Translation of a Diagnostic Test for Lupus Flare Prediction From Bench to Clinic (TOTAL FEEDBACK)

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.

Study Overview

• Status: Unknown
• Conditions: SLE; Lupus Erythematosus; System; Lupus Erythematosus; Lupus Flare

Detailed Description

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.

• Study Type: Observational
• Enrollment (Anticipated): 60

Contacts and Locations

Study Locations

• United States
  • Florida
    • Fort Lauderdale, Florida, United States, 33324
      • Iris Research and Development
  • Maryland
    • Greenbelt, Maryland, United States, 20770
      • Arthritis and Pain Associates of PG County
  • Pennsylvania
    • Duncansville, Pennsylvania, United States, 16635
      • Altoona Center for Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

60 patients with Systemic Lupus Erythematosus will comprise the study population. These patients will satisfy all inclusion/exclusion criteria for study enrollment.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SLEDAI	Systemic Lupus Erythematosus Disease Activity Index - measures the patient's disease activity through clinical and laboratory values	Baseline Physician Visit
SLEDAI	Systemic Lupus Erythematosus Disease Activity Index - measures the patient's disease activity through clinical and laboratory values	Three-month Physician Visit
SLEDAI	Systemic Lupus Erythematosus Disease Activity Index - measures the patient's disease activity through clinical and laboratory values	Six-month Physician Visit

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SF-36	Short Form 36 Questions. General Wellness measurement	Baseline at Physician Visit
SF-36	Short Form 36 Questions. General Wellness measurement	Month One via Preferred Medium
SF-36	Short Form 36 Questions. General Wellness measurement	Month Two via Preferred Medium
SF-36	Short Form 36 Questions. General Wellness measurement	Month Three at Physician Visit
SF-36	Short Form 36 Questions. General Wellness measurement	Month Four via Preferred Medium
SF-36	Short Form 36 Questions. General Wellness measurement	Month Five via Preferred Medium
SF-36	Short Form 36 Questions. General Wellness measurement	Month Six at Physician Visit

Collaborators and Investigators

• Sponsor: Progentec Diagnostics, Inc.
• Collaborators: Oklahoma Center for the Advancement of Science and Technology
• Investigators: Principal Investigator: Eldon Jupe, Ph.D., Progentec Diagnostics, Inc.

Publications and helpful links

General Publications

• Munroe ME, Vista ES, Guthridge JM, Thompson LF, Merrill JT, James JA. Proinflammatory adaptive cytokine and shed tumor necrosis factor receptor levels are elevated preceding systemic lupus erythematosus disease flare. Arthritis Rheumatol. 2014 Jul;66(7):1888-99. doi: 10.1002/art.38573.
• Munroe ME, Vista ES, Merrill JT, Guthridge JM, Roberts VC, James JA. Pathways of impending disease flare in African-American systemic lupus erythematosus patients. J Autoimmun. 2017 Mar;78:70-78. doi: 10.1016/j.jaut.2016.12.005. Epub 2017 Feb 2.

Helpful Links

• Link to Progentec's website

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 31, 2019
• Primary Completion (ANTICIPATED): December 31, 2020
• Study Completion (ANTICIPATED): December 31, 2020

Study Registration Dates

• First Submitted: July 9, 2019
• First Submitted That Met QC Criteria: July 11, 2019
• First Posted (ACTUAL): July 12, 2019

Study Record Updates

• Last Update Posted (ACTUAL): September 16, 2020
• Last Update Submitted That Met QC Criteria: September 14, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: Lupus; SLE; Systemic Lupus Erythematosus; Lupus Flare; Flare Prediction
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Connective Tissue Diseases; Lupus Erythematosus, Systemic
• Other Study ID Numbers: OCAST-OARS AR18-019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No