A Prospective Comparative Study Involving Multiple Units to Evaluate the Efficacy and Safety of Telitacicept and Belimumab in the Treatment of Systemic Lupus Erythematosus.

Sponsor
Yipeng Liu
Study ID
NCT07069972
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Study Details

The objective of this observational study is to compare the efficacy and safety of telitacicept versus belimumab in systemic lupus erythematosus (SLE) patients aged 18-65 years. The primary questions it aims to answer are: * In the overall SLE population: What are the SRI-4 response rates for both drugs? * In the lupus nephritis subgroup: What are the major renal response rates for both drugs? Participants will autonomously select their treatment regimen (add-on telitacicept or belimumab) based on: * The patient's objective clinical condition at enrollment * Physician's assessment * Joint decision-making between physicians and patients/family members As an observational study, no active intervention will be implemented.

Key Dates

First listed
Jul 17, 2025
Start date
Feb 1, 2026
Status verified
Jun 2025
Primary completion
Sep 30, 2029
Completion
Sep 30, 2029

Study Design

Enrollment
180 participants (estimated)

Arms

  • Arm: The Telitacicept group（the overall SLE population）
    The participants in this group were diagnosed with SLE and were selected to use Telitacicept as the treatment drug.This study is an observational study and no active intervention is carried out.
  • Arm: The Belimumab group（the overall SLE population）
    The participants in this group were diagnosed with SLE and were selected to receive belimumab as the treatment drug.This study is an observational study and no active intervention is carried out.
  • Arm: The Telitacicept group（the lupus nephritis subgroup）
    The participants in this group were diagnosed with LN and were selected to receive telitacicept as the treatment drug.This study is an observational study and no active intervention is carried out.
  • Arm: The Belimumab group（the lupus nephritis subgroup）
    The participants in this group were diagnosed with LN and were selected to receive belimumab as the treatment drug.This study is an observational study and no active intervention is carried out.

Primary Outcome Measure

The percentage of patients with a Systemic Lupus Erythematosus Response Index-4 (SRI-4) response(the overall SLE population) [ Time Frame: From baseline to the end of 2-year treatment period ]

Central Contacts

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