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NCT Number: NCT07053137

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.

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Systemic Lupus Erythematosus Autoimmune Diseases Belimumab Connective Tissue Diseases Efficacy and Safety Immune System Diseases Lupus Erythematosus, Systemic Skin and Connective Tissue Diseases Telitacicept

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Qianfoshan Hospital

Jinan, Shandong, 250000, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. The percentage of patients with a Systemic Lupus Erythematosus Response Index-4 (SRI-4) response

    Time frame: From baseline to the end of 1-year treatment period

    • The SELENA-SLEDAI score decreased by ≥ 4 points compared to the baseline;
    • And there were no new BILAG-assessed grade A organs or ≤ 2 new BILAG-assessed grade B organs compared to the baseline;
    • And the overall physician assessment (PGA) did not deteriorate (an increase of < 0.30 points compared to the baseline).

Secondary outcomes

  1. Proportion of Participants with Stable SLEDAI and PGA Scores

    Time frame: From baseline to the end of 1-year treatment period

    The percentage of study participants whose SLEDAI score decreased by at least 4 points and whose PGA did not worsen.

  2. The proportion of participants in the study who had their hormone dosage reduced

    Time frame: From baseline to the end of 1-year treatment period

    The ratio of study participants whose prednisone dose was reduced by ≥25% or ≤7.5 mg/day compared to the baseline at 44-48 weeks.

  3. The time of recurrence occurrence

    Time frame: From baseline to the end of 1-year treatment period

    The time of the first recurrence or the first severe recurrence.

Sponsors and collaborators

Lead sponsor

Yipeng Liu

Other

Collaborators

  • Affiliated Hospital of Shandong University of Traditional Chinese Medicine
  • Beijing Friendship Hospital
  • Renmin Hospital of Wuhan University

Registry information

Official study title

Comparing Efficacy and Safety of Telitacicept and Belimumab in Systemic Lupus Erythematosus: A Retrospective Multicenter Cohort Study

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 8, 2025
Registry last updated
Feb 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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