The analysis of the predicting parameters related to the efficacy and safety of azathioprine given to Chinese patients with neuromyelitis optica spectrum disorders
Not Applicable
Completed
- Conditions
- euromyelitisoptica spectrum disorders (NMOSD)Nervous System DiseasesNeuromyelitisoptica spectrum disorders (NMOSD)
- Registration Number
- ISRCTN16551495
- Lead Sponsor
- Beijing Tiantan Hospital
- Brief Summary
2017 results in https://pubmed.ncbi.nlm.nih.gov/28679367/ (added 26/11/2020)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 32
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
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
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br> 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)<br> 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)<br>
- Secondary Outcome Measures
Name Time Method 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.