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

Completed

• Conditions: Systemic Lupus Erythematosus

• Registration Number: NCT05347992
• Lead Sponsor: DxTerity Diagnostics

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 information

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.

Study Timeline

• Study First Submitted: 2022-04-11
• Study First Submitted QC: 2022-04-22
• Study First Posted: 2022-04-27
• Study Start: 2022-05-03
• Primary Completion: 2023-05-25
• Study Completion: 2023-08-17
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-06
• Last Update Posted: 2025-01-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 423

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Longitudinal monitoring	36 months	Percentage of participants with correlation between IFN-1 high status and increased flares by SAF36 and medical records.

Trial Locations

Locations (1)

DxTerity Diagnostics, Inc.; 🇺🇸 Compton, California, United States