Clinical Trial

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

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Summary
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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-07-16.
Trial Details
NCT Number NCT07069972
Lead Sponsor Yipeng Liu
Collaborators: Renmin Hospital of Wuhan University, Affiliated Hospital of Shandong University of Traditional Chinese Medicine
Conditions Systemic Lupus Erythematosus
Enrollment 180 participants
Start Date 2026-02-01
Primary Completion 2029-09-30 (estimated)
Study Completion 2029-09-30 (estimated)
Updated on ClinicalTrials.gov 2026-02-02