Neuromyelitisoptica spectrum disorders (NMOSD) Nervous System Diseases Neuromyelitisoptica spectrum disorders (NMOSD)
Conditions
Interventions
Once patients are enrolled, blood samples for the TPMT genomic analysis, TPMT activity detection, AQP-4 IgG are routinely collected at the acute phase before any therapy, along with CSF samples for CS
Sponsors
Beijing Tiantan Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Fulfill the International Consensus Diagnostic Criteria for Neuromyelitis Optica Spectrum Disorder 2015 2. Aged 18 to 80 years 3. Never been exposed to any immunosuppressive agent 4. Without blood transfusion three months before sampling 5. More than 12 months with AZA treatment and, greater than 4 weeks since a dose change, to ensure a stable AZA metabolite profile
Exclusion criteria
Exclusion criteria: 1. Intolerable to AZA treatment due to any severe adverse reaction such as the leukocyte counts less than 4×109/L, other severe cardiovascular disease or hepatopathy 2. Planned or current pregnancy and/or breast-feeding 3. Other unsuitable characteristics considered by the clinicians
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Annual relapse rate was calculated as the relapse times per year. The relapse time is assessed through patient interviews at monthly regular clinic visits and emergency circumstances (visit at the clinic because of the acute onset) 2. Disability is assessed using the Expanded Disability Status Scale (EDSS) at the acute stage (one month within the onset without any treatment), the remission stage (30 days after the AZA therapy) and the end of follow-up (more than a year of the AZA therapy) | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety is assessed by recording adverse events by routine blood tests to assess white cell counts, hepatic and renal functions, which are regularly completed every week for the first month of AZA intake, every two weeks for the second month and then monthly thereafter for one year. | — |
Countries
China
Contacts
Public ContactXinghu Zhang
Outcome results
None listed