Division of Rheumatology

Clinical Trials

1.    Einstein Lupus Cohort 

Investigation into Rheumatic Diseases 

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. Patients ages 18+ are eligible to participate. 

  

2.    METRO (Multi-Ethnic Translational Research Optimization) Lupus Consortium 

The METRO study, is a part of a larger 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 

  

 3.   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 

  

 4.   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. The study 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.  

                                                 

 5.   SABLE Study  

A 5-Year Prospective Observational Registry to Assess Adverse Events of Interest and Effectiveness in Adults with Active, Autoantibody-Positive Systemic Lupus Erythematosus Treated with or without BENLYSTA™ (belimumab) 

The SABLE study is a prospective observational study. It aims to understand, risks, benefits and potential side effects of taking BENLYSTA™ for lupus patients. Patients ages 18+ are eligible to participate. 

Sponsor: Human Genome Sciences, Inc 

  

6.    SPOCS Study  

Prospective Observational cohort of patients with moderate-to-severe SLE to characterize cross-sectional and longitudinal disease activity, treatment patterns and effectiveness, outcomes and comorbidities, healthcare resource utilization, and the impact of SLE on quality of life by type I interferon gene expression 

The SPOCS study is prospective observational cohort study. It aims to describe the relationship between clinical features and healthcare resource utilization as well as health-related quality of life in lupus patients. They are also interested in studying how the genes related to type I interferon may be linked with how lupus starts and develops over time. Patients ages 18+ are eligible to participate.  

Sponsor: AstraZeneca 

  

 7.   Aker Biomarine Study- AMP-004  

A Double-Blind, Placebo-Controlled Randomized, Multicenter Study to Assess Changes in Omega-3 Index in Erythrocytes and Clinical Benefit after 24 Weeks of Daily Consumption of AKBM-3031 (Omega-3 Phospholipids from krill), Followed by a 24 Week Open-Label Extension, in Patients with Systemic Lupus Erythematosus (SLE) 

The main purpose of this study is to investigate whether treatment with krill oil is able to replenish the omega-3 deficiency associated with lupus. They are also investigating whether taking krill oil has positive effects in SLE patients with regards to slowing down the progression of the disease and preventing disease flares. Patients age 18+ are eligible to participate. 

Sponsor: Aker Biomarine 

  

 8.   Janssen Study - Protocol CNTO1275SLE3001; Phase 3  

A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel group Study of Ustekinumab in Subjects with Active Systemic Lupus Erythematosus 

This is a phase 3 trial aiming to evaluate the use of STELARA® in patients with lupus. STELARA® has already been approved for the treatment of plaque psoriasis and Crohn’s Disease. Patients ages 16-75 are eligible to participate.  

Sponsor: Janssen Research & Development, LLC 

 

 For more information please contact:  

Nicole Jordan 

Clinical Research Coordinator 

Division of Rheumatology 

Montefiore Medical Center / Albert Einstein College of Medicine 

njordan@montefiore.org / 718-920-6416 

  

or 

  

Dalynah M. Maldonado 

Clinical Research Coordinator 

Division of Rheumatology 

Montefiore Medical Center / Albert Einstein College of Medicine 

dalmaldo@montefiore.org / 718-430-8583 

Grand Rounds

 

2009-2015 Grand Rounds 

Contact Info

Division of Rheumatology
Albert Einstein College of Medicine
Jack and Pearl Resnick Campus
1300 Morris Park Avenue
Forchheimer Bldg., Rm 701N
Bronx, NY 10461

718.430.2078
Fax: 718.430.8789

For Clinical Appointments Please Call: 1.866.633.8255 

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