A Prospective Comparative Study Involving Multiple Units to Evaluate the Efficacy and Safety of Telitacicept and Belimumab in the Treatment of Systemic Lupus Erythematosus.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Systemic Lupus Erythematosus. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Comparing Efficacy and Safety of Telitacicept and Belimumab in Systemic Lupus Erythematosus: A Prospective Multicenter Cohort Study.
Overview
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.
Primary outcome measures
- 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]
- The response rate for major kidney treatments(the lupus nephritis subgroup) [Time frame: From baseline to the end of 2-year treatment period]
Secondary outcome measures (4)
- Complete renal response rate(the lupus nephritis subgroup) [Time frame: From baseline to the end of 2-year treatment period]
- Proportion of Participants with Stable SLEDAI and PGA Scores(the overall SLE population) [Time frame: From baseline to the end of 2-year treatment period]
- The proportion of participants in the study who had their hormone dosage reduced(the overall SLE population) [Time frame: From baseline to the end of 2-year treatment period]
- The time of recurrence occurrence(the overall SLE population) [Time frame: From baseline to the end of 2-year treatment period.]
Eligibility criteria
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;
- 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
- Any of the following conditions exists: active central nervous system disease, severe active lupus nephritis, HIV infection, hepatitis B or C virus infection, low gamma globulinemia, liver dysfunction;
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Qianfoshan Hospital — Jinan
Identifiers
NCT: NCT07069972 · YXLL-KY-2025(106)