Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06458972
Status:
RECRUITING
Last Update Posted:
2024-06-14
First Post:
2024-05-31
Brief Title:
Safety Efficacy and Compliance of Telitacicept in the Treatment of Systemic Lupus Erythematosus SLE
Sponsor:
Tongji Hospital
Organization:
Tongji Hospital
Study Overview
Official Title:
Safety Efficacy and Compliance of Telitacicept in the Treatment of Systemic Lupus Erythematosus SLE in the Real World a Multicenter Retrospective Study
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Systemic lupus erythematosus SLE is a highly specific autoimmune disease that involves multiple systems due to abnormal immune activation It is a classical diffuse connective tissue disease with autoimmune inflammation as its prominent manifestation B cells are the core of systemic lupus erythematosus SLE pathogenesis B Lymphocyte Stimulator BLyS also called BAFF and A Proliferation-Inducing Ligand APRIL are signals for B cell maturation B Lymphocyte Stimulator BLyS participates in promoting the development and maturation of B cells while A Proliferation-Inducing Ligand APRIL participates in promoting the activation of mature B cells and the secretion of antibodies by plasma cells Telitacicept is composed of the extracellular specific soluble portion of Transmembrane Activator and Calcium-modulating Cyclophilin Ligand CAML Interactor TACI and the Fragment crystallizable Fc segment of human Immunoglobulin G1 IgG1 It is the only globally approved dual-target biological agent for the treatment of systemic lupus erythematosus SLE blocking B Lymphocyte Stimulator BLyS and A Proliferation-Inducing Ligand APRIL hindering the development and activation of B cells and the production of antibodies comprehensively inhibiting the maturation proliferation and differentiation of B cells at different stages In this study the investigators will explore the adherence and influencing factors of telitacicept in systemic lupus erythematosus SLE patients its effectiveness and safety providing a stronger basis for clinical management of systemic lupus erythematosus SLE patients
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None