Systemic Lupus Erythematosus (SLE)
Conditions
Interventions
Experimental group: Telitacicept combined with standard therapy
Control group: standard therapy
Sponsors
The First Hospital of China Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-70 years; 2. Meet the 2012 SLICC classification standard for systemic Lupus Erythematosus; 3. Active NPSLE. Neuropsychiatric lupus was named according to the 1999 ACR diagnostic criteria. According to the ''excluded'' and ''associated'' factors named by the ACR in 1999, there are no other diagnoses that might explain neuropsychiatric symptoms and contain only one or more of the following manifestations: Epilepsy, aseptic meningitis, acute confusion, myelopathy, demyelinating syndrome, acute inflammatory demyelinating multiple radiculopathy, cognitive dysfunction, cranial neuropathy, multiple mononeuritis or psychotic manifestations; 4. The attribution and severity of neuropsychiatric symptoms in patients with SLE are discussed in consultation with rheumatologists, neurologists, psychiatrists, neuroradiologists, and infectiologists; 5. Subjects voluntarily participate and sign informed consent.
Exclusion criteria
Exclusion criteria: 1. Complicated with other connective tissue diseases or inflammatory diseases; 2. Mental illness or family history; 3. Associated with other diseases that may cause neuropsychiatric symptoms, including tumors, drugs (such as immunosuppressants), infections, metabolic encephalopathy, electrolyte disturbances; 4. Patients with high risk factors of cardiovascular and cerebrovascular diseases and family history, who cannot be excluded from cardiovascular and cerebrovascular diseases; 5. Any medical condition that may require multiple courses of systemic glucocorticoid therapy (e.g. uncontrolled asthma, COPD); 6. Intravenous cyclophosphamide use within 6 months or oral cyclophosphamide treatment within 3 months; 7. Received one other B cell biotherapy within 3 months or two other B cell biotherapy within 6 months or B-cell clearance therapy such as rituximab within 12 months; 8. Use human immunoglobulin within 1 month; 9. Receiving angiotensin converting enzyme inhibitors or angiotensin receptor antagonists; 10. Patients who have undergone major surgery in the past month or plan to undergo major surgery during treatment; 11. Pregnant or lactating patients; 12. Patients of childbearing age are unwilling or unable to use highly effective contraceptive methods during the 28 days before and 3 months after administration; 13. A history of malignant tumors or lymphoproliferative diseases within the 5 years prior to screening: 14. Previous recipients of stem cell transplantation (including hematopoietic stem cell transplantation and mesenchymal stem cell transplantation); (1) Admitted patients with treated squamous cell carcinoma and basal cell carcinoma without evidence of recurrence; (2) To admit patients with cervical carcinoma in situ who have documented formal surgical cure; 15. Have received splenectomy; 16. Present infections or infections that are difficult to control that require antibiotic or antiviral treatment; 17. Alcohol or drug abuse, according to the investigator; 18. The Investigator considers that there are any circumstances which may cause the patient to be unable to complete the study or present a significant risk to the patient.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| BILAG neurological score; | — |
Secondary
| Measure | Time frame |
|---|---|
| SLEDAI-2K score;SLICC/ACR injury score;PGA score;Brain MRI imaging score;Montreal cognitive assessment questionnaire score; | — |
Countries
China
Contacts
Public ContactYang Pingting
Outcome results
None listed