Systemic lupus erythematosus
Conditions
Interventions
Belimumab+SoC group:Belimumab+SoC
SoC group:SoC
Sponsors
Affiliated Hospital of Guilin Medical College
Eligibility
Sex/Gender
All
Age
16 Years to 65 Years
Inclusion criteria
Inclusion criteria: (1) Patients initially diagnosed with SLE meeting the SLE classification criteria by the ACR in 1997; (2) Enrolled patients will be at the age of 16 to 65 years, male and female; (3) Enrolled patients will be with the active diseasedefined as a SELENA-SLEDAI score >= 8 points in the screening period; (4) Positive autoantibodies of ANA and/or anti-ds-DNA antibody; (5) Patients have to receive a SLE regimen: corticosteroids, antimalarial drugs, non-steroidal anti-inflammatory drugs (NSAIDs), azathioprine, mycophenolate , cyclophosphamide, methotrexate, leflunomide, tacrolimus, thalidumide.
Exclusion criteria
Exclusion criteria: (1) With severe infection, active tuberculosis, hepatitis B or C virus activation, HIV infection; (2) Patients with end-stage liver or kidney diseases, malignant tumors, and severe cardiovascular and cerebrovascular diseases.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| SELENA-SLEDAI;BILAG; | — |
Secondary
| Measure | Time frame |
|---|---|
| adverse event; | — |
Countries
China
Contacts
Public ContactHanyou Mo
Affiliated Hospital of Guilin Medical College
Outcome results
None listed