NCT07053137Active, not recruiting
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.
Comparing Efficacy and Safety of Telitacicept and Belimumab in Systemic Lupus Erythematosus: A Retrospective Multicenter Cohort Study
Source: ClinicalTrials.gov · Last updated 2 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 180 (estimated)
- First submitted
- 13 Jun 2025
- Start date
- 30 Nov 2025
- Primary completion date
- 31 Mar 2026
- Lead sponsor
- Yipeng Liu
- Diseases
- Lupus (SLE)
- NCT number
- NCT07053137
What you commit to
- Study type: Observational
- Planned participants: 180
- From 30 Nov 2025 to the primary completion date, 31 Mar 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Pregnant women, or women planning to get pregnant in the near future while taking the medication, or lactating women;
- Patients who have received treatment with tixagrel or belimumab for less than 12 weeks.
Other illness
- Having active central nervous system diseases;
Lab values
- eGFR \< 30 mL/min/1.73m², or undergoing hemodialysis or kidney transplantation;
Other
- Participants who are simultaneously participating in other clinical studies;
Who the study is looking for
- 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.
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Qianfoshan Hospital Coordinator of this site? Confirm its status | Jinan | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.