ELEVATE - (Empower Lupus Erythematosus Patients Via Allowing RemoTe Evaluation)
NCT ID: NCT05347992
Last Updated: 2025-01-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
423 participants
OBSERVATIONAL
2022-05-03
2023-08-17
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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
No interventions assigned to this group
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
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
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
18 Years
ALL
No
Sponsors
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DxTerity Diagnostics
INDUSTRY
Responsible Party
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Principal Investigators
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Robert Terbrueggen, PhD
Role: PRINCIPAL_INVESTIGATOR
DxTerity Diagnostics
Locations
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DxTerity Diagnostics, Inc.
Compton, California, United States
Countries
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Other Identifiers
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DXT-MCD-AI01
Identifier Type: -
Identifier Source: org_study_id
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