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Lupus Erythematosus, Systemic clinical trials

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NCT ID: NCT00611663 Completed - Clinical trials for Lupus Erythematosus, Systemic

Safety Study of Two Vaccine Strategies in Patients With Systemic Lupus Erythematosus

VACCILUP
Start date: May 2008
Phase: Phase 2/Phase 3
Study type: Interventional

The aim of this study is to compare the immunological efficacy of two pneumococcal vaccination strategies in patients with systemic lupus erythematosus (SLE) treated with corticosteroids associated or not with other immunosuppressive drugs : 1) a prime-boost strategy using vaccination with conjugate vaccine (Prevenar®) at week 0 and Poly Saccharidic vaccine (Pneumo23®) after 6 months (W24)2) compared to the standard vaccination with Poly Saccharidic vaccine (Pneumo23®) at W24 after placebo at W0

NCT ID: NCT00611611 Completed - Clinical trials for Systemic Lupus Erythematosus

BLYS and IFN in SLE

Start date: October 2007
Phase: N/A
Study type: Observational

This protocol tests whether changes in BLyS or IFN can be detected in a normal immune response to a vaccine and, if so, whether the response differs between those with lupus and healthy controls.

NCT ID: NCT00610805 Withdrawn - Clinical trials for Systemic Lupus Erythematosus

Cardiology Prevention in Systemic Lupus Erythematosus (SLE)

Start date: November 2009
Phase: N/A
Study type: Interventional

We propose a feasibility study of aggressive CV risk factor management directed by preventive cardiology compared to usual care. We will determine: 1) the efficacy of a preventive cardiology program compared to usual care in slowing the progression of carotid IMT and plaque, and 2) the effect of a preventive cardiology program versus usual care at achieving CV risk factor target goals. We hypothesize Lupus patients randomized to the preventive cardiology program will have less cardiovascular progression over two years than those lupus patients who are given standard care for cardiovascular risk, defined by carotid intima-media thickness and plaque.

NCT ID: NCT00608673 Completed - Clinical trials for Discoid Lupus Erythematosus

Comparing the Therapeutic Efficacy of Pimecrolimus Cream With Betamethasone Cream for Discoid Lupus Erythematosus

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

Discoid lupus erythematosus lesions are commonly treated with corticosteroids, but corticosteroids may induce side effects such as thinning of the skin or scarring. Therefore, an alternative medication with the same efficacy, but without the side-effects is sought after. Pimecrolimus is a newer drug specially designed to treat inflammatory diseases of skin. Its efficacy in treating discoid lupus erythematosus has not been studied extensively yet. However studies performed till now show promising results. Long-term topical use of this medication has not shown any serious side-effects in other skin diseases. In this study we aimed at comparing pimecrolimus efficacy with that of a common therapeutic choice, betamethasone valerate 0.1% cream, to see if pimecrolimus can be used as an alternative medication in treating discoid lupus erythematosus.

NCT ID: NCT00608127 Unknown status - Clinical trials for Systemic Lupus Erythematosus (SLE)

Study to Evaluate the Safety, Tolerability and Short Term Efficacy of Extracorporeal Specific Immunoadsorption LupusorbTM Columns for the Treatment of Systemic Lupus Erythematosus (SLE) Patients

Start date: January 2007
Phase: N/A
Study type: Interventional

Systemic Lupus Erythematosus (SLE) is a chronic, autoimmune, inflammatory disease primarily affecting women of childbearing age, and associated with severe morbidity and mortality of its victims. The existing therapy, however, is not specific and its inevitable side effects may themselves be fatal. Therefore, it is a widely recognized need for, and it would be highly advantageous to have a safe, specific rapidly effective and well-defined treatment of SLE, devoid of the disadvantages. We have shown that VRT101 a peptide present in the extracellular laminin is a target for pathogenic lupus autoantibodies. Using this peptide we have developed the LupusorbTM - an immune-adsorption column which specifically binds pathogenic antibodies from monoclonal cultures as well as from patients` plasma. The investigational product named LupusorbTM Column is a sterile medical device for single use and can be classified into category IIb (synthetic ligands, peptides) according to Annex IX of the European Medical Device Directive 42/93/EEC. The proposed study, a pilot non-randomized open label study, will test the safety, Tolerability and short term efficacy of a single immunoadsorption procedure in SLE patients.

NCT ID: NCT00594932 Completed - Clinical trials for Systemic Lupus Erythematosus

Biomarker-Linked Outcomes of Cellcept in Lupus Arthritis

Start date: November 2006
Phase: Phase 1/Phase 2
Study type: Interventional

We hypothesize that mycophenolate mofetil(Cellcept)is safe and effective for lupus arthritis. In this study, patients with lupus will be randomly assigned to receive mycophenolate mofetil or placebo (inert pills) for three months. At the end of three months all patients will receive mycophenolate mofetil for three additional months. The effectiveness on arthritis and other symptoms of lupus will be measured by joint counts and by the BILAG instrument (a measure of overall lupus disease activity. Additionally special blood tests aimed at understanding the biologic effects of mycophenolate mofetil will also be performed at some visits. The primary outcome measurement will be the safety and effectiveness of this treatment (as compared to placebo) at the three month point. The trial will continue in a blinded fashion (neither the investigator or the participants know who is getting mycophenolate and who is getting placebo) until 24 patients have completed the first three months of the protocol.

NCT ID: NCT00588393 Completed - Clinical trials for Rheumatoid Arthritis

FolateScan in Autoimmune Disease

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

This study will gather information on the safety of FolateScan and the ability of FolateScan to detect inflammation in the joints and other organs in people with arthritis (rheumatoid arthritis and osteoarthritis), systemic lupus erythematosus, multiple sclerosis, interstitial pneumonitis, Crohn's disease as well as in healthy persons without these conditions.

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: NCT00582881 Recruiting - Clinical trials for Systemic Lupus Erythematosus (SLE)

Characteristics and Disease Progression of Mixed Connective Tissue Disease and Systemic Lupus Erythematosus

Start date: October 2007
Phase:
Study type: Observational

Systemic lupus erythematosus (SLE) and mixed connective tissue disease (MCTD) are long-term autoimmune diseases in which the immune system attacks parts of the body. The abnormal immune reaction causes inflammation of and damage to various body parts and can affect joints, skin, kidneys, heart, lungs, blood vessels, and the brain. SLE and MCTD often affect young women, especially black and Hispanic women, and there is no known cure. Knowing more about SLE and MCTD will help in developing new and effective treatments. The purpose of this study is to characterize immune system abnormalities, genetic components, and disease progression in people with SLE and MCTD.

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.