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U-M LUPUS PROGRAM
Division of Rheumatology

 

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Clinical Trials

Clinical trials are a type of research study design to test new treatments or diagnostic tests in those affected by a specific disease or condition. They help achieve a better understanding of the disease that is being investigated and determine the effectiveness and safety of new treatments.

Our group actively participates in different clinical trials giving our patients the opportunity to receive promising new treatments or participate in new diagnostic procedures. Participation is completely voluntary. To view a list of studies that are currently recruiting volunteers please visit the University of Michigan’s Clinical Research website.

For general information on clinical trials please visit

www.clinicaltrials.gov

www.centerwatch.com

Current Trials

Magnetic Resonance Spectroscopy, Perfusion, and Diffusion Tensor Imaging in Neuropsychiatric Lupus (Enrollment Closed)

A study to determine if certain types of Magnetic Resonance scanning will help to better detect markers in the brain that are related to the neuropsychiatric symptoms of SLE. This longitudinal study will assess the utility of sophisticated imaging processes such as diffusion weighted tensor imaging in determining levels of cerebral damage in neuropsychiatric lupus and predicting long term outcome. 

Ovarian reserve in women treated with chemotherapy and hormonal therapies versus controls

The primary goal of this research is to learn more about the aging process of the ovaries and how this might affect the ability of female patients with autoimmune disease (such as SLE or vasculitis, or cancer) to have children; also to examine these associations in relation to exposure to chemotherapy.   Healthy controls with no prior exposure to chemotherapy or radiation therapy will also be included.

Female patients between the ages of 21 and 50 with autoimmune diseases, such as systemic lupus erythematosus or vasculitis, cancer, and controls will be included in the study.  Some of the patients will have received chemotherapy, including cyclophosphamide (Cytoxan).  This study is currently enrolling, please contact study coordinator Emily Lewis.

Multi-Center, Open label Continuation Trial of LymphoStat-B ™ Antibody (Monoclonal AntiBLyS Antibody) in Subjects with Systemic Lupus Erythematosus (SLE) who completed the Phase 2 Protocol LBSL02 (Enrollment Closed)

A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 76-Week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006, LympoStat-B™), a Fully Human Monoclonal Anti-Blys Antibody, in Subjects with SLE (Enrollment Closed)

The purpose of these studies is to determine whether the investigational drug LymphoStat-B is safe and effective in treating systemic lupus erythematosus (SLE). In people with SLE, the body produces antibodies that fight against its own normal cells. B-cells are an important type of white cell in your blood that produce these antibodies. BLyS (which stands for B-Lymphocyte Stimulator) is a protein that is naturally found in the body. It helps B-cells grow and survive. The drug LymphoStat-B is intended to stop or slow down the activity of BLyS. Stopping the activity of BLyS may help lower the number of B cells that produce antibodies.

A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Rituximab in Subjects with ISN/RPS, Class III or IV Lupus Nephritis (Enrollment Closed)

The purpose of this study is to determine whether the investigational drug rituximab is safe and effective in treating systemic lupus erythematosus (SLE) and lupus nephritis. Rituximab has been approved by the Federal Drug Administration (FDA) as an effective drug for the treatment of non-Hodgkin’s B-cell lymphoma (a cancer), and for certain patients with rheumatoid arthritis, but has not been approved for the treatment of SLE or lupus nephritis. 

Future Studies

Long term outcomes of children born to Systemic Lupus Erythematosus (SLE) patients

The purpose of this study is to gather information about mothers with SLE and their children. The information gathered will be used to perform a review of the long-term outcomes of children born to mothers who have SLE so that better information can be provided to women with SLE who are planning pregnancy.

 

 
   
   

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