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Lupus Erythematosus, Systemic clinical trials

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NCT ID: NCT02925351 Completed - Clinical trials for Rheumatoid Arthritis

Fluorine F 18 Clofarabine PET/CT in Imaging Patients With Autoimmune or Inflammatory Diseases

Start date: January 25, 2016
Phase: Early Phase 1
Study type: Interventional

This pilot trial studies how well fluorine F 18 clofarabine positron emission tomography (PET)/computed tomography (CT) works in imaging patients with autoimmune or inflammatory diseases. Fluorine F 18 clofarabine is an imaging agent or tracer which may be taken up by inflammatory tissue in the body. Diagnostic imaging, such as PET/CT scans, can be used to measure the amount of injected tracer that is taken up by inflammatory tissue. PET/CT scan may help to determine how fluorine F 18 clofarabine is distributed throughout the body.

NCT ID: NCT02922114 Completed - Clinical trials for Lupus Erythematosus, Systemic

Comparison of the Clinical Examination and the Joint Ultrasonography in Lupus Patients

LUPUS
Start date: September 2013
Phase: N/A
Study type: Interventional

Arthritis is a current manifestation of systemic lupus erythematosus (SLE) and participates to the SLEDAI composite score calculation (0 to 105). Ultrasonography (US) is a validated and sensitive tool for joint assessment. Published studies showed US joint abnormalities in systemic lupus erythematosus patients with or without joint pain. Nevertheless, ultrasonography evaluations were not standardized and no study compared clinical and ultrasonography assessments. The objectives were 1) to describe ultrasonography joint abnormalities in systemic lupus erythematosus population, 2) to compare clinical and ultrasonography standardized joint assessments, 3) to estimate the reliability of clinical swollen joint count (C-SJC) and SLEDAI (C-SLEDAI) score versus ultrasonography-SJC and ultrasonography-SLEDAI.

NCT ID: NCT02920424 Withdrawn - Clinical trials for Lupus Erythematosus, Systemic

A Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of JNJ-56022473 in Subjects With Systemic Lupus Erythematosus

Start date: June 30, 2017
Phase: Phase 1
Study type: Interventional

The purpose of this study is to assess the safety and tolerability of JNJ-56022473 following multiple subcutaneous (SC) study agent administrations in subjects with Systemic Lupus Erythematosus (SLE) and to determine whether premedication with corticosteroids is required to improve the tolerability of SC JNJ-56022473.

NCT ID: NCT02920346 Completed - Sjogren's Syndrome Clinical Trials

Prospective Maternal Surveillance of SSA (Sjögren Syndrome A) Positive Pregnancies Using a Hand-held Fetal Heart Rate Monitor

Start date: March 2014
Phase:
Study type: Observational

The purpose of the research study "Heart Sounds at Home" is for pregnant SSA or SSA/SSB (Sjögren syndrome B) antibody positive mothers to use a Doppler fetal heart rate monitor to detect abnormal heart rates and rhythms in their babies before they are born.

NCT ID: NCT02917265 Terminated - Clinical trials for Systemic Lupus Erythematosus

Transcutaneous Vagus Nerve Stimulation for the Treatment of Lupus

TRUST
Start date: November 2015
Phase: Phase 2
Study type: Interventional

This is a 3-month double blinded randomized controlled study of transcutaneous electrical vagus nerve stimulation (tVNS) compared to a sham stimulation for the treatment of patients with active systemic lupus erythematosus (SLE).

NCT ID: NCT02908100 Completed - Clinical trials for Systemic Lupus Erythematosus

A Study of the Safety and Efficacy of GDC-0853 in Participants With Moderate to Severe Active Systemic Lupus Erythematosus

Start date: January 19, 2017
Phase: Phase 2
Study type: Interventional

This is a study to evaluate the safety and efficacy of GDC-0853 in combination with standard of care therapy in participants with moderate to severe active systemic lupus erythematosus (SLE).

NCT ID: NCT02891213 Not yet recruiting - Lupus Erythematosus Clinical Trials

Study of the Role of Soluble Forms of RAGE (sRAGE/esRAGE) as Diagnostic and Prognostic Biomarkers of Systemic Lupus Erythematosus.

R-PA14098
Start date: November 2016
Phase: N/A
Study type: Observational

Systemic Lupus Erythematosus (SLE) is the most common systemic autoimmune disease. The clinical manifestations are severe and affect multiple target organs such as the kidney, central nervous system, skin, heart and joints. Despite the progress made in the therapeutic approach with new immunosuppressive regimens, morbi-mortality is still high. Therefore, it's important to identify new biomarkers to help clinicians to predict severity and evolution of the disease for better adaptation of treatments and try to improve the prognosis. RAGE (Receptor for Advanced Glycation Endproducts) : RAGE (Receptor for Advanced Glycation Endproducts) is an ubiquitous membrane receptor, involved in development of many diseases such as diabetes, chronic renal failure but also in vascular remodelling, inflammatory, infectious deseases and cancer. RAGE regulates a number of crucial cell processes like inflammation, and tissue and cellular homeostasis. RAGE is able to bind not only the advanced glycation end products (AGEs) such as pentosidine, carboxymethyllysine (CML), methyl-glyoxal-hydroimidazolone-1 (MG- H1), but also other ligands such as HMGB1 (high mobility group box1), and S100A8/A9 proteins which have been correlated in recent studies to the activity index of SLE. The activation of RAGE leads to a cascade of intracellular signaling and activation of the transcription factor NF-ΚB . NF-ΚB enable the traduction of proinflammatory cytokines such as IL-6, IL-1α ,IFN-γ. In SLE, these cytokines involved in perpetuation of inflammation and tissue damages including lupus nephritis. Moreover, the activation of RAGE induces the expression of adhesion molecule such as sICAM -1 and sVCAM -1 wich were recently involved in SLE vasculitis. Soluble forms of RAGE, sRAGE and esRAGE : RAGE is a proinflammatory membrane receptor. But RAGE also exists in soluble plasma forms, esRAGE (secreted form) and sRAGE (a truncated form as cleaved by MMP9 and ADAM10 enzymes). esRAGE and sRAGE have the same ligand-binding specificity as RAGE and may function as a 'decoy receptor' by binding pro-inflammatory ligands and preventing them from accessing cell surface RAGE (Kierdorf and Fritz, 2013). Therefore, both soluble forms have an anti-inflammatory action. Several studies have shown a decrease in circulating levels of sRAGE in patients with Rheumatoid Arthritis, or Sjögren Syndrome compared with healthy controls. However, the role of RAGE in SLE remains unknown. RAGE and Systemic Lupus Erythematosus, recent advances : Our team (Laboratory of Nephrology, CNRS UMR 7369, URCA) showed in a study in lupus RAGE knockout mice (B6/ MRL-FAS lpr/J RAGE-/-) a strong involvement of RAGE in systemic manifestations SLE. Recently, another report showed that sRAGE has an anti-inflammatory effect on the lupus nephritis and could be a potent therapy in mice. In humans, two studies show a correlation between the plasma level of sRAGE and lupus phenotype ( Nienhuis et al. , 2008). Working hypothesis : Based on the results and those of the current studies, the investigators think that RAGE axis and its soluble forms play a crucial role in the complex pathogenesis of SLE. The investigators hypothesize that plasma levels sRAGE and esRAGE are a reflection of the activity and the development of SLE in humans. Soluble forms of RAGE and ligands may be novel biomarkers of SLE and sRAGE a potent therapeutic target.

NCT ID: NCT02885610 Completed - Clinical trials for Systemic Lupus Erythematosus

Study of RC18 Administered Subcutaneously to Subjects With Systemic Lupus Erythematosus(SLE)

Start date: December 2015
Phase: Phase 2
Study type: Interventional

The purpose of this study is to initially access the safety and effectivity of RC18 combined with standard treatment and Placebo combined with standard therapy in subjects with Moderate to severe SLE, Besides ,to provide dose basis for follow-up clinical trials.

NCT ID: NCT02880852 Completed - Clinical trials for Systemic Lupus Erythematosus

Belimumab Phase I Study in Chinese Subjects With Systemic Lupus Erythematosus

Start date: January 23, 2017
Phase: Phase 1
Study type: Interventional

In China, Belimumab (GSK1550188) will be developed for a dosing regimen of once-monthly intravenous (IV) infusion for the treatment of SLE. This open-label, single dose study will evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of belimumab in Chinese SLE subjects. A total of approximately 20 subjects will be enrolled to receive IV infusion of 10 milligrams per kilogram (mg/kg) GSK1550188 on Day 0 for the treatment of SLE. Subjects will be followed for 84 days after the administration of drug.

NCT ID: NCT02875691 Completed - Clinical trials for Lupus Erythematosus, Systemic

Effect of Green Tea on Treatment of Lupus

Start date: September 2015
Phase: Phase 2
Study type: Interventional

This randomized double blind clinical trial performed on 68 patients (32 in intervention and 36 in control group) diagnosed with SLE. The patients in intervention group were given daily dose of 1000mg of aqueous green tea extract (of 6 gram of dried green tea leaf) in form of two capsules ( 500 mg). Also in control group, the patients were given daily dose of 1000mg of cellulose in form of two capsules ( 500 mg) Variables include SLE disease activity, some biomarkers of inflammation and oxidative stress and anthropometric indicators at baseline and end of the study. The investigators used SLEDAI (systemic lupus erythematous disease activity index ) questionnaire for evaluating the clinical signs of the disease. The questionnaires filled out at baseline and after 3 month.