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Systemic Lupus Erythematosus clinical trials

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NCT ID: NCT01642706 Recruiting - Clinical trials for Rheumatoid Arthritis

Regulatory B Cells in Inflammatory Rheumatisms and Biomarkers of Response to Biologic Treatments

Start date: July 2, 2012
Phase:
Study type: Observational

B cells are known to play an important role in auto-immune diseases by activating T cells, secreting inflammatory cytokines and autoreactive antibodies. However, a sub-type of B cells named regulatory B cells or Bregs has recently shown capacities to prevent or cure arthritis in mouse models. Bregs have also been identified in humans.

NCT ID: NCT00866229 Recruiting - Clinical trials for Systemic Lupus Erythematosus

Efficacy and Adverse Effect of Simvastatin Compare to Rosuvastatin in Systemic Lupus Erythematosus (SLE) Patients With Corticosteroid Therapy and High Low-Density Lipoprotein (LDL) Cholesterol Level

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

Early statin therapy in SLE patients that have high cholesterol level and other atherosclerosis risk should reduce atherosclerosis and coronary artery events in later course of disease. By the way, statin is used in restricted groups of rheumatologists due to awareness of side effects; myositis and hepatitis, that are frequently found in SLE patients more so than other groups of atherosclerosis patients and reporting data of autoimmune diseases that occur after statin use.

NCT ID: NCT00775476 Recruiting - Clinical trials for Systemic Lupus Erythematosus

Treatment of Systemic Lupus Erythematosus (SLE) With N-acetylcysteine

NAC
Start date: March 31, 2022
Phase: Phase 2
Study type: Interventional

Systemic lupus erythematosus (SLE) is a chronic inflammatory disease which often has debilitating and potentially life-threatening consequences. The cause of SLE is unknown and current therapies lack specificity and carry significant side-effects. We previously discovered the depletion of glutathione in lymphocytes of patients with SLE and associated this metabolic change with the elevation of the mitochondrial transmembrane potential. This study will titrate to tolerance during an initial 3 month open label period and then subjects will be randomized to one of 2 arms. It was determined by statistical analysis that each group must have 105 subjects. All subjects will be enrolled and evaluated for tolerance of NAC between dosages of 2.4 g/day and 4.8 g/day for 3 months. After A 3-month open-label dose-titration phase, SLE subjects will be randomized into 2 groups of 105 subjects either to continue the tolerated dosage of NAC or switched to equal number of placebo capsules. There will be up to seven study visits per SLE subject, including the screening and wash out visits. Visits 2-6 will be scheduled three months apart. The study will last 13 months with the wash-out visit. Each subject will donate approximately 100 ml of blood for biomarker studies at each visit. Healthy control subjects will donate blood at the same time. They will be matched to the SLE subjects by gender, age within 10 years, and ethnicity. Their blood will be used as reference for biomarker assays. There is a consent form required to participate in the phase II study.

NCT ID: NCT00756769 Recruiting - Clinical trials for Systemic Lupus Erythematosus

Systemic Lupus Erythematosus in Gullah Health

SLEIGH
Start date: April 2003
Phase:
Study type: Observational

Systemic lupus erythematosus (SLE) is an autoimmune disease characterized by the production of autoantibodies, multiple organ involvement, and diverse clinical symptoms and immunologic manifestations. African Americans are at a disproportionately higher risk of developing SLE, develop SLE at an earlier age, and have increased morbidity and mortality compared with European Americans. Our central study hypothesis is that there are specific genetic factors that interact with environmental exposures leading to the development of SLE. The African American Gullah population from the Sea Islands of South Carolina and Georgia are unique in their genetic homogeneity with minimal non-African genetic admixture, making them an ideal cohort to address questions of environmental and genetic influence on the development and progression of SLE.

NCT ID: NCT00750971 Recruiting - Clinical trials for Systemic Lupus Erythematosus

Autologous Stem Cell Transplantation for Refractory Systemic Lupus Erythematosus (ASSIST)

ASSIST
Start date: August 2008
Phase: Phase 2
Study type: Interventional

While glucocorticoids and immunosuppressants ameliorate manifestations of SLE in many patients, current therapies are insufficient to control the disease in a subset of patients, and their clinical prognosis remains poor due to the development of vital organ failure, cumulative drug toxicity and to the increased risk of cardiovascular disease and malignancy. Immunoablative chemotherapy followed by autologous hematopoietic stem cell transplantation (ASCT) has recently emerged as a promising experimental therapy for severely affected patients, providing them the potential to achieve treatment-free, long-term remission. The investigators postulate that immunoablative therapy eliminates or effectively reduces the level of autoreactive T and B lymphocytes and then regeneration of de novo immunity resets the autoreactive immune system into a self-tolerant, protective immune system resulting in prolonged and treatment-free remission.

NCT ID: NCT00747578 Recruiting - Clinical trials for Rheumatoid Arthritis

Health-Related Quality of Life and Disease-Related Costs: Comparison Between Ankylosing Spondylitis, Rheumatoid Arthritis and Systemic Lupus Erythematosus in Taiwan

Start date: September 2008
Phase: N/A
Study type: Observational

Ankylosing spondylitis (AS), rheumatoid arthritis (RA) and systemic lupus erythematosus (SLE) are the most common rheumatic diseases dealt with rheumatologists in Taiwan. In previous studies, the 3 diseases all have broad impacts on health-related quality of life of patients and drive enormous economic burden on patients and society. The objective of this study is to compare health-related quality of life and disease-related costs between patients with the 3 different diseases. We will invite at least 100 patients with AS, RA or SLE respectively who are regularly followed in the outpatient clinic of the Division of Rheumatology at Taichung Veterans General Hospital (VGHTC) to participate in the study. Patients who have cognitive impairment, who are older than 65 years old or younger than 18 years old, who have overlapping syndrome of any 2 of the 3 rheumatic diseases (eg. RA overlapping with SLE) or who have visited rheumatologists in the outpatient clinics at VGHTC for less than 4 times in 2008 will be excluded. Patients who agree to take part will attend a comprehensive clinical examination in the outpatient department. Patients will complete a questionaire including demographic and disease characteristics, and health-related quality of life at the time of survey. The questionaires about disease-related costs will be completed once per quarter throughout 2009. The four questionaires about costs will be given at the time of initial survey and will be returned by returned by mail or in the following outpatient clinics visits every 3 months in 2009. The result of this study will help patients to realize their own health-related quality of life and disease-related costs and help government in Taiwan to realize the socioeconomic burden of the 3 common rheumatic diseases and to allocate health care resources more properly in the future.

NCT ID: NCT00527176 Recruiting - Clinical trials for Systemic Lupus Erythematosus

Pulse Corticosteroid Therapy and Effect on Brain Water Diffusivity

Start date: September 2007
Phase: N/A
Study type: Observational

In daily clinical use, pulse high dosis corticosteroids are used to treat cerebral edema in different pathological situations ( surgery, trauma, tumors...). Dehydration can theorically concern extra-cellular or intracellular water, or both. The relative proportion of those two components are not known, as well their kinetics. Diffusion Weighted Imaging ( DWI) is a none invasive and none toxic technique to study those phenomena.We can also study the diffusivity anisotropy not using a Gaussian distribution but rather a non- gaussian one, more close to the reality ( q Space Imaging ). Finally, we can study the compartment redistribution between slow and rapid water molecules diffusion by bi-exponential decomposition of the diffusion signal, corresponding, theorically, respectively to the intra- and extra-cellular component. Hypothesis : The high dosis steroid pulse therapy modifies or not the water free diffusion in DWI and qSI ? Is there a modification in the diffusivity of both rapid and slow component ?

NCT ID: NCT00519454 Recruiting - Clinical trials for Systemic Lupus Erythematosus

Estrogen and Gender Biased Autoimmunity

Start date: April 2005
Phase: N/A
Study type: Observational

This study involves research to investigate how estrogen affects women of childbearing age and its correlation to Systemic Lupus Erythematosus. The findings from this study might help determine how body cells, called T Cells, react to estrogen. The study will seek to determine if cells from women with Lupus, react differently from cells in persons without Lupus. We will attempt to identify genetic factors that determine the effects of estrogen on Lupus cells.

NCT ID: NCT00512694 Recruiting - Clinical trials for Systemic Lupus Erythematosus

Duke Lupus Registry

Start date: July 2007
Phase:
Study type: Observational

Lupus is a systemic autoimmune disease that can present with many varied symptoms, including joint pain, fevers, kidney disease, and rashes. Lupus can affect anyone, but it is most common in younger women. The Duke Lupus Registry will collect information and blood samples from patients with lupus (systemic lupus erythematosus or cutaneous lupus) seen in the Duke Rheumatology clinics. The goal of this Registry is to understand how lupus changes over time so that we can improve the treatment of patients with lupus.

NCT ID: NCT00441220 Recruiting - Clinical trials for Systemic Lupus Erythematosus

Cyclophosphamide in Lupus Nephritis

Start date: October 2006
Phase: N/A
Study type: Observational

Cyclophosphamide is widely used in the treatment of cancer and autoimmune diseases such as lupus nephritis. However, there is considerable variability in the response to cyclophosphamide treatment. Cyclophosphamide is a pro-drug that requires initial activation by CYP liver enzymes. Recent clinical studies have indicated a possible role of one CYP enzyme, CYP2C19 in this activation step. This enzyme has a genetic polymorphism (variants which lack functional activity) and people who have inherited these variants are poor metabolisers of certain drugs. The aim of this study is to determine whether response to therapy in a New Zealand population of lupus nephritis patients is determined by cyclophosphamide bioactivation (the metabolic phenotype) and CYP genotype. Currently there is no way of predicting a patient's response to cyclophosphamide. An understanding of the factors which contribute to the therapeutic failure in lupus nephritis is particularly important due to the high morbidity and mortality associated with this disease. There are other treatment options for lupus nephritis patients who fail to respond to cyclophosphamide. If successful, this study may help identify patients who are unlikely to respond to cyclophosphamide and thus should not be unnecessarily be exposed to the drug and may justify the use of newer, more costly immunosuppressive drugs such as mycophenolate mofetil and rituximab.