Inebilizumab in Acute Neuromyelitis Optica Spectrum Disorders
This study is aimed to observe the effectiveness and safety of inebilizumab in the acute phase of neuromyelitis optica spectrum disorders.
| Condition(s) | Neuromyelitis Optica Spectrum Disorder |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| Summary | This study is aimed to observe the effectiveness and safety of inebilizumab in the acute phase of neuromyelitis optica spectrum disorders. |
| Who can participate | Inclusion Criteria: * 1\. Age ≥ 18 years with anti-AQP4-IgG seropositive NMOSD as defined by 2015 NMOSD diagnostic criteria by IPND (International Panel for NMO Diagnosis); 2. In the acute phase of NMOSD (definition of acute phase: new neurological symptoms or aggravation of existing symptoms within 30 days before screening, lasting at least 24 hours without with fever); 3. Patients who plan to receive or are receiving intravenous methylprednisolone therapy; 4. Expanded disability status scale (EDSS) score ≤ 8 and ≥ 2.5 during the screening period; 5. Able and willing to give written informed consent; 6. Women of childbearing potential who agree to use adequate contraception during the study. Exclusion Criteria: * 1\. Lactating and pregnant females; 2. Participate in other interventional s |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Xuanwu Hospital, Beijing |
| Locations | Beijing, Beijing Municipality, China |
| Start date | 2024-07-09 |
| NCT ID | NCT05891379 |
| Official listing | https://clinicaltrials.gov/study/NCT05891379 |