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

DxTerity

Status: Completed

Conditions: Systemic Lupus Erythematosus

Study type: Observational

Funder types: Industry

Identifiers

NCT05347992

DXT-MCD-AI01

Details and patient eligibility

About

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

Full description

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.

Enrollment: 423 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

423 participants in 2 patient groups

Standard of Care

Description:

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

Description:

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