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

Systemic Lupus Erythematosus Clinical Trial

— ELEVATE  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05347992
• Other study ID #: DXT-MCD-AI01
• Status: Active, not recruiting
• Start date: May 3, 2022
• Est. completion date: March 1, 2025

Study information

• Verified date: February 2023
• Source: DxTerity Diagnostics
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 423
• Est. completion date: March 1, 2025
• Est. primary completion date: October 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic
• Systemic Lupus Erythematosus

Locations

Country	Name	City	State
United States	DxTerity Diagnostics, Inc.	Compton	California

Sponsors (1)

Lead Sponsor	Collaborator
DxTerity Diagnostics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	36 months
Secondary	Longitudinal monitoring	Percentage of participants with correlation between IFN-1 high status and increased flares by SAF36 and medical records.	36 months