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

NCT07069972 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 180

Last updated 2026-02-02

No results posted yet for this study

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.

Conditions

Sponsors & Collaborators

  • Renmin Hospital of Wuhan University

    collaborator OTHER

  • Affiliated Hospital of Shandong University of Traditional Chinese Medicine

    collaborator OTHER

  • Yipeng Liu

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-01
Primary Completion
2029-09-30
Completion
2029-09-30

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07069972 on ClinicalTrials.gov