Lupus Erythematosus Clinical Trial
— TOTAL FEEDBACKOfficial title:
Translation of a Diagnostic Test for Lupus Flare Prediction From Bench to Clinic
Verified date | September 2020 |
Source | Progentec Diagnostics, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Active, not recruiting |
Enrollment | 60 |
Est. completion date | December 31, 2020 |
Est. primary completion date | December 31, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Altoona Center For Clinical Research | Duncansville | Pennsylvania |
United States | IRIS Research and Development | Fort Lauderdale | Florida |
United States | Arthritis and Pain Associates of PG County | Greenbelt | Maryland |
Lead Sponsor | Collaborator |
---|---|
Progentec Diagnostics, Inc. | Oklahoma Center for the Advancement of Science and Technology |
United States,
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. — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | SLEDAI | Systemic Lupus Erythematosus Disease Activity Index - measures the patient's disease activity through clinical and laboratory values | Baseline Physician Visit | |
Primary | SLEDAI | Systemic Lupus Erythematosus Disease Activity Index - measures the patient's disease activity through clinical and laboratory values | Three-month Physician Visit | |
Primary | SLEDAI | Systemic Lupus Erythematosus Disease Activity Index - measures the patient's disease activity through clinical and laboratory values | Six-month Physician Visit | |
Secondary | SF-36 | Short Form 36 Questions. General Wellness measurement | Baseline at Physician Visit | |
Secondary | SF-36 | Short Form 36 Questions. General Wellness measurement | Month One via Preferred Medium | |
Secondary | SF-36 | Short Form 36 Questions. General Wellness measurement | Month Two via Preferred Medium | |
Secondary | SF-36 | Short Form 36 Questions. General Wellness measurement | Month Three at Physician Visit | |
Secondary | SF-36 | Short Form 36 Questions. General Wellness measurement | Month Four via Preferred Medium | |
Secondary | SF-36 | Short Form 36 Questions. General Wellness measurement | Month Five via Preferred Medium | |
Secondary | SF-36 | Short Form 36 Questions. General Wellness measurement | Month Six at Physician Visit |
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