Program for Autoimmune Diseases and Clinical Research
Cynthia Aranow, MD Associate Investgator |
Meggan Mackay, MD Associate Investigator |
The Clinical Trials Unit of the Center for Autoimmune and Musculoskeletal Disease at the Feinstein Institute is committed to providing expert care and patient education combined with clinical research projects designed to further our understanding of autoimmune disease and develop improved therapies for these difficult and sometimes fatal diseases.
Drs. Meggan Mackay and Cynthia Aranow are co-directors of the Clinical Trials Unit under their chairperson, Dr. Betty Diamond. Both Drs. Aranow and Mackay are specialists in Rheumatology with additional expertise in Lupus. They have extensive experience in running and designing clinical trials as well as in other types of research studies. The Center for Autoimmune Disease is comprised of investigators in basic science and clinical medicine and the collaborative efforts between basic scientists and clinical investigators has resulted in the Center’s unique ability to study autoimmune disease using innovative methods.
The Autoimmune Disease Center focuses its research efforts on Systemic Lupus Erythematosus and Rheumatoid Arthritis in addition to other autoimmune diseases. We have established several clinics in St. Albans, Queens, the Bronx, Manhattan and Long Island (Garden City and at The Feinstein Institute in Manhasset) and are committed to caring for all patients regardless of reimbursement. All patients are encouraged to participate in clinical research efforts. Involvement in research can be a powerful means for patients to learn more about their disease and know that they are contributing to the fight for a cure. Clinical research does not always mean testing new medications; there are three kinds of clinical research; Observational Studies, Translational Studies and Clinical Trials.
Observational Studies collect information on patient as they are followed regularly in the clinics and do not involve new medications or invasive procedures. These studies help determine how things like gender, age, environment, medications and ethnicity may affect outcomes of patients with autoimmune disease. All information collected in these studies is coded so that it is difficult for information to be linked directly to an individual patient and patient confidentiality is preserved.
Translational Studies use blood, urine or tissue samples combined with clinical information from patients to study abnormalities in the immune system, discover how they contribute to autoimmune disease and identify targets for the development of new therapies. These types of studies can also include genetic testing to help understand why some individuals are at higher risk for developing autoimmune disease than others.
Clinical Trials are studies that are designed to test new medications or existing medications that have already been approved for a different disease.
Research projects currently ongoing in the Clinical Trials Unit include observational studies of brain involvement in lupus, many translational studies of immune dysfunction in Lupus and Rheumatoid Arthritis and many clinical trials of new medications for Lupus, Rheumatoid Arthritis and Scleroderma. We are happy to see any patients diagnosed with autoimmune disease or those who have been told they may have one of these diseases.
Dr. Cynthia Aranow is a rheumatologist specializing in lupus and rheumatoid arthritis. She received her medical degree from NYU School of Medicine, and completed her internship, residency and rheumatologic training at Montefiore Hospital and Albert Einstein College of Medicine, Bronx New York. She has received the Edmund Dubois Memorial Award in recognition of excellence and accomplishment in the study of SLE. At the Feinstein Institute, Dr Aranow is the Clinical Director of the LCTC (Lupus Clinical Trials Consortium) a philanthropically funded organization which promotes readiness for interventional studies of promising agents for SLE. As a member of the Systemic Lupus International Cooperating Clinics (SLICC), she has contributed to multicenter international studies looking at clinical outcomes in lupus Dr. Aranow is involved with many patient organizations, including local chapters of the Lupus Foundation of America, and she is on the medical-scientific committee for the Arthritis Foundation..
Dr. Meggan Mackay is a rheumatologist whose primary interests are in Systemic Lupus Erythematosus, Rheumatoid Arthritis, Scleroderma and vasculitis. Dr. Mackay is a graduate of New York Medical College where she was awarded the New York Medical College Trustee Scholarship for Academic Excellence and was a junior inductee into the Alpha Omega Alpha Honor Society. She obtained a Master of Science from the Clinical Research Training Program at the Albert Einstein College of Medicine. Prior to her arrival at the Feinstein Institute, Dr. Mackay had been on the faculty at Columbia University Medical Center and the Albert Einstein College of Medicine where she was the Associate Director of Medicine at Jacobi Medical Center. At Einstein she was awarded the Davidoff Teaching Award and the Harry Gordon Award for Outstanding Clinical Teaching. She has worked extensively with the Arthritis Foundation, the SLE Foundation and the Lupus Alliance to promote community awareness and education about lupus, rheumatoid arthritis and other rheumatologic diseases.
Although we specialize in adult medicine, adolescent and pediatric patients are welcome! Please call our Feinstein Lupus Hotline with any questions or to schedule an appointment:
1-877-33 LUPUS (1-877-335-8787)
Ongoing Clinical Research Studies
I. Clinical Trials
- Lupus Nephritis (kidney disease)
- Abatacept (Orencia) plus cyclophosphamide for active lupus nephritis sponsored by the NIH/Immune Tolerance Network.
- Etanercept plus cellcept for treatment of lupus nephritis sponsored by the NIH/Autoimmune Centers of Excellence.
- Rituximab for the treatment of membranous (Class V) lupus nephritis.
- Abatacept (Orencia) plus cellcept for the treatment of lupus nephritis sponsored by a pharmaceutical company.
- Ocrelizumab for treatment of lupus nephritis sponsored by a pharmaceutical company.
- General Lupus
- Vitamin D in SLE; effects of vitamin D supplementation on the interferon signature in patients with stable or minimally active lupus sponsored by the NIH/Autoimmune Centers of Excellence.
- Anti-interferon alpha monoclonal antibody for patients with active lupus not including kidney or brain disease.
- Atacicept for treatment of lupus patients with active non-kidney, non-brain involving SLE.
- Anti-gamma interferon monocolonal antibody for patients who are clinically inactive. This trial is a Phase I study (a study which is in an early phase of drug development) looking primarily at safety of a novel immunoregulatory agent for treatment of SLE.
Rheumatoid Arthritis
Lovastatin in Rheumatoid Arthritis. This study is investigating the potential anti-inflammatory effects of a commonly prescribed cholesterol lowering agent, lovastatin in patients with rheumatoid arthritis. Patients with moderately active disease are studied in this trial that is sponsored by the NIH/Autoimmune Centers of Excellence.
Switching Anti-TNF-α Agents in RA. The goal of this study sponsored by the NIH/Autoimmune Centers of Excellence, is to determine the efficacy of switching from one type of TNF inhibitor (such as Etanercept or Humira) to another. This should help identify patients who may have a better response to one TNF inhibitor versus the other.
Mechanism of action of anti-TNF drugs in RA. The goal of this study is to explore how two anti-TNF drugs, Etanercept and Humira, affect B cells in the immune system.
Scleroderma
Rituximab for the treatment of severe pulmonary hypertension associated with scleroderma. This clinical trial is sponsored by the NIH/Autoimmune Centers of Excellence.
II. Observational Studies
Cognitive and Emotional Disturbances and Lupus:
Lupus patients are invited to participate in these studies that use imaging techniques such as PET scan, MRI and functional MRI to evaluate the effect of specific auto-antibodies on brain function.
Rheumatology Specimen and Clinical Data Bank
This is a cohort of subjects that includes patients with autoimmune diseases as well as healthy subjects and family members. De-identified clinical information is collected from subjects and stored in our computerized data bank. Blood, urine and/or tissue samples are collected for use in the laboratory at different time intervals.
SLICC (Systemic Lupus International Collaborating Clinics) Inception Cohort
We participate in this international study that enrolls only patients diagnosed with lupus within the last 12 months. Recently diagnosed lupus patients are welcome to enroll in this study designed to investigate cardiovascular and neurologic disease in patients with lupus. Patients are seen once a year for this observational study.
III. Translational Studies
In collaboration with Drs. Betty Diamond, Anne Davidson, Peter Gregersen and others at the Feinstein Institute, there are several ongoing studies of immune cells and genetics that include the following:
Characterization of anti-DNA B Cells in Lupus: This study is designed to investigate immune abnormalities of B cells in lupus patients and how they contribute to disease.
Utilization of phosphospecific flow cytometry technique in autoimmune disease: Phosphoflow is a new technique that we are using to identify different intracellular signaling cascades in patients with rheumatic diseases.
Microarray analysis of urinary pellets in active lupus nephritis: This study uses microarray technology to detect genes that may be involved in kidney inflammation in patients with lupus nephritis (Kidney disease).
Molecular Signatures in Lupus: Untangling Infection from Inflammation: Microarray analysis of immune cells from blood samples obtained from lupus patients with a fever will be used to differentiate infection from lupus flare as a cause of the fever.
Dendtitic Cells and SLE: These studies look at the function and characteristics of dendritic cells (an important cell in the immune system) in SLE. A major emphasis of this study currently is to evaluate the ability effects of vitamin D to modulate cells in the immune system
Call 877-33 LUPUS (1-877-335-8787) for additional information or to schedule an appointment.
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Name: Sanita Kandasami |
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Name: Andrew Shaw |