Actively Recruiting

Age: 18Years - 70Years
All Genders
NCT06458972

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

Led by Tongji Hospital · Updated on 2024-11-19

139

Participants Needed

1

Research Sites

52 weeks

Total Duration

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Sponsors

T

Tongji Hospital

Lead Sponsor

J

Jingzhou Central Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older and no more than 70 years old
  • Diagnosed with systemic lupus erythematosus (SLE) according to 2019 ACR/EULAR classification criteria
  • Currently receiving treatment with telitacicept
Not Eligible

You will not qualify if you...

  • Having other rheumatic immune system diseases
  • Being in the active stage of acute or chronic infections
  • Using other biologic treatments
  • Having wasting diseases such as malignant tumors

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Tongji Hospital

Wuhan, Hubei, China, 43003

Actively Recruiting

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Research Team

D

Dong Lingli, MD

CONTACT

C

Cai Shaozhe, MD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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