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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	Yes
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

INCLUSION CRITERIA:

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.

EXCLUSION CRITERIA:

- 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04018222
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Progentec Diagnostics, Inc.
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Eldon Jupe, Ph.D.
Principal Investigator Affiliation	Progentec Diagnostics, Inc.
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry, Other
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	System; Lupus Erythematosus, Lupus Erythematosus, SLE, Lupus Flare
Study Website:	View Trial Website

Additional Details

The purpose of this study is to further validate an algorithm used in a lupus flare-prediction that has been developed. The investigators will be looking at different proteins in the blood that are commonly associated with lupus flares and could warn of the risk of a future flare. Participation in this study will involve three separate visits with a research physician for six months. These will proceed as a baseline visit, a three-month visit, and a six-month visit. During each of these visits the physician assesses the participant's physical condition and take blood samples for both research and medical purposes. Throughout this study, the participant will also complete a series of questionnaires to assess their wellness and day-to-day challenges. After the initial visit, the participant will be contacted to complete a monthly survey that evaluates if there have been any changes in your condition. This survey can be completed either via email, a phone call discussion, or the study's unique research app. Three of these six surveys will be completed during the physician's visit, however, the other three will be completed in the preferred medium. Throughout the six-month period while you are on this study, if at any point the participant experiences a flare, they are encouraged to visit the research physician. During this visit, they will receive a physician's evaluation to ensure your medical condition and collect blood samples for our research at no cost to the participant.

Arms & Interventions

Arms

: Lupus Cases

This cohort of patients will involve individuals with a confirmed medical history of Systemic Lupus Erythematosus. Qualified individuals will satisfy all Inclusion/Exclusion criteria.

: Healthy Controls

This cohort of patients will involve individuals whom do not have a diagnosis of Systemic Lupus Erythematosus or any other rheumatological or auto-immune diseases. Qualified individuals will satisfy all Inclusion/Exclusion criteria.

Interventions

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

IRIS Research and Development, Fort Lauderdale, Florida

Status

Recruiting

Address

IRIS Research and Development

Fort Lauderdale, Florida, 33324

Site Contact

Kathy Perez, M.D.

[email protected]

954-476-2338

Greenbelt, Maryland

Status