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

NCT04018222 | Unknown

• 1 other identifier: OCAST-OARS AR18-019
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 3

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.

Conditions

System; Lupus Erythematosus; Lupus Erythematosus; SLE; Lupus Flare

Keywords

Systemic Lupus Erythematosus; SLE; Lupus Flare; Flare Prediction; Lupus

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (7)

• SF-36

  Baseline at Physician Visit

• SF-36

  Month One via Preferred Medium

• SF-36

  Month Two via Preferred Medium

• SF-36

  Month Three at Physician Visit

• SF-36

  Month Four via Preferred Medium

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

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

Sponsors & Collaborators

• Progentec Diagnostics, Inc.: lead
• Oklahoma Center for the Advancement of Science and Technology: collaborator

Study Sites (3)

IRIS Research and Development

Fort Lauderdale, Florida, 33324, United States

Location

Arthritis and Pain Associates of PG County

Greenbelt, Maryland, 20770, United States

Location

Altoona Center For Clinical Research

Duncansville, Pennsylvania, 16635, United States

Location

Related Publications (2)

• 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.

  PMID: 24578190 BACKGROUND

• 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.

  PMID: 28162788 BACKGROUND

Related Links

• Link to Progentec's website

Biospecimen

Retention: SAMPLES WITH DNA

Patients will submit blood samples beyond what is required for standard of care treatment of Systemic Lupus Erythematosus. The additional blood samples (6 tubes, approximately 9 or 10 teaspoons of blood) will be used for blood-protein evaluation and DNA extraction. Blood samples are the only biospecimens that will be collected for this study.

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Eldon Jupe, Ph.D.

  Progentec Diagnostics, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2019
• First Posted: July 12, 2019
• Study Start: May 31, 2019
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: September 16, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)