Division of Rheumatology

Clinical Trials

1. Einstein Lupus Cohort: Investigations into Rheumatic Diseases
A longitudinal cohort started in the Division of Rheumatology in 2002. Its main goal is to investigate elements in the blood, urine, stool and cerebral spinal fluid, joint fluid and tissue of Lupus and other rheumatologic patients and to assess their roles in causing and /or affecting the disease. Particularly looking to identify markers and to use these markers to eventually learn how to treat patients with better results and less risk.
Blood and urine samples are collected at each patient visit and immediately taken to the Einstein Biorepository where the samples are process and stored. 

2. CORRONA: THE CONSORTIUM OF RHEUMATOLOGY RESEARCHERS OF NORTH AMERICA, INC. (The CORRONA Organization)- The CORRONA RA registry
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 gathered from the CORRONA RA registry is maintained in a comprehensive database (the CORRONA RA Database).

3. CLASS : Complement Activation In Lupus Spectrum
The primary objective of the study is to demonstrate that subjects with SLE and probable SLE have similar activation of their complement system as determined by looking at positive CB-CAPs (elevated C4d on erythrocytes and/or B cells). The objective of this study is also to demonstrate that CB-CAPs can distinguish probable SLE from a control group of subjects with other rheumatic diseases. The study seeks to enroll patients with probable SLE, SLE, primary Sjorgen’s, and other rheumatic diseases
Sponsor: Exagen Diagnostics, Inc.

4. SABLE: 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 objective of the SABLE study is to evaluate the incidence of adverse events of special interest (AESI) over 5 years in adults with active autoantibody-positive systemic lupus erythematosus (SLE) who are treated with or without BENLYSTA:
Sponsor: Human Genome Science

5. AMP/ METRO STUDY- Accelerating Medicines Partnership/ METRO (Multi-Ethnic Translational Research Optimization) Lupus Consortium.
The AMP RA/Lupus Network is a collaborative group composed of leading scientists from all over the United States and internationally. The Network is conducting systems-level studies to understand the gene expression and signaling pathways in tissues from affected end organs, including synovium (the tissue that lines joints) for Rheumatoid Arthritis (RA), kidney and skin for Lupus, and blood cells. Our site the METRO Lupus Cohort will seek to develop, standardize and validate advanced technologies to identify critical signaling pathways in tissues (renal and skin), blood cells and urine in Lupus Nephritis patients. Patients who are scheduled to have a standard of care renal biopsy are approached for consenting a piece of the kidney tissue and skin tissue for research.

6. 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 in identical fashion from healthy subjects as the biopsy procedure for lupus nephritis patients. 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.

7. PREDICTRA: A Phase 4 Trial Assessing the Impact of Residual Inflammation Detected via Imaging Techniques, Drug Levels and Patient Characteristics on the Outcome of Dose Tapering of Adalimumab in Clinical Remission Rheumatoid Arthritis (RA) Subjects (PREDICTRA).
The primary objective is to investigate the association between residual disease activity at Baseline as detected by magnetic resonance imaging (MRI) and the occurrence of flares in RA subjects randomized to an adalimumab dose tapering regimen controlled by adalimumab withdrawal.
Sponsor: AbbVie (Primary)

8. GP17-302 -A randomized double-blind parallel-group multicenter study to demonstrate similar efficacy and to compare safety and immunogenicity of GP2017 and Humira® in patients with moderate to severe active rheumatoid arthritis.
The purpose of this study is to demonstrate similar efficacy and safety of GP2017 and US licensed Humira® in patients with moderate to severe rheumatoid arthritis (RA) with inadequate response to Disease modifying anti-rheumatic drugs (DMARDs), including methotrexate (MTX). This study is part of the clinical development program of GP2017 and aims to support the worldwide registration of GP2017 as a biosimilar product to Humira®.
Sponsor: Sandoz

9. SPOCS-Systemic Lupus Erythematosus (SLE) Prospective Observational Cohort Study (SPOCS)
SPOCS is prospective observational cohort of patients with moderate-to-severe SLE. The study seeks to characterize the 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.
SPOCS is an international, multicenter, prospective observational cohort study with bi-annual study visits over a 3-year follow-up designed to systematically describe the comprehensive SLE patient journey regarding clinical features, disease progression and treatment, SLE outcomes, health status assessments (PROs), and health care resource utilization (HCRU) in a general population of moderate-to-severe SLE patients.
Sponsor: AbbVie (Primary)- AstraZeneca

Contact  

Nicole C. Jordan, BSc, MA
Clinical Research Coordinator
(718) 920-6416
Fax: (718) 515-6103
njordan@montefiore.org 

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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

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