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Systemic Lupus Erythematosus clinical trials

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NCT ID: NCT00858884 Withdrawn - Clinical trials for Systemic Lupus Erythematosus

Libman-Sacks Endocarditis as a Cause of Neuropsychiatric Systemic Lupus Erythematosus

Start date: August 2006
Phase: N/A
Study type: Interventional

The purpose of this study is to determine whether Libman-Sacks endocarditis (inflammation of the heart valves) is the cause of neuropsychiatric manifestations (stroke, transient ischemic attacks, cognitive dysfunction, seizures, acute confusional state, or psychosis) in patients with systemic lupus erythematosus. Hypothesis of the study: Libman-Sacks endocarditis (especially valve vegetations or "small valve growths") generate macro (large) and micro (tiny) emboli that occlude the medium and small cerebral vessels resulting in altered perfusion, ischemic brain injury, and major NPSLE (stroke, TIA, seizures, cognitive dysfunction, acute confusional state, or psychosis).

NCT ID: NCT00752999 Withdrawn - Clinical trials for Systemic Lupus Erythematosus

Efficacy and Safety Study of R935788 Tablets to Treat Systemic Lupus Erythematosus

SOLEIL
Start date: November 2008
Phase: Phase 2
Study type: Interventional

Approximately 225 patients meeting study entry requirements will be enrolled and randomized (2:1, active versus placebo superimposed on background treatment) to R788 or placebo. Patients will be followed for efficacy and safety parameters for 6 months. The investigator should taper corticosteroids if clinically warranted.

NCT ID: NCT00610805 Withdrawn - Clinical trials for Systemic Lupus Erythematosus

Cardiology Prevention in Systemic Lupus Erythematosus (SLE)

Start date: November 2009
Phase: N/A
Study type: Interventional

We propose a feasibility study of aggressive CV risk factor management directed by preventive cardiology compared to usual care. We will determine: 1) the efficacy of a preventive cardiology program compared to usual care in slowing the progression of carotid IMT and plaque, and 2) the effect of a preventive cardiology program versus usual care at achieving CV risk factor target goals. We hypothesize Lupus patients randomized to the preventive cardiology program will have less cardiovascular progression over two years than those lupus patients who are given standard care for cardiovascular risk, defined by carotid intima-media thickness and plaque.

NCT ID: NCT00508898 Withdrawn - Clinical trials for Systemic Lupus Erythematosus

The Efficacy and Safety of Calcitriol for the Treatment of Lupus Nephritis and Persistent Proteinuria

Start date: May 2008
Phase: Phase 4
Study type: Interventional

Glomerulonephritis and renal failure represent one of the most life-threatening manifestations of systemic lupus erythematosus (SLE). Although immunosuppressive therapy is often effective for the treatment of acute lupus nephritis, a significant proportion of patients show persistent proteinuria after resolution of the acute nephritic process, and develop progressive renal failure. There is preliminary evidence that calcitriol and other vitamin D analogs can reduce proteinuria in patients with chronic kidney diseases. The investigators plan to conduct a randomized control study to evaluate the safety and efficacy of calcitriol in the treatment of SLE patients with persistent proteinuria. Sixty patients with clinically quiescent SLE and persistent proteinuria despite conventional therapy will be recruited. They will be treated with calcitriol for 48 weeks. Proteinuria, renal function, lupus disease activity, serum and urinary inflammatory markers will be monitored. This study will explore the potential anti-proteinuric and immunomodulating effects of calcitriol in the treatment of SLE, which is a common and life threatening disease in young adults.

NCT ID: NCT00390091 Withdrawn - Clinical trials for Systemic Lupus Erythematosus

Study of LJP 394 (Abetimus Sodium) in Lupus Patients

Start date: September 2006
Phase: Phase 2
Study type: Interventional

The primary purpose of this study is to assess the safety and pharmacodynamic effect of LJP 394 at doses of 100 mg, 300 mg and 900 mg on anti-dsDNA antibody levels in patients with SLE.

NCT ID: NCT00382837 Withdrawn - Clinical trials for Systemic Lupus Erythematosus

Study of Epratuzumab in Systemic Lupus Erythematosus

Start date: January 2007
Phase: Phase 3
Study type: Interventional

Epratuzumab is an investigational antibody designed to help treat SLE. The purpose is to evaluate safety and long term efficacy in concert with standard SLE treatments

NCT ID: NCT00278590 Withdrawn - Clinical trials for Systemic Lupus Erythematosus

Allogeneic Stem Cell Transplantation in Systemic Lupus Erythematosus

Start date: July 2004
Phase: Phase 1
Study type: Interventional

This trial is designed to evaluate the safety of treating systemic lupus erythematosus participants with cyclophosphamide and CAMPATH-1H followed by allogeneic stem cell transplant. There will be no randomization in this study. All subjects who are determined to be eligible for the study treatment will receive cyclophosphamide and CAMPATH-1H followed by allogeneic stem cell transplant. The purpose of the intense chemotherapy is to destroy the cells in the immune system which may be causing this disease. The purpose of the stem cell infusion is to produce a normal immune system that will no longer attack body. The study purpose is to examine whether this treatment will result in improvement in the lupus disease.

NCT ID: NCT00230035 Withdrawn - Clinical trials for Systemic Lupus Erythematosus

Lupus Immunosuppressive/Immunomodulatory Therapy or Stem Cell Transplant (LIST)

Start date: September 2005
Phase: Phase 2
Study type: Interventional

Systemic lupus erythematosus, also known as lupus or SLE, is a chronic, multisystem, autoimmune disease in which the body's internal system of defense attacks its own normal tissues. This abnormal autoimmune response can result in damage to many parts of the body, especially the skin, joints, lungs, heart, brain, intestines, and kidneys. Both genetic and environmental risk factors are involved in the development of lupus, but these are poorly understood. SLE has an overall 10-year survival between 80 and 90%. However, we estimate that severe lupus not responding to the usual available treatments has a 50% mortality rate in 10 years. Kidney problems occur in 30% to 50% of lupus patients and may progress to kidney failure. Kidney disease due to lupus occurs more frequently in African-Americans and Hispanics. Lupus can affect many parts of the body and cause damage, but the severe form can result in death from kidney disease; cardiovascular disease, specifically atherosclerosis; central nervous system disease; and infections. Currently, no single standard therapy for treatment of severe SLE exists. Usually physicians prescribe an aggressive regimen of one or a combination of immunosuppressive/immunomodulatory treatments. This approach to therapy for all forms of severe SLE derives largely from studies of lupus nephritis. Current treatment, although effective in many people, are not effective in all patients and are associated with drug-induced morbidity. The design of the control arm for this study reflects the current status of treatment of SLE in the academic setting. Investigators may choose from a list of commonly used and currently available immunosuppressive/immunomodulatory treatments to optimize the treatment of their patients, based on their past treatment history and response to those treatments. Study treatments may consist of corticosteroids, cyclophosphamide (CTX), azathioprine, methotrexate, cyclosporine, mycophenolate mofetil (MMF), plasmapheresis, intravenous immunoglobulin (IVIG), rituximab, and leflunomide. Treatment may be changed as frequently and as necessary within the first year of the study to control the manifestations of SLE in each patient. New therapies that become available during the course of this trial may be added to the list of approved medications for this study. In response to the absence of a uniformly effective treatment for severe lupus, autologous hematopoietic stem cell transplantation (HSCT) has been proposed as a potential therapy. Hematopoietic stem cells are immature blood cells that can develop into all of the different blood and immune cells the body uses. Researchers believe that resetting the immune system may stop or slow down the progression of the disease. The main purpose of this study is to compare two ways of treating SLE: 1) high-dose immunosuppressive therapy (HDIT) followed by HSCT and 2) currently available immunosuppressive/immunomodulatory therapies.