A Prospective Comparative Study Involving Multiple Units to Evaluate the Efficacy and Safety of Telitacicept and Belimumab in the Treatment of Systemic Lupus Erythematosus.
NCT ID: NCT07069972
Last Updated: 2025-07-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
180 participants
OBSERVATIONAL
2025-08-01
2028-06-30
Brief Summary
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* 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.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
No interventions assigned to this group
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.
No interventions assigned to this group
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.
No interventions assigned to this group
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.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Meets the revised SLE classification criteria of the American College of Rheumatology in 1997 or the SLE diagnostic classification criteria issued by EULAR/ACR in 2019;
* The SELENA-SLEDAI score is at least 8 points (clinical symptoms are no less than 6 points, excluding positive anti-double-stranded DNA (anti-dsDNA) and low complement);
* Has not responded well to hormone and/or immunosuppressant treatment, is intolerant or has recurrence, and is willing to accept tixocortinib/belimumab as a therapeutic drug.
Exclusion Criteria
* eGFR \< 30 mL/min/1.73m², or undergoing hemodialysis or kidney transplantation;
* Pregnant women, or women who are about to become pregnant in the near future, or lactating women;
* Participants who are simultaneously participating in other clinical studies;
* Within 1 year before randomization, received B-cell targeted therapy (including belimumab);
* During treatment, used traditional Chinese medicine with immunosuppressive effects (such as Tripterygium wilfordii, White Peony Root, etc.) in combination.
18 Years
65 Years
ALL
No
Sponsors
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Renmin Hospital of Wuhan University
OTHER
Affiliated Hospital of Shandong University of Traditional Chinese Medicine
OTHER
Yipeng Liu
OTHER
Responsible Party
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Yipeng Liu
Clinical Professor
Locations
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Qianfoshan Hospital
Jinan, Shandong, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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YXLL-KY-2025(106)
Identifier Type: -
Identifier Source: org_study_id
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