[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100507745":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":29,"centralContacts":33,"locations":38,"responsibleParty":56,"collaborators":10,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":10,"eligibilityCriteria":64,"healthyVolunteers":60,"sex":65,"minAge":66,"maxAge":10,"enrollmentInfo":67,"targetDuration":10,"studyType":70,"phases":10,"briefSummary":71,"conditions":72,"keywords":74,"overallStatus":41,"whyStopped":10,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":86},{"fullName":5,"class":6},"Xuanwu Hospital, Beijing","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Exposed group",null,"intravenous Intravenous methylprednisolone (IVMP) plus intravenous inebilizumab",[13],"Drug: Inebilizumab",{"label":15,"type":10,"description":16,"interventionNames":17},"Non-exposed group","IVMP plus oral immunosuppressant (Mycophenolate Mofetil or Azathioprine)",[18],"Drug: oral immunosuppressant",[20,25],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":10},"DRUG","Inebilizumab","Inebilizumab: 300mg IV on Day1 and Day 15. The first dose of inelizumab is given during IVMP.",[9],{"type":21,"name":26,"description":27,"armGroupLabels":28,"otherNames":10},"oral immunosuppressant","Oral immunosuppressants (azathioprine or mycolate mofetil) are initiated during IVMP.",[15],[30],{"name":31,"affiliation":5,"role":32},"Junwei Hao, MD","PRINCIPAL_INVESTIGATOR",[34],{"name":31,"role":35,"phone":36,"phoneExt":10,"email":37},"CONTACT","010-83198277","haojunwei@vip.163.com",[39],{"facility":40,"status":41,"city":42,"state":43,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"Xuanwu Hospital, Capital Medical University","RECRUITING","Beijing","Beijing Municipality","100053","China","CN",{"type":48,"coordinates":49},"Point",[50,51],116.39723,39.9075,{"lat":51,"lon":50},[54],{"name":55,"role":35,"phone":36,"phoneExt":10,"email":37},"Junwei Hao",{"type":57,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100507745","inebilizumab-in-acute-neuromyelitis-optica-spectrum-disorders-100507745",false,"NCT05891379","Inebilizumab in Acute Neuromyelitis Optica Spectrum Disorders","Effectiveness and Safety of Inebilizumab in the Acute Phase of Neuromyelitis Optica Spectrum Disorders-a Multicentric, Prospective, Real Word Study","Inclusion Criteria:\n\n* 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.\n\nExclusion Criteria:\n\n* 1\\. Lactating and pregnant females; 2. Participate in other interventional studies within 30 days before screening or within 5 half-lives of the investigational agent before enrollment; 3. Combined with severe mental disorders and other conditions and unable to cooperate with follow-up; 4. History of malignancies; 5. Received plasma exchange, immunoadsorption or intravenous immunoglobulin therapy within 1 month before screening; 6. Patients with negative hepatitis B surface antibody (HBsAg) and positive hepatitis B core antibody (HBcAb), or HBsAg-positive virus carriers, or patients with active tuberculosis or positive tuberculosis screening without appropriate treatment history; 7. Other situations that researchers think are not suitable to participate in this study.","ALL","18 Years",{"count":68,"type":69},50,"ESTIMATED","OBSERVATIONAL","This study is aimed to observe the effectiveness and safety of inebilizumab in the acute phase of neuromyelitis optica spectrum disorders.",[73],"Neuromyelitis Optica Spectrum Disorder",[73,75,76],"inebilizumab","observational study","2024-09-08",{"date":79,"type":80},"2024-09-19","ACTUAL",{"date":82,"type":80},"2024-07-09",{"date":84,"type":69},"2025-07-31",{"name":5,"class":6},1]