Participate in Investigator-Initiated Studies
What are Investigator-Initiated Studies?
These studies are conducted by individual researchers who have control over the study and its design, as opposed to larger studies conducted by companies or institutions that may have an entire research team. Researchers may or may not be funded to conduct these studies. All studies we share must be certified by an ethics review committee, such as an Institutional Review Board (IRB). We do not share study information without proof of approval.
Booster Effects with Autoimmune Treatments in Patients with Poor Response to Initial COVID-19 Vaccine
A new NIH-sponsored multi-location clinical trial will evaluate the benefit of additional COVID-19 vaccine doses in both adult autoimmune disease patients (SLE, RA, MS, SSc and Pemphigus) and pediatric autoimmune disease patients (SLE, JIA, JDM, and POMS) who are on immunosuppressive medications and had an adverse response to initial or booster COVID-19 vaccination.
- Must be taking 1 of the following medications: mycophenolate mofetil or mycophenolic acid, methotrexate, or b-cell depletion therapies.
- Must be willing to receive an additional COVID-19 vaccine dose.
Participants will be followed carefully for up to 48 weeks to monitor any effects the vaccination may have on disease activity.
For more information regarding this study, contact Kate York, firstname.lastname@example.org, or visit www.autoimmunecovidbooster.org.
Study’s end recruitment date is: June 2024.
TCR Pathfinder: Sequencing a Dynamic Lymphocyte Repertoire in Autoimmunity during Pregnancy (Project CLIO)
Project Clio aims to better understand pregnancy-related immune system changes to help make advancements for disease modifying therapies. Participants of this study will give a blood sample before becoming pregnant. Participants who do become pregnant will give more blood samples during the first, second, and third trimester. A final blood sample will be collected during a postpartum visit.
Project Clio stands to provide the greatest assistance to those who are planning to become pregnant and for all people with autoimmune disorders. The findings from the research will help to provide more knowledge on the impact of autoimmune diseases in pregnant individuals.
- Age 18 years (or older)
- Currently pregnant or planning to become pregnant.
- Diagnosed with non-nephrotic SLE or Multiple Sclerosis
- Located in: Connecticut, Massachusetts, New Hampshire, Vermont, and Rhode Island.
Participants who complete the study will have sequences of their immune cells (B and T cells) made available to them, potentially allowing for future personalized medical treatments. Processed data will be kept in two separate online data systems; one with unidentifiable data which will be publicly available and another with identifiable data which will only be available by study participants.
Participants will receive monetary compensation for participation.
For more information regarding this study, contact Rakiesha Gay at email@example.com or visit www.projectclio.org.
Study’s end recruitment date is: TBD – Rolling.
Novel Phase 2 double-blind, randomized, controlled clinical trial to evaluate the efficacy of centrally acting, non-toxic ACE inhibition in cognitive impairment associated with SLE
Problems with memory and concentration (cognitive problems) are common in lupus. Cognitive problems can be caused by things like depression, fatigue, medication, and infections. However, previous studies that have been done in animal models of lupus and in lupus patients suggest that inflammation due to lupus can affect the brain directly.
The Feinstein Institutes for Medical Research, Division of Autoimmune, Musculoskeletal and Hematopoietic Diseases is conducting a novel phase 2 double-blind, randomized, controlled clinical trial to evaluate the efficacy of centrally acting, non-toxic ACE inhibition in cognitive impairment associated with SLE.
This research study will test the effects of a centrally acting ACE inhibitor, named lisinopril, on resting metabolism in the brain and on cognitive function. Participants will take Lisinopril or Benazepril by oral administration daily, based on titration. The investigators will see if Lisinopril will decrease resting metabolism in the brain and improve cognitive function (memory and concentration) compared to a non-centrally acting ACE inhibitor called benazepril. Imaging (PET Scan) will be conducted at baseline and 12-months.
- Must be located in New York.
- Must be able to understand and provide informed consent.
- Must be between 18 and 65 years of age.
- Must have stable disease activity and medication doses for 4 weeks prior to screening (stable disease activity is defined as no increase in disease activity requiring an increase or addition of immunosuppressive medications).
Compensation is available for participants.
For more information regarding this study, contact Dr. Meggan MacKay at firstname.lastname@example.org.
Study’s end recruitment date: November 1, 2024.
If you are a researcher interested in sharing your study information, please submit inquires with study details, a signed copy of IRB approval on institutional letterhead, and the subject line "Investigator Initiated Studies Posting Request" via e-mail to email@example.com. The Lupus Foundation of America reviews and approves all investigator-initiated studies prior to posting on our website.