systemic lupus erythematosus
Conditions
Interventions
Sponsors
Shandong Provincial Qianfoshan Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1.Aged between 18 and 65 years old; 2.Compliant with the revised SLE classification criteria of the American College of Rheumatology in 1997 or the SLE diagnostic classification criteria published by EULAR/ACR in 2019; 3.The SELENA-SLEDAI score must be at least 8 points (with clinical symptoms scoring no less than 6 points, excluding positive anti-double-stranded DNA (anti-dsDNA) and low complement levels); 4.Patients who have been using telitacicept or belimumab for at least 12 weeks;
Exclusion criteria
Exclusion criteria: 1.Having active central nervous system diseases; 2.eGFR less than 30 mL/min/1.73m^2, or undergoing hemodialysis or having a kidney transplant; 3.Pregnant women, or women who are about to become pregnant after taking medication, and lactating women; 4.Research participants who also participated in other clinical studies; 5.Received treatment with telitacicept or belimumab for less than 12 weeks;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate of systemic lupus erythematosus; | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of study participants with a SLEDAI decrease of at least 4 points and no worsening in PGA;Proportion of study participants whose prednisone dose decreased by >=25% from baseline or was <=7.5 mg/day at 44-48 weeks;Time of first relapse or first severe relapse; | — |
Countries
China
Contacts
Public ContactYipeng Liu
Shandong Provincial Qianfoshan Hospital
Outcome results
None listed