systemic lupus erythematosus
Conditions
Interventions
Group 1 :
Group 2:
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Patients with definite diagnosis of SLE, aged 18-70 years, meeting the SLE classification criteria established by the International Lupus Research Clinical Collaboration Group (SLICC) in 2012 or EULAR/ACR in 2019; 2. Disease activity when signing the informed consent form: SLEDAI-2000 <= 12 and no glucocorticoids were used; 3. Those who signed the informed consent and were able to complete the program according to the plan; 4. Hydroxychloroquine was used throughout the study, and the dose was stable; 5. If in addition to hydroxychloroquine, other immunosuppressants (methotrexate, azathioprine, cyclosporine, tacrolimus, etc.) are still being used, the dose is required to be stable for at least 2 weeks; 6. Women of childbearing age should strictly avoid pregnancy during the observation period.
Exclusion criteria
Exclusion criteria: 1. Past medical history or current medical history combined with other diffuse connective tissue diseases; 2. There are severe and poorly controlled concomitant diseases that the investigator believes are clinically significant, such as (but not limited to) nervous system, cardiovascular, renal, hepatic, endocrine or gastrointestinal diseases; 3. Patients with severe organ dysfunction have one of the following: serum creatinine > 1.5 times the upper limit of normal value; ALT or AST > 1.5 times the upper limit of normal value; total bilirubin > 1.5 times the upper limit of normal value; quantitative urine protein > 1 g/24h; Granulocytes < 0.5 x 10^9/L; PLT < 20 x 10^9/L; 4. Have a history of malignant tumors; 5. Active hepatitis B, hepatitis C or combined HIV infection; 6. Those who have used MabThera or other biological agents within 3 months; 7. People with allergies; 8. Other circumstances that the investigator judges to be inappropriate to participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Systemic Lupus Erythematosus Response Index 4; | — |
Secondary
| Measure | Time frame |
|---|---|
| SLE International Cooperation Group Injury Index; | — |
Countries
China
Contacts
Public ContactMin Yang
West China Hospital, Sichuan University
Outcome results
None listed