Clinical Trials Our research faculty are at the forefront of the efforts to explore and investigate new diagnostic and classification methods, promising biomarkers to monitor disease activity, and exciting new therapeutics to provide our patients with individualized, cutting-edge diagnostic and treatment options. To that end, we are actively recruiting interested patients to disease registries, as well as clinical and pharmaceutical trials. Einstein Lupus Cohort 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. METRO (Multi-Ethnic Translational Research Optimization) Lupus Consortium 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 Single-Cell RNA Sequencing in Kidney and Skin Biopsies from Living Donor Kidney Transplant Grafts 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 CORRONA RA Registry 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. Systemic Lupus Erythematosus (SLE) Prospective Observational Cohort Study (SPOCS) 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 Replacement with Krill Oil in Disease Management of SLE 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 EQUALISE Study 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. Safety and Effectiveness of Belimumab in Systemic Lupus Erythematosus(SABLE) 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. Sponsor: Human Genome Sciences, Inc For more information please contact: Nicole Jordan Clinical Research Coordinator Email: njordan@montefiore.org Phone: (718) 920-6416 The Community Health Worker Lupus Clinical Trials Training Program (LuCTT) The Community Health Worker Lupus Clinical Trials Training Program (LuCTT) aims to increase minority patient participation in clinical trials by engaging community health workers to improve health literacy, explain how clinical trials work and address issues of mistrust in the medical system. Sponsor: Office of Minority Health For more information please contact: Dr. Irene Blanco Principal Investigator Email: irene.blanco@einsteinmed.org For more information please contact: Md Hussain, MBBS Clinical Research Coordinator mhussain@montefiore.org (718) 920-6416
