View clinical trials related to Systemic Lupus Erythematosus.
Filter by:The key of this prospective study is to identify a potentially increased cardiovascular risk in patients with systemic Lupus erythematodes, with and without renal affection. Three groups of patients will be compared.
This study is an open-label, randomized, 2 parallel group, single dose study in healthy Japanese males to assess the pharmacokinetics and safety/tolerability of single intravenous administration and single subcutaneous administration of GSK1550188. Serial blood samples for the determination of GSK1550188 concentration will be collected and safety assessments will be performed for each treatment group
The treatment of systemic lupus erythematosus (SLE) may change in the future due to the availability of new biological treatments, especially monoclonal antibodies in patients with active disease. However, one of the main causes of treatment failure in SLE is the lack of treatment adherence since "drugs don't work in patients who don't take them." Hydroxychloroquine (HCQ-Plaquenil) has a long terminal elimination half- life, and investigators have demonstrated that patients who do not take HCQ for a long time have undetectable or very-low blood HCQ concentrations (< 200 ng/ml). The rate of severe non-adherence was 7% in a cohort of 203 patients and was even higher in patients with active disease: 8 out of 35 (23%) in patients with a SLEDAI ≥6 and 6 out of 20 (30%) in patients with a SLEDAI ≥12. Investigators will evaluate the importance of non-adherence to the treatment in a large population of SLE patients with active disease. This will be done with blood HCQ monitoring in a translational multicentric prospective study.
The purpose of this study is to evaluate the efficacy, safety and tolerability of belimumab administered subcutaneously (SC) to adult subjects with Systemic Lupus Erythematosus (SLE).
This 12 week study will observe patients with and without systemic lupus erythematosus who have persistent antiphospholipid antibodies in the blood who are starting a medicine called hydroxychloroquine. It will measure if these patients have a change in a blood test called the annexin A5 resistance assay over that 12 week period.
Individuals with systemic lupus erythematosus (SLE, lupus) appear to be at increased risk for the development of shingles, a painful reactivation of the varicella zoster virus that causes chicken pox. The investigators propose to study the immune response to commercially available Zostavax vaccine (shingles vaccine) in adult patients with SLE who have minimal disease activity and are on mild immunosuppressant medications, and to compare the immune response to that seen in healthy people following vaccination. Acceptable immunosuppressive drugs permitted in the study are those felt to be safe according to Centers for Disease Control guidelines. Ten healthy people and 10 SLE patients (all over 50 years of age) will be recruited to receive a single, standard dose of Zostavax. Blood samples and physical examination will be performed prior to injection, then 2,6,and 12 weeks following vaccination. All participants will receive active vaccine, there is no placebo group.
The primary objective of the study is to evaluate the safety, tolerability and Pharmacokinetics (PK) of Epratuzumab in Japanese subjects with moderate to severe general SLE as add on to standard of care treatment during the trial.
The purpose of this study is to evaluate the efficacy and safety of MEDI-546 compared to placebo in subjects with chronic, moderately-to-severely active systemic lupus erythematosus (SLE) with an inadequate response to standard of care treatment for SLE.
Systemic lupus erythematosus (SLE) is a chronic multi-system inflammatory autoimmune disease. Vitamin D has potent immunomodulatory properties that have promoted its potential use in the treatment of autoimmune conditions, including SLE. We assessed vitamin D status in SLE patients and determined alterations in inflammatory, hemostatic markers as well as disease activity before and after vitamin D supplementation. 248 SLE patients were enrolled in this randomized placebo-controlled study. Patients were randomized 2:1 to receive either oral cholecalciferol 2000 IU/day or placebo for 12 months. Outcome measures included assessment of alterations in levels of IL-1, IL-6, IL-18, TNF-alpha, Anti-dsDNA, ANA, fibrinogen and von Willebrand Factor (vWF) before and after 12 months supplementation. Disease activity was measured by the SLEDAI. Vitamin D levels were measured by Liaison immunoassay; (normal 30-100ng/ml). Serum levels between 10-30 ng/ml were classified as vitamin D insufficiency, and levels < 10 ng/ml as vitamin D deficiency.The mean 25(OH) D level at baseline was 19.8 ng/ml in patients compared to 28.7 ng/ml in controls.
The primary objective of the study is assess the safety and tolerability of long-term epratuzumab treatment in subjects with Systemic Lupus Erythematosus (SLE)