systemic lupus erythematosus
Conditions
Interventions
Test group:Telitacicept 160 mg / time once a week subcutaneous injection therapy.
Sponsors
Department of Dermatology, Second Affiliated Hospital of Xi 'an Jiaotong University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: ( 1 ) Age = 18 years old, regardless of gender ; ( 2 ) SLE patients with definite diagnosis, the diagnostic criteria are as above ; ( 3 ) SLEDAI-2K score = 6 and CLASI-A score = 8 ; ( 4 ) Glucocorticoid dose = 20 mg / d, and stable vital signs ; ( 5 ) Voluntary participation in this study, and signed informed consent.
Exclusion criteria
Exclusion criteria: ( 1 ) Persons known to be allergic to research drugs ; ( 2 ) pregnant or lactating women ; ( 3 ) Severe active central nervous system lupus ; ( 4 ) Severe active lupus nephritis ; ( 5 ) Patients with severe liver and / or renal dysfunction ; ( 6 ) Persons infected with HIV, hepatitis B or hepatitis C ; ( 7 ) patients who are participating in clinical studies of other drugs ; ( 8 ) Patients who dropped out or did not follow the established experimental plan due to reasons ; ( 9 ) The researchers judged that there were other reasons that were not suitable for participation in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| SRI4 response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| LLDAS compliance rate;The ratio of achieving the area and severity index of skin lupus erythematosus, CLASI-20, CLASI-50, and CLASI-70;Hormone usage reduction;The ratio of baseline changes in blood/urine routine and other test indicators before and after treatment to normal recovery;The ratio of preoperative and postoperative immunological indicators to baseline changes and recovery to normal;The ratio of changes in cytokine levels before and after treatment to baseline and recovery to normal;Changes in the systemic lupus erythematosus international treatment clinic/American Society of Rheumatology systemic loss index; | — |
Countries
China
Contacts
Public ContactXia Yumin
Department of Dermatology, Second Affiliated Hospital of Xi 'an Jiaotong University
Outcome results
None listed