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Lupus Erythematosus, Systemic clinical trials

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NCT ID: NCT00583362 Completed - Clinical trials for Systemic Lupus Erythematosus

A Continuation Trial for Subjects With Systemic Lupus Erythematosus That Have Completed Protocol LBSL02

Start date: May 4, 2005
Phase: Phase 2
Study type: Interventional

This is a continuation study to evaluate the long-term safety and efficacy of LymphoStat-B™ in subjects with SLE disease, that completed study LBSL02 and benefitted from treatment.

NCT ID: NCT00582465 Completed - Clinical trials for Lupus Erythematosus, Systemic

Study to Evaluate the Natural History of Osteoporosis in Children and Adolescents With Systemic Lupus Erythematosus

BMD
Start date: July 21, 1999
Phase:
Study type: Observational

This is a study to determine if people with Lupus have weak bones. Test which is a better method for detecting bone changes: - Dual energy X-ray absorptiometry (DXA) - Single energy quantitative computed tomography (SEQCT) Evaluate whether weak bones are associated with things like medications or amount of fat and muscle.

NCT ID: NCT00563082 Completed - Clinical trials for Lupus Erythematosus, Systemic

Analyzing the Association of Gene Variants With Increased Risk of Coronary Heart Disease in Women With Systemic Lupus Erythematosus

Start date: May 2000
Phase:
Study type: Observational

Systemic lupus erythematosus (SLE) is an autoimmune disease that predominantly affects younger premenopausal women. The risk of coronary heat disease (CHD) in women with SLE is up to 50 times higher than in the general population. The conventional risk factors are insufficient to explain this increased risk of CHD in SLE-affected women. This study will perform genetic analysis to determine if genetic variation in the F2 gene is associated with both SLE risk and CHD risk in women with SLE.

NCT ID: NCT00556192 Completed - Clinical trials for Systemic Lupus Erythematosus

Can Targeted Elimination of B-cell Depletion Therapy and/or Combination Therapy on Systemic Lupus Erythematosus

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

This prospective randomized control trial is undertaken to evaluate the safety and efficacy of anti-CD20 monoclonal antibody, rituximab, used as 1. monotherapy, 2. in combination with cyclophosphamide, in the treatment of proliferative lupus nephritis, as compared with standard immunosuppressive therapy with cyclophosphamide and azathioprine.

NCT ID: NCT00544102 Completed - Insulin Resistance Clinical Trials

Insulin Resistance and Atherosclerosis in Women With Lupus

Start date: October 11, 2007
Phase:
Study type: Observational

This study will test the effects of insulin resistance on atherosclerosis (hardening of the arteries) in women who have systemic lupus erythematosus, more commonly known as lupus. Women with lupus have a higher chance of developing atherosclerosis than the general population, and as a result are more susceptible to heart attack and stroke. Insulin resistance is a particular risk factor for atherosclerosis, and recent small studies have shown that insulin resistance is more common in lupus patients than in those without lupus. The study will consist of a series of tests designed to assess whether there is an association between insulin resistance and atherosclerosis in women with lupus. This research may lead to further studies on possible treatments to reduce the risk of heart disease in lupus patients. Volunteers must be women between 30 and 55 years of age who were diagnosed with lupus within five or more years prior to the study. Volunteers who have kidney failure, diabetes, or existing atherosclerosis will be excluded from the study, as will volunteers who have had pulse steroid therapy within four weeks of the testing or who have been pregnant within one year of the testing. Participants will undergo the following procedures on an outpatient basis: - Blood and urine tests for research purposes. - Electrocardiogram (EKG) to test the general health of the heart. - Oral glucose tolerance test to measure blood glucose and insulin levels. This test is commonly used to diagnose diabetes and pre-diabetic insulin resistance. - Cardiac multidetector computed tomography (MDCT) to determine the amount of calcium present in coronary arteries. This test is used to diagnose atherosclerosis. - Carotid artery ultrasound to show the speed of blood flow through the carotid arteries. This test will show abnormalities and/or blockages in the carotid arteries. - Abdominal ultrasound to determine if the participant has hepatic steatosis ( fatty liver ), which is often found in individuals with insulin resistance and diabetes. - Carotid artery magnetic resonance imaging/angiogram (MRI/MRA) to measure the thickness of blood vessels. This test is used to diagnose atherosclerosis. - Abdominal MRI to estimate abdominal fat. Volunteers may be asked to participate in an MRI/MRA study to evaluate the arteries of the heart. This test is optional and not required by the insulin resistance/atherosclerosis study. The entire series of procedures will require one to three visits to complete.

NCT ID: NCT00541749 Completed - Clinical trials for Systemic Lupus Erythematosus

A Study of rhuMAb IFNalpha in Adults With Systemic Lupus Erythematosus

Start date: February 2007
Phase: Phase 1
Study type: Interventional

This is a Phase I, randomized, placebo-controlled, double-blind, dose-escalation study of single and repeat doses of rhuMAb IFNalpha, administered through the SC or IV route, in adults with Systemic Lupus Erythematosus.

NCT ID: NCT00523588 Completed - Clinical trials for Cutaneous Lupus Erythematosus

Treatment of Cutaneous Lupus Erythematosus (CLE) With the 595 nm Flashlamp Pulsed Dye Laser

Start date: March 2007
Phase: Phase 2
Study type: Interventional

The purpose of using the 595 nm Vbeam Perfecta™ flashlamp-excited, pulsed dye laser in this study is to help improve study patients' skin disease. Cutaneous lupus erythematosus (CLE) often presents with disfiguring vascular lesions which are frequently difficult to treat with the available therapeutic measures, such as photoprotection, topical steroids, and antimalarials. Laser therapy provides an alternative treatment option for CLE patients. Although there has been documented experience with laser treatment in CLE patients, no study comparing treated lesions to the natural course of the disease has been conducted.

NCT ID: NCT00522002 Completed - Clinical trials for Rheumatoid Arthritis

CLUE Study: Connective Tissue Disease Leg Ulcer Etiology Study

CLUE
Start date: August 2007
Phase: N/A
Study type: Observational

To explore the hypothesis that leg ulcers are associated with hypercoagulable states, the CLUE study will evaluate patients with connective tissue disease associated leg ulcers, to identify risk factors (especially hypercoagulability and immunologic characteristics), characterize pathogenesis, predict response to therapy, and assess the impact of lower extremity ulcers on quality of life.

NCT ID: NCT00519363 Completed - Clinical trials for Systemic Lupus Erythematosus

Statins and Lupus: Effects of Statins on Clinical Lupus Parameters, Serological Markers and Toll-like Receptors

Start date: September 2007
Phase: Phase 1/Phase 2
Study type: Interventional

This is an open label pilot clinical trial on a cohort of 15 Lupus patients from the Center for Rheumatic Disease. Clinical evaluations and laboratory tests will be done and then if eligible, the patients will receive oral atorvastatin, at a fixed dose of 40mg/day. Statins have been shown to induce clinical improvement in rheumatoid arthritis patients, as well as lupus patients. The effectiveness has been noted within 8 to 14 days, we will do our study for 3 months. Clinical and laboratory tests will be checked at the 1 and 3 month interval. We hypothesize that statin drugs (atorvastatin) slow the progression of SLE(Systemic Lupus Erythematosus) disease activity and down regulates TLR(Toll-like receptors) 2,4,and 9 pathways in addition to lowering lipid levels.

NCT ID: NCT00513591 Completed - Clinical trials for Rheumatoid Arthritis

Duke Autoimmunity in Pregnancy Registry

DAP Registry
Start date: August 2007
Phase:
Study type: Observational

It is difficult to predict how a women with an autoimmune disease will do during pregnancy. Some women will improve, others will worsen. Some pregnancies progress normally and others become very complicated. The Duke Autoimmunity in Pregnancy (DAP) Registry will enroll women with autoimmune diseases, such as lupus, rheumatoid arthritis, scleroderma, and Sjogren's syndrome who wish to become, or already are, pregnant. We will follow these women throughout pregnancy to better understand how their autoimmune disease affects their pregnancy, and vice versa.