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Lupus Erythematosus, Systemic clinical trials

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NCT ID: NCT00181298 Completed - Clinical trials for Systemic Lupus Erythematosus

Memantine in Systemic Lupus Erythematosus

Start date: March 2006
Phase: N/A
Study type: Interventional

Neuropsychiatric manifestations of Systemic Lupus Erythematosus (NPSLE) are both common and an important source of morbidity. Of the case definitions for NPSLE syndromes that have recently been developed, cognitive dysfunction appears to be the most prevalent. A novel mechanism is that a subset of SLE patients with cognitive dysfunction have antibodies in the NR2 glutamate receptor. We propose, in a double -blind placebo-controlled trial, to determine whether SLE patients, with or without the NR2 glutamate receptor antibody, have significant improvement using memantine, an inhibitor of the NMDA receptor.

NCT ID: NCT00172666 Recruiting - Clinical trials for Rheumatoid Arthritis

Decoy Receptor 3 (DcR3) Polymorphisms in Rheumatoid Arthritis (RA) and Systemic Lupus Erythematosus (SLE)

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

Although SLE and RA are correlated with genetic predisposing factors such as human leukocyte antigen (HLA) class II, both diseases and other genetic factors might have contributed to the development of dysregulated lymphocyte activation and autoimmunity. Decoy receptor 3 (DcR3)/TR6 is a secreted protein belonging to the tumor necrosis factor (TNF) receptor family. It binds to Fas ligand (FasL), LIGHT, and TL1A that are all TNF family members. It was noted that soluble or solid phase DcR3-Fc co-stimulated proliferation, lymphokine production and cytotoxicity of mouse and human T cells upon T-cell receptor (TCR) ligation. Recently, the investigators found that the serum level of soluble DcR3 was higher in SLE patients than in healthy control subjects (unpublished data). Taken together, the investigators propose that in autoimmune diseases, such as RA and SLE, activated T cells secrete more DcR3 than non-autoimmune controls, which may, in turn, costimulate T cells further and cause dysregulated lymphocyte activation. With the aim to establish the possible correlation between DcR3 genetic polymorphisms, DcR3 expressions, and autoimmune phenotypes, the investigators offer this proposal. They plan to investigate the single nucleotide polymorphisms (SNPs) in the DcR3 gene. The genetic polymorphisms on the DcR3/TR6 gene and circulating DcR3 level will be compared between RA, SLE and non-autoimmune control subjects.

NCT ID: NCT00155532 Completed - Clinical trials for Systemic Lupus Erythematosus

Skin Denervation in Systemic Lupus Erythematosus

Start date: April 2002
Phase: Phase 1
Study type: Interventional

To address the issues of skin denervation and its clinical and pathological correlations in systemic lupus erythematosus

NCT ID: NCT00152555 Terminated - Clinical trials for Lupus Erythematosus, Systemic

Physical Therapy for Systemic Lupus Erythematosus (SLE)

Start date: March 2003
Phase: N/A
Study type: Interventional

The purpose of this study is to see if there is an improvement in patient's quality of life, pain, and fatigue after undergoing a supervised exercise program. If improvement is found, this will help guide standard of care with lupus patients with a focus on exercise for improvement of endurance, pain and overall health.

NCT ID: NCT00137969 Completed - Clinical trials for Lupus Erythematosus, Systemic

A Study to Evaluate the Safety of Rituximab Retreatment in Subjects With Systemic Lupus Erythematosus

EXPLORER
Start date: May 10, 2005
Phase: Phase 2/Phase 3
Study type: Interventional

This is a Phase II/III, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of rituximab compared with placebo when combined with a single stable background immunosuppressive medication in subjects with moderate to severe systemic lupus erythematosus (SLE). The primary efficacy endpoint of the trial will be evaluated at 52 weeks.

NCT ID: NCT00125307 Completed - Lupus Nephritis Clinical Trials

Tacrolimus for the Treatment of Systemic Lupus Erythematosus With Membranous Nephritis

Start date: January 2004
Phase: Phase 4
Study type: Interventional

The investigators study the efficacy and safety of tacrolimus in the treatment of membranous nephritis secondary to systemic lupus erythematosus.

NCT ID: NCT00124514 Completed - Clinical trials for Systemic Lupus Erythematosus

Triptorelin for Ovary Protection in Childhood Onset Lupus

Start date: June 2003
Phase: Phase 2
Study type: Interventional

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

NCT ID: NCT00120887 Completed - Clinical trials for Systemic Lupus Erythematosus

Lupus Atherosclerosis Prevention Study

Start date: April 2002
Phase: Phase 4
Study type: Interventional

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).

NCT ID: NCT00119678 Completed - Clinical trials for Systemic Lupus Erythematosus

Abatacept in the Treatment and Prevention of Active Systemic Lupus Erythematosus (SLE) Flares in Combination With Prednisone

Start date: September 2005
Phase: Phase 2
Study type: Interventional

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.

NCT ID: NCT00113971 Terminated - Clinical trials for Lupus Erythematosus, Systemic

Pharmacokinetics Study of Epratuzumab in Systemic Lupus Erythematosus (SLE)

Start date: April 2005
Phase: Phase 2
Study type: Interventional

The goal of this study is to evaluate how epratuzumab is processed by the body (pharmacokinetics) and whether 2 dose levels of epratuzumab are safe and effective in patients with SLE.