A Comparative Study of the Efficacy and Safety of Telitacicept and Belimumab in the Treatment of Systemic Lupus Erythematosus Involving Multiple Units, Based on Previous Data.

NCT ID: NCT07053137

Last Updated: 2025-07-08

Study Results

Results pending

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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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

180 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-05-01

Study Completion Date

2025-08-31

Brief Summary

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The objective of this observational study is to compare the efficacy and safety of tixocutibine and belizumab in the treatment of systemic lupus erythematosus in patients aged 18-65 years with systemic lupus erythematosus. The main question it aims to answer is: In the overall population of systemic lupus erythematosus: What is the response rate (SRI-4) of the two drugs in treating systemic lupus erythematosus? Which drug has better efficacy and safety? This study is a retrospective study. The participants will not receive any treatment.

Detailed Description

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Conditions

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Systemic Lupus Erythematosus Telitacicept Belimumab Efficacy and Safety

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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The Belimumab group

The participants in the study had previously used belimumab as a therapeutic drug.

No interventions assigned to this group

The Telitacicept group

The participants in the study had previously used telitacicept as a therapeutic drug.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Age range: 18 - 65 years old;
* 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;
* SELENA-SLEDAI score of at least 8 points (clinical symptoms of no less than 6 points, excluding positive anti-double-stranded DNA (anti-dsDNA) and low complement);
* Patients who have been using tofacitinib or belimumab for at least 12 weeks.

Exclusion Criteria

* Having active central nervous system diseases;
* eGFR \< 30 mL/min/1.73m², or undergoing hemodialysis or kidney transplantation;
* Pregnant women, or women planning to get pregnant in the near future while taking the medication, or lactating women;
* Participants who are simultaneously participating in other clinical studies;
* Patients who have received treatment with tixagrel or belimumab for less than 12 weeks.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Renmin Hospital of Wuhan University

OTHER

Sponsor Role collaborator

Affiliated Hospital of Shandong University of Traditional Chinese Medicine

OTHER

Sponsor Role collaborator

Beijing Friendship Hospital

OTHER

Sponsor Role collaborator

Yipeng Liu

OTHER

Sponsor Role lead

Responsible Party

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Yipeng Liu

Clinical Professor

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Qianfoshan Hospital

Jinan, Shandong, China

Site Status

Countries

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China

Other Identifiers

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YXLL-KY-2025(101)

Identifier Type: -

Identifier Source: org_study_id

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