Systemic Lupus Erythematosus
Conditions
Interventions
Belimumab group:Belimumab
Non Belimumab :Non Belimumab
Sponsors
Xi'an Jiaotong University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. SLE patients,diagnosed according to the SLE classification criteria formulated by the international lupus research clinical collaboration group (SLICC)in 2012 or EULAR/ACR in 2019. 2. Patients with active, autoantibody positive SLE with a SELENA-SLEDAI=8. 3. Seropositive antinuclear antibodies (ANAs) and/or anti-doublestranded-DNA (anti-dsDNA) antibody screening are required. 4. Patients/Guardian who give consent. 5. On stable SLE treatment regimen. 6. Women of childbearing age were strictly contraception during the observation period.
Exclusion criteria
Exclusion criteria: 1. Pregnant or nursing 2. Have received treatment with any B cell targeted therapy. 3. Have received treatment with a biological investigational agent in the past year. 4. Have received IV cyclophosphamide within 180 days of Day 0. 5. Have severe lupus kidney disease. 6. Have active central nervous system (CNS) lupus. 7. Have required management of acute or chronic infections within the past 60 days. 8. Have current drug or alcohol abuse or dependence. 9. Have a historically positive test or test positive at screening for HIV, hepatitis B, or hepatitis C. 10. Patients / Guardians who do not give consent because of any reason will be excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| SELENA-SLEDAI score; | — |
Countries
China
Contacts
Public ContactXIA YUMIN
Xi'an Jiaotong University/Second Affiliated Hospital of Xi'an Jiaotong University
Outcome results
None listed