Translation of a Diagnostic Test for Lupus Flare Prediction From Bench to Clinic

Status unconfirmed

Conditions studied: System; Lupus Erythematosus, Lupus Erythematosus, SLE, Lupus Flare

In brief

This study is investigating the development of a diagnostic test intended to predict flares in patients with Systemic Lupus Erythematosus. Over a six-month period, the participant will donate blood samples for researchers to evaluate the types of proteins that are in their blood. During this time the participant will also visit a research physician to undergo a physical exam that will include an evaluation of the disease's level of activity. Questionnaires will be answered too, either via email, phone call, or a research app for android and iPhone devices. During this six-month period, if the participant experiences a lupus flare, they are strongly encouraged to visit the research physician to receive a complimentary medical evaluation.

Key facts

Study ID

NCT04018222

Run by

Progentec Diagnostics, Inc.

People needed

60

Starts

2019-05-31

Expected to finish

2020-12-31

Last updated by the study team

2020-09-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Lupus Patients
• Females or males age 18 or older
• Meet ≥ 4 American College of Rheumatology (ACR) classification criteria for SLE, by medical record review and/or clinical/laboratory assessment OR
• Meet ≥ 4 Systemic Lupus Collaborating Clinic (SLICC) classification for SLE, including at least one clinical and one immunologic criterion, by medical record review and/or clinical/laboratory assessment OR
• Meet SLE classification by SLICC with ANA positivity
• Have a clinical diagnosis of active SLE, per physician assessment
• Have the ability to understand the requirements of the study, provide written informed consent including consent for the use and disclosure of research-related health information, and comply with the study data collection procedures
• Healthy Controls
• Matched to a currently-enrolled patient that is self-reported race, gender, and current age within 5 years.
• No medical history of rheumatological or auto-immune diseases.

You may not qualify if…

• Active diagnosis of Lupus Nephritis
• Inability to comply with the study data collection procedures
• Currently being treated with cyclophosphamide
• Treated with rituximab within the last six months
• Currently being treated with an investigational drug
• Pregnancy

Where it is running

• IRIS Research and Development — Fort Lauderdale, Florida, United States
• Arthritis and Pain Associates of PG County — Greenbelt, Maryland, United States
• Altoona Center For Clinical Research — Duncansville, Pennsylvania, United States

Full record on ClinicalTrials.gov

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