View clinical trials related to Systemic Lupus Erythematosus.
Filter by:This study will be a non-interventional prospective study. Assessment of parameters will be carried out as if the patient is treated in a real-life clinical setting. The patients should be enrolled into this project after evaluation of eligibility criteria by the investigator in clinical sites who have an experience in management of patients with SLE. No additional procedures besides those already used in the routine clinical practice will be applied to the patients. The purpose of this study is to estimate prevalence of confirmed SLE in patients in rheumatological settings who has the reproductive issues and certain clinical and laboratory manifestations specific for immunoinflammatory diseases in Russia. We will follow all the local regulatory requirements regarding adverse event reporting (pharmacovigilance). It is planned to enrol 2000 patients in clinical sites in Russian Federation (N ≤ 15). The study will include two visits. During the screening visit women who meet the inclusion/non-inclusion criteria will be offered to participate and sign the informed consent form (ICF). Initial patient's data input will be done retrospectively (case report forms [CRF] will be filled in, a patient's visit will be conducted in accordance with the routine practice and healthcare professionals (HCPs) recommendations on an individual basis). An experienced rheumatologist will collect the baseline patient's characteristics such as demographic data, clinical profile, detailed obstetric/reproductive history. Women who had pregnancies in the past will be asked about the course of all pregnancies and their outcomes. Women will be asked to provide the corresponding medical records or discharge summaries, if possible, in order to input the data from them into the CRFs (the documents will be given back to women at the same visit). The immunologic blood test will be conducted in the reference laboratory. According to clinical examination and laboratory test results (ANA, immunoassay for specific antibodies (anti-Sm, and-dsDNA), antiphospholipid antibodies (anticardiolipin antibodies, anti-β3GP1 antibodies, lupus anticoagulant, complement components C3, C4, etc.) SLE diagnosis will be made or rejected. One follow-up visit will be conducted for those women who were referred to a laboratory testing for SLE. The visit will include the laboratory analyses assessment by an experienced rheumatologist with a subsequent confirmation or rejection of the SLE diagnosis. The last date of enrolment - Dec 2023. Last patient last visit (approximately 4 months from the study start): patient's data input will be done for enrolled patients.
The ERYTHRO study is a retrospective medical chart review study of patients in the AMANA and ATUc Early Access Programs (EAPs) across a number of countries, to assess anifrolumab usage and patient experience in treating SLE in a real-world setting. Since patient safety data are already collected and reported according to regulatory requirements through EAPs, this study will not collect safety data.
The purpose of this study is to determine the safety and tolerability of imvotamab in patients with severe systemic lupus erythematosus who have failed prior therapies. Participants will be given imvotamab through a vein (i.e., intravenously).
The goals of this clinical study are to learn more about the study drug, GS-0272, and its safety and tolerability following multiple doses in participants with rheumatoid arthritis (RA) and systemic lupus erythematosus (SLE). The primary objectives of this study are to assess the safety and tolerability of multiple ascending subcutaneous (SC) doses of GS-0272 and to characterize the pharmacokinetics of GS-0272 following multiple SC doses of GS-0272, in participants with RA or SLE.
To investigate the immunogenicity, reactogenicity and safety of 2 doses of the adjuvanted herpes zoster subunit vaccine (Shingrix) in patients with SLE in a randomized trial.
The goal of this case control observational study is to asses anxiety, sleep, depression and quality of life in Systemic Lupus Erythematosus (SLE) patients. The main aims are: - asses anxiety, sleep, depression and quality of life in SLE patients - their relation to disease activity we will compare SLE patients to healthy subjects.
Inflammatory rheumatic diseases affect 1% of the population. Treatment of such diseases should be based on disease activity, safety issues and other patient characteristics such as comorbidities (EULAR, 2022), leading to a higher risk of cardiovascular diseases. To this end, the general treat-to-target approach, as recommended in the EULAR guidance, may require several successive treatment lines based on updates to the patients' profile and close monitoring as the keystone of its implementation. Regular feedback from patients could be used to fuel such strategies. This feedback can be collected using an ePRO (electronic Patient Reported Outcome). The purpose of this study is therefore to assess patient management using the information provided by patients through e-PROs, which will transfer the data provided by the patient to the physician and will notify the investigators via email when a patient has completed a form (no data interpretation or alerts). The hypothesis is that the more physicians are provided with insights into their patients' health, the more they will function in a treat-to-target approach and the more often they will tend to adjust their patients' treatments.
The goal of this clinical trial is to determine whether mycophenolate mofetil(MMF) combined with tacrolimus(TAC) can maintain remission in patients with lupus nephritis (LN) who have reached treatment targets after steroid tapering. The main question[s] it aims to answer are: - The efficacy, safety and tolerability of MMF combined with TAC regimen in the treatment of LN patients in the maintenance period. - The influence of low-dose steroid on carotid intima thickness (CIMT). - The omics and cell-free RNA (cfRNA) spectral differences related to lupus flare. - The differences in health economics between steroid tapering and steroid maintenance patients. Participants will be randomly assigned into 2 groups. In the steroid tapering group, participants will take MMF+TAC treatment without steroid for 1 year, and participants who stop steroid treatment without lupus flare will be randomly assigned to monotherapy with MMF or TAC. In the steroid maintenance group, participants will take MMF+TAC+steroid for 1 year, and participants without lupus flare will be randomly assigned to therapy with MMF + steroid or TAC + steroid.
systemic lupus Erythematosus (SLE) is a multi system autoimmune disorder abroad spectrum of clinical presentations. Diagnosis of SLE depending on Systemic Lupus International Collaborating Clinics (SLICC) Criteria. SLICC Criteria requires either that a patient satisfy at least 4 of 17 Criteria including at least 1 of 11 clinical criteria and 1 of 6 immunological criteria or the patient has biopsy -proven nephritis compatible with SLE in the presence of antinuclear antibodies (ANA)or anti_double stranded DNA (dsDNA) antibodies. Anti_KU antibodies included in (ANA), reported in many autoimmune disorders like SLE,Sjogren syndrome, idiopathic lung fibrosis and myositis. So the aim of the work is to determine the relationship between Anti_KU antibodies and SLE manifestations.
Systemic lupus erythematosus (SLE) is the prototype systemic autoimmune disease. Neuropsychiatric SLE (NPSLE) is a major cause of morbidity. Its pathophysiology remains unclear and target autoantigens have not yet been identified. Site- specific autoantigen expression might correlate with imaging abnormalities. Based on existing expertise on the use of peptide/protein arrays and on antigen-specific T cell tracking, we plan to identify new fingerprints and targets for NPSLE. SLE patients +/- NPSLE and healthy subjects will undergo advanced magnetic resonance imaging. Three-dimensional data on structural or functional brain architecture will be integrated with brain transcriptome atlases and candidate antigens for autoreactive autoantibodies and T lymphocytes identified and validated. The evidence will add to current knowledge on NPSLE pathophysiology, provide new multimodal diagnostic tools for better patient care and a platform for innovative, personalized treatments.