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

Recruiting now

Conditions studied: Systemic Lupus Erythematosus

In brief

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.

Key facts

Study ID

NCT06458972

Run by

Tongji Hospital

People needed

139

Starts

2024-01-01

Expected to finish

2024-12-31

Last updated by the study team

2024-11-19

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥ 18 years old, not exceeding 70 years old (including 70 years old);
• Patients diagnosed with systemic lupus erythematosus (SLE) according to 2019 American College of Rheumatology/European League Against Rheumatism (2019ACR/EULAR) international classification diagnostic criteria;
• Accepting the treatment of telitacicept.

You may not qualify if…

• Subjects who meet any of the following criteria should be excluded from this study:
• Patients with other rheumatic immune system diseases;
• Patients in the active stage of acute and chronic infections;
• Patients using other biologics;
• Patients with wasting diseases such as malignant tumors

Where it is running

• Tongji Hospital — Wuhan, Hubei, China (enrolling)

Full record on ClinicalTrials.gov

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