View clinical trials related to Systemic Lupus Erythematosus.
Filter by:To address the issues of skin denervation and its clinical and pathological correlations in systemic lupus erythematosus
The purpose of this study is to test the safety of triptorelin when used for the protection of the ovaries (pair of female reproductive organs) during cyclophosphamide therapy for systemic lupus erythematosus (SLE; lupus) and to see what effects (good or bad) it has on patients. The study will be done with female patients who have been diagnosed with systemic lupus erythematosus, are younger than 21 years of age, and require intravenous cyclophosphamide to control the disease. Each patient will be in the study for approximately 23 months, until 4 months after the intravenous cyclophosphamide treatment has been completed. This study is currently being conducted at 3 sites across the United States and Brazil (Los Angeles, Cincinnati and San Paulo Brazil). A total of 50 patients will participate in this study. Each patient will be randomized (assigned) to one of 5 groups. Randomization means that patients are put into a group completely by chance. It is like flipping a coin. Neither the patient nor the study staff knows what group the patient is in. The patient has a 20% chance of being placed in any group. This is a dose escalation study, each patient will receive the first dose of the study drug (T1 - T4, placebo). If a patient has complete ovarian suppression on day 27 after the initial injection of study drug, then she will remain on this weight-adjusted dose of study drug throughout the study. The dose will be increased up for a weight gain of 5kg or greater. The dose will not be adjusted downward for a weight loss. If COS was not maintained with the 1st dose of study drug, then the subsequently injected 2nd dose will be increased by 25% or at least 20 microgram/kg/dose. The maximal dose of 150 microgram/kg/dose will not be exceeded. The absolute maximum dose is 20 mg. Funding Source: FDA OOPD and Watson Pharmaceuticals
Cardiovascular disease, specifically from atherosclerosis, is the major cause of mortality in systemic lupus erythematosus (SLE) in developed countries. Coronary artery disease and stroke contribute to long-term morbidity in surviving patients. Atherosclerosis in SLE is multifactorial, with immune/inflammatory endothelial damage, traditional cardiovascular risk factors, and prothrombotic factors all playing important roles. Multiple groups have shown that hyperlipidemia is predictive of later atherosclerosis in SLE. In the general population, statins have become the drug of choice in preventing atherosclerotic events, through two mechanisms: lipid lowering that helps to prevent progression, and stabilization of plaques to prevent rupture. In the Lupus Atherosclerosis Prevention Trial we will determine if atorvastatin reduces the progression of atherosclerosis on helical computed tomography (CT) and carotid duplex. Recent work has confirmed that statins have an immunomodulatory role. This study will also determine whether statins improve clinical lupus activity or lupus serologies (anti-dsDNA and complement).
The purpose of this clinical research study is to learn whether Abatacept can treat and prevent lupus flares; specifically, in patients with active lupus flares in at least one of three organ systems: skin (discoid lesions); inflammation of the lining of the heart (pericarditis), or inflammation of the lining of the lung (pleuritis/pleurisy); or inflammation of more than 4 joints (arthritis). All participants will receive prednisone or prednisone-equivalent treatment in combination with study medication. The safety of this treatment will also be studied.
The purpose of the study is to evaluate the safety & efficacy of Epratuzumab with standard treatments for patients with SLE.
Open label safety and efficacy follow-up.
Women with lupus and other related disorders produce certain antibodies in the blood. Some women have these antibodies even if they have not yet developed symptoms of lupus or Sjogren's syndrome. When these women become pregnant, they may pass the antibodies to their infants. The infants may then develop a disease called neonatal lupus. The symptoms of neonatal lupus include an abnormally slow heart beat (heart block) and a skin rash. This registry collects information on women and infants affected by neonatal lupus as well as other family members who may be healthy.
The Lupus Genetics Studies and Lupus Family Registry & Repository are working to find the genes that reveal the causes of systemic lupus erythematosus (SLE, or lupus). The study is enrolling families of all ethnic backgrounds from the United States, Canada, Puerto Rico, and the Virgin Islands that have one or more living members diagnosed with SLE.
This study will explore the diverse health beliefs and behaviors among minority patients with rheumatic diseases. These diseases may cause joint pain, stiffness or swelling. Some can involve bones, muscles, tendons or ligaments. Some cause abnormalities of the immune system-the body's defense against disease. Some rheumatic diseases are painful or deforming and some can be life-threatening. Many rheumatic diseases occur more often and more severely in certain minority communities. This study will explore psychosocial and cultural factors related to rheumatic disease in minorities. Patients enrolled in the NIAMS protocol Natural History or Rheumatic Disease in Minority Communities (protocol #01-AR-0227) may participate in this study. Participants will be evaluated at the NIAMS Community Health Center at the Upper Cardozo Health Center in Washington, D.C. Participants will be interviewed about individual and community health behavior, and health beliefs about rheumatic disease and its effects on several areas of their life, including mood and physical activity. The interview will be in one of the following formats: 1) in-depth cognitive interview, 2) focus group, or 3) face-to-face interview, as follows: In-Depth Cognitive Interview Participants take part in a one-time interview conducted by one investigator, observed by another, and tape recorded. The interview lasts from 1 to 2 hours. Focus Groups Participants take part in a group interview of from 6 to 10 people during a one-time tape-recorded session that lasts from 2 to 2-1/2 hours. The group discussion is led by a moderator and a facilitator, who takes notes and makes observations. Face-to Face Interview Participants are interviewed twice - first upon enrollment at the NIAMS Community Health Center and again after 6 months' follow-up at the Center.
This study will examine families in which one sibling of a sibling pair, or twin pair, has developed a systemic rheumatic disease and one has not, to see if and how the two differ in the following: - Blood cell metabolism; - Types of cells in the blood; - Environmental exposures or genetic factors that might explain why one developed disease and the other did not. Families in which one sibling has developed a systemic rheumatic disease, rheumatoid arthritis, systemic lupus erythematosus, scleroderma, dermatomyositis, or myositis, and the other has not, are eligible for this study. The siblings may or may not be twins, but must be of the same gender and be within a 5-year age difference. Biological parents, or, in some cases, children, will also be included in the study. Normal, healthy volunteers will serve as control subjects. Participants will undergo some or all of the following tests and procedures: - Medical history and physical examination. Participants will also be asked permission to obtain medical records for review. - Questionnaires about environmental exposures at work, at home, and elsewhere. Probands (participants with rheumatic disease) and their healthy siblings will also answer questions about infections, vaccinations, medications or dietary supplements, sun exposure, and stressful events during the year before disease diagnosis in the affected sibling. - Blood and urine collection for the following tests: - Routine blood chemistries and other studies to rule out certain diseases or medical problems; - Evidence of past toxic exposures and certain infections; - Presence of cells from the mother in the child s blood and vice versa. (Recent studies suggest that during pregnancy or delivery, cells from the mother and baby may be exchanged and circulate in the body for many years, possibly causing problems); - In twin or sibling pairs, presence of certain genes that may be more common in patients with systematic rheumatic diseases as compared with their unaffected siblings and normal volunteers; - In identical twins, comparison of their blood cell metabolism to see if and how the metabolism differs in people with rheumatic disease. Participants may be asked for permission to have some of their blood and urine samples stored and to obtain previously collected blood or tissue biopsy specimens that are no longer needed for clinical care, for research purposes. They may also be asked to give additional blood or urine samples. Participants will be followed every year for 5 years (either in person or by questionnaire) to evaluate any changes in their condition. The final 5-year evaluation will repeat some of the questionnaires and procedures described above.