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Lupus Erythematosus, Systemic clinical trials

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NCT ID: NCT03816345 Recruiting - Clinical trials for Rheumatoid Arthritis

Nivolumab in Treating Patients With Autoimmune Disorders and Advanced, Metastatic, or Unresectable Cancer

Start date: July 16, 2019
Phase: Phase 1
Study type: Interventional

This phase Ib trial studies the side effects of nivolumab and to see how well it works in treating patients with autoimmune disorders and cancer that has spread to other places in the body or cannot removed by surgery. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.

NCT ID: NCT03802188 Recruiting - Clinical trials for Systemic Lupus Erythematosus

Hydroxychloroquine in Systemic Lupus Erythematosus

Start date: May 9, 2018
Phase:
Study type: Observational

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.

NCT ID: NCT03747159 Recruiting - Clinical trials for Lupus Erythematosus, Systemic

Synergetic B-cell Immunomodulation in SLE - 2nd Study.

SynBioSe-2
Start date: October 1, 2018
Phase: Phase 3
Study type: Interventional

In follow-up of the previous SynBioSe Study the present study is a randomized controlled trial designed to further investigate the long-term clinical and imunological efficacy of combination B-cell targeting by starting treatment with belimumab (anti-BAFF) followed by rituximab(anti-CD20) in lupus nephritis patients.

NCT ID: NCT03746028 Recruiting - Clinical trials for Systemic Lupus Erythematosus

The Lupus prEGnAnCY Cohort: An International Prospective Cohort of Lupus Pregnancies

LEGACY
Start date: June 6, 2018
Phase:
Study type: Observational [Patient Registry]

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.

NCT ID: NCT03562065 Recruiting - Lupus Erythematosus Clinical Trials

Treatment of Refractory Systemic Lupus Erythematosus by Allogeneic Mesenchymal Stem Cells Derived From the Umbilical Cord

MSC-SLE
Start date: September 11, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

Systemic lupus erythematosus (SLE) is a rare (prevalence: 40- 50/100 000 persons) heterogeneous auto-immune and auto-inflammatory disease (AD), affecting both sexes and all races, with a peak incidence / prevalence among black people and a predilection for women in the 3rd-4th decade of life. SLE is characterized by successive periods of flares and remission, which may all vary in duration and quality. Prognosis of severe forms of SLE, which affect lung, heart or brain in addition to renal involvement, has improved, but still evolution remains pejorative in a subset of patients whose 10 years mortality remains 10-15%, even in tertiary referral centers. For 20 years, no new prospective clinical trial in the course of SLE has demonstrated its effectiveness. New biological therapies have not yet made the long awaited breakthrough in the treatment of severe SLE and only anti-Blys monoclonal antibody has gained indication in moderately active SLE. In addition, serious adverse side effects (progressive multifocal leukoencephalopathy) observed with several biologics in AD patients has dampened their expected benefits. For SLE subjects resistant to 1er or 2nd line conventional treatment, there is a need to develop more effective therapies with fewer long term side effects, based on new immunomodulatory and immunosuppressive strategies. According to their in vitro immunomodulatory properties and ability to induce tissue repair mechanisms, mesenchymal stem cells (MSC) have been proposed as a new therapy for several AD, including SLE. The use of allogeneic umbilical cord-derived MSC is based on experimental and human clinical data, particularly produced by Nanjing team (Pr Sun) in China. It is also logical to select SLE patients with the same severity criteria as those used worldwide to validate the efficacy of anti-Blys therapies. Similarly, the analysis of the expected results should take into account criteria similar or comparable to those used for the pivotal clinical trials. This trial is a unique opportunity to set up collaboration between Saint-Louis APHP, clinical expert center for cell therapy in AD, and University College London for cell manufacturing.

NCT ID: NCT03543839 Recruiting - Clinical trials for Lupus Erythematosus, Systemic

Trial of Belimumab in Early Lupus

Start date: September 15, 2020
Phase: Phase 4
Study type: Interventional

This two year study will evaluate the effects of giving belimumab (Benlysta) to patients with Early Lupus. Early lupus is a diagnosis of lupus within 2 years. Subjects will be randomized to receive belimumab or placebo during the first year. During the second year, subjects who were randomized to belimumab will be rerandomized to continue to receive belimumab or to receive placebo. The study will look at clinical effects as well as effects on the immune system.

NCT ID: NCT03527472 Recruiting - Clinical trials for Lupus Erythematosus, Systemic

Memantine for the Treatment of Cognitive Impairment in Systemic Lupus Erythematosus

ClearMEMory
Start date: August 23, 2018
Phase: Phase 2
Study type: Interventional

A phenome-wide association study (PheWAS) identified an association between a variant in the human gene for the N2A subunit of the N-methyl-D-aspartate (NMDA) receptor, GRIN2A, and Systemic Lupus Erythematosus (SLE). A single nucleotide polymorphism (SNP) in this gene encodes for increased NMDA receptor activity. Based on the potential function of the associated SNP and published literature, alterations in SNP function signaling may underlie a cluster of symptoms. The objective of this study is to evaluate the safety, tolerability and efficacy of memantine, an NMDA receptor antagonist, in a precise patient subset with SLE. Participants will complete a full 14-week clinical trial, receiving either memantine or a placebo. Participants' blood will be drawn to test for various antibodies as well as organ function. Patients' urine will also be collected to assess organ function and pregnancy for females at a number of specific time points. The overall goal is to develop a safe and inexpensive therapeutic approach to reduce debilitating cognitive symptoms in a precisely selected SLE sub-population.

NCT ID: NCT03473912 Recruiting - Clinical trials for Rheumatoid Arthritis

Meir Medical Center Rheumatologic Biobank

Start date: April 16, 2018
Phase:
Study type: Observational [Patient Registry]

Serum, synovial fluid and skin biopsies from patients will be collected to the biobank with rheumatoid diseases. These samples will later be used for clinical and basic research, following approval of each specific study by the IRB. The investigators intend to extract protein, DNA and RNA from each sample.

NCT ID: NCT03459274 Recruiting - Clinical trials for Rheumatoid Arthritis

Feasibility of an Immersive Virtual Reality Based Biofeedback Intervention for Outpatients in Rheumatology

Start date: March 16, 2018
Phase:
Study type: Observational

The purpose is to study the use of virtual reality (VR) and biofeedback in rheumatology clinics to help manage chronic pain in patients with rheumatologic diseases. The objective is to know the usefulness of VR/biofeedback-based therapy in the clinic.

NCT ID: NCT03446339 Recruiting - Clinical trials for Systemic Lupus Erythematosus

Pulmonary Hypertension Screening for Rheumatology Patients (SOPHIE)

PAH
Start date: August 3, 2017
Phase:
Study type: Observational

Pulmonary arterial hypertension (PAH) is a serious and often fatal complication of connective tissue diseases including systemic sclerosis and systemic lupus erythematosus. It has been reported primarily from European series that the prevalence of PAH in patients with connective tissue diseases particularly systemic sclerosis is as high as 15-20%. However, given the paucity of medical literature in the area from Chinese population, the prevalence of PAH amongst Chinese patients with these conditions is largely unknown. Even worse, PAH is often undiagnosed amongst patients with connective tissue diseases due to the lack of awareness and/or access to echocardiography, which is a non-invasive first-line screening tool for PAH. As a result, most patients at diagnosis of PAH are at a relatively late stage, rendering pharmacological treatment less effective. Here, the investigators propose a territory-wide pulmonary hypertension screening for patients with connective tissue disease in order to (1) detect pulmonary hypertension amongst patients with connective tissue disease through systematic screening, and (2) understand the prevalence of pulmonary hypertension in Chinese patients with connective tissue diseases.