Active clinical trials for "Lupus Erythematosus, Systemic"

Diagnosis and follow up of a lupus cohort in a multidisciplinary consultation in Brest ( France)

The goal of this observational and pilot study is to better understand how depression symptoms may contribute to how well adolescent and young adults with lupus follow-up with their lupus clinical care. The main questions it aims to answer are: Whether anhedonia (a core symptom of depression) predicts disengagement in care Whether a patient-tailored mobile health application built to improve both engagement in care and depression symptoms will be feasible and acceptable to adolescents and young adults with lupus. Participants with systemic lupus, ages 15-24 from the Bronx, New York will be asked to complete questionnaires; some will be asked to participate in focus groups to help adapt the mobile health app; participants will also be invited to join a pilot study to try the mobile health app for 6 months and answer questionnaires to document the experience.

Background: Systemic lupus erythematosus (SLE) is a disease that affects females nine times more often than males. People with SLE are often treated with cyclophosphamide (CYC). But CYC can damage a woman s ovaries; it may cause infertility. A drug called GnRHa is sometimes given to protect the ovaries during CYC therapy. But no one really knows how effective GnRHa treatment is. This natural history survey will compare women who received GnRHa during CYC therapy with those who did not. Objective: To find out whether GnRHa can help protect women s ovaries during CYC. Eligibility: Women under age 40 years starting CYC treatment with or without GnRHa. Design: This study will do 2 things: It will conduct patient surveys. It will collect data from medical records. Participants will complete a one-time survey. They will answer questions about their menstrual cycle. They will be asked about their history of pregnancy or infertility. Participants can take the survey in 4 ways: On paper, sent through the mail. Online, in a secure web page managed by the NIH. By phone. In person, during a routine visit to the NIH clinic. The survey will take about 30 minutes. Participants medical records will be reviewed. Researchers will look for data about the participants SLE disease. This may include their symptoms and the results of their blood tests. It may also include the details of prior treatments. Researchers will also collect data about participants reproductive history. This may include their personal or family history of infertility. It may include any fertility treatments and any sexually transmitted infections.

The purpose of this study is to investigate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of RO7507062 in participants with systemic lupus erythematosus (SLE). The study will have 2 parts: Part 1 is a single ascending dose-finding (SAD) part and Part 2 is a dose escalation with fractionated dosing part.

Lupus nephritis (LN) may affect approximately half of patients with Systemic Lupus Erythematosus (SLE). LN is a major cause of morbidity and the most important predictor of mortality in patients with SLE. Some 5-20% of patients with LN may develop end-stage renal disease within 10 years of follow-up from the time of diagnosis. Other studies have described progression to end-stage renal disease in 10-30% of patients with LN. The European League Against Rheumatism, the European Renal Association and the European Dialysis and Transplant Association have recently updated their recommendations for the management of LN. These recommend the use of intravenous (IV) methylprednisolone boluses followed by lower doses of oral glucocorticoids (GC) and place mycophenolate mofetil (MMF) and the European regimen of cyclophosphamide (CYC) as the immunosuppressive drugs of first choice, with the IV CYC regimen for certain more aggressive cases. They also consider the use of "multitarget therapy" based on the combination of tacrolimus (TAC) and MMF and GC in patients with proteinuria in the nephrotic range who have not responded to the first line of treatment. For refractory active renal disease, they recommend as an alternative the use of rituximab (RTX) 1000 mg IV repeated after 15 days. Belimumab has been shown to be significantly more effective than placebo in the treatment of patients with active LN. This finding will lead to positioning belimumab in the therapeutic algorithm for LN. However, in clinical practice these immunosuppressive drugs are not always effective in the treatment of LN, and even one in 3 patients with an initial favorable response may experience renal recurrence. The choice of the appropriate treatment for LN and its early initiation are key to improve the prognosis of these patients and to avoid progression to chronic renal failure. The identification of biomarkers capable of predicting the response (or lack thereof) to one or another therapy at the time of LN diagnosis would allow to implement precision medicine, thus constituting a revolution in the treatment of patients with LN. Allows more targeted treatments with greater specificity to be established. The objective of this project is to analyze histopathological biomarkers in the renal biopsy to predict the renal response to the different drugs used in the treatment of LN. This would contribute to a more specific and cost-effective therapeutic strategy.

The goal is to evaluate adverse pregnancy outcomes (APO), their predictors and potential preventive therapies, such as aspirin (ASA). The investigator aims to improve the outcomes for women with SLE and offsprings. By quantifying the risk of APO conferred by clinical risk factors that can be assessed early in pregnancy (i.e. first trimester), health professionals could be better equipped to estimate the individual risk of SLE pregnancies and the need for heightened surveillance and guide counseling for prophylactic measures, including ASA. Moreover findings from this study could eventually lead to the choice and weighting of first trimester clinical factors in future clinical prediction models for APO in SLE. The investigator's research efforts will improve reproductive health of SLE women, "mitigating the damage, functional loss, and disability that result from a chronic inflammatory disorder", such as SLE.

Multicenter, national, two-armed cluster-randomized controlled trial to evaluate the effect of a treat-to-target (T2T) strategy in in systemic lupus erythematosus (SLE). 14 centers will be randomized 1:1 to T2T or standard of care. Per arm 303 patients with SLE who are not in remission will be included and receive either tight control with 6-weekly visits with the aim to reach remission or SoC with control visits and treatment adjustment according to the physicians discretion. Study duration is 120 weeks using damage accrual and Health related Quality of Life as major outcomes.

The purpose of this study is to unravel the proportion of monogenic lupus in children onset Systemic lupus erythematosus (SLE), and to find out the diagnostic strategy for early detection of monogenic lupus.

This is a randomized, multi-site, adaptive, open-label clinical trial comparing the immune response to different additional doses of COVID-19 vaccine in participants with autoimmune disease requiring IS medications. All study participants will have negative serologic or suboptimal responses (defined as a Roche Elecsys® Anti-SARS-CoV-2 S result ≤200 U/mL) or a low immune response (defined as a Roche Elecsys® Anti-SARS-CoV-2 S result >200 U/ml and ≤2500 U/mL) to their previous doses of COVID-19 vaccine. The study will focus on 5 autoimmune diseases in adults: Systemic Lupus Erythematosus (SLE) Rheumatoid Arthritis (RA) Multiple Sclerosis (MS) Systemic Sclerosis (SSc), and Pemphigus. This study will focus on 4 autoimmune diseases in pediatric participants: Systemic Lupus Erythematosus (SLE) Juvenile Idiopathic Arthritis (JIA) Pediatric-Onset Multiple Sclerosis (POMS) Juvenile Dermatomyositis (JDM)

In order to achieve accurate diagnosis and treatment of the disease, we performed RNA sequencing and ATAC(Assay for Transposase Accessible Chromatin) chromatin open sequencing in lupus patients in the early stage. By comparing with normal controls, other rheumatic immune diseases (rheumatoid arthritis), and before and after treatment, dozens of disease-causing genes independently associated with the disease were identified. Based on the previous omics results, this project will analyze its changes in different outcomes of lupus patients, and use machine learning methods to establish an optimal severe prediction model, so as to build an early diagnosis system based on novel biomarkers and reduce all-cause mortality in patients with treatment failure rate. It is expected to produce good social and economic benefits.