View clinical trials related to Lupus Erythematosus, Systemic.
Filter by:Systemic lupus erythematosus (SLE) is a chronic autoimmune disease characterized by the production of multiple autoantibodies. The prevalence and significance of antibodies against Ficolin-2 have not been yet investigated. The aims of this study were to determine the prevalence of anti-ficolin-2 antibodies among SLE patients and to investigate their potential as diagnostic and/or prognostic biomarkers in SLE. This study is a secondary phase of a serum sample analysis done in early 2015 in order to determine the prevalence of anti-ficolin-2 antibodies among the same cohort as the previously declared study (ClinicalTrials.gov ID: NCT02625831; Unique Protocol ID: 1841851v0). In this retrospective study, clinical data were obtained from medical files and blood samples were selected from preexisting biological collection. SLE patients (n=165) were informed and did not objected, they were matched to healthy controls (n=48). Disease activity was determined according to the SLEDAI score. Anti-ficolin-2 antibodies levels were measured in sera by ELISA and correlated to previously obtained Anti-ficolin-3, Anti-ficolin-2, anti-dsDNA and anti-C1q antibodies levels. The titer of anti-ficolin-2 antibodies was correlated with the SLEDAI score (p<0.0001). The presence of anti-ficolin-2 antibodies was associated with anti-ficolin-3 antibodies, anti-C1q and anti-dsDNA antibodies. Interestingly, the combination of anti-ficolin-3, anti-ficolin-2 and anti-C1q antibodies demonstrated higher specificity than any other traditional biomarker. These results suggest that anti-ficolin-3 and anti-ficolin-2 antibodies could be useful for the diagnosis of active nephritis in SLE patients.
There is substantial clinical and biological intra and inter-patient variability in SLE. Vascular, renal and neurologic deficiency can be organ-threatening or even life-threatening, leading to increased morbidity and mortality. Thus, biomarkers of disease activity and prognosis are required for regular follow-up of SLE patients. Implication of Toll-like Receptors (TLRs) in SLE has been extensively studied in mice models and humans. Self nuclear antigens bind to TLRs which are located on the surface of dendritic cells, B-cells, and endothelial cells, leading to production of pro-inflammatory cytokines and pathologic autoantibodies involved in organ dysfunction of SLE patients. Moreover, TLR expression in SLE is significantly higher and significantly correlated with disease activity. Annexin A2 (ANXA2) is a member of the annexins superfamily which exists as a monomer or heterotetramer and is implicated in several biological processes. Most notably, it binds to ẞ2GP1/anti-ẞ2GP1 antibodies and mediates endothelial cell activation via a TLR4 signaling pathway, highlighting its key role in Antiphospholipid Syndrome (APS) frequently associated with SLE. ANXA2 is also involved in the physiopathology of SLE. Anti-DNA autoantibodies can bind with ANXA2 expressed on mesangial cells in lupus nephritis. Besides, a french study carried out in Amiens' University Hospital showed that vascular lesions in lupus nephritis were associated with a significant increase in vascular expression of ANXA2.
Objective: To compare the efficacy of topical 10% nifedipine versus 5% sildenafil in patients with secondary Raynaud's phenomenon (RP). Methods: A randomized, double-blind, placebo-controlled pilot study took place in 10 patients with secondary RP. Topical 10% nifedipine on one hand and 5% sildenafil on the other hand were applied. The thumbs didn't receive any cream and served as a control group. The primary outcome was the improvement of blood flow and vessel diameter of the digital arteries measured by high frequency color Doppler ultrasound before and 1 hour after treatment.
A poor therapeutic observance is described between 3 and 76% cases in systemic lupus. It is associated with an increased risk of relapses, hospitalizations, morbidity and poor renal prognosis. New treatment protocols exist and are indicated in second intention in case of good compliance. An assessment of therapeutic adherence is therefore essential. Patients with systemic lupus diagnosed for at least 6 months, or skin lupus, who have been prescribed with Plaquenil (hydroxychloroquine), will be included in the study. The study primary objective is to determine risk factors for non-observance The secondary objectives are to: - Measure the observance rate of patients with systemic lupus in Martinique. - Describe the parameters that influence observance: evaluation of the disease and associated comorbidities, psychosocial assessment, assessment of the doctor-patient relationship, evaluation of the disease representations.
This study will be conducted to characterize pharmacokinetics, pharmacodynamics, safety, and tolerability of anifrolumab given via the subcutaneous (SC) route of administration in adult Systemic Lupus Erythematosus (SLE) subjects with a type I Interferon (IFN) test high result and active skin manifestations while receiving Standard of Care (SOC) treatment. In addition, the efficacy of anifrolumab on SLE skin manifestations will be characterized.
The purpose of this study is to evaluate the efficacy and safety of ILT-101 (human recombinant interleukin 2 (IL-2)) in patients with moderate to severe systemic lupus erythematosus.
This trial is to study Acthar Gel in participants with active systemic lupus erythematosus (SLE). The doctor will assign eligible patients to one of two groups (like flipping a coin). Participants will receive the treatment assigned to their group for 24 weeks: - Acthar Gel - Placebo Gel, which looks like Acthar Gel, but has no medicine in it. The doctor or his staff will take measurements and ask questions to: - see how well the gel is working - see how safe it is for patients with SLE
This study asks whether persons with lupus will use and uptake the information and services of the web-based lupus interactive navigator (LIN) on a regular basis and whether this uptake will be associated with better self-management, improved coping, higher sense of control over their life, and overall improved health. Systemic lupus erythematosus is an incurable chronic multi-organ inflammatory disease that affects preferentially young women. Unmet needs include a 15% excess in mortality, high morbidity and poor work outcomes. Despite prevalence of 1:2000, lupus is mostly unknown from the public and access to specialized care remains limited. Therefore, persons with lupus and their caregivers have difficulty finding high quality information relevant to their "lupus journey". The LIN research team consists of a lupus clinical expert and researcher, a clinical psychologist and behavioral researcher, and a health information specialist. This team, funded by the Canadian Institutes of Health Research (CIHR), was responsible for the development of the LIN, a web-based navigator designed to promote self-care. The LIN is completed and the team will work with several stakeholders for dissemination: Lupus Canada, the Canadian Network for Improved Outcomes in Systemic Lupus Erythematosus (CaNIOS), the Arthritis Alliance of Canada, and lupus patient advisers. CaNIOS centres will be to randomized to immediate access to the LIN (LIN_NOW group) or usual care with crossover at 3 months (LIN_WAIT group). At baseline, all patients meeting entry criteria will be contacted, and asked to complete online questionnaires. At three months, a second online assessment will be performed before crossing over those from the centres randomized to usual care in order to now provide them with an access to the LIN. A final assessment will be performed at six months. Comparisons of baseline versus LIN exposure over three months will be performed in all patients at the end of the study; comparison of LIN use versus usual care will be done at three months; and retention of use at six months after LIN exposure will be documented in the first group randomized to LIN. The main outcome will be the Patient Activation Measure, a valid tool that measures the level of patient engagement. Secondary outcomes will include variables describing access and use of the LIN captured by the LIN server, coping, self-efficacy, and global health status.
The objective of this clinical study is to evaluate the potential effect of anti-infection of low-does IL-2 in patients with SLE.
This study is designed to examine safety, tolerability, pharmacokinetics, pharmacodynamics and clinical effect of repeat dosing of GSK2646264 in patients with subacute and chronic cutaneous lupus erythematosus (CLE) lesions and in acute CLE like lesions induced by photoprovocation (PV). Current study is two group study. In Group A, Patients with fewer than two active lesions will be enrolled and exposed to photoprovocation (PV) for 3 consecutive days. Patients that develop PV lesions at any time during this period, as determined by the local investigative team, will receive 1% strength GSK2646264 on 1 lesion and placebo on 1 lesion daily and either 1% strength GSK2646264 or placebo on an area of uninvolved skin, for skin pharmacokinetic (PK) of study drug, for 28 days. In Group B, Patients that have a minimum of 2 active existing CLE lesions as determined by the investigators will be enrolled into group B and have one lesion treated with 1% GSK2646264 and 1 lesion with placebo. A completed patient will be defined as a subject who receives at least 25 days of study drug and completes the end of treatment biopsy (at day 28) and assessment. Thereafter patients will be followed for 28 days in Group A only or until complete resolution of induced PV lesions, as determined by the investigator.