Systemic lupus erythematosus
Conditions
Interventions
Standard group:Stably using the following medications (either as monotherapy or in combination): glucocorticoids, antimalarials, and immunosuppressants including mycophenolate (mycophenolate mofetil o
Telitacicept group:Standard of care plus Taitacept (160 mg administered subcutaneously once weekly for up to 48 weeks
dose may be reduced to 80 mg once weekly after Week 24 for safety considerations).
Sponsors
The First Affiliated Hospital of Xi'an Jiaotong University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1.fulfill the 2019 EULAR/ACR criteria for systemic lupus erythematosus; 2.SLEDAI-2K score >= 4; 18-65 years old, male or female; 3.comprehend the study's purpose and procedure, and voluntarily sign the informed consent form; 4.Participants are willing and capable of adhering to scheduled visits, treatment protocols, laboratory assessments, imaging procedures, and other research-related activities;
Exclusion criteria
Exclusion criteria: 1.Pregnant and lactating women; 2.combined with other autoimmune diseases, such as rheumatoid arthritis, systemic sclerosis; 3.serious diseases of vital organs, serious infections, tuberculosis, malignant tumors, etc. 4.received other biologics targeting B cells within 3 months before enrollment;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the proportion of patients with lupus low disease activity state;Compared with baseline B-cell proportions, absolute counts, and changes in their function and homeostasis.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of patients achieving low disease activity state (LLDAS) at Weeks 48 and 72;Proportion of patients with a reduction of >=4 points in SLEDAI-2K score from baseline at Weeks 24, 48, and 72;Changes in clinical parameters from baseline at Weeks 4, 12, 24, 36, 48, 60, and 72;Proportion of patients who reduced glucocorticoid dose to prednisone =25% reduction in glucocorticoid dose from baseline;Time to achievement of glucocorticoid dose reduction to prednisone =25% reduction from baseline;Time to dose reduction (as assessed by the investigator) of immunosuppressants or Taitacept compared with baseline;Change from baseline in Physician’s Global Assessment (PGA) score at Weeks 24, 48, and 72;SF-36 score, EQ-5D score, depression and anxiety scores, and FACIT-Fatigue score at Weeks 24, 48, and 72;Proportion of patients experiencing disease flare between Weeks 48 and 72;Time from achieving LLDAS to first disease flare;Incidence of infections within 72 weeks of treatment;The incidence of adverse events;Changes in B-cell homeostasis and function from baseline at Weeks 4, 12, 24, 36, 48, and 72;Changes in type I interferon-stimulated gene expression levels from baseline at Weeks 4, 12, 24, 36, 48, and 72; | — |
Countries
China
Contacts
Public ContactHe Lan
The First Affiliated Hospital of Xi'an Jiaotong University
Outcome results
None listed