Systemic lupus erythematosus
Conditions
Interventions
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; (2) Patients should meet the 2012 SLICC classification criteria for systemic Lupus Erythematosus. Patients should meet at least 4 of the classification criteria, including at least 1 clinical criteria and 1 immunological criteria; (3) Active NPLE. 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, myasthenia gravis, acute inflammatory demyelinating disease, multiple mononeuritis or psychotic manifestations; (4) Rheumatologists, neurologists, psychiatrists, neuroradiologists, and infectiologists consult to discuss the attribution and severity of neuropsychiatric symptoms in patients with SLE; (5) The subject voluntarily participates and signs informed consent.
Exclusion criteria
Exclusion criteria: (1) Presentation of other forms of NPLE (except, as determined by the investigator, for confirmed APS patients with high tier-positive antiphospholipid antibodies, multiple antiphospholipid antibody positivity, and thromboembolic events as the primary presentation); (2) associated with other connective tissue diseases or inflammatory diseases; (3) accompanied by mental disease or family history; (4) Associated with other diseases that may cause neuropsychiatric symptoms, including tumors, drugs (such as immunosuppressants), infections, metabolic encephalopathy, electrolyte disturbances; (5) Patients with high risk factors of cardiovascular and cerebrovascular diseases and family history, and cannot be excluded from cardiovascular and cerebrovascular diseases; (6) Any condition that may require multiple courses of systemic glucocorticoid therapy (e.g. uncontrolled asthma, COPD) (7) intravenous cyclophosphamide use within 6 months or oral cyclophosphamide treatment within 3 months; (8) Received one other B cell biotherapy within 3 months, or two other B cell biotherapy within 6 months, and B cell clearance therapy such as rituximab within 6 months; (9) Use of human immunoglobulin within 1 month; (10) receiving angiotensin converting enzyme inhibitors or angiotensin receptor antagonists; (11) Patients who have undergone major surgery in the past month or plan to undergo major surgery during treatment; (12) Pregnant or lactating women; (13) women of childbearing age are unwilling or unable to use highly effective contraceptive methods during the 28 days before and 3 months after administration; (14) Have a history of malignant tumor or lymphoproliferative disease within 5 years prior to screening: ? allowed after treatment and no evidence of recurrence of skin squamous cell carcinoma and basal cell carcinoma patients into groups; ? allows for file record has officially surgery to cure patients with cervical carcinoma in situ in the group; (15) Previous recipients of stem cell transplantation (including hematopoietic stem cell transplantation and mesenchymal stem cell transplantation); (16) had undergone splenectomy (17) Existing infections or infections that are difficult to control that require antibiotic or antiviral treatment; (18) Severe congestive heart failure (New York Heart Society Class III or IV) (19) Patients who are allergic to mouse proteins or other antibodies (20) Alcohol or drug abuse, according to the investigator; (21) The Investigator considers that there are any circumstances that may cause the subject to be unable to complete the study or pose a significant risk to the subject.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement in BILAG nervous system score at week 24.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in SLEDAI-2K at Week 12 and 24 from baseline;PGA changes at week 12 and week 24 from baseline;Improvement in BILAG nervous system score at week 12;Changes of brain MRI imaging scores at 24 weeks;Changes in psychological questionnaire scores at week 24 from baseline;The change of SLICC/ACR injury score at week 24;Cumulative glucocorticoids dosage at week 24; | — |
Countries
China
Contacts
Public ContactYang Pingting
The First Hospital of China Medical University
Outcome results
None listed