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Lupus Erythematosus, Systemic clinical trials

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NCT ID: NCT06314282 Not yet recruiting - Clinical trials for Systemic Lupus Erythematosus (SLE)

INTERSTELLAR - International Study Evaluating Lupus Outcomes After Anifrolumab Real World Use

INTERSTELLAR
Start date: June 30, 2024
Phase:
Study type: Observational

INTERSTELLAR study will generate critical prospective real-world evidence on the benefits of adding Anifrolumab to standard of care treatment for SLE in routine clinical practice, to inform physicians, payers and patients. The study will use clinical assessments that are relevant for SLE-treating physicians in routine clinical practice, as well as introduce a specific measure for skin manifestations to affirm the potency of anifrolumab in treating SLE-related skin manifestations. The study will use standardized objectives, inclusion/exclusion criteria and outcome measures across all countries participating in this study including GCC (Qatar, KSA), Mexico, CAMCAR (Costa Rica, Panama, Dominican Republic), Colombia, Argentina, Taiwan, and Egypt, and any other countries that may be included in the study, in order to facilitate a comparison and analysis across all countries included in this study.

NCT ID: NCT06297408 Not yet recruiting - Clinical trials for Systemic Lupus Erythematosus

Relma-cel for Moderate to Severe Active Systemic Lupus Erythematosus

Start date: March 2024
Phase: Phase 1
Study type: Interventional

To assess the safety tolerability pharmacokinetics and pharmacodynamics of Relma-cel in moderate or severe active systemic lupus erythematosus (SLE) subjects in China.

NCT ID: NCT06293365 Not yet recruiting - Clinical trials for Rheumatoid Arthritis

Two-period Crossover Study to Demonstrate the Comparability of Pharmacokinetics of Subcutaneous Ianalumab Between 2mL Auto-injector/2mL PFS with1mL Pre-filled Syringe in Adult Participants With Autoimmune Disease

Start date: June 26, 2024
Phase: Phase 2
Study type: Interventional

The purpose of this study is to demonstrate the comparability of ianalumab exposure following the sub-cutaneous (s.c.) administration of one injection of 300 mg/2 mL auto-injector (AI) versus two injections of 150 mg/1 mL pre-filled syringe (PFS), and to evaluate the safety and tolerability of ianalumab following the s.c. administration of both devices in participants with rheumatoid arthritis (RA), Sjögren's disease (SjD), or systemic lupus erythematosus (SLE). A second optional cohort may be included with the objective of demonstrating the comparability of pharmacokinetics of ianalumab between 1 x 2 mL Pre-filled Syringe (PFS) and 2 x 1 mL PFS.

NCT ID: NCT06287125 Not yet recruiting - Clinical trials for Systemic Sclerosis and Systemic Lupus Erythematous

Renal Assessment for Early Detection of Renal Impairment in Systemic Sclerosis and Systemic Lupus Erythematosus Patients

Start date: March 1, 2024
Phase:
Study type: Observational

- Evaluate renal resistive index in SSc and SLE patients for early detection of renal impairment. - Evaluate renal multi-parametric MRI in SSc and SLE patients for early detection of renal impairment. - Measure the serum levels of CD147 in SSc and SLE patients and its correlation with renal impairment. - Correlation between detected markers and other assessment tools.

NCT ID: NCT06255028 Not yet recruiting - Clinical trials for Systemic Lupus Erythematosus

A Study of CNTY-101 in Participants With Moderate to Severe Systemic Lupus Erythematosus (SLE)

CALiPSO-1
Start date: August 2024
Phase: Phase 1
Study type: Interventional

CALiPSO-1 is a Phase 1, multi-center, dose-finding study to evaluate the safety and efficacy of CNTY-101 in participants with moderate to severe systemic lupus erythematosus.

NCT ID: NCT06238531 Not yet recruiting - Clinical trials for Systemic Lupus Erythematosus

A Clinical Trial to Evaluate Safety of Gusacitinib in Patients With Systemic Lupus Erythematosus (SLE) or Lupus

Start date: May 8, 2024
Phase: Phase 1
Study type: Interventional

Background: Systemic lupus erythematosus (SLE), also called lupus, is a disease that causes the body s immune system to attack healthy tissue. Lupus causes swelling and inflammation in the skin, skin, joints, kidneys, brain, blood vessels, and other organs. There is no cure for lupus. Current treatments do not help everyone and may have adverse effects. Better treatments are needed. Objective: To test a study drug (Gusacitinib) in people with lupus. Eligibility: People aged 18 years and older with lupus. Design: Participants will be screened. They will have a physical exam with blood and urine tests and a test of their heart function. They will have a chest X-ray. They will have tests that use blood pressure cuffs to measure blood flow and pressure throughout the body. Participants will have 9 clinic visits and 6 phone visits over about 7 months. The study has 3 parts. Part 1: Gusacitinib is a tablet taken by mouth. Participants will be divided into 3 groups. One group will receive the study drug, and a second group will get a placebo. The placebo looks like the study drug but does not contain any medicine. Both of these groups will take their tablets once a day for 12 weeks. The third group will continue to take their usual medications for lupus throughout the study. Part 2: All participants who took the study drug or placebo in part 1 will take the study drug once a day for 12 weeks. Part 3: All participants who took the study drug will stop taking it for 4 weeks.

NCT ID: NCT06232304 Not yet recruiting - Clinical trials for Systemic Lupus Erythematosus of Childhood (Disorder)

Transforming Care for Individuals With Childhood-onset Systemic Lupus Erythematosus

cSLE
Start date: April 1, 2024
Phase: N/A
Study type: Interventional

This study aims to investigate the feasibility and effectiveness of a cognitive behavioral coping skills program, Treatment and Education Approach for Childhood-onset Lupus (TEACH), for youth with cSLE when integrated into medical care. This TEACH program aims to teach participants skills in order to cope with fatigue, pain, and depressive symptoms--symptoms that commonly affect adolescents and young adults with lupus.

NCT ID: NCT06228222 Not yet recruiting - Clinical trials for Systemic Lupus Erythematosus

Predictors of Remission and Renal Outcomes in Lupus Nephritis in Assuit University Hospitals.

Start date: January 25, 2024
Phase:
Study type: Observational

the goal of this opservetional study is to identify predictors of remission and renal outcomes in SLE patients affected with Lupus nephritis. the main question it aims to answer is: *What are the clinical, histological and chemical parameters that connected to undesirable renal prognosis in LN? All patients will be subjected to the following: Complete through history taking, clinical examination disease activity will be assessed by SLEDAI. The Laboratory investigations and renal biopsy.

NCT ID: NCT06227559 Not yet recruiting - Clinical trials for Systemic Lupus Erythematosus

The Role of Some Hematological Parameters in Juvenile Systemic Lupue Erythematosus

Start date: February 1, 2024
Phase:
Study type: Observational

Juvenile systemic lupus erythematosus is an autoimmune disorder with multisystem involvement, leading to inflammatory damage to the joints, kidney, central nervous system, and hematopoietic system. Although the prevalence rate of juvenile systemic lupus erythematosus in a developing country is not known, as per literature the female-to-male ratio rises from 4.5 : 1 in adolescence to 8--12 : 1 in adult-onset patients. - The full mechanism of SLE is still unknown however, production of autoantibodies and immune complex deposition with subsequent infiltration of neutrophils, hyper-activation of B and T cells, reduced ability of immune complexes and apoptotic cell clearance, and defects in multiple immune regulatory networks, are central to organ inflammation and subsequent damage in SLE. Systemic lupus erythematosus goes on with organ involvements by remission and relapses.

NCT ID: NCT06210295 Not yet recruiting - Clinical trials for Refractory Anemia in Systemic Lupus Erythematosis

Anemia in Systemic Lupus Erythematosus Specially Refractory Type

Start date: March 9, 2024
Phase:
Study type: Observational

Systemic lupus erythroematosis (SLE) is a systemic autoimmune disease with multisystemic involvement. The condition has several phenotypes, with varying clinical presentations from mild mucocutaneous manifestations to multiorgan and severe central nervous system involvement. Several immunopathogenic pathways play a role in the development of SLE. Despite recent advances in technology and understanding of the pathological basis and risk factors for SLE, the exact pathogenesis is still not well known. Diagnosis of SLE can be challenging, and while several classification criteria have been posed, their utility in the clinical setting is still a matter of debate. Management of SLE is dictated by organ system involvement. Despite several agents shown to be efficacious in treating SLE, the disease still poses significant morbidity and mortality risks in patients[1]. Haematological abnormalities are common in systemic lupus erythroematosis. Anemia is found in about 50% of patients.