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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. 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) 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) 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. 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.
Return to Table of Contents Clinical Pharmacology Research Program
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