Clinical Trials
Observational Studies
Translational 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.