View clinical trials related to Systemic Lupus Erythematosus.
Filter by:In patients with systemic lupus erythematosus, immunosuppressive therapy to the point of complete immune ablation and hematopoietic stem cell recovery.
The purpose of this study is to perform genetic testing in and to collect information from families affected by lupus in order to identify the genetic factors associated with systemic lupus erythematosus (SLE).
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.
It is thought that Edratide may be able to reduce the symptoms of SLE.
The PROMISSE Study is an observational study of 700 pregnant patients, enrolled at nine major clinical centers. The purpose of the study is 1) to determine whether certain proteins (called complement split products) that can injure healthy organs can be used to predict poor pregnancy outcome in patients with systemic lupus erythematosus (SLE) and anti-phospholipid syndrome (APS), and/or 2) to determine whether elevated levels of circulating antiangiogenic factors predict pregnancy complications in patients with aPL antibodies and/or SLE.
The purpose of this study is to evaluate the effect of DHEA on endothelial dysfunction in patients with systemic lupus by measuring: 1. changes in brachial artery flow-mediated dilatation (FMD) and 2. changes in biomarkers of cardiovascular risk. Patients will be enrolled in a randomized, double-blinded crossover trial of DHEA or placebo for ten weeks, then crossed over to the alternate treatment arm after a six-week washout period. HYPOTHESIS: Dehydroepiandrosterone (DHEA) administration in premenopausal women with SLE modifies cardiovascular risk by improving vascular endothelial function and other biomarkers associated with cardiovascular heart disease.
Several studies have shown that persons with systemic lupus erythematosus (SLE) have poor general health and a higher risk of heart attack and bone loss (osteoporosis) compared to the general population. Some of the risks associated with heart attacks and bone loss are modifiable (can be changed). For example, high blood pressure, high cholesterol, smoking, lack of exercise are risk factors associated with heart attacks that can be changed. Whereas, age and a family history of heart attacks are risk factors that can not be changed. Similarly, a diet low in calcium, smoking and lack of exercise are modifiable risk factors associated with osteoporosis; while, family history and age are not modifiable. The Health Improvement and Prevention Program (HIPP) in Systemic Lupus Erythematosus was developed to increase the general health in persons who have lupus and to help reduce the risk of heart attacks and bone loss. This intervention program gives comprehensive information about lupus and provides tools on how to live better with lupus. The program includes visits with a nurse case manager who will work in close collaboration with the lupus team. She will work on an individual basis with each participant to develop a mutually agreed upon personalized care plan aimed at improving general health, coping skills and heart and bone health. HIPP STUDY (Health Improvement And Prevention Program) Dr Paul Fortin Principal Investigator Primary and Secondary objectives: - To improve health status, decrease cardiovascular risk and improve endothelial function in persons with SLE compared to usual care. - To improve bone health behaviors and prevent decrease in bone mineral density. - To improve adherence to treatments. - To help persons with Lupus move toward wellness by increasing knowledge. - To show that HIPP is cost effective and could become standard care. Duration: 2 years Enrollment 240 patients Study Design: - Randomized prospective study of HIPP compared to usual care, patients will be crossed over at Mth 12. Data collected for 24 mths. - Demographic, health status, cost, SLE knowledge, coping, cardiovascular and osteoporosis information will be collected. - All patients will undergo clinical evaluation to measure disease activity, BMD (every 2 years) and Flow mediated Doppler (every year) - HIPP now patients will attend 4 knowledge sessions, covering SLE, coping with chronic disease, cardiovascular disease in Lupus, bone health in Lupus. - HIPP now patients will be followed by nurse coordinator and receive an individualized risk assessment, telephone follow-up, smoking cessation counseling. For those found at risk stress reduction (Mindfulness Based Stress Reduction) and or bone health program will be provided. Hipp now patients will attend Cardiac Rehabilitation Program at TWH. All HIPP now pts will attend the Cardiac Rehabilitation program at the TWH. Inclusion Criteria: SLE according to ACR, >18 yr, Female, must read and write french or english Exclusion Criteria: MI, TIA, CVA, Other arterial occlusion, PVD, Osteoporosis as defined by BMD, Pregnant now, active cancer For further information contact Study Coordinator Anne Cymet Tel # 13-2895 Pager 416-664-
Systemic Lupus Erythematosus is a relatively common autoimmune disease that affects mainly women.Cardiovascular disease as a result of accelerated atherosclerosis is a major cause of mortality and morbidity in SLE.Previous research has shown that 35-40% of patients with SLE have abnormalities of myocardial perfusion even when they have no coronary stenoses on coronary angiography. The reason for these frequent perfusion abnormalities in the absence of angiographically significant CAD remains uncertain, but could conceivably result from endothelial dysfunction. In SLE, coronary endothelial dysfunction could result from the inflammatory process involved in the SLE disease itself, a finding that could explain the correlation between disease activity and the development of CAD in these patients.As such endothelial dysfunction may account for accelerated atherosclerosis and cardiac perfusion defects (without angiographically significant coronary lesions). We propose to first evaluate whether endothelial dysfunction occurs in these patients and is more frequent in patients with myocardial perfusion abnormalities. Endothelial function will be assessed by measuring flow-mediated brachial artery dilatation. In the 250 patients included in the study we will correlate endothelial function and myocardial perfusion abnormalities to SLE disease activity, to its treatment and to the presence of CAD risk factors In a subgroup of patients (estimated 5 patients) in whom it is clinically indicated, coronary angiography will be performed in order to assess the presence of significant coronary stenoses (>50%),coronary artery reserve and coronary endothelial dysfunction. We will then attempt to reverse abnormalities in endothelial function and myocardial perfusion by therapy with an ACE inhibitor(Quinapril).Patients with myocardial perfusion abnormalities will be randomised to receive Medication A(oral Quinapril or Placebo) for 8 weeks, will have all baseline investigations repeated and then will switch over and receive medication B(Quinapril or placebo) for a further 8 weeks followed by repeat investigations.
Neuropsychiatric manifestations of Systemic Lupus Erythematosus (NPSLE) are both common and an important source of morbidity. Of the case definitions for NPSLE syndromes that have recently been developed, cognitive dysfunction appears to be the most prevalent. A novel mechanism is that a subset of SLE patients with cognitive dysfunction have antibodies in the NR2 glutamate receptor. We propose, in a double -blind placebo-controlled trial, to determine whether SLE patients, with or without the NR2 glutamate receptor antibody, have significant improvement using memantine, an inhibitor of the NMDA receptor.
Although SLE and RA are correlated with genetic predisposing factors such as human leukocyte antigen (HLA) class II, both diseases and other genetic factors might have contributed to the development of dysregulated lymphocyte activation and autoimmunity. Decoy receptor 3 (DcR3)/TR6 is a secreted protein belonging to the tumor necrosis factor (TNF) receptor family. It binds to Fas ligand (FasL), LIGHT, and TL1A that are all TNF family members. It was noted that soluble or solid phase DcR3-Fc co-stimulated proliferation, lymphokine production and cytotoxicity of mouse and human T cells upon T-cell receptor (TCR) ligation. Recently, the investigators found that the serum level of soluble DcR3 was higher in SLE patients than in healthy control subjects (unpublished data). Taken together, the investigators propose that in autoimmune diseases, such as RA and SLE, activated T cells secrete more DcR3 than non-autoimmune controls, which may, in turn, costimulate T cells further and cause dysregulated lymphocyte activation. With the aim to establish the possible correlation between DcR3 genetic polymorphisms, DcR3 expressions, and autoimmune phenotypes, the investigators offer this proposal. They plan to investigate the single nucleotide polymorphisms (SNPs) in the DcR3 gene. The genetic polymorphisms on the DcR3/TR6 gene and circulating DcR3 level will be compared between RA, SLE and non-autoimmune control subjects.