View clinical trials related to Systemic Lupus Erythematosus.
Filter by:The aim of this study is to to determine whether atorvastatin 40mg per day is effective in the treatment of SLE.
The purpose of this clinical research study is to learn if addition of abatacept is safe and improves the effectiveness of treatment of patients with active lupus nephritis who are also taking mycophenolate mofetil (MMF) and corticosteroids.
The purpose of this study is to evaluate the efficacy, safety, tolerability, and impact on quality of life of two different doses of belimumab administered in addition to standard therapy in subjects with active, autoantibody-positive systemic lupus erythematosus (SLE) disease.
The purpose of this study is to test the safety and effectiveness of different doses of vitamin D in patients with Systemic Lupus Erythematosus (SLE). A long term goal is to determine if vitamin D could be used as a treatment and/or preventative of SLE.
SLE(Systemic Lupus Erythematosus) is an autoimmune disese that primarily occurs in women(9:1 compared to men). The disease is activated by genetic and environmental factors, yet the female gender is the strongest risk factor. The sex hormone estrogen has been proven in the past to be an enhancer of the immune response. Estrogen serves as a ligand for two specific receptor proteins. Lab studies that we have already done have shown estrogen significantly increases these two ligands in the T cells from SLE females, but not in T cells from normal women. These estrogen-dependent increases are blocked by the estrogen receptor antagonist ICI 182,780. The objective of this research is to investigate if ICI 182,780 alters disease progression and/or activity in females with SLE and may provide a new treatment for women with SLE. This is based on previous work we have done.
The main objective of study PLUS is to determine the potential benefits of individualized HCQ dosing schedules aimed at maintaining the whole-blood HCQ concentration above 1000 ng/ml
The purpose of this study is to evaluate the efficacy, safety, tolerability, and impact on quality of life of two different doses of belimumab administered in addition to standard therapy in subjects with active, autoantibody-positive systemic lupus erythematosus (SLE) disease.
Previous experimental data strongly suggest that B lymphocytes have intrinsic abnormalities during lupus in mice spontaneously affected by the disease. This study tries to define these abnormalities by looking at the gene expression profile of purified B lymphocytes from patients with non active systemic lupus , compared with the gene expression profile of purified B lymphocytes from healthy donnors.
Hypothesis, HRT does not increase the risk of lupus activity exacerbation, it is effective for the relief of menopausal symptoms and improves bone mineral density. Double-blind, randomized, placebo controlled clinical trial. Objectives 1. Determine the effect of HRT on disease activity, menopausal symptoms, bone mineral density, lipid profile, and mammographic parenchymal density in menopausal women with SLE. 2. Determine the incidence rate of major side effects of HRT in menopausal women with SLE. Outcome Measures 1. Primary outcome will be global disease activity throughout the follow-up period. 2. Incidence of lupus flares, time to the first flare, changes in SLEDAI values from baseline at each follow-up visit, maximum disease activity, lupus treatment, hospitalizations, thromboses, and deaths. Menopausal symptoms and depression will be assessed utilizing the Greene Climacteric Scale questionnaire and the Beck Depression Inventory. Bone mineral density of lumbar spine and hip will be performed with dual energy x-ray absorptiometry. In addition, blood and urine samples to measure biochemical markers of bone turnover. Estradiol levels, lipid profile,coagulation tests, cervical cytology examinations, mammography. Inclusion Criteria: (Any two of the following criteria) 1. Amenorrhea of 6 months or more 2. Serum FSH level of 30 IU/L or more 3. Menopausal symptoms 4. Age 48 years or older. Exclusion Criteria: 1. Women older than 65 years 2. Severe lupus activity at baseline 3. Use of estrogens within 3 months of the screening visit 4. Serum creatinine of 2.0 mg/dL or more 5. Hypertriglyceridemia 500 mg/dL or more 6. Metabolic bone diseases 7. Liver disease 8. Untreated hyperthyroidism 9. Recent thrombosis 10. Malignancy 11. Endometrial hyperplasia 12. Undiagnosed uterine bleeding 13. Cervical dysplasia. Subject allocation Random assign, using a computer-generated randomization list to: Conjugated equine estrogens 0.625 mg/day plus 5 mg/day of medroxyprogesterone acetate p.o. for the first 10 days per-month, or biologically inert placebo.All women will receive 1200 mg of calcium carbonate and 800 IU of vitamin D, daily. Follow-up procedure All patients will be evaluated by a rheumatologist and a reproductive health specialist at baseline,1,2,3,6,9,12,15,18,21, and 24 months. Rheumatic evaluation: 1. General information (baseline). 2. Lupus activity (every visit). 3. Medications: (every visit) Gynecological evaluation: Onset of symptoms since the previous visit using a standardized questionnaire. In addition, a gynecological examination will be performed. Criteria for early termination of the study: A patient will be discontinued from the study whenever any of the following criteria would be present: 1. Development of severe lupus activity (SLEDAI > 30). 2. Development of any putative complication to hormone therapy. 3. Development of any other severe complications due neither to SLE nor hormone therapy. 4. Need prolonged immobilization. Statistical analysis: Between-group comparisons of lupus activity, maximum SLEDAI, and change in SLEDAI score from baseline at each follow-up visit. Incidence-density rates of flares with relative risk and 95 percent confidence intervals.Probability of flares throughout the study using life-table analyses and log-rank test. Climacteric symptoms as the mean value of the Green’s scale score at baseline and at each follow-up visit, between-group and intra-group. Bone mineral density as the mean value at baseline, 12 and 24 months, between and intra-group. The proportion of patients in each group who develop secondary effects, as well as the number who quit the study during the follow-up period. Continuous variables will be compared using Student's t-test, and categorical variables using chi-square or Fisher’s exact test. Within-group comparisons will be done using the Wilcoxon signed-rank test. P values will be two-sided. Analyses will be conducted by the intention-to-treat method.
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.