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

NCT05347992 | Completed

• 1 other identifier: DXT-MCD-AI01
• Study Type: observational
• Target: 423
• Locations: 1 country
• Sites: 1

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

Conditions

Systemic Lupus Erythematosus

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Longitudinal monitoring

  36 months

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adults diagnosed with SLE

You may qualify if:

• 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

You may not qualify if:

• \. Participants unable to complete study requirements

Sponsors & Collaborators

• DxTerity Diagnostics: lead

Study Sites (1)

DxTerity Diagnostics, Inc.

Compton, California, 90220, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Fingerstick blood

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Robert Terbrueggen, PhD

  DxTerity Diagnostics

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2022
• First Posted: April 27, 2022
• Study Start: May 3, 2022
• Primary Completion: May 25, 2023
• Study Completion: August 17, 2023
• Last Updated: January 7, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)