Systemic lupus erythematosus
Conditions
Interventions
Belimumab group (total systemic lupus erythematosus population):None
Telitacicept Group(the overall SLE population):None
Sponsors
Shandong Provincial Qianfoshan Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1.The age ranges from 18 to 65; 2.Meet the classification criteria for SLE revised by the American College of Rheumatology in 1997 or the diagnostic classification criteria for SLE released by EULAR/ACR in 2019. 3.The SELENA-SLEDAI score is at least 8 points (with clinical symptoms no less than 6 points, excluding positive anti-double-stranded DNA (anti-dsdna) and low complement). 4.Patients who have had poor responses, intolerance or relapses to hormone and/or immunosuppressant therapy and are willing to accept Telitacicept/Belimumab as a treatment option.
Exclusion criteria
Exclusion criteria: 1.Any of the following conditions exists: active central nervous system disease, severe active lupus nephritis, HIV infection, hepatitis B or C virus infection, hypogammaglobulinemia, liver dysfunction; 2.eGFR less than 30 mL/min/1.73m^2, or undergoing hemodialysis or kidney transplantation; 3.Women during pregnancy, or those who are planning to get pregnant in the near future, and breastfeeding women; 4.Participants who are also involved in other clinical studies; 5.Within one year prior to randomization, had received B-cell targeted therapy (including belimumab); 6.During the treatment period, these immunosuppressive traditional Chinese medicines (such as Tripterygium wilfordii, Paeonia lactiflora, etc.) were used in combination.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Major Renal Response;SRI-4; | — |
Secondary
| Measure | Time frame |
|---|---|
| Complete renal response rate;Composite indicator; | — |
Countries
China
Contacts
Public ContactLiu Yipeng
Shandong Provincial Qianfoshan Hospital
Outcome results
None listed