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Lupus Erythematosus, Systemic clinical trials

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NCT ID: NCT05157334 Recruiting - Clinical trials for Rheumatoid Arthritis

The Effect of Deep Breathing and Transcutaneus Electrical Nerve Stimulation on Heart Rate Variability

Start date: September 1, 2021
Phase: N/A
Study type: Interventional

This interventional study aims to investigate the effect of deep breathing (DB) and transcutaneous electrical vagus nerve stimulation (tVNS) on heart rate variability (HRV) in healthy participants and patients with rheumatoid arthritis (RA) or systemic lupus erythematosus (SLE). HRV is used as a surrogate measure of vagal nerve tone. The study consists of three sub-projects: Sub-project 1: To compare the effect of one session of DB and one session of non-invasive auricular tVNS on vagal nerve tone measured by HRV in healthy participants and in patients with RA and SLE. The hypotheses is that DB has a similar effect on HRV as non-invasive electrical tVNS. Sub-project 2: A dose-response study in healthy participants comparing the effect of 5, 15 and 30 minutes of DB on HRV. The hypothesis was that HRV increases as a function of the number of minutes the DB is performed in healthy participants. Sub-project 3: To investigate the effect of the optimal dose found in sub-project 2 in patients with RA and SLE measured by HRV, and to investigate its reproducibility by doing it twice.The hypothesis was that HRV increases after DB in patients with RA and SLE, and the effect is reproducible. In all three sub-projects the washout period will be investigated by measuring HRV three times after the intervention. We hypothesise that the effect of DB and tVNS on HRV decreases over time.

NCT ID: NCT05090189 Recruiting - Clinical trials for Systemic Lupus Erythematosus

Exercise and Nutrition Recommendations for Patients Using Glucocorticoids (ENRG)

Start date: August 27, 2021
Phase: N/A
Study type: Interventional

This parallel-group randomized, controlled, clinical trial aims to investigate the influence of a 6-month home-based, remotely-monitored, exercise training intervention on musculoskeletal health in patients with Systemic Lupus Erythematosus who have undergone glucocorticoid pulse therapy.

NCT ID: NCT05039840 Recruiting - Clinical trials for Systemic Lupus Erythematosus

Efficacy and Safety of SAR441344 in the Treatment of Systemic Lupus Erythematosus

APATURA
Start date: November 10, 2021
Phase: Phase 2
Study type: Interventional

This is a multinational, randomized, placebo-controlled, parallel treatment, Phase 2, double-blind, 2 arm study evaluating the efficacy and safety of SAR441344 in comparison with placebo in the treatment of participants aged 18 to 70 years with active Systemic Lupus Erythematosus (SLE). Study details include: - Study duration: 36 weeks - Treatment duration: 24 weeks - Visit frequency: every 2 weeks

NCT ID: NCT05030779 Recruiting - Clinical trials for Systemic Lupus Erythematosus

A Study of CD19/BCMA Chimeric Antigen Receptor T Cells Therapy for Patients With Refractory Systemic Lupus Erythematosus

Start date: September 10, 2021
Phase: Early Phase 1
Study type: Interventional

A Study of CD19/BCMA Chimeric Antigen Receptor T Cells Therapy for Patients With Refractory Systemic Lupus Erythematosus

NCT ID: NCT05029336 Recruiting - Clinical trials for Systemic Lupus Erythematosus

Autologous Stem Cell Transplant (ASCT) for Autoimmune Diseases

Start date: December 2024
Phase: Phase 2
Study type: Interventional

A subset of autoimmune diseases (ADs) in children and young adults are life-threatening and unresponsive to conventional treatments. In these patients, the delivery of high dose immunosuppressive therapy followed by autologous stem cell transplant (ASCT) offers a treatment strategy capable of purging the pathogenic, autoreactive immune system and an opportunity for "immune reset." This strategy has been used in adults across a myriad of indications with evidence for efficacy. This study proposes a pilot study to evaluate this therapeutic strategy in children and young adults with systemic sclerosis (SSc) and systemic lupus erythematosis (SLE), two potentially life threatening autoimmune diseases that may response to this therapeutic approach.

NCT ID: NCT05015465 Recruiting - Clinical trials for Juvenile Systemic Lupus Erythematosus

AS-OCT Study of Cornea and Tear Film Parameters in Juvenile SLE Patients

Start date: July 1, 2020
Phase:
Study type: Observational

The aim of thie study to assess tear film parameters such as tear meniscus height (TMH), tear meniscus area (TMA), and tear meniscus depth (TMD). In addition, corneal pachymetry and epithelial thickness maps in juvenile SLE patients and compared to healthy subjects of similar age and gender.

NCT ID: NCT05007340 Recruiting - Clinical trials for Systemic Lupus Erythematosus

ILD-SARDs Registry and Biorepository

ILD-SARDs
Start date: August 24, 2021
Phase:
Study type: Observational [Patient Registry]

A complex interaction between demographic, environmental and genetic mechanisms impact the onset, severity and outcome of ILD-SARDs through dysregulation of the immune system and lung pro-biotic pathways. Comorbidity and genetic risk indicate that there are overlapping pathogenic mechanisms among SARDs, some of which underlie ILD in different SARDs. The purpose of this biobank is to study the clinical, pathological, laboratory, and imaging characteristics of SARDs patients with lung involvement. This will help identify as unique features underlying lung involvement in SARDs. In addition, this may lead to the discovery of novel mechanisms of disease and potentially novel targets of treatment for SARDs patients with lung disease.

NCT ID: NCT05001737 Recruiting - Clinical trials for Systemic Lupus Erythematosus

Evaluate Efficacy, Safety and Tolerability, PK and PD of Emapalumab in Children and Adults With MAS in Still's or SLE

EMERALD
Start date: December 15, 2021
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the safety, tolerability and efficacy of emapalumab in children and adults with macrophage activation syndrome (sHLH/MAS) in Still's disease (including systemic juvenile idiopathic arthritis and adult onset Still's disease) or with sHLH/MAS in systemic lupus erythematous, resenting an inadequate response to high dose glucocorticoid treatment.

NCT ID: NCT04976465 Recruiting - Pregnancy Related Clinical Trials

Treatment and Clinical Outcomes Among SLE Patients in Pregnancy

Start date: January 1, 2018
Phase: Phase 1
Study type: Interventional

Systemic lupus erythematosus (SLE) is a kind of systemic autoimmune disease which can cause multiple organs and system damage, which often occurs in women of childbearing age. Compared with healthy pregnant women, SLE patients have higher incidence of premature delivery, preeclampsia and fetal loss during pregnancy. Since SLE patients usually have disease activity during pregnancy and postpartum, and a variety of maternal and fetal diseases are closely related to SLE, it is very important to monitor the disease activity and drug treatment of SLE patients during pregnancy.

NCT ID: NCT04971590 Recruiting - Clinical trials for Systemic Lupus Erythematosus

Study to Assess Demographic, Pharmacologic, Biomarker, Clinical Features and Quality of Life (QoL) of Participants With Lupus Nephritis

Start date: September 14, 2021
Phase:
Study type: Observational

This is a multicenter prospective study to assess clinical characteristics, demographics, treatment and health-related quality of life (HRQoL) of lupus nephritis (LN) participants across 5 Gulf countries (United Arab Emirates [UAE], Qatar, Bahrain, Kuwait and Oman).