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Safety and Efficacy of Telitacicept in the Treatment of Systemic Lupus Erythematosus (SLE)

NCT06458972 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 139

Last updated 2024-11-19

No results posted yet for this study

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.

Conditions

Sponsors & Collaborators

  • Jingzhou Central Hospital

    collaborator OTHER

  • Wuhan Central Hospital

    collaborator OTHER

  • Xiangyang Central Hospital

    collaborator OTHER

  • Wuhan No.1 Hospital

    collaborator OTHER

  • China Three Gorges University, Yichang, China

    collaborator OTHER

  • Shanghai Zhongshan Hospital

    collaborator OTHER

  • The First People's Hospital of Jingzhou

    collaborator UNKNOWN

  • Tongji Hospital

    lead OTHER

Principal Investigators

  • Dong Lingli, MD · Tongji Hospital

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-01
Primary Completion
2024-12-01
Completion
2024-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06458972 on ClinicalTrials.gov