Status:

COMPLETED

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

Lead Sponsor:

DxTerity Diagnostics

Conditions:

Systemic Lupus Erythematosus

Eligibility:

All Genders

18+ years

Brief 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 inform...

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 w...

Eligibility Criteria

Inclusion

  • (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

  • 1\. Participants unable to complete study requirements

Key Trial Info

Start Date :

May 3 2022

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

August 17 2023

Estimated Enrollment :

423 Patients enrolled

Trial Details

Trial ID

NCT05347992

Start Date

May 3 2022

End Date

August 17 2023

Last Update

January 7 2025

Active Locations (1)

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1

DxTerity Diagnostics, Inc.

Compton, California, United States, 90220