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

NCT05347992 — Completed, 423 participants, DxTerity Diagnostics

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Registry	NCT05347992, acronym ELEVATE
Status	Completed
Study type	Observational
Enrollment	423 (Actual)
Sponsor	DxTerity Diagnostics (Industry)
Conditions	Systemic Lupus Erythematosus
Dates	start 2022-05-03, primary completion 2023-05-25, completion 2023-08-17, first posted 2022-04-27, last updated 2025-01-07
Locations	1 site in United States

-Summary

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

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+Detailed 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.

+Arms and interventions

Arm	Type	Interventions	Description
Standard of Care			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			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

+Outcome measures

Primary outcomes

Concordance between self collected samples and traditional venous draws [36 months]: 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.

Secondary outcomes

Longitudinal monitoring [36 months]: Percentage of participants with correlation between IFN-1 high status and increased flares by SAF36 and medical records.

+Eligibility

Sex: All, ages: 18 Years to any

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)

Facility	City	Country	Status
DxTerity Diagnostics, Inc.	Compton, California	United States

+Investigators

Robert Terbrueggen, PhD, Principal investigator, DxTerity Diagnostics