[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100606965":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":21,"centralContacts":25,"locations":10,"responsibleParty":30,"collaborators":10,"id":33,"slug":34,"hasResults":35,"nctId":36,"briefTitle":37,"officialTitle":38,"acronym":10,"eligibilityCriteria":39,"healthyVolunteers":35,"sex":40,"minAge":41,"maxAge":10,"enrollmentInfo":42,"targetDuration":10,"studyType":45,"phases":10,"briefSummary":46,"conditions":47,"keywords":49,"overallStatus":54,"whyStopped":10,"lastUpdateSubmitDate":55,"lastUpdatePostDateStruct":56,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":10},{"fullName":5,"class":6},"First Affiliated Hospital of Chongqing Medical University","OTHER",[8,12,15,18],{"label":9,"type":10,"description":11,"interventionNames":10},"IVMP group",null,"Methylprednisolone, intravenous infusion, 1000 mg\u002Fday for 5 consecutive days.",{"label":13,"type":10,"description":14,"interventionNames":10},"IVMP + Plasma Exchange (PE) group","IVMP combined with plasma exchange, 2000-3000 mL per session, once every 1-2 days, for a total of 3-5 sessions.",{"label":16,"type":10,"description":17,"interventionNames":10},"IVMP + Efgartigimod group","IVMP combined with efgartigimod, intravenous infusion, 10 mg\u002Fkg once weekly for 4 weeks.",{"label":19,"type":10,"description":20,"interventionNames":10},"IVMP + Eculizumab group","IVMP combined with eculizumab, intravenous infusion of 900 mg once weekly for 4 weeks.",[22],{"name":23,"affiliation":5,"role":24},"Jinzhou Feng, Ph.D","PRINCIPAL_INVESTIGATOR",[26],{"name":23,"role":27,"phone":28,"phoneExt":10,"email":29},"CONTACT","023-89012487","203756@cqmu.edu.cn",{"type":24,"investigatorFullName":31,"investigatorTitle":32,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Feng Jinzhou","Associate professor","100606965","efficacy-and-safety-of-monoclonal-antibody-in-acute-phase-of-neuromyelitis-optica-spectrum-disorder-100606965",false,"NCT07182409","Efficacy and Safety of Monoclonal Antibody in Acute Phase of Neuromyelitis Optica Spectrum Disorder","Efficacy and Safety of Monoclonal Antibody in Acute Phase of Neuromyelitis Optica Spectrum Disorder（MAAP-NMO），A Prospective, Multicenter Cohort Study","Inclusion Criteria:\n\n1. Age at onset ≥18 years, any gender.\n2. Patients meeting the 2015 International Panel for NMO Diagnosis (IPND) criteria for NMOSD and currently in the acute phase, defined as new or significantly worsened neurological deficits lasting \\>24 hours, with onset within \\\u003C14 days, excluding pseudo-relapses caused by fever, infection, or metabolic disturbances. The acute relapse must meet at least one of the following clinical phenotypes: a) Optic neuritis (ON): EDSS visual function score ≥3; b) Transverse myelitis (TM): EDSS pyramidal function score ≥2. NMOSD-related syndromes (e.g., area postrema syndrome, acute brainstem syndrome, acute diencephalic syndrome, cerebral syndrome) may be present as concomitant features but cannot be the sole or primary manifestation.\n3. Serum AQP4-IgG positive by cell-based assay (CBA) with a titer ≥1:32, and negative for MOG-IgG (CBA or LCBA) and GFAP-IgG.\n4. Expanded Disability Status Scale (EDSS) score at enrollment ≥3 and ≤8 points.\n5. Planned to receive or currently receiving intravenous methylprednisolone (IVMP) treatment, and not on or only using conventional immunosuppressive maintenance therapy.\n6. Able to comply with standardized follow-up, with an expected minimum follow-up of 12 months during the study period.\n7. Signed informed consent by the patient or legal guardian (if applicable).\n\nExclusion Criteria:\n\n1. Participation in a randomized clinical trial with blinded treatment allocation.\n2. Received treatment with monoclonal antibody (including rituximab, satralizumab, inebilizumab, eculizumab, efgartigimod, etc.) within 3 months prior to screening.\n3. Received treatment with IVIg, plasma exchange (PE), IVMP, or oral corticosteroids \\>30 mg\u002Fday within 1 month prior to screening.\n4. Incomplete or unavailable follow-up data, expected inability to complete follow-up, or poor compliance.\n5. Patients who have independently discontinued immunotherapy or demonstrate poor adherence.\n6. Presence of severe underlying diseases or other conditions that may affect the safety of immunotherapy or the interpretation of study results, including but not limited to: a) Chronic or active infections requiring long-term systemic treatment (e.g., progressive multifocal leukoencephalopathy, chronic renal infection, chronic respiratory infection with bronchiectasis, active tuberculosis, active hepatitis C, etc.); b) Positive hepatitis B serology (except in individuals with prior vaccination); c) History or suspicion of tuberculosis; d) Positive HIV serology; e) History or current clinically significant adverse reactions (including severe allergic reactions) related to corticosteroids, FcRn antagonists, or complement inhibitors.\n7. Pregnant or breastfeeding women, or women planning pregnancy in the near future (contraception required during treatment).\n8. Any other condition deemed by the investigators to make participation in the study inappropriate.","ALL","18 Years",{"count":43,"type":44},40,"ESTIMATED","OBSERVATIONAL","This study aims to evaluate the efficacy and safety of different monoclonal antibody in the acute phase of neuromyelitis optica spectrum disorder (MAAP-NMO). It will also examine immune-related biomarkers and their relationship with treatment response to provide evidence for optimizing acute-phase therapeutic strategies.",[48],"NMOSD",[48,50,51,52,53],"Intravenous methylprednisolone","Efgartigimod","Eculizumab","Plasma exchange","NOT_YET_RECRUITING","2025-09-12",{"date":57,"type":58},"2025-09-19","ACTUAL",{"date":60,"type":44},"2025-10-01",{"date":62,"type":44},"2027-06-30",{"name":5,"class":6}]