[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100478032":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":25,"locations":35,"responsibleParty":52,"collaborators":55,"id":58,"slug":29,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":29,"eligibilityCriteria":63,"healthyVolunteers":59,"sex":64,"minAge":65,"maxAge":29,"enrollmentInfo":66,"targetDuration":29,"studyType":69,"phases":70,"briefSummary":73,"conditions":74,"keywords":76,"overallStatus":38,"whyStopped":29,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":87},{"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,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"Tangdu Hospital","RECRUITING","Xi'an","Shaanxi","China",{"type":43,"coordinates":44},"Point",[45,46],108.92861,34.25833,{"lat":46,"lon":45},[49,50,51],{"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":53,"investigatorTitle":54,"investigatorAffiliation":5,"oldNameTitle":29,"oldOrganization":29},"Jun Guo, MD","Department of Neurology",[56],{"name":57,"class":6},"Henan Provincial People's Hospital","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":67,"type":68},5,"ESTIMATED","INTERVENTIONAL",[71,72],"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.",[75],"Neuromyelitis Optica Spectrum Disorder",[75,77,9],"Aquaporin 4","2026-01-28",{"date":80,"type":81},"2026-01-30","ACTUAL",{"date":83,"type":81},"2022-06-28",{"date":85,"type":68},"2026-07-31",{"name":5,"class":6},1]