Neuromyelitis optica spectrum disorders (NMOSD)
Conditions
Interventions
Intervention Group:MMF treatment
Sponsors
Huashan Hospital, Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Han nationality, aged 18-75 (including 18 and 75), no gender limit; 2. The clinical diagnosis of NMOSD, in line with the NMOSD diagnostic criteria revised by the International Optic Neuritis Diagnosis Group in 2015, is not affected by disease duration, disease severity, baseline Expanded Disability Status Scale (EDSS) and AQP4-IgG serological status; 3. Receiving immunosuppressive MMF treatment and the dose is stable: MMF treatment is 20 mg/kg per day (maintained at 1.0-2.0 g/day); 4. Combined with glucocorticoids and in a stable reduction process: oral prednisone by body weight after the acute phase treatment ? tapering at a rate of 5 mg per week ? 30 mg/day x 1 month ? tapering at a rate of 2.5 mg per week ? maintain 7.5mg/day for a total of 6 months of hormone therapy; 5. For those who use RTX before receiving MMF treatment, the B cell count should be at a normal value; 6. Acute rescue therapy (such as IV glucocorticoids, plasma exchange and/or intravenous immune globulin) must be terminated for more than one month; 7. The clinical data are available, and the follow-up is supported; 8. Voluntarily sign the informed consent form (and date it).
Exclusion criteria
Exclusion criteria: 1. Combined use of other immunosuppressive drugs (such as AZA, cyclophosphamide, methotrexate, tacrolimus, etc.); 2. Patients with alcoholism; 3. Severe hepatic and renal insufficiency (Child-Pugh grade C; CrCl<15mL.min-1); 4. Insufficient clinical data.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time from treatment to first relapse;Mean change in recurrence interval; | — |
Secondary
| Measure | Time frame |
|---|---|
| Type of relapse;Severity of relapse;Lymphocyte count after treatment;Annual recurrence rate; | — |
Countries
China
Contacts
Public ContactMa Chunlai
Huashan Hospital, Fudan University
Outcome results
None listed