Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04018222
Other study ID # OCAST-OARS AR18-019
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date May 31, 2019
Est. completion date December 31, 2020

Study information

Verified date September 2020
Source Progentec Diagnostics, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

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

Study Design


Locations

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

Sponsors (2)

Lead Sponsor Collaborator
Progentec Diagnostics, Inc. Oklahoma Center for the Advancement of Science and Technology

Country where clinical trial is conducted

United States, 

References & 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. — 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

Outcome

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
See also
  Status Clinical Trial Phase
Recruiting NCT03543839 - Trial of Belimumab in Early Lupus Phase 4
Terminated NCT02080195 - Nonmyeloablative Conditioning and Transplantation for Patients With Refractory Systemic Lupus Erythematosus (SLE) Phase 1/Phase 2
Completed NCT03098823 - A Crossover Study to Compare RAYOS to IR Prednisone to Improve Fatigue and Morning Symptoms for SLE Phase 4
Recruiting NCT03562065 - Treatment of Refractory Systemic Lupus Erythematosus by Allogeneic Mesenchymal Stem Cells Derived From the Umbilical Cord Phase 1/Phase 2
Recruiting NCT05545839 - Transition to Adulthood Through Coaching and Empowerment in Rheumatology N/A
Completed NCT05098600 - The Epidemiology, Management and Comorbidities in Alopecia Areata in Czech Republic
Completed NCT04128579 - Study of EQ001 (Itolizumab) in Systemic Lupus Erythematosus With or Without Active Proliferative Nephritis Phase 1
Recruiting NCT06161363 - Description of Compliance With Hydroxychloroquine Treatment in Patients With Systemic Lupus Erythematosus
Completed NCT03421184 - Dietary Phytoestrogens as Risk Factors for Systemic Lupus Erythematosus N/A
Not yet recruiting NCT02891213 - Study of the Role of Soluble Forms of RAGE (sRAGE/esRAGE) as Diagnostic and Prognostic Biomarkers of Systemic Lupus Erythematosus. N/A
Completed NCT01686555 - A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of ABT-199 in Female Patients With Systemic Lupus Erythematosus (SLE) Phase 1
Completed NCT02747277 - Analysis of B Cells From Autoimmune Individuals
Not yet recruiting NCT06426316 - The Role of Cytokines and Regulatory T Lymphocytes in Migraine Pathophysiology. N/A
Recruiting NCT04213690 - A Pilot Study to Explore the Role of Gut Flora in Lupus
Recruiting NCT03913754 - Psycho-social Consequences of Systemic Lupus Erythematosus
Recruiting NCT06072287 - The Living With a Long-Term Condition Study
Completed NCT02455089 - Prognosis Assessment of the Increase of GADD34 Gene Expression for Patient Suffering From Systemic Lupus Erythematosus N/A
Completed NCT04089930 - Long-term Immunogenicity of a Live Herpes Zoster Vaccine in Systemic Lupus Erythematosus (SLE) Patients
Completed NCT05945784 - Exploring Accessible Beauty for Individuals With Upper Extremity Deficits
Completed NCT03253666 - Nurses' Health Study and Health Professionals Follow-Up Study (Dermatological Component)

External Links