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System; Lupus ErythematosusTOTAL FEEDBACKNCT04018222

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

An observational study of System; Lupus Erythematosus and Lupus Erythematosus, run by Progentec Diagnostics, Inc. at 3 sites in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
How many people
60 participants
Where
3 sitesUnited States
Study dates
31 May 2019to 31 Dec 2020
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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

Who may be able to join

  • 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
Show all 10Show fewer
  • 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.

Who cannot join

  • 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

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • Altoona Center For Clinical Research

    Duncansville, Pennsylvania, 16635

  • IRIS Research and Development

    Fort Lauderdale, Florida, 33324

  • Arthritis and Pain Associates of PG County

    Greenbelt, Maryland, 20770

Other trials in United States

About this study

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.

Read the 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.

Keywords
Systemic Lupus Erythematosus, SLE, Lupus Flare, Flare Prediction, Lupus
Medical subject headings
Lupus Erythematosus, Systemic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT04018222
Study groupRoleWhat they receive
Lupus CasesThis cohort of patients will involve individuals with a confirmed medical history of Systemic Lupus Erythematosus. Qualified individuals will satisfy all Inclusion/Exclusion criteria.
Healthy ControlsThis 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 being measured

The primary outcome is the main question the study is designed to answer.

  1. SLEDAI

    Systemic Lupus Erythematosus Disease Activity Index - measures the patient's disease activity through clinical and laboratory values

    Measured: Baseline Physician Visit

  2. SLEDAI

    Systemic Lupus Erythematosus Disease Activity Index - measures the patient's disease activity through clinical and laboratory values

    Measured: Three-month Physician Visit

  3. SLEDAI

    Systemic Lupus Erythematosus Disease Activity Index - measures the patient's disease activity through clinical and laboratory values

    Measured: Six-month Physician Visit

Secondary outcomes (7)

  1. SF-36

    Short Form 36 Questions. General Wellness measurement

    Measured: Baseline at Physician Visit

  2. SF-36

    Short Form 36 Questions. General Wellness measurement

    Measured: Month One via Preferred Medium

  3. SF-36

    Short Form 36 Questions. General Wellness measurement

    Measured: Month Two via Preferred Medium

  4. SF-36

    Short Form 36 Questions. General Wellness measurement

    Measured: Month Three at Physician Visit

  5. SF-36

    Short Form 36 Questions. General Wellness measurement

    Measured: Month Four via Preferred Medium

  6. SF-36

    Short Form 36 Questions. General Wellness measurement

    Measured: Month Five via Preferred Medium

  7. SF-36

    Short Form 36 Questions. General Wellness measurement

    Measured: Month Six at Physician Visit

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jul 2019
  2. Study start31 May 2019
  3. Primary completion31 Dec 2020 (estimated)
  4. Study completion31 Dec 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04018222
Sponsor's protocol ID
OCAST-OARS AR18-019
Acronym
TOTAL FEEDBACK
Status last verified
Sep 2020
First submitted
9 Jul 2019
Last updated
16 Sep 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 24578190

  • 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.

    PubMed 28162788

Questions about this trial

What is this clinical trial studying?

An observational study of System; Lupus Erythematosus and Lupus Erythematosus, run by Progentec Diagnostics, Inc. at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 16 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

SLEDAI (time frame: Baseline Physician Visit). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04018222, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2020; AzTrials last refreshed its copy on 26 Oct 2026.

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