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Clinical Pharmacology Research Program
Current Research Projects

SLE Studies


Studies that involve blood drawing, medical history, and physical examinations: no changes in medicines

Oklahoma Lupus Cohort and Registry for the Antiphospholipid Syndrome - This project is a study of a group (cohort) of patients with lupus and/or the antiphospholipid syndrome (APS). This project has two goals: 1) to study the causes of lupus and APS and their complications (such as heart disease, strokes, and the side effects of medications) and 2) to examine the justification for possible new treatments for these disorders by studying blood samples and relating this to the clinical problems that patients develop. This study involves taking your health history including your lifestyle, habits and/or medical condition and a physical examination every three months and donating blood samples. No medications are given in this study and your medical care will not be affected in any way. This study is expected to continue for a minimum of 15 years and include up to 5,000 adult and pediatric patients from all over the United States.
*Open for recruitment

SLE Criteria Study - The purpose of this study is to collect information to lead to a more accurate diagnosis of lupus and to better categorize sub-groups of patients for optimal understanding and treatment of their disorders.

PROMISSE Study - A national study of risk factors in pregnancy in SLE.

Evaluation of Autoimmune B Cell repertoire and disease activity in patients with SLE - A laboratory study of a possible risk factor in lupus.

Brain Connections - The purpose of this national research study is to understand the many ways lupus can affect brain function.

 

Studies in which participants receive new (investigational) treatments:

Study to evaluate the safety and tolerability of AMG 623 in Systemic Lupus Erythematosus - AMG has been shown in animal studies to neutralize B-cell activating factor (BAFF). (This investigational drug is being developed by Amgen.)

Plasmapheresis - The purpose is to help obtain antibodies from lupus patients to improve diagnostic testing and to test the effects of plasmapheresis on certain kinds of inflammation related to lupus that can be tested in the blood.

Genentech u2970g #05-28 - The purpose of this study is to further investigate the drug Rituximab in the treatment of lupus nephritis. (sponsored by Genentech)
*Open for recruitment

Genentech u2971g #05-13 - This is a research study of an investigational product called rituximab (RituxanŽ). Rituximab is a monoclonal antibody that has been approved for the treatment of non-Hodgkin’s B-cell lymphoma (a cancer) by the Food and Drug Administration (FDA) but has not been approved for the treatment of systemic lupus erythematosus (SLE). (sponsored by Genentech)
*Closed for recruitment

IM101-042 #05-17 - The purpose of this study is to see if the investigational drug, abatacept, is better than placebo (inactive substance) on a background of glucocorticosteroids (which means that everybody in the study will receive glucocorticosteroids, like prednisone) in decreasing lupus activity and preventing future flares of lupus.
The study is being conducted and sponsored by Bristol-Myers Squibb Pharmaceutical Research Institute.
*Closed for recruitment

MedImmune #06-06 - The main goal of the study is to see if it is safe, and to measure the amount of MEDI-545 in the blood when the drug is given at different dosages when given to patients who have mild SLE with skin symptoms. The study is sponsored by MedImmune, Inc.
*Open for recruitment

 

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Clinical Pharmacology Research Program
Clinical Pharmacology Scientific Staff