Compares two lupus drugs, telitacicept and belimumab, in adults with lupus
Compares telitacicept and belimumab in adults with systemic lupus erythematosus.
Plain-language title generated from the registry record
Registry title: A Prospective Comparative Study Involving Multiple Units to Evaluate the Efficacy and Safety of Telitacicept and Belimumab in the Treatment of Systemic Lupus Erythematosus.
Key facts
- Where
- Jinan, ChinaSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Source: NCT07069972, who can take part
Where in China
- Qianfoshan HospitalJinan, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Yipeng Liu
- Trial code
- NCT07069972
- Record updated
- 2 February 2026
- Original description
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:Read full original descriptionShow less
Comparing Efficacy and Safety of Telitacicept and Belimumab in Systemic Lupus Erythematosus: A Prospective Multicenter Cohort Study.
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.
Inclusion: 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: Within 1 year before randomization, received B-cell targeted therapy (including belimumab); 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; During treatment, used traditional Chinese medicine with immunosuppressive effects (such as Tripterygium wilfordii, White Peony Root, etc.) in combination.