View clinical trials related to Lupus Erythematosus, Systemic.
Filter by:This is a phase I, interventional, single arm, open label, treatment study to evaluate the safety and tolerability of BCMA-CD19 cCAR T cells in patients with relapsed and/or refractory SLE.
A study of CM313 in subjects with systemic lupus erythematosus
The natural history of Systemic lupus erythematosus (SLE) is characterized by relapses or flares alternated with periods of remission. Flares are associated with accrual of organ damage independently of other risk factors, both contributing to a considerable morbidity. No useful biomarker is currently available to predict which patients with a quiescent disease are at risk of flare. The 3TR project (funded by the Innovative Medicines Initiative 2 Joint Undertaking under grant agreement No 831434, and supported by European Union's Horizon 2020 research and innovation programme and EFPIA) is a transdisciplinary consortium that primary aims at identifying biosignatures as predictors of response and non-response to therapy in seven different autoimmune, allergic and inflammatory diseases, including SLE. 3TR will perform a longitudinal multi-dimensional molecular analysis in patients with these diseases. A molecular profiling approach is a modern and innovative way to investigate and stratify heterogeneous diseases on the basis of their common biomolecular pathways. The main hypothesis of the 3TR project is that data obtained from multiomic analysis across the seven different diseases will identify shared biological pathways that better predict the response or non-response to therapy despite their differences in terms of clinical phenotypes and pathogenetic mechanisms. Therefore patients from multiple European centers participating in 3TR will be recruited for a longitudinal clinical follow-up and collections of several samples that will be used to perform multi-omic analysis.
People with inflammatory diseases treated with immune-suppressing medication are recommended to have regular blood-tests to monitor for potential side-effects of this treatment on their blood count, liver and kidneys. However, it is not clear that monitoring is needed as frequently as currently recommended in the long-term, with side-effects being rare after one year of treatment. A study is currently underway to determine the optimal blood-test monitoring strategy which is cost-effective but still safe. Any changes in the monitoring strategy must be acceptable to patients and the healthcare professionals (HCP) that treat them. This study aims to measure how often patients' with common inflammatory conditions on long-term immune suppressing medication attend their monitoring blood tests as currently recommended, and uncover patients' and HCP views and experiences of the current blood-test monitoring strategy, and the acceptability of potential changes to this in the future. Firstly, patients with an inflammatory condition on long-term immune suppressing treatment will be invited to complete a questionnaire which will ask about their demographic information, medical condition(s), immune-suppressing treatment, adherence to the monitoring blood tests and willingness to take part in an interview. Then, both patients and HCPs who care for such patients will be invited to take part in a single, semi-structured interview. Interviews will be face-to-face, by telephone or video-call, last up to one hour and digitally audio-recorded. Patient interviews will explore their perceptions of risk, benefits and experiences of current testing, and views on the new testing frequencies emerging from the study prior. HCP interviews will explore their perceptions of current testing including, the practicalities, usefulness, risks and benefits of the blood tests, and views on the new testing frequencies emerging from the study prior. The findings will shape the recommendations for a new monitoring strategy, ensuring it is acceptable to patients and HCPs.
The aim of this study is to examine the effect of Self-acupressure application on pain, fatigue and sleep quality in sle patients.
Women with systemic lupus erythematosus (SLE) have a high risk of placenta-mediated complications, which can lead to substantial cardiac morbidities in affected women and their offspring. In addition, maternal autoantibodies, which are actively transferred across the placenta during pregnancy, can affect the cardiovascular health of SLE offspring. Hydroxychloroquine (HCQ) is effective in preventing adverse pregnancy outcomes in SLE and might be beneficial in preventing fetal cardiovascular damage mediated by maternal autoantibodies. However, there are concerns that HCQ might cause maternal and neonatal cardiac toxicity. A novel imaging technique (i.e. speckle tracking echocardiography), which allows early identification of cardiac dysfunction, has proven superior to any other in assessing cardiac function in mothers and neonates experiencing placenta-mediated complications and in identifying drug cardiotoxicity. Yet, there has been no study using speckle tracking echocardiography to evaluate the cardiovascular health of pregnant SLE women and their offspring, as well as the potential adverse cardiac effect of HCQ. Moreover, due to unavailability of assays, HCQ dosing in SLE is generally done blindly, without checking drug levels. To fill these key knowledge gaps, the investigators aim to: 1) assess the impact of placenta-mediated complications on maternal and neonatal cardiac function, 2) evaluate if HCQ exposure (as measured by whole-blood levels) is associated with maternal and neonatal outcomes including cardiac toxicity, and 3) determine the effect of maternal autoantibodies on neonatal cardiac function. Ultimately, our proposal will help optimize reproductive and cardiovascular outcomes in lupus women and their offspring.
The aim of this research project is to better understand the origin and clinical significance of two lupus-specific "genetic signatures" (IFN signature and plasma cell signature) in patient subgroups with well-defined clinical characteristics. Our aim is to correlate these genetic signatures with cell activation profiles and the production of specific cytokines in different populations from whole blood and in short-term cultures of these circulating cells.
Background: People with systemic lupus erythematosus (SLE) are at risk of developing complications in their blood vessels. This can increase the risk of heart attacks or stroke. No medications have been effective at reducing this risk in people with lupus. Objective: To test whether a drug (anifrolumab) can improve blood vessel function and reduce blood vessel inflammation in people with SLE. Eligibility: People aged 18 to 80 years with SLE. Design: Participants will undergo screening. They will have a physical exam. They will have blood and urine tests. They will have a test of their heart function and a chest X-ray. They will answer questions about their SLE symptoms. Participants will visit the clinic 9 times in 8 months. After screening, visits will be 4 weeks apart. Each visit may take up to 4 hours. Participants will receive infusions from a tube attached to a needle inserted into a vein in the arm (IV). Some will receive anifrolumab. Others will receive a placebo treatment. They will not know which one they are getting. At some visits they will have additional tests: CAVI (cardio-ankle vascular index) tests blood vessel function. Participants will lie still for 20 minutes. Small electrodes will be placed on both wrists with stickers. A microphone will be placed on their chest. Blood pressure cuffs will be wrapped around their ankles and arms. FDG-PET/CT is an imaging procedure. Participants will receive a substance through an IV line. They will lie on a table for 110 minutes while a machine captures images of their body.
Dysbiosis, or disruption of the gut microbiota, leads to the onset of autoimmunity. Increasing data suggest that the gut microbiota is changed in various murine lupus models as well as in human systemic lupus erythematosus SLE patients. Ingestion of lactobacilli, which have immunoregulatory properties, may be a viable strategy for controlling disease development and progression in patients with lupus, such as increasing the remission period and decreasing flare frequency.
A Phase 2, Open-Label Extension study to evaluate the long-term safety and tolerability of daxdilimab in participants with Systemic Lupus Erythematosus completing the treatment period of the RECAST SLE clinical study.