[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100478032":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":25,"locations":35,"responsibleParty":53,"collaborators":56,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":29,"eligibilityCriteria":65,"healthyVolunteers":61,"sex":66,"minAge":67,"maxAge":29,"enrollmentInfo":68,"targetDuration":29,"studyType":71,"phases":72,"briefSummary":75,"conditions":76,"keywords":78,"overallStatus":38,"whyStopped":29,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},{"fullName":5,"class":6},"Tang-Du Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Ofatumumab","EXPERIMENTAL","The enrolled patients will receive ofatumumab (20 mg\u002F0.4 ml) subcutaneously administered at baseline, Day 7, Day 14 and monthly thereafter. Patients will receive ofatumumab therapy for a total of 48 weeks.",[13],"Drug: Ofatumumab",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"DRUG","The enrolled patients will receive ofatumumab (20 mg\u002F0.4 ml) subcutaneously administered at baseline, Day 7, Day 14 and monthly thereafter. Patients will receive ofatumumab therapy for a total of 48 weeks.\n\nThe first 4 infusions will be administered at study center site; subsequent infusions will be given in the patient's home with a nurse online interview to administer the infusion.",[9],[20],"Arzerra",[22],{"name":23,"affiliation":5,"role":24},"Jun Guo, M.D.","PRINCIPAL_INVESTIGATOR",[26,31],{"name":23,"role":27,"phone":28,"phoneExt":29,"email":30},"CONTACT","86-29-8477 8844",null,"guojun_81@163.com",{"name":32,"role":27,"phone":33,"phoneExt":29,"email":34},"Yan Jia, M.S.","86-29-8471 7483","neurologist_jiayan@163.com",[36],{"facility":37,"status":38,"city":39,"state":40,"zip":29,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"Tangdu Hospital","RECRUITING","Xi'an","Shaanxi","China","CN",{"type":44,"coordinates":45},"Point",[46,47],108.92861,34.25833,{"lat":47,"lon":46},[50,51,52],{"name":23,"role":27,"phone":28,"phoneExt":29,"email":30},{"name":32,"role":27,"phone":33,"phoneExt":29,"email":34},{"name":23,"role":24,"phone":29,"phoneExt":29,"email":29},{"type":24,"investigatorFullName":54,"investigatorTitle":55,"investigatorAffiliation":5,"oldNameTitle":29,"oldOrganization":29},"Jun Guo, MD","Department of Neurology",[57],{"name":58,"class":6},"Henan Provincial People's Hospital","100478032","phase-1-ofatumumab-in-aqp4-igg-seropositive-nmosd-100478032",false,"NCT05504694","Ofatumumab in AQP4-IgG Seropositive NMOSD","Efficacy and Safety of Ofatumumab in AQP4-IgG Seropositive NMOSD: an Open-label, Single-arm, Multicentre Prospective Pilot Study","Inclusion Criteria:\n\n* Diagnosis of NMOSD according to the 2015 International Panel Diagnostic Criteria for NMOSD with AQP4-IgG.\n* Clinical evidence of at least 2 relapses (including first attack) in past 24 months with at least 1 relapse occurring in the preceding 12 months.\n* Adults aged ≥18 years old.\n* Expanded disability status scale (EDSS) score between 0 and 7.5 (inclusive).\n* Provision of written informed consent to participate in this study.\n* Only oral corticosteroids were permitted at screening (≤10mg equivalent per day), which should be terminated within one month.\n* Effective contraception was used for female patients with fertility during the treatment or at least 3 months after stopping medication.\n\nExclusion Criteria:\n\n* Progressive neurological deterioration unrelated to relapses of NMOSD, or presence of neurological findings suspected with PML.\n* Pregnant or breastfeeding patients and those with family planning during the study period.\n* Patients participating in any other clinical therapeutic study at the screening or within 30 days of screening.\n* Patients with splenectomy or history of no spleen, and those with planned surgery (excluding minor surgery) during the study period.\n* Presence of uncontrolled severe concurrent diseases; long-term glucocorticoids or immunosuppressants use due to other autoimmune diseases, or presence of other chronic diseases that cannot receiving immunosuppression.\n* Active infection at within 4 weeks before baseline.\n* Positive for HBV or HCV.\n* Evidence of latent or active tuberculosis (TB).\n* Have received any live or live-attenuated vaccine within 6 weeks before baseline.\n* History of malignancy in past 5 years, including solid tumor, malignant hematopathy and carcinoma in situ.\n* History of severe allergic reactions to biological agents.\n* Inability to provide written informed consent.","ALL","18 Years",{"count":69,"type":70},5,"ESTIMATED","INTERVENTIONAL",[73,74],"PHASE1","PHASE2","This is an open-label, single-arm, multicentre prospective pilot study to assess the efficacy and safety of ofatumumab in patients with AQP4-IgG seropositive neuromyelitis optica spectrum disorder (NMOSD) in China.",[77],"Neuromyelitis Optica Spectrum Disorder",[77,79,9],"Aquaporin 4","2026-01-28",{"date":82,"type":83},"2026-01-30","ACTUAL",{"date":85,"type":83},"2022-06-28",{"date":87,"type":70},"2026-07-31",{"name":5,"class":6},1]