Participate in Investigator-Initiated Studies

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. 

Eligible Participants:

• 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, kate_york@rhoworld.com, or visit www.autoimmunecovidbooster.org. 

Study’s end recruitment date is: June 2024.
 

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. 

Participant Eligibility:

• 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 rakiesha@projectclio.org or visit www.projectclio.org.
 
Study’s end recruitment date is: TBD – Rolling.

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.

Eligible Participants:

• 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 mmackay@northwell.edu.

Study’s end recruitment date: November 1, 2024.

The Medical University of South Carolina, in partnership with the National Institutes of Health and the Lupus Foundation of America are enrolling for an FDA approved clinical trial to determine if novel stem cell therapy is effective in treating active lupus. The treatment consists of mesenchymal stem/stromal cells (MSCs) that come from umbilical cords.  The cells are made at the Clean Cell Facility at the Medical University of South Carolina. It is believed these cells can correct some of the immune system problems that cause lupus.

There are two parts to this study: Cohort I and Cohort II. During Cohort I, participants will either receive a dose of 1,000,00 stem cells or placebo (i.e., no cells). For Cohort II, participants will either receive a dose of 5,000,000 stem cells or placebo. The treatment is a one-time infusion that takes approximately half an hour.

Participant Eligibility:

• Age 18 to 75.
• Have lupus nephritis and/or lupus without nephritis.
• Have active lupus despite being on immunosuppressive therapy for 3 months for non-renal disease or 6 months of treatment for lupus nephritis.
• Can NOT be on Benlysta, Rituxan, or Saphnelo at screening (must be off medications for 3-6 months prior to participation).
• Located in: California, Georgia, Illinois, New York, North Carolina, Oklahoma, or South Carolina

Participants will receive monetary compensation for participation.

For more information regarding this study, contact Dr. Gary Gilkeson at gilkeson@musc.edu or visit www.medicine.musc.edu.

Study’s end recruitment date is: 07/01/2024.

The Oklahoma Medical Research Foundation: Arthritis and Clinical Immunology Research Program, in partnership with the National Institute of Allergy and Infectious Diseases (NIAID) is recruiting for an interventional Phase-2 study to evaluate the potential effectiveness and to better understand immunologic changes associated with the loss of clinical response after 24 weeks use of Mycophenolate Mofetil (MMF) in patients with SLE. This study will also explore and compare the effectiveness of voclosporin when added to MMF. Participants will be randomized into 4 groups and receive various dosing of MMF: experimental (MMF), placebo for MMF, MMF and placebo for voclosporin, and MMF and voclosporin.
 
Participant Eligibility:

• Age 18 to 60.
• Meet EULAR/ACR criteria for SLE with moderately severe, active, but non-organ threatening disease.
• Must have completed SARS-CoV-2 primary vaccine series and up to date on booster doses according to CDC guidelines at least 14 days prior to initiation of screening.
• Women of childbearing potential must have negative serum pregnancy test at screening.
• Able or willing to use reliable methods of contraception, as outlined in the Mycophenolate REMS brochure for health care providers, from 4 weeks prior to first randomization to 6 weeks after completion of the study. This criterion applies to females of reproductive potential.
• Located in: California, Connecticut, Georgia, Massachusetts, Minnesota, New York, North Carolina, Oklahoma, and Pennsylvania.

Participants will receive monetary compensation for participation.
 
For more information regarding this study, contact Kaitlin McShea at Kaitlin_McShea@rhoworld.com or visit https://clinicaltrials.gov/ct2/show/NCT05306873?term=ALE10&draw=2&rank=1.
 
Study’s end recruitment date is: 01/01/2025.

This research study, conducted by Brandon Biggs, ABD, MS, at Concordia University of Chicago, is dedicated to investigating the relationships between pain, fatigue, and kinesiophobia (fear of movement) and their impact on the engagement in physical activities among individuals living with systemic lupus erythematosus (SLE). The study involves the administration of five comprehensive questionnaires, about demographics, pain levels, fatigue, kinesiophobia, and patterns of physical activity. The completion of these questionnaires is estimated to take approximately 10-12 minutes.

Participant Eligibility:

• Age 18 or older.
• Diagnosed with SLE.
• Not pregnant.
• Not incarcerated.
• Located: 50 contiguous states in United States of America

For more information regarding this study, contact Mr. Brandon Biggs, ABD, MS at Crf_briggsbc@cuchicago.edu or visit cuchicago.qualtrics.com/jfe/form/SV_0oH3xYxt9P3t0Ym.

Study’s end recruitment date is: 07/07/2024