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OpenTrials
Completed

NCT Number: NCT05347992

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

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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Key information

Conditions

Systemic Lupus Erythematosus Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Lupus Erythematosus, Systemic Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

DxTerity Diagnostics, Inc.

Compton, California, 90220, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

(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 criteria

  • Participants unable to complete study requirements

Treatment and study plan

Primary outcomes

  1. Concordance between self collected samples and traditional venous draws

    Time frame: 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

  1. Longitudinal monitoring

    Time frame: 36 months

    Percentage of participants with correlation between IFN-1 high status and increased flares by SAF36 and medical records.

Sponsors and collaborators

Lead sponsor

DxTerity Diagnostics

Industry

Registry information

Acronym: ELEVATE

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Apr 27, 2022
Registry last updated
Jan 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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