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

Last updated: November 15, 2024
Sponsor: Tongji Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Systemic Lupus Erythematosus

Lupus

Bone Diseases

Treatment

N/A

Clinical Study ID

NCT06458972
TJ-IRB20231298
  • Ages 18-70
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age ≥ 18 years old, not exceeding 70 years old (including 70 years old);

  2. Patients diagnosed with systemic lupus erythematosus (SLE) according to 2019American College of Rheumatology/European League Against Rheumatism (2019ACR/EULAR)international classification diagnostic criteria;

  3. Accepting the treatment of telitacicept.

Exclusion

Exclusion Criteria:

Subjects who meet any of the following criteria should be excluded from this study:

  1. Patients with other rheumatic immune system diseases;

  2. Patients in the active stage of acute and chronic infections;

  3. Patients using other biologics;

  4. Patients with wasting diseases such as malignant tumors

Study Design

Total Participants: 139
Study Start date:
January 01, 2024
Estimated Completion Date:
December 31, 2024

Connect with a study center

  • Tongji Hospital

    Wuhan, Hubei 43003
    China

    Active - Recruiting

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