NMOSD
Conditions
Interventions
Plasma exchange+Ofatumumab+Mycophenolate mofetil:Ofatumumab
Plasma exchange+Mycophenolate mofetil:Mycophenolate mofetil
Sponsors
Renji Hospital, School of Medicine, Shanghai Jiao Tong University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1: Aged 18 to 75 years old 2: Meet the 2015 international consensus diagnostic criteria for Neuromyelitis Optica Spectrum Disorders and astrocyte water channel aquaporin-4 (AQP4) antibody positivity 3: Acute phase of NMOSD: new onset of neurological symptoms within 30 days before screening or aggravated original symptoms, lasting for at least 24 hours without accompanying fever 4: Voluntarily sign informed consent;Age 20-year-old patients need parental consent. 5: Ability to follow study protocols and schedules and to report symptoms. 6: Women who were not pregnant or lactating at the time of screening agreed to use effective contraception during the study period.
Exclusion criteria
Exclusion criteria: 1: Evidence or known history of clinically significant infection at the time of screening, including but not limited to: ? chronic or persistently active infectious disease ? Previous severe opportunistic or atypical infection? Previous or active HBV infection (HBsAg or HBcAb positive) ? Active tuberculosis ?HIV. 2: Prior treatment with a BTK inhibitor (such as ibrutinib) at any time. 3: Use RTX or any B-cell depleting agent (e.g., ibilizumab) or other monoclonal antibody (e.g., Sutellizumab or tolizumab) within 6 months prior to screening. 4: Treatment with mitoxantrone or cyclophosphamide in the 12 months prior to screening. 5: Pregnant or nursing women and patients with birth plans in the last 48 weeks. 6: Patients who are participating in other clinical trials. 7: Patients diagnosed with malignant tumors. 8: Patients with alcohol and drug abuse. 9: Have received any live or attenuated vaccine within 4 weeks before the first administration of the study drug, or have received any inactivated vaccine within 2 weeks before the first administration of the study drug. 10: Patients with neurological findings consistent with PML or confirmed PML. 11: Patients who, according to investigator judgment or investigator assessment, may not be able to comply with the trial procedure and are not suitable for evaluation in the trial due to underlying medical conditions. 12: The following laboratory findings were abnormal during screening or baseline examination: ?AST or ALT levels were more than 2 times the upper limit of normal, or GGT levels were more than 2 times the upper limit of normal ? White blood cell (WBC) count<3,500/mm3 (<3.5 x 10 9 /L). 13: Can't accept magnetic resonance imaging inspection during the trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| CD19+, CD20 + B lymphocyte count in peripheral blood; | — |
Secondary
| Measure | Time frame |
|---|---|
| Time of first recurrence after treatment;Magnetic resonance T2 number of new lesions change from baseline;Changes in Extended Disability Status Scale (EDSS) scores from baseline at 24 and 48 weeks; | — |
Countries
China
Contacts
Public ContactYangtai Guan
Renji Hospital, School of Medicine, Shanghai Jiao Tong University
Outcome results
None listed