PROACTIVE™ Study Overview

What is the PROACTIVE™ study?

Progentec’s PROACTIVE™ study (“Study”) stands for “Persons At Risk Of Lupus - A Novel Approach To Classify Those At Risk of Lupus Using Innovative Virtual + Digital Engagement Models.” This research study applies Progentec’s virtual and digital technologies along with proprietary immunological profiling to attempt and classify your autoimmune condition as lupus.

Why do I qualify for this Study?

Your score on the Connective Tissue Disease Screening Questionnaire (CSQ) (www.autoimmuneornot.com) indicates that you are at “probable” or “possible” risk of being classified with lupus. Based on this result, you may qualify for enrollment in the Study.

What are the key requirements to be recruited for the Study?

The Study has a number of requirements for inclusion and exclusion of participants. Broadly, these consist of age (between 18 & 45), Pregnancy Status (not pregnant at the time) and willingness to abide by other requirements of the Study. You need to be a resident of the United States and not residing in Hawaii, Alaska or Puerto Rico. Additionally, participants may be disqualified if the evaluation of Medical Records by a PCP/Nurse Practitioner indicates that the participant is not eligible.

How can I take the Study Qualification Screener?

The Study Qualification Screener is readily available to candidates on this site once the Connective Tissue Disease Screening Questionnaire (CSQ) has been completed. Please visit www.autoimmuneornot.com to complete the CSQ and find out if you qualify.

Will this be covered by my insurance, or how much will this cost out of pocket?

All Study evaluations, medical testing, wearable and app technology required by the study will be provided at no cost to you or your insurance. No additional compensation will be paid to you for participation in the study.

What are my responsibilities as a Study participant?

Responsibilities include consenting to the Study and being actively engaged in the Study for the entire duration, providing contact information for your current provider - the Study findings will be shared with them, and gathering medical records from the providers seen by you during the last 12 months and make them available to the Study within a stipulated time.

What do I get from participating in this study besides a potential lupus classification? If anything else, when do I receive it?

Progentec will provide free access to their Mobile App and Withings ScanWatch wearable device once you have met all Inclusion Criteria.

What happens once I have met all Inclusion Criteria? 

The study clinician will review your medical records to confirm that you meet all Inclusion Criteria and have not been previously diagnosed with lupus. If criteria are met, you will enter the Lupus Classification Phase of the study.

Is there somewhere that I can check my status?

Throughout the Study process the clinical study coordinator will provide email updates and/or SMS for required next steps, as well as for updated status checks.

How will the study clinicians draw blood and take required samples?

Study clinicians will order routine lab tests (if not already available in the medical records), as well as blood and other samples will be collected for study biomarker analyses. There will not be any in-person visits to clinics and samples for the medical tests will be collected using mobile services in most cases, unless such services are not available in your area.

How will the study clinicians complete their evaluations?

There will be three levels of evaluation completed by study clinicians and all will be conducted via a virtual telehealth session with you.

When do I find out if I have received a lupus classification or not?

A final study report summary will be generated following the completion of all three levels of these evaluations. This summary report will be made available to your primary healthcare provider and will include final evaluation by physicians including a classification in cases where such a determination is possible in their opinion.

What happens once I have received my final comprehensive report?

You will have an option to enter into the Long Term Follow Up Phase of the PROACTIVE Study, which will include follow-up monitoring (including tele-health sessions, use of our App & Smart watch) for a period of up to six (6) years to study disease progression, during which you will be requested to provide continued access to medical records, and to provide blood and other samples annually for the period.

What resources will be made available to me once I have completed the study?

You will have access to our health literacy related programs available through the LupusCorner platforms, including a weekly newsletter, series of podcasts, access through all social media platforms (Facebook, Instagram, Twitter, Youtube), and the LupusCorner website that includes weekly lupus articles.

Additionally, Progentec will assist those participants who need care from a rheumatologist but are not able to have access to one, by helping them with a list of providers with tele-health services to support them.

If you have a rheumatologist and that physician advises active monitoring, Progentec will work with the rheumatologist to offer our remote patient monitoring services (aiSLE MGMT). aiSLE MGMT is an advanced patient monitoring service that employs health coaching, digital monitoring as well as biomarker technologies.

Progentec also plans to provide our Newsletter for the newly classified, that will offer weekly information beneficial to their lupus journey (tips and tricks, important lupus news updates, health and nutrition content, and more).

As you navigate through your transition, you will also be able to participate in periodic remote sessions hosted by lupus experts, rheumatologists, and health coaches. These will include open conversation regarding lupus topics, as well as a Q&A session for group members.