neuromyelitis optica Spectrum disorders
Conditions
Interventions
Inalizumab group:routine+Inalizumab
Sponsors
Department of Neurology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Eligibility
Sex/Gender
All
Age
18 Years to 90 Years
Inclusion criteria
Inclusion criteria: (1) Fulfillment of the diagnostic criteria for AQP4-IgG antibody-positive NMOSD established by the International Panel for NMO Diagnosis (IPND) in 2015; (2) Treatment with inelizumab; (3) At least one documented clinical visit during the observation period after initiation of treatment with inelizumab. (4) Age = 18 years; (5) Signed written informed consent as required by local regulations.
Exclusion criteria
Exclusion criteria: (1) Significant cardiovascular disease (including severe arrhythmias), hepatic, renal, respiratory, endocrine, or hematological disease, or other medical conditions that, in the opinion of the Investigator, would preclude participation in the study or require hospitalization for the duration of the study; (2) Acute infection requiring treatment 4 weeks prior to screening; (3) The patient has a chronic infection requiring treatment; (4) Currently have active hepatitis or have severe liver disease and history of such disease. (5) Those who are HIV antibody positive; (6) Those with malignant tumors; (7) Those who are allergic to biological products of human origin; (8) Women who are pregnant or breastfeeding and those who plan to have children during the trial period; (9) Persons with known alcohol or drug abuse/addiction that may have an impact on compliance with the trial requirements; (10) Individuals who, in the opinion of the investigator, are not suitable to participate in the trial (e.g., severe mental disorders).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| EDSSMGFA rating scale;Immunological marks;Ophthalmic examination;Visual evoked potential;MRI; | — |
Countries
China
Contacts
Public ContactBitao Bu
Department of Neurology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Outcome results
None listed