Clinical trial NCT04018222: Translation of a Diagnostic Test for Lupus Flare Prediction From Bench to Clinic
Official title: Translation of a Diagnostic Test for Lupus Flare Prediction From Bench to Clinic
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: System; Lupus Erythematosus
Lupus Erythematosus
SLE
Lupus Flare
Keywords: Systemic Lupus Erythematosus
SLE
Lupus Flare
Flare Prediction
Lupus
Lead sponsor: Progentec Diagnostics, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Oklahoma Center for the Advancement of Science and Technology
First posted: 2019-07-12
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

Brief summary: 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.

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.

Eligibility 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

Primary outcomes:
measure: SLEDAI
timeFrame: Baseline Physician Visit
measure: SLEDAI
timeFrame: Three-month Physician Visit
measure: SLEDAI
timeFrame: Six-month Physician Visit
Secondary outcomes:
measure: SF-36
timeFrame: Baseline at Physician Visit
measure: SF-36
timeFrame: Month One via Preferred Medium
measure: SF-36
timeFrame: Month Two via Preferred Medium
measure: SF-36
timeFrame: Month Three at Physician Visit
measure: SF-36
timeFrame: Month Four via Preferred Medium
measure: SF-36
timeFrame: Month Five via Preferred Medium
measure: SF-36
timeFrame: Month Six at Physician Visit
Other outcomes:
Locations:
city: Fort Lauderdale
country: United States
facility: IRIS Research and Development
state: Florida
city: Greenbelt
country: United States
facility: Arthritis and Pain Associates of PG County
state: Maryland
city: Duncansville
country: United States
facility: Altoona Center For Clinical Research
state: Pennsylvania
Study officials:
affiliation: Progentec Diagnostics, Inc.
name: Eldon Jupe, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.