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Recruiting NCT06458972

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

— Observational Systemic Lupus Erythematosus

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Systemic Lupus Erythematosus. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Safety and Efficacy of Telitacicept in the Treatment of Systemic Lupus Erythematosus (SLE) in the Real World: a Multicenter Retrospective Study

Overview

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.

Primary outcome measures

  • Safety of Estrogens in Lupus National Assessment-Systemic Lupus Erythematosus Disease Activity Index （SELENA-SLEDAI） [Time frame: Baseline and Month1, Month 2, Month 3, Month 6, Month 9, Month 12 after injecting Telitacecipt]
  • Physician's Global Assessment [Time frame: Baseline and Month1, Month 2, Month 3, Month 6, Month 9, Month 12 after injecting Telitacecipt]
  • Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) [Time frame: Baseline and Month 3, Month 6, Month 9, Month 12 after injecting Telitacecipt]
  • Serum anti-double stranded DNA (anti-dsDNA) [Time frame: Baseline, Month 6, Month 12 after injecting Telitacecipt]
  • Serum complement C3 levels [Time frame: Baseline, Month 6, Month 12 after injecting Telitacecipt]
  • Serum complement C4 levels [Time frame: Baseline, Month 6, Month 12 after injecting Telitacecipt]
  • Serum immunoglobulin quantification [Time frame: Baseline, Month 6, Month 12 after injecting Telitacecipt]
  • Levels of C-reactive protein (CRP) levels [Time frame: Baseline and Month1, Month 2, Month 3, Month 6, Month 9, Month 12 after injecting Telitacecipt]
  • Levels of interleukin-10 (IL-10) levels [Time frame: Baseline and Month 6，Month 12 after injecting Telitacecipt]
  • Levels of ferritin levels [Time frame: Baseline and Month1, Month 2, Month 3, Month 6, Month 9, Month 12 after injecting Telitacecipt]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 1 center
  • Tongji Hospital — Wuhan

Identifiers

NCT: NCT06458972 · TJ-IRB20231298

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗