes

Longitudinal monitoring

Percentage of participants with correlation between IFN-1 high status and increased flares by SAF36 and medical records.

Time frame: 36 months

Data from ClinicalTrials.gov

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