Systemic Lupus Erythematosus
Conditions
Interventions
case series:Nil
Sponsors
Department of Rheumatology, Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Age: Subjects were at least 18 years old at the screening visit. 2. SLE diagnosis: meet the 1997 American College of Rheumatology (ACR) SLE classification criteria or the 2009 ACR proposed SLE classification criteria or the 2019 EULAR/ACR SLE diagnostic criteria. 3. SLE patients who started to receive belimumab within 1 week before enrollment; 4. Disease severity: (one or more of the following criteria are met) Active SLE, defined as SLENA SLEDAI score = 6 points before belimumab use (SELENA SLEDAI score see Annex 2: SELENA SLEDAI Disease Activity Sex score); or SLE patients cannot achieve low disease activity after hydroxychloroquine combined with one or more immunosuppressive drugs; or SLE patients receive prednisone >= 10 mg/d treatment, and there is serological activity at the same time. 5. SLE treatment: The enrolled patients can receive the following drugs alone or in combination before receiving belimumab: Glucocorticoids (prednisone or prednisone-like drugs); Other immunosuppressive or immunomodulatory agents include methotrexate, azathioprine, leflunomide, mycophenolate mofetil (including mycophenolate mofetil, mycophenolate mofetil hydrochloride, mycophenolate sodium ), calcineurin inhibitors (eg, tacrolimus, cyclosporine), cyclophosphamide, or thalidomide. Antimalarial drug (hydroxychloroquine). Nonsteroidal anti-inflammatory drugs (NSAIDs), including sulfasalazine. 6. Consent to contraception (any of the following); IUDs; oral contraceptives (progestin or combined progestins); condoms. 7. Sign the informed consent.
Exclusion criteria
Exclusion criteria: 1. Received B cell depletion therapy (CD20 monoclonal antibody) within 1 year; 2. Received the following treatments within 90 days before screening: anti-TNF-a, IL-6, IL-1, abatacept therapy, plasma exchange, blood adsorption, hemodialysis, mesenchymal stem cell transplantation; 3. During the screening period, there is a clinical assessment of severe infection that may be life-threatening; 4. Active viral hepatitis, positive for HBV-DNA or HCV-RNA; 5. Have a history of HIV positive test; 6. Active tuberculosis diagnosed clinically; 7. Have injected live vaccine or attenuated live vaccine within 4 weeks before screening; 8.Those with a history of peptic ulcer or gastric bleeding in the past; warfarin or other anticoagulant drugs have been used within 14 days before screening; 9. Those with a history of malignant tumor, except for cured, carcinoma in situ and basal cell carcinoma; 10. Pregnant women and lactating women. 11. The patient has severe mental illness or suicidal tendencies 12. After the investigator evaluates the condition, the patient is considered unsuitable for enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| SELENA SLEDAI score;Physician's Global Assessment, PGA; | — |
Secondary
| Measure | Time frame |
|---|---|
| patient self-assessment score;SELENA SLEDAI score;PGA;dsDNA;complement;mmunoglobulin;oral glucocorticoid dose reduction;immune cell profile in peripheral blood; | — |
Countries
China
Contacts
Public ContactBaoChunde
Department of Rheumatology, Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Outcome results
None listed