Compassionate Use for Subcutaneous (SC) Belimumab
Systemic Lupus ErythematosusGlaxoSmithKline (GSK) have submitted a Biologic License Application (BLA) for the subcutaneous formulation of belimumab which is currently under review by the Food and Drug Administration (FDA). The goal of this individual patient compassionate use supply is to provide a patient with subcutaneous belimumab for the period of 1 year or until the subcutaneous formulation of belimumab becomes approved for use by the FDA and is commercially available to this patient, whichever is sooner. You can access GSK's Policy on Compassionate via http://www.gsk.com/media/3368/compassionate-use.pdf.
Individual Patient Expanded Access IND of Autologous HB-adMSCs for the Treatment of Systemic Lupus...
System; Lupus ErythematosusThis protocol is part of an FDA Individual Patient Expanded Access IND. This study is to be conducted according to US and International Standards of Good Clinical Practice (FDA Title 21 part 312 and International Conference on Harmonization guidelines), applicable government regulations and Hope Biosciences Stem Cell Research Foundation policies and procedures.
Register of Patients With Anti-Phospholipids Syndrome (APS) and/or Systemic Lupus Erythematosus...
Anti-Phospholipids Syndrome (APS)Systemic Lupus Erythematosus (SLE)The purpose of that register is to collect medical information about patients suffering of APS with or without associated SLE.
Psycho-social Consequences of Systemic Lupus Erythematosus
Lupus Erythematosusthis project will allow us to evaluate and understand the impact of SLE on the couple's life and its relational and affective components. In addition, the Psy-LUP study will describe the representations that sick people and their relatives have of lupus disease. All the data collected will make it possible to target interventions with 1) patients and their relatives, in terms of therapeutic education, psychosocial support, support groups (associations); 2) caregivers caring for people with SLE, so that they can integrate the issues of the patient's experience in their care practice and their reflection on therapeutic strategies.
Translation of a Diagnostic Test for Lupus Flare Prediction From Bench to Clinic
System; Lupus ErythematosusLupus Erythematosus2 moreThis study is investigating the development of a diagnostic test intended to predict flares in patients with Systemic Lupus Erythematosus. Over a six-month period, the participant will donate blood samples for researchers to evaluate the types of proteins that are in their blood. During this time the participant will also visit a research physician to undergo a physical exam that will include an evaluation of the disease's level of activity. Questionnaires will be answered too, either via email, phone call, or a research app for android and iPhone devices. During this six-month period, if the participant experiences a lupus flare, they are strongly encouraged to visit the research physician to receive a complimentary medical evaluation.
Prevalence and Seroconversion of COVID-19 in Autoimmune Diseases in Europe
COVID-19Systemic Lupus Erythematosus4 moreThe coronavirus disease 2019 (COVID-19) pandemic is a potentially fatal disease that represents a great global public health concern. In European countries such as Spain, Italy, Germany, Portugal, England and France, the pandemic has been of utmost importance. To date, no treatment has been robustly validated, and two theoretically opposite therapeutic strategies are proposed, based either on antiretroviral therapy or on immunomodulating agents. In this complex context, people living with immune-mediated inflammatory diseases (IMID) raise specific concerns due to their potentially increased risk of infections or of severe infections. Among IMID, Sjögren's syndrome, systemic lupus erythematosus, rheumatoid arthritis, spondyloarthritis and giant cell arteritis are some key diseases. In this cross-sectional, observational, multi-centric study, the investigators aim to assess both clinical and serological prevalence of COVID-19 among samples of IMID patients in Europe. In parallel, the investigators aim to compare the prevalence of COVID-19 seroconversion across these five IMIDs, their penetration across different 6 European countries (France, Italy, Spain, Germany, United Kingdom and Portugal), and to assess the severity of COVID-19 in these patients. Moreover, changes in treatment will be assessed, including immunomodulatory tapering or discontinuation, its causes over the outbreak period, as well as the incidence of IMID flares and their severity over this same period. Finally, patient's perceptions towards the pandemic will be evaluated and compared to medication beliefs. Data will be collected through questionnaires during medical visit or phone consultation and serological tests will be performed within routine blood collection. As so, all study procedures are comprised within usual care. Through this study the investigators expect to have a better knowledge of the clinical and serological prevalence of COVID-19 in IMID across Europe, along with the psychological, clinical, and therapeutic impact of COVID-19 in this particular patient population.
Expression of CXCR4 in Patients With Systemic Lupus Erythematosus
Systemic Lupus ErythematosusThe objective of this study is to estimate the possible role of CD184 in the pathogenesis of SLE; comparing its level among SLE cases to healthy controls.
Serologic Profile of SARS CoV2 in COVID-19 Patients With Systemic Diseases
SARS-CoV InfectionSystemic Disease7 moreAn observational study aiming to assess the serological profile of SARS-Cov2 patients with systemic diseases such as systemic lupus erythematosus, Sjogren syndrome, sarcoidosis, inflammatory myopathies, Behçet's disease, Rheumatoid arthritis and Spondyloarthritis
Role of Altered CD40-Ligand Gene Transcription in Systemic Lupus Erythematosus
Lupus ErythematosusSystemicSystemic lupus erythematosus is an often devastating autoimmune disease which affects 1 in 2,000 women in the United States. Recently, several research laboratories have reported that a protein, named CD40-ligand (CD154), is overexpressed by a subset of white blood cells, called lymphocytes, in patients with lupus. Expression of CD154 appears critical to the generation of antibodies that cause disease in lupus. Blocking CD154 interactions in the immune system has been shown to decrease disease activity in animal models of lupus. We propose to study the regulation of CD154 in patients with lupus in hopes of inhibiting its abnormal and deleterious expression.
Haematological Indices in Systemic Lupus Erythematosus
Rheumatic DiseasesSystemic Lupus ErythematosusThe aim of this study is to investigate the value of several hematological indices such as: neutrophil-lymphocyte ratio. platelet-lymphocyte ratio. red blood cell distribution width. mean platelet volume (MPV), RDW/platelet ratio. neutrophil / C3 ratio. All these as biomarkers of activity in systemic lupus erythematosis patients.