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98 active trials for Systemic Lupus Erythematosus

Telangiectatic Palmoplantar Keratoderma in Systemic and Subacute Lupus Erythematosus

Palmoplantar keratoderma (PPK) associated to livid telangiectatic erythema during systemic lupus erythematosus (SLE) and subacute cutaneous lupus erythematosus (SCLE) is a rare phenomenon seldom reported in literature. The investigators hypothesize that clinic-immunologic assessment and detailed investigation of cutaneous biopsy specimen of PPK and erythema of patients suffering from SLE and SCLE could lead to determine more precisely nosological settings of this injury. Report the different therapeutics with efficacy assessment could be helpful to highlight useful treatment for these patients.

Start: April 2020

Prediction of Relapse Risk in Stable Systemic Lupus Erythematosus

Whether and when systemic lupus erythematosus (SLE) patients with stable disease should withdraw glucocorticoid (GC)? How about the relapse risk? What are the risk factors for disease flare? All the above are unclear. Long-course GC treatment has a lot of side-effects even in a sustaining low dose. The aim of this study is to explore the relapse risk after GC withdrawal in SLE patients with stable disease more than one year and to establish a predictive model for flare risk stratification.

Start: October 2016

Belimumab (BENLYSTA®) Pregnancy Registry

This global Belimumab Pregnancy Registry will collect prospective data on pregnancies and pregnancy outcomes on a voluntary basis in women with systemic lupus erythematosus (SLE) who have received commercially supplied belimumab within the 4 months prior to and/or during pregnancy. The registry will also evaluate outcomes of infants born to mothers who were exposed to belimumab within the 4 months prior to and/or during pregnancy. This registry will add to the current clinical experience with belimumab and will complement reproductive data from animal toxicology studies. It will also assist clinicians in weighing the potential risks against the benefits of treatment for individual patients with SLE. GlaxoSmithKline (GSK) will sponsor the Belimumab Pregnancy Registry in countries where it holds Marketing Authorization.

Start: July 2012

Efficacy and Safety of Low-dose IL-2 in Patients With SLE: a Multicenter, Randomised, Placebo-controlled Trial

The management of active systemic lupus erythematosus (SLE) is challenging due to the heterogeneous nature of the disease and lack of specific treatment. Current treatment regimens mainly rely on corticosteroids and immunosuppressive agents which are associated with substantial adverse effects including various infections. Therefore, there is an unmet need for new therapies with better efficacy and less adverse effects. Defective IL-2 production contributes to the unbalanced immune system in SLE. Previous short term open-labelled trials showed that low-dose IL-2 was efficient and tolerated in active SLE. It was suggested that low-dose IL-2 treatment promoted regulatory T cells (Treg) and inhibited T helper 17 cells (Th17) and follicular helper T cells (Tfh). The immunological rebalancing was associated with the induction of remission in SLE patients. To establish that which low doses of IL-2 would be more efficacious and safe in active SLE, we carried out a multi-center, randomized, double-blind, placebo-controlled trial of three doses of IL2 (0.2 MIU, 0.5 MIU or 1 MIU) versus placebo.

Start: September 2019

Evaluation of Janus Kinase_3 in Juvenile Onset Systemic Lupus Erythematosus

One of the best understood mechanisms by which cytokines activate signals, thus eliciting specific responses in target cells, involves enzymes such as Janus kinases (JAKs) and transcriptional factors such as signal transducers and activators of transcription (STATs). For immune mediated diseases, both activating and inactivating mutations of JAKs and STATs may cause abnormalities in immune homeostasis. Polymorphisms of JAK/STAT genes have been linked to susceptibility for rheumatoid arthritis (RA) , systemic lupus erythematosus (SLE), psoriatic arthritis (PA) and inflammatory bowel disease (IBD) . Janus_kinase 3 expression will be evaluated in the serum and renal tissue of lupus patients during active stage of the disease through this study

Start: July 2020

Neutrophil Extracellular Traps in Systemic Sclerosis

Systemic sclerosis (SSC) is a systemic disease characterized by limited or diffuse cutaneous sclerosis, microangiopathy, overproduction of autoantibodies and variable organ damage due to vasculopathy and/or fibrosis. The loss of self-tolerance is believed to be caused by the dysregulation of both innate and adaptive immune systems and may involve reactive oxygen species (ROS). Neutrophils are potent producers of ROS and may play a role in endothelial cells and fibrobasts dysfunction, as in autoantibodies generation. However, their role in SSC pathogenesis remains to be determined. Recent studies discovered abnormal regulation of neutrophil extracellular traps (NETs) in other auto-immune diseases such as systemic lupus erythematosus (SLE). NETs are web-like structures composed of chromatin backbones and granular molecules. They are released by activated neutrophils through a process called "NETosis". Nets were first described in 2004 as a novel host defense mechanism to trap and kill foreign pathogens. Recent evidence shows that NETs also participate in the pathogenesis of a variety of inflammatory and autoimmune diseases, including SLE. We hypothesis that this phenomenon could be dysregulated in SSC as in SLE and could play a prominent role in the induction of autoimmunity, as well as in the induction and perpetuation of organ damages.

Start: October 2017

The Epidemiology, Management, and the Associated Burden of Mental Health, Atopic and Autoimmune Conditions in Alopecia Areata

This study series consists of three related studies and aims to explore and describe many important elements of Alopecia areata over three key areas: (i) the current epidemiology of Alopecia areata, (ii) the prevalence and incidence of psychiatric co-morbidities in people with Alopecia areata and (iii) the prevalence and incidence of autoimmune and atopic conditions in people with Alopecia areata.

Start: March 2020

At-Home Research Study for Patients With Autoimmune, Inflammatory, Genetic, Hematological, Infectious, Neurological, CNS, Oncological, Respiratory, Metabolic Conditions

We are the missing link in clinical trials, connecting patients and researchers seamlessly and conveniently using a mobile health platform to advance medical research. We make it easy for patients to contribute to research for medical conditions that matter most to them, regardless of their location or ability to travel.

Start: July 2013

Haematological Indices in Systemic Lupus Erythematosus

The 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.

Start: December 2019

Safety and Efficacy of SM934 Compared to Placebo in Adult Subjects With Active Systemic Lupus Erythematosus

This is a single-center, randomized, double-blind, placebo-controlled, phase 2 study. The purpose of the study is to initially evaluate the safety and efficacy of SM934 combined with steroids compared to placebo in adult subjects with active systemic lupus erythematosus (SLE) over a 12-week period.

Start: July 2019

Treatment of Periodontal Disease in Systemic Lupus Erythematosus

Many studies have conducted to evaluate the relationship of systemic inflammatory diseases with periodontal disease. Previous evaluations suggest that there is no significant association between patients with Systemic lupus erythematosus (SLE) and Periodontitis (PD). However, some of the studies have shown relevancy between these two inflammatory diseases and have suggested to explore more for further knowledge. The aim of the study is to establish and investigate a relationship between SLE and PD. The study which will take place in two centers and will recruit 30 patients which will enter a pilot randomized controlled trial. Individuals enrolled into the study will be randomly assigned to the test or control group in a 1:1 ratio. Study will be divided in to six visits for the patients and the length of the study will be of 6 months. Visit 1 will be consisting of Screening including consent and Periodontal examination of the patients. Visit 2 includes orthopantomogram (OPG), Comprehensive periodontal examination recording, Blood samples collection vascular function assessment and optical coherence tomography (OCT). Intensive periodontal treatment (IPT) for test group and control periodontal treatment (CPT) for control group including medical history recording according to group allocation in visit 3 for control group and (3a and 3b) for test group will take place. Follow ups after two months will be conducted in Visit 4 for both groups including Demographics, medical history and concomitant medications recording, comprehensive periodontal examination recording, OCT, blood samples/saliva samples collection and vascular function assessment. Visit 3 and 5 will be conducted as periodontal treatment (IPT for test group and CPT for the control group), medical history recording, including demographics, Alogrithm for cardiovascular disease (Qrisk3) questionnaire (Visit 3 only) to assess the cardio-vascular risk medical history and concomitant medications recording, comprehensive periodontal examination recording, blood samples collection and vascular function assessment. Last visit will be 6 months follow up.

Start: October 2019

Predictors of Mortality in Patients With Autoimmune Diseases Admitted to the Intensive Care Unit

Autoimmune diseases, such as systemic lupus erythematosus, rheumatoid arthritis, myositis, or anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis, may affect multiple organ systems. Occasionally, patients deteriorate acutely requiring advanced care in an intensive care unit (ICU). In an ICU setting, mortality is estimated with scoring systems, such as APACHE or SAPSII. Since there are limited data available on their use in autoimmune diseases, with the current study, we aim to assess the usefulness of these ICU scores and analyze predictors of mortality in this particular group of patients.

Start: July 2019

BENLYSTA® Special Drug Use Investigation

The objective of this study is to collect and assess the information about long-term safety and effectiveness of Benlysta for intravenous injection and Benlysta for subcutaneous injection (hereinafter referred to as "Benlysta") in daily clinical practice. The aim of conducting this drug use investigation (DUI) in all subjects until data are accumulated from a certain number of subjects after Benlysta being marketed, data will be collected on safety and effectiveness of Benlysta in an early stage and thereby to take the necessary measures for proper use of Benlysta. Approximately 600 subjects will be enrolled in to this study. The observation period per subject will be 52 weeks from the start of Benlysta administration. BENLYSTA is the registered trademark of GlaxoSmithKline (GSK) group of companies.

Start: January 2018

Study of AC0058TA in Patients With Systemic Lupus Erythematosus (SLE)

This is a Phase 1b, double blind, randomized, placebo-controlled study of the safety and tolerability, pharmacokinetics and pharmacodynamics of AC0058TA in patients with systemic lupus erythematosus (SLE).

Start: November 2018

Glucocorticoids Withdrawal in Early Systemic Lupus Erythematosus

This is a 36 months, randomized, double-blind, placebo-controlled, parallel-groups, equivalence multicenter trial in patients with inactive Systemic Lupus Erythematosus to evaluate if low disease activity can be sustained with withdrawal of glucocorticoids in patients on stable clinical remission or low disease activity.

Start: June 2019

Hydroxychloroquine in Systemic Lupus Erythematosus

A Systemic lupus erythematosus, SLE is disease in which immune system is over-active causing inflammation in joints skin or any organ system. There are many areas where better approaches in SLE could improve outcomes. One example relates to hydroxychloroquine (HCQ) key drug which can reduce risk of serious disease flares. There are increasing concerns about eye damage main side effect with long-term use of HCQ. At present investigators cannot precisely predict which SLE patient is most likely to flare once HCQ is tapered. It is not clear what drives risk of eye damage. Investigators' study will fill these knowledge gaps. Investigators' hypothesis is that baseline demographic and clinical factors are associated with risk of SLE flare after HCQ taper/discontinuation and with risk of retinal toxicity in all HCQ exposed patients. Research will link and analyze data on 3700 SLE patients across Canada.

Start: May 2018

Lupus Interval Monitoring to Manage Disease Flare and Enable Treatment Optimization

To develop a test to characterize and monitor SLE disease activity status from a participant's home by analyzing the gene expression from participant self-collected blood samples using a novel fingerstick collection kit.

Start: April 2017

Exploratory Study of DHA in Systemic Lupus Erythematosus Patients

The primary objective of the study is to assess the efficacy of DHA in patients with SLE.

Start: March 2018