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Lupus Erythematosus, Systemic clinical trials

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NCT ID: NCT05339217 Recruiting - Clinical trials for Systemic Lupus Erythematosus

Efficacy and Immunological Evaluation of Telitacicept and Low Dose IL2 in the Treatment of Systemic Lupus Erythematosus

Start date: February 7, 2023
Phase: Phase 3
Study type: Interventional

The purpose of this study was to explore the clinical and immunological efficacy of Telitacicept and low dose IL-2 on systemic lupus erythematosus.

NCT ID: NCT05306873 Recruiting - Clinical trials for Systemic Lupus Erythematosus

Examining Distinct Immunophenotypes to Validate and Enhance Rational Treatment in Systemic Lupus

DIVERT
Start date: October 28, 2022
Phase: Phase 2
Study type: Interventional

The primary purpose of this study is to evaluate the potential effectiveness of 24 weeks of MMF within previously discovered immunologically defined subsets of SLE patients. Treatment effects will be evaluated within the individual immunologically-homogenous subsets defined at screening. This study will also explore and compare pre-randomization gene expression patterns among responders and non-responders to MMF and MMF plus voclosporin, use comprehensive immunophenotyping to study the immunologic changes that accompany treatment- induced disease improvement and to better understand immunologic changes associated with the loss of clinical response.

NCT ID: NCT05306574 Recruiting - Clinical trials for Systemic Lupus Erythematosus

A Study of Telitacicept for the Treatment of Moderately to Severely Active Systemic Lupus Erythematosus (REMESLE-1)

Start date: June 20, 2022
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of telitacicept in the treatment of moderately to severely active SLE.

NCT ID: NCT05292456 Recruiting - Clinical trials for Rheumatoid Arthritis

Monıtorıng Glucocortıcoıd Treatment In Patıents Followed In Rheumatology Clınıc

Start date: February 1, 2021
Phase:
Study type: Observational

Hypothesis 1: A reduction in side effects is achieved with monitoring glucocorticoid treatment by using the Glucocorticoid Toxicity Index (GTI) in patients using glucocorticoids. Hypothesis 2: Monitoring treatment by using GTI in patients using glucocorticoids causes a decrease in glucocorticoid toxicity and an increase in the quality of life of patients. Hypothesis 3: With the involvement of the clinical pharmacist in the multidisciplinary team in patients using glucocorticoids, the drug-related problems of the patients are detected and prevented. The aim of this study was to evaluate the glucocorticoid treatment of patients with RA, SLE and vasculitis treated with glucocorticoids prospectively by a multidisciplinary team with GTI. In addition, it was aimed to identify and prevent drug-related problems by reviewing all drugs used in these patients by the clinical pharmacist.

NCT ID: NCT05262686 Recruiting - Clinical trials for Systemic Lupus Erythematosus

Efficacy and Immunological Evaluation of Belimumab Plus Low Dose IL-2 in the Treatment of Systemic Lupus Erythematosus

Start date: April 1, 2022
Phase: Phase 3
Study type: Interventional

The purpose of this study was to explore the clinical and immunological efficacy of belimumab plus low dose IL-2 in systemic lupus erythematosus.

NCT ID: NCT05261529 Recruiting - Clinical trials for Lupus Erythematosus, Systemic

Effects of an Intervention With EVOO and Physical Activity in Patients With Systemic Lupus Erythematosus

EFINUTRILES
Start date: November 3, 2021
Phase: N/A
Study type: Interventional

In addition to the different pharmacological therapies available for the treatment of Systemic Lupus Erythematosus (SLE) as well as for its numerous associated complications (cutaneous, articular, hematological, neuropsychiatric, renal...), it has recently been proposed that 'health-related lifestyles' could have a determining role in balancing numerous organic processes at all levels. In line with this, the benefits of following a healthy dietary pattern such as the Mediterranean Diet and, specifically, the intake of Extra Virgin Olive Oil (EVOO) as well as the realization of regular physical exercise (PE) have been examined in numerous chronic non-communicable diseases such as obesity or cancer. However, in patients with autoimmune diseases, such as SLE, the possible effects of this synergy has not been investigated to date. Having demonstrated both the protective effect of a healthy dietary pattern and that of regular PE on the progression and risks associated with SLE in cross-sectional studies, non-intervention research has been developed that combines both strategies simultaneously, with nutritional supplementation or PE occurring independently. It is hypothesized that supplementation with EVOO in these patients together with PE will produce superior benefits compared to EVOO supplementation alone, showing changes in the phenotype of SLE and other parameters such as levels of chronicity/gravity, biomarkers (oxidative stress, immunological, inflammation), cardiovascular status and body composition.

NCT ID: NCT05260255 Recruiting - Clinical trials for Vitamin D Deficiency

Effect of Vitamin D Supplement on Disease Activity in SLE

Start date: June 15, 2021
Phase: N/A
Study type: Interventional

To study the effect of vitamin D supplementation on disease activity of SLE ( SLEDAI-2K ) and IL-6 level

NCT ID: NCT05243875 Recruiting - COVID-19 Clinical Trials

Lupus Education Alliance Program

LEAP
Start date: November 1, 2023
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the evaluate the effect of education-only vs. navigation interventions on COVID-19 testing and vaccination for people with systemic lupus erythematosus.

NCT ID: NCT05236491 Recruiting - Clinical trials for Rheumatoid Arthritis

COvid-19 Vaccine Booster in Immunocompromised Rheumatic Diseases

COVBIRD
Start date: March 9, 2022
Phase: Phase 2/Phase 3
Study type: Interventional

People living with Systemic autoimmune rheumatic diseases (SARDs) face a new and urgent dilemma: immunosuppression increases risk for worse COVID-19 infection, yet an immune stimulation, such as vaccination, could re-activate their disease. Fear of vaccine-related disease reactivation is not of concern in other immunosuppressed groups (e.g. patients receiving chemotherapy or hemodialysis) but in SARDs, disease flare could lead to organ failure or even death. Specific research in this population is therefore critical. Moreover, among SARD patients, those on anti-CD-20 monoclonal antibody (mAb) (i.e. rituximab (anti-CD-20 mAb)), a medication used to treat inflammatory types of arthritis, have extremely low immunity post-COVID-19 mRNA vaccine. This study will test the hypothesis that a booster dose of a COVID-19 vaccine is safe and enhances post-vaccine humoral and cellular responses in SARDs patients on anti-CD-20 mAb treatment. The magnitude of this response depends on the type of COVID-19 vaccine administered and is optimal when the booster dose is a vaccine from a different group than the one used for primary immunization (mix-and-match approach).

NCT ID: NCT05193591 Recruiting - Clinical trials for Lupus Erythematosus, Systemic

Anti-C1s, Anti-HMGB1 and Anti-C1q Autoantibodies in Systemic Lupus Erythematosus (DYSALARM-322)

DYSALARM-322
Start date: January 20, 2022
Phase:
Study type: Observational

Systemic lupus erythematosus (SLE) is a chronic autoimmune disease characterized by the production of multiple autoantibodies and accumulation of immune complexes resulting in systemic inflammatory response and tissue damage. Dysfunction of proteins initially known to initiate the classical pathway for complement activation (C1q and C1s), and their functional interference with the multifunctional protein HMGB1 (High-Mobility Group Box 1), appears to be associated with SLE. On the other hand, C1s, HMGB1 and C1q can be targeted by anti-C1s, anti-HMGB1 and anti-C1q autoantibodies from lupus patients, whose functional impact remains to be explored, in particular for non-canonical functions, independent of the complement activation cascade. Studies are needed to investigate the pathogenic role of these autoantibodies in SLE, including possible interference with the inactivation of HMGB1. This project plans to investigate the role of anti-C1s, anti-HMGB1 and anti-C1q autoantibodies in the pathogenesis of Systemic Lupus Erythematosus. This pilot study will be performed for 30 patients with active SLE on serum, realized for routine patient care. The investigators will identify the molecular targets recognized by anti-C1s, anti-HMGB1 and anti-C1q autoantibodies purified from the SLE patients' serum. The investigators will also explore the functional role of these purified autoantibodies.