Clinical Trials

The Einstein Lupus Cohort is a longitudinal cohort started by the Division of Rheumatology in 2002. This study aims to investigate the role of biological markers in the risk of disease progression. We want to learn about genetic characteristics that may be involved in the risk of developing lupus and their contribution to the severity of the disease. Our goal is to learn how to treat patients with better results and less risk.

The METRO study, is a part of a larger Accelerating Medicines Partnership (AMP) collaboration, working together to understand lupus and the involvement of lupus in the kidneys (lupus nephritis). The goal of the AMP collaboration is to develop new diagnostic tests and therapeutic options for patients. Patients ages 18+ are eligible to participate. 
Sponsor: NIH-AMP (Accelerating Medicines Partnership) Initiative

The purpose of this study is to examine the gene expression profiles in healthy kidney tissue that was collected from healthy subjects. The interplay between the various cell types in the healthy, not inflamed kidney tissue will inform us on the baseline gene expression profiles. Since healthy subjects cannot be asked to undergo a kidney biopsy, tissue is obtained from healthy kidney donors at the time of the kidney transplant.  
Sponsor: NIH-AMP (Accelerating Medicines Partnership) Initiative

The Consortium of Rheumatology Researchers of North America, Inc(the Corrona Organization)  
The CORRONA Rheumatoid Arthritis (RA) Registry is a prospective, multi-center, longitudinal, observational study that collects data from RA patients. Thestudy collects and documents utilization patterns, effectiveness, and safety of DMARDs (Disease Modifying Anti-Rheumatic Drugs), biologic agents and any other treatments currently used in the management of RA. Information is maintained in the CORRONA RA Database. 
Sponsor: Consortium of Rheumatology Researchers of North America, Inc.

The SPOCS study is prospective observational cohort studyof patients with moderate-severe lupus. It aims to describe the relationship between clinical features and healthcare resource utilization as well as health-related quality of life in lupus patients. It also explores how the genes related to type I interferon may be linked with how lupus starts and develops over time. 
Sponsor: AstraZeneca

Omega-3 fatty acids are known to be immunomodulatory, and lupus patients have been found to have lower than normal levels of omega-3 fatty acids. The purpose of this study is to examine the benefits of supplemental krill oil, a rich source of omega-3 fattyacids, in reducing disease activity in lupus patients. 
Sponsor: Aker Biomarine

Study of Itolizumab in Subjects with Systemic Lupus Erythematosus With or Without Active Lupus Nephritis
T cells are important in the early inflammatory process, and have been shown to play a role in localizing lupus manifestations to specific organs, such as the kidneys and skin. Itolizumabis a monoclonal antibody that targets T cellsand prevents their activation, without decreasing their overall level. It is already used internationally for the treatment of psoriasis, and has recently been shown to be effective in controlling lupus kidney diseasein animal models. This study aims to characterize the safety and tolerability of Itolizumab in lupus patients–the first step in the process of making this medication available for the treatment of Lupus. 
Sponsor: Equillium, Inc.

This is a 5-year prospective observational registry aimedto collect information regarding the side effects and effectiveness of BENLYSTA (belimumab) when given with other lupus medicines to adults with active systemic lupus erythematosus.

For more information please contact: 
Nicole Jordan
Clinical Research Coordinator
Phone: 718-920-6416
Email: njordan@montefiore.org