Neuromyelitis Optica Spectrum Disorders
Conditions
Interventions
Cases:Plasma exchange + a Recombinant Human B Lymphocyte Stimulator Receptor:Immunoglobulin G( IgG ) Fc Fusion Protein for Injection
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) Meet the 2015 international consensus diagnostic criteria for Neuromyelitis Optica Spectrum Disorders and astrocyte water channel aquaporin-4 (AQP4) antibody positivity (results acceptable within 24 weeks before signing the informed consent; (2) Aged 18 to 75 years old; (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) Recurrent NMOSD (including acute onset during screening)= 2 recurrences occurred 12 months before screening; (5) Consent to use effective contraception during the study period; (6) Voluntarily sign informed consent.
Exclusion criteria
Exclusion criteria: (1) Progressive deteriorating neurological disorders that are not associated with NMOSD; (2) Currently suffering from active hepatitis or serious liver disease and medical history (>2 times normal value of liver function test); HBsAg-surface antigen positive patients are excluded. Patients with anti-HBc positive are needed for HBV-DNA quantitative test, who are not excluded if negative (3) Currently suffering from renal insufficiency (including acute kidney injury and chronic kidney disease, the estimated serum creatinine clearance rate calculated by Cockcroft-Gault equation is < 60mL/min); (4) Pregnant, lactating women and men or women who have birth plans in the coming 48 weeks; (5) Have participated in any clinical trial in the first 28 days of the initial screening or 5 times half-life period of the study compound (taking shorter time); (6) Post-splenectomy; (7) Allergic reactions: patients with a history of allergies to contrast agents and human-derived biological products for parenteral administration; (8) Severe psychiatric symptoms and are not compatible with clinical studies; (9) Can't accept magnetic resonance imaging inspection during the trial; (10) Have used rituximab or mitoxantrone 3 months prior to enrollment; (11) Investigator considers candidates not appropriating for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time of first clinical relapse after enrollment; | — |
Secondary
| Measure | Time frame |
|---|---|
| EDSS scores;OSIS scores;Hauser walking index;MRI;OCT tests;VEP;Immunologic status; | — |
Countries
China
Contacts
Public ContactYangtai Guan
Renji Hospital, School of Medicine, Shanghai Jiao Tong University
Outcome results
None listed