neuromyelitis optica spectrum disorder (NMOSD)
Conditions
Interventions
1:Intravenous 200mg Rituximab, 1/week*2, if the proportion of CD19+ B lymphocytes in peripheral blood is above 1% then repeat administration (200mg)
2:Oral azathioprine (2.5-3 mg/kg bodyweight/day) or mycophenolate mofetil (750~3000mg/day)
Sponsors
The Ophthalmology Department of the Chinese Peoples Liberation Army Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Meet the diagnostic criteria for NMO-ON (fulfill one of following criteria: (1) Meet the international consensus diagnostic criteria for NMOSD Proposed by the international panel for NMO diagnosis in 2015; (2) Recurrent ON or first-episode unilateral or bilateral ON secondary to NMOSD with AQP4-Ab and/or NMO-IgG seropositive, testing by both cell-based assay andenzyme-linked immunosorbent assay); 2. Aged from 18 to 70 years; 3. Agreed with the protocol for this study and signed informed consent.
Exclusion criteria
Exclusion criteria: 1. During the Pregnancy or breastfeeding; 2. Allergic to any ingredient of Rituximab or AZA/MMF; or respiratory system infection is not suitable for use of this drug; 3. Patients with severe cardiovascular, liver, kidney or hematopoietic diseases or diabetes, with blood pressure >=140/90 mmHg; 4. History of application of other DMT drugs (e.g. Interferon, natalizumab, FTY-720, etc.) or injected imported rituximab in the last half-year; 5. Participated in clinical trials of other new drugs within the last 3 months; 6. Cannot complete the clinical trial protocol or cannot meet follow-up requirements due to severe mental or language disorders; 7. The researcher thinks that it is inappropriate to participate in the clinical trial due to other reasons; Or do not agree to participate in this research project.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Annual Relapse Rate;Best Corrected Visual Acuity;EDSS score;side effects; | — |
Countries
China
Contacts
Public ContactShihui Wei
The General Hospital of Chinese Peoples Liberation Army
Outcome results
None listed