NMOSD
Conditions
Interventions
Plasma exchange+inebilizumab treatment group:None
Plasma exchange+Mycophenolate mofetil group:None
Sponsors
Punan hospital in Pudong new district, Shanghai
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. Patients who meet the 2015 international consensus diagnostic criteria for neuromyelitis optica spectrum disease (NMOSD) and are positive for AQP4 antibody; 2. Age greater than or equal to 18 years old; 3. The condition of NMOSD is in the acute stage, that is, there are new neurological deficit symptoms within 30 days before screening, or the original symptoms are aggravated, and the symptoms last for at least 24 hours, and there is no accompanying fever; 4. Agree to use effective contraception for the duration of the study; 5. Voluntarily sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Patients with active hepatitis B virus infection, that is, patients with active hepatitis B who are hepatitis B surface antigen (HBsAg) positive and hepatitis B virus antibody positive; 2. Patients with active or untreated latent tuberculosis; 3. Those who may be allergic to inezolizumab as judged by the investigator; 4. Pregnant women, lactating women and patients with birth plans in the past 52 weeks; 5. Patients who, in the opinion of the investigator, are not suitable to participate in the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in peripheral plasma cells/B cells; | — |
Secondary
| Measure | Time frame |
|---|---|
| Time of first recurrence after treatment;Number of relapses;Changes in Expanded Disability Status Scale (EDSS) score from baseline (at weeks 28 and 52).;Changes in Hauser Ambulation Index from baseline (at weeks 28 and 52);Changes in OSIS (Optic Spinal Inflammatory Lesion Score) for neuromyelitis optica-type injury from baseline (at weeks 28 and 52);Changes in the number of new T2 lesions on magnetic resonance imaging (MRI) from baseline (at week 52); | — |
Countries
China
Contacts
Public ContactYangtai Guan
Punan Branch of Ren Ji Hospital, Shanghai Jiao Tong University School of Medicine(Punan hospital in Pudong new district, Shanghai)
Outcome results
None listed