[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"nmosd\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:nmosd":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,10,0,[8,41,70,97,122,151,171,196,223,243],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100593735","phase-4-rituximab-versus-ravulizumab-inebilizumab-satralizumab-and-eculizumab-in-nmosd-100593735",false,"NCT07010302","Rituximab Versus Ravulizumab, Inebilizumab, Satralizumab, and Eculizumab in NMOSD","A Comparative Clinical Effectiveness Trial of Rituximab Versus Ravulizumab, Inebilizumab, Satralizumab and Eculizumab To Prevent Relapses in Neuromyelitis Optica Spectrum Disorder","BEST-NMOSD","Inclusion Criteria:\n\n* Diagnosis of NMOSD according to the 2015 International Panel for NMO Diagnosis (IPND) consensus criteria.\n* Seropositivity for AQP4 immunoglobulin G (AQP4-IgG) confirmed by a cell-based assay (either live or fixed) that meets the threshold for positivity set by the local testing laboratory.\n* Age ≥18 years at the time of consent.\n* Ability and willingness to provide informed consent and comply with all study procedures, including scheduled visits, laboratory tests, and assessments.\n* Eligible to receive any of the study drugs based on clinical judgment\n\nExclusion Criteria:\n\n* Known active hepatitis B virus (HBV) infection, defined as a positive hepatitis B surface antigen or detectable HBV DNA by PCR.\n* Known active hepatitis C virus (HCV) infection, defined as detectable HCV RNA by PCR.\n* Known active or latent tuberculosis, evidenced by a positive interferon-gamma release assay (IGRA) unless fully treated per local guidelines before enrollment.\n* Known or suspected immunodeficiency disorders, including but not limited to HIV infection with CD4 count \\\u003C200 cells\u002Fmm³ or any condition requiring chronic immunosuppressive therapy outside the scope of the study drugs.\n* Pregnancy or breastfeeding, or intention to conceive during the study period. Pregnancy is excluded due to insufficient safety data for the investigational treatments in this population. Women of childbearing potential must agree to use effective contraception throughout the study and for a defined period following the last dose of study drug, per product labeling or institutional guidance.\n* Any medical, psychiatric, or neurological condition that, in the investigator's opinion, may interfere with study participation, pose additional risk to the participant, or confound interpretation of study results.\n* Inability or unwillingness to comply with the requirements of the protocol, including scheduled visits, evaluations, or procedures, based on investigator assessment.\n* Known hypersensitivity or severe allergic reaction to any component of the study drugs or pre-medications required for infusion.","ALL","18 Years",{"count":20,"type":21},540,"ESTIMATED","INTERVENTIONAL",[24],"PHASE4","Neuromyelitis Optica Spectrum Disorder (NMOSD) is a rare autoimmune condition that mainly affects the eyes and spinal cord, causing serious symptoms such as vision loss, paralysis, and severe pain. This trial compares the effectiveness and safety of five medications commonly used to prevent NMOSD relapses: rituximab, ravulizumab, inebilizumab, satralizumab, and eculizumab.\n\nIn this study, 160 adults with NMOSD who test positive for a specific antibody (AQP4-IgG) will participate. They will be randomly assigned to receive either rituximab or one of the four other FDA-approved medications. The main goal is to find out which treatment best prevents relapses and has fewer serious side effects. The trial will also measure disability, patient satisfaction, quality of life, and biomarkers that help track disease activity.\n\nParticipants will have regular assessments, including medical exams, surveys, and tests for vision, walking ability, and brain function. They will report any side effects or health issues experienced during the study. The trial will last from one to four years for each participant.\n\nThis research aims to help patients and doctors make better-informed treatment decisions by providing clear evidence about the best available therapies for NMOSD.",[27],"NMOSD","NOT_YET_RECRUITING","2026-06-23",{"date":31,"type":32},"2026-06-24","ACTUAL",{"date":34,"type":21},"2026-08-01",{"date":36,"type":21},"2030-05",{"name":38,"class":39},"Massachusetts General Hospital","OTHER",3,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":48,"enrollmentInfo":49,"targetDuration":4,"studyType":22,"phases":51,"briefSummary":53,"conditions":54,"keywords":56,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":69},"100635802","phase-3-efficacy-safety-pharmacokinetics-pharmacodynamics-and-immunogenicity-study-of-ravulizumab-in-chinese-adults-with-neuromyelitis-optica-spectrum-disorder-nmosd-100635802","NCT07557420","Efficacy, Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity Study of Ravulizumab in Chinese Adults With Neuromyelitis Optica Spectrum Disorder (NMOSD)","A Phase 3b, Open-label, Single-arm, Multicenter Study to Evaluate the Efficacy, Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Ravulizumab in Chinese Adult Participants With Neuromyelitis Optica Spectrum Disorder (NMOSD)","Key Inclusion (essential)\n\n* Diagnosis: NMOSD per 2015 international consensus criteria, and anti AQP4 antibody positive at Screening.\n* Disease activity: ≥1 attack\u002Frelapse in the past 12 months.\n* Disability: EDSS ≤7.\n* Background therapy: If on IST and\u002For oral corticosteroids, participant should be on a stable maintenance regimen prior to Screening and plan to remain stable during the study unless relapse occurs. (Detailed agent specific duration\u002Fdose rules to be confirmed at screening.)\n* Body weight: ≥40 kg.\n* Vaccinated against meningococcal infections from serogroups A, C, W, Y (and B where available) within the 3 years prior to study intervention administration on Day 1.\n\nKey Exclusion (essential)\n\n* Pregnancy\u002Flactation: Pregnant, breastfeeding, or intending to conceive during the study.\n* Infection risk: History of meningococcal disease or unresolved meningococcal disease, active systemic infection within 14 days, or fever ≥38°C within 7 days before Day 1.\n* Hypersensitivity: To murine proteins or ravulizumab excipients.\n* Serious comorbidities: Any condition that in the Investigator's judgment adds risk or interferes with participation\u002Fassessment.\n* Viral infections: Known HIV, active HBV, or active HCV.\n* Prior\u002Fconcomitant immunomodulatory treatments:\n\n  * B cell-depleting therapy (e.g., rituximab, inebilizumab) within 3 months before Screening.\n  * Mitoxantrone or satralizumab within 3 months before Screening.\n  * IVIg within 3 weeks before Screening.\n  * Any prior or current complement inhibitor.\n\nNote: Other protocol-defined criteria may apply and should be verified during full eligibility review.","130 Years",{"count":50,"type":21},21,[52],"PHASE3","The primary objective of this study is to confirm the efficacy, safety, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of ravulizumab in the treatment of Chinese adults with anti-aquaporin-4 (AQP4) antibody (Ab) + neuromyelitis optica spectrum disorder (NMOSD).",[27,55],"Neuromyelitis Optica Spectrum Disorder",[57,27,58],"Ravulizumab","Neuromyelitis optica spectrum disorder","2026-06-17",{"date":61,"type":32},"2026-06-18",{"date":63,"type":21},"2026-08-31",{"date":65,"type":21},"2028-10-31",{"name":67,"class":68},"Alexion Pharmaceuticals, Inc.","INDUSTRY",5,{"id":71,"slug":72,"hasResults":11,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":4,"eligibilityCriteria":76,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":77,"targetDuration":79,"studyType":80,"phases":4,"briefSummary":81,"conditions":82,"keywords":84,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":90,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},"100513515","registry-of-patients-with-aqp4-nmosd-treated-with-alexion-c5-inhibitor-therapies-100513515","NCT05966467","Registry of Patients With AQP4+ NMOSD Treated With Alexion C5 Inhibitor Therapies","A Long-Term, Prospective, Observational, Registry of Patients With Anti-Aquaporin 4 Antibody-Positive (AQP4+) Neuromyelitis Optica Spectrum Disorder (NMOSD) Treated With Alexion Complement Component 5 (C5) Inhibitor Therapies (ALXN-C5IT)","Inclusion Criteria:\n\n* Participant is ≥ 18 years of age at the time of enrollment in the Registry.\n* Participant must have a confirmed diagnosis of AQP4+ NMOSD.\n* At the time of enrollment in the Registry, participants must be receiving treatment with ALXN-C5IT for the purpose of chronic relapse prevention in a manner consistent with the local label. Specifically, they should have received at least 1 dose of eculizumab within 4 weeks prior to enrollment or at least 1 dose of ravulizumab within 12 weeks prior to enrollment.\n* Participants must have both the following historical data available to be enrolled in the Registry: ALXN-C5IT dosing information since initiation and number and types of relapses from 1 year prior to ALXN-C5IT initiation through Registry enrollment.\n\nExclusion Criteria:\n\n* Participants currently enrolled in an interventional clinical study for the treatment of AQP4+ NMOSD in which the intervention is a drug.",{"count":78,"type":21},122,"5 Years","OBSERVATIONAL","Long-term, multicenter, multinational, observational, registry of patients with AQP4+ NMOSD that is designed to collect data on clinical outcomes and safety in patients prescribed Alexion C5 inhibitor therapies (C5IT). The registry will also collect data on patient reported outcomes (PROs), quality of life (QoL), and targeted AQP4+ NMOSD therapies used to provide evidence on the real-world impact of ALXN-C5IT on patients with AQP4+ NMOSD.",[55,27,83],"AQP4+ NMOSD",[55,27,85,83,86,87,88],"C5 Inhibitor Therapies","Patient Registry","Alexion C5IT","Soliris","RECRUITING",{"date":61,"type":32},{"date":92,"type":32},"2024-02-01",{"date":94,"type":21},"2029-09-27",{"name":67,"class":68},33,{"id":98,"slug":99,"hasResults":11,"nctId":100,"briefTitle":101,"officialTitle":102,"acronym":103,"eligibilityCriteria":104,"healthyVolunteers":11,"sex":17,"minAge":105,"maxAge":106,"enrollmentInfo":107,"targetDuration":4,"studyType":22,"phases":109,"briefSummary":110,"conditions":111,"keywords":4,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":113,"startDateStruct":115,"completionDateStruct":117,"leadSponsor":119,"locationsCount":121},"100454603","phase-3-a-study-to-evaluate-pharmacokinetics-efficacy-safety-tolerability-and-pharmacodynamics-of-satralizumab-in-pediatric-patients-with-aquaporin-4-antibody-positive-neuromyelitis-optica-spectrum-disorder-nmosd-100454603","NCT05199688","A Study To Evaluate Pharmacokinetics, Efficacy, Safety, Tolerability, And Pharmacodynamics Of Satralizumab In Pediatric Patients With Aquaporin-4 Antibody Positive Neuromyelitis Optica Spectrum Disorder (NMOSD)","A Phase III, Multicenter, Open-Label, Uncontrolled Study To Evaluate Pharmacokinetics, Efficacy, Safety, Tolerability, And Pharmacodynamics Of Satralizumab In Pediatric Patients With AQP4 Antibody Positive Neuromyelitis Optica Spectrum Disorder (NMOSD)","SAkuraSun","Inclusion Criteria:\n\n* Age at screening 2-11 years, inclusive\n* Body weight at screening \\>=10 kg\n* For female patients of childbearing potential (postmenarchal): agreement to either remain completely abstinent (refrain from heterosexual intercourse) or to use a reliable means of contraception\n* Diagnosed as having NMOSD with AQP4 antibody seropositive status as defined by the Wingerchuk 2015 criteria Clinical evidence of at least one documented attack (including first attack) in the last year prior to screening\n* Neurological stability for \\>=30 days prior to both screening and baseline\n* Expanded Disability Status Scale (EDSS) 0 to 6.5\n* For patients receiving a baseline immunosuppressant treatment and planning to continue on these therapies, treatment must be at stable dose for 4 weeks prior to baseline\n\nExclusion Criteria:\n\n* Pregnancy or lactation\n* Evidence of other demyelinating disease mimicking NMOSD\n* Active or presence of recurrent bacterial, viral, fungal, mycobacterial infection, or other infection at baseline\n* Evidence of chronic active hepatitis B or C\n* Evidence of untreated latent or active tuberculosis (TB)\n* Receipt of a live or live-attenuated vaccine within 6 weeks prior to baseline\n* History of severe allergic reaction to a biologic agent","2 Years","11 Years",{"count":108,"type":21},8,[52],"This study will primarily evaluate the pharmacokinetics of satralizumab in pediatric patients aged 2-11 years with anti-aquaporin-4 (AQP4) antibody seropositive neuromyelitis optica spectrum disorder (NMOSD). Efficacy, safety, tolerability, and pharmacodynamics will be evaluated in a descriptive manner, given the small number of patients who will be enrolled in this study.",[55,27],"2026-06-05",{"date":114,"type":32},"2026-06-09",{"date":116,"type":32},"2026-05-06",{"date":118,"type":21},"2029-09-12",{"name":120,"class":68},"Hoffmann-La Roche",13,{"id":123,"slug":124,"hasResults":11,"nctId":125,"briefTitle":126,"officialTitle":126,"acronym":4,"eligibilityCriteria":127,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":128,"enrollmentInfo":129,"targetDuration":4,"studyType":22,"phases":131,"briefSummary":133,"conditions":134,"keywords":4,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":141,"lastUpdatePostDateStruct":142,"startDateStruct":144,"completionDateStruct":146,"leadSponsor":148,"locationsCount":150},"100575717","early-phase-1-clinical-study-on-targeted-cd19bcma-car-t-therapy-for-autoimmune-diseases-100575717","NCT06775912","Clinical Study on Targeted CD19\u002FBCMA CAR-T Therapy for Autoimmune Diseases","Inclusion Criteria:\n\n1. The subjects voluntarily participated in the study and signed the informed consent form.\n2. Age ≥18 years old and ≤70 years old, both sexes.\n3. Organ function and laboratory tests:\n\n   1. Liver function: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3× upper limit of normal (ULN), total bilirubin (TBIL) ≤2×ULN (except Gilbert's syndrome).\n   2. Renal function: creatinine ≤1.5×ULN or creatinine clearance ≥40 ml\u002Fmin.\n   3. Blood routine: neutrophil count ≥1×109\u002FL, hemoglobin ≥60g\u002FL, platelet count ≥20×109\u002FL, lymphocyte count \\>0.3×109\u002FL.\n   4. Coagulation: international normalized ratio (INR) ≤ 1.5×ULN, or prothrombin time (PT) ≤ 1.5×ULN.\n   5. Oxygen saturation (SpO2) ≥92% at rest in room air.\n   6. Left ventricular ejection fraction (LVEF) ≥50% on echocardiography.\n4. Negative serum or urine pregnancy test results in female subjects of childbearing potential at screening.\n5. Women of childbearing potential must agree to use a highly effective method of contraception for at least 28 days before initiation of elution and up to 12 months after RD06-04 reinfusion. Men of childbearing potential had to agree to the use of an effective barrier method of contraception from the initiation of lymphoidectomy until 12 months after reinfusion of RD06-04 and had to refrain from donating semen or sperm throughout the trial.\n\nSLE Patient Inclusion Criteria:\n\n1. A definitive diagnosis of SLE according to the 2019 European League Against Rheumatism (EULAR) \u002F American College of Rheumatology (ACR) classification criteria or the 2012 Systemic Lupus International Collaborating Clinics (SLICC) criteria.\n2. Positive antinuclear antibodies (ANA) at screening, and\u002For positive anti-double-stranded DNA (anti-dsDNA) antibodies, and\u002For positive anti-Smith antibodies.\n3. A SLEDAI-2K score \\>6 at screening, and a 'clinical' SLEDAI-2K score ≥4.\n\nSSc Patient Inclusion Criteria:\n\n1. Diagnosed with SSc according to the 2013 ACR\u002FEULAR classification criteria.\n2. Diagnosed with diffuse cutaneous SSc at screening, with a disease duration ≤6 years.\n\nAAV Patient Inclusion Criteria:\n\n1. Meeting the diagnostic criteria for ANCA-associated vasculitis established by the 2022 ACR\u002FEULAR, including Microscopic Polyangiitis (MPA), Granulomatosis with Polyangiitis (GPA), and Eosinophilic Granulomatosis with Polyangiitis (EGPA).\n2. Positive testing for ANCA-associated antibodies 3 months before screening or at screening (specifically, positive anti-myeloperoxidase antibodies, MPO-ANCA, or positive anti-proteinase 3 antibodies, PR3-ANCA).\n\nIIM Patients Inclusion Criteria:\n\n1. Diagnosed with IIM according to the 2017 ACR\u002FEULAR classification criteria (including probable or definite diagnosis, i.e., probability ≥55%), including subtypes such as Dermatomyositis (DM), Anti-Synthetase Syndrome (ASS), and Immune-Mediated Necrotizing Myopathy (IMNM).\n2. Patients in the active phase, defined as those with at least 2 of the following six core set measures being abnormal: decreased muscle strength (MMT-8 \\\u003C142), Physician Global Assessment (PhGA, 10cm VAS) ≥2cm, Patient Global Assessment (PtGA, 10cm VAS) ≥2cm, Extramuscular Disease Activity Total Score (assessed using the MDAAT scoring tool) ≥2cm, Health Assessment Questionnaire (HAQ) ≥0.25, and Creatine Kinase (CK) muscle enzyme levels ≥1.5×ULN\n\nSjögren's Syndrome (SS) Patient Inclusion Criteria:\n\n1. Diagnosed with primary Sjögren's Syndrome according to the 2016 ACR\u002FEULAR classification criteria.\n2. Positive for anti-SSA\u002FRo antibodies detected 3 months before screening or at screening.\n3. A score of ≥5 on the European League Against Rheumatism Sjögren's Syndrome Disease Activity Index (ESSDAI) at screening.\n\nExclusion Criteria:\n\n1. SLE Patients: Those with uncontrolled lupus crisis within the 8 weeks prior to screening, including rapidly progressive lupus nephritis, severe neuropsychiatric lupus, severe hemolytic anemia, severe immune thrombocytopenia, agranulocytosis, severe cardiac damage, severe lupus pneumonia, severe lupus hepatitis, and severe vasculitis, as assessed by the investigator as unsuitable to participate in this study.\n2. IIM Patients: Presence of severe rhabdomyolysis or CK levels ≥120×ULN at screening.\n3. Patients with severe asthma or Chronic Obstructive Pulmonary Disease (COPD) are eligible. Patients with mild or moderate asthma or COPD who are receiving stable treatment can also be enrolled.\n4. There has been an active infection requiring systemic treatment within 2 weeks prior to the urethral irrigation, such as infectious pneumonia, tuberculosis, etc.\n5. Positive for hepatitis B surface antigen (HBsAg), or positive for hepatitis B core antibody (HBcAb) with detectable hepatitis B virus (HBV) DNA in peripheral blood; positive for hepatitis C virus (HCV) antibody with detectable HCV RNA in peripheral blood; positive for human immunodeficiency virus (HIV) antibody; positive for syphilis antibody.\n6. Pregnant or breastfeeding women.\n7. Any condition that, in the investigator's opinion, may affect study participation, pose a safety risk to the patient, or potentially confound the interpretation of study results.","70 Years",{"count":130,"type":21},18,[132],"EARLY_PHASE1","This is an open clinical pharmacological translational Research Study, aiming to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of RD06-05 in patients with active SLE, SSc, AAV, IIM, NMOSD, MS, MG",[135,136,137,27,138,139,140],"SLE","Systemic Sclerosis","IIM","MS","MG","ANCA Associated Vasculitis (AAV)","2026-01-30",{"date":143,"type":32},"2026-02-02",{"date":145,"type":32},"2025-01-03",{"date":147,"type":21},"2027-06-01",{"name":149,"class":68},"Nanjing Bioheng Biotech Co., Ltd.",1,{"id":152,"slug":153,"hasResults":11,"nctId":154,"briefTitle":155,"officialTitle":155,"acronym":27,"eligibilityCriteria":156,"healthyVolunteers":157,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":158,"targetDuration":4,"studyType":80,"phases":4,"briefSummary":160,"conditions":161,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":162,"lastUpdatePostDateStruct":163,"startDateStruct":165,"completionDateStruct":167,"leadSponsor":169,"locationsCount":69},"100613397","prospective-cohort-study-of-neuromyelitis-optica-spectrum-disorders-nmosd-100613397","NCT07266051","Prospective Cohort Study of Neuromyelitis Optica Spectrum Disorders (NMOSD)","Inclusion Criteria Inclusion Criteria for the NMOSD Patient Group\n\n* Aged 18 years or older, regardless of sex\n* Fulfilled the diagnostic criteria for Neuromyelitis Optica Spectrum Disorders as defined by the 2021 Chinese guidelines for the diagnosis and management of NMOSD\n* Seropositive for AQP4-IgG\n* Provided informed consent by the participant or their legal guardian\n\nInclusion Criteria for the Healthy Control Group\n\n* Aged 18 years or older, regardless of sex\n* Gender- and age-matched healthy individuals\n* Provided informed consent by the participant or their legal guardian\n\nExclusion Criteria\n\n* Diagnosis of other serious systemic diseases (e.g., malignancy)\n* Presence of severe psychiatric disorders that would preclude compliance with study procedures and\u002For follow-up assessments\n* History of infectious pathologies of the central nervous system\n* Those with severe liver and kidney function impairment or dysfunction of other vital organs\n* Patients with other conditions that do not allow participation in clinical research\n* Patients allergic to gadolinium-DPTA\n* Patients with other conditions that do not allow participation in clinical research",true,{"count":159,"type":21},4000,"This study aims to characterize sex hormone alterations and their potential clinical significance in NMOSD patients from Southern China through comprehensive hormonal profiling.",[27],"2025-12-11",{"date":164,"type":32},"2025-12-18",{"date":166,"type":21},"2025-12",{"date":168,"type":21},"2030-12",{"name":170,"class":39},"Xiamen Hospital of Traditional Chinese Medicine",{"id":172,"slug":173,"hasResults":11,"nctId":174,"briefTitle":175,"officialTitle":176,"acronym":4,"eligibilityCriteria":177,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":178,"targetDuration":4,"studyType":80,"phases":4,"briefSummary":180,"conditions":181,"keywords":182,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":187,"lastUpdatePostDateStruct":188,"startDateStruct":190,"completionDateStruct":192,"leadSponsor":194,"locationsCount":4},"100606965","efficacy-and-safety-of-monoclonal-antibody-in-acute-phase-of-neuromyelitis-optica-spectrum-disorder-100606965","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.",{"count":179,"type":21},40,"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.",[27],[27,183,184,185,186],"Intravenous methylprednisolone","Efgartigimod","Eculizumab","Plasma exchange","2025-09-12",{"date":189,"type":32},"2025-09-19",{"date":191,"type":21},"2025-10-01",{"date":193,"type":21},"2027-06-30",{"name":195,"class":39},"First Affiliated Hospital of Chongqing Medical University",{"id":197,"slug":198,"hasResults":11,"nctId":199,"briefTitle":200,"officialTitle":200,"acronym":201,"eligibilityCriteria":202,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":203,"enrollmentInfo":204,"targetDuration":4,"studyType":22,"phases":206,"briefSummary":208,"conditions":209,"keywords":4,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":214,"lastUpdatePostDateStruct":215,"startDateStruct":217,"completionDateStruct":219,"leadSponsor":221,"locationsCount":150},"100599698","assessment-of-transcranial-alternating-current-stimulations-clinical-efficacy-in-treating-cognitive-impairment-of-idiopathic-inflammatory-demyelinating-diseases-100599698","NCT07087873","Assessment of Transcranial Alternating Current Stimulation's Clinical Efficacy in Treating Cognitive Impairment of Idiopathic Inflammatory Demyelinating Diseases","TACS-CI-IIDDs","Inclusion Criteria:\n\n* Age: 18-60 years old.\n* Diagnosis: Patients with neuromyelitis optica spectrum disease, multiple sclerosis and other inflammatory demyelinating diseases of the central nervous system that meet the diagnostic criteria.\n* Medications have been stable for at least three months.\n\nExclusion Criteria:\n\n* Recurrence has been recorded in the past 3 months.\n* Have a pacemaker or other metal implant in the body.\n* Impaired skin integrity at the site of electrode placement.\n* Previous organic brain disease such as epilepsy, hydrocephalus, central nervous system tumors, brain injury, or intracranial infection.\n* Combined with severe or unstable organic diseases, such as heart, liver and kidney and other organ dysfunction.\n* Pregnant or lactating women, those who are planning to become pregnant in the near future.\n* Patient compliance is poor.\n* In the opinion of the investigator, there is a situation that is not suitable to participate in this study.","60 Years",{"count":205,"type":21},128,[207],"NA","This study aims to explore the imaging and electrophysiological characteristics of idiopathic inflammatory demyelinating diseases (IIDDs), and their correlation with clinical manifestations. It also evaluates the effectiveness of transcranial electrical stimulation in alleviating clinical symptoms of IIDDs patients, and analyzes the key factors affecting the treatment efficacy. By uncovering the overall and individual characteristics of IIDDs, this study seeks to enhance therapeutic outcomes through personalized neuromodulation programs. The findings will provide a basis for applying non-invasive brain stimulation (NIBS) in IIDDs treatment and offer new ideas for future personalized medicine approaches.",[210,211,27,212,213],"Idiopathic Inflammatory Demyelinating Disorders of the Central Nervous System","MS (Multiple Sclerosis)","Acute Disseminated Encephalomyelitis","Transcranial Alternating Current Stimulation","2025-07-24",{"date":216,"type":32},"2025-07-28",{"date":218,"type":32},"2025-05-30",{"date":220,"type":21},"2027-10-31",{"name":222,"class":39},"Xuanwu Hospital, Beijing",{"id":224,"slug":225,"hasResults":11,"nctId":226,"briefTitle":227,"officialTitle":228,"acronym":4,"eligibilityCriteria":229,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":230,"targetDuration":231,"studyType":80,"phases":4,"briefSummary":232,"conditions":233,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":234,"lastUpdatePostDateStruct":235,"startDateStruct":237,"completionDateStruct":239,"leadSponsor":241,"locationsCount":150},"100585497","clinical-study-to-evaluate-the-effects-of-the-complement-c5-inhibitor-ravulizumab-on-serum-neurofilament-light-chain-snfl-and-glial-fibrillary-acidic-protein-sgfap-levels-in-patients-with-aquaporin-4-positive-aqp4-ab-neuromyelitis-optica-spectrum-disorder-nmosd-100585497","NCT06903130","Clinical Study to Evaluate the Effects of the Complement C5 Inhibitor Ravulizumab on Serum Neurofilament Light Chain (sNfL) and Glial Fibrillary Acidic Protein (sGFAP) Levels in Patients With Aquaporin-4-Positive (AQP4-Ab+) Neuromyelitis Optica Spectrum Disorder (NMOSD)","An Exploratory, Non-Interventional, Prospective, Multicenter, Nationwide, Clinical Study to Evaluate the Effects of the Complement C5 Inhibitor Ravulizumab on Serum Neurofilament Light Chain (sNfL) and Glial Fibrillary Acidic Protein (sGFAP) Levels in Patients With Aquaporin-4-Positive (AQP4-Ab+) Neuromyelitis Optica Spectrum Disorder (NMOSD)","Inclusion Criteria\n\nPatients are eligible to be included in the study only if all of the following criteria apply:\n\nAge\n\n1. Patient must be 18 years of age or older, at the time of signing the informed consent.\n\n   Type of Patient and Disease Characteristics\n2. Anti-AQP4 Ab-positive at screening and a diagnosis of NMOSD as defined by the 2015 international consensus diagnostic criteria (Wingerchuk, 2015). A historically positive anti-AQP4 Ab test may be acceptable if the test was performed using an acceptable, validated cell-based assay from an accredited laboratory.\n3. At least 1 clinical attack prior to the Prescreening\u002FScreening Periods.\n4. Treatment-naïve patients or patients under specific off-label treatments (rituximab, corticosteroids, azathioprine, mycophenolate mofetil) or the complement C5 inhibitor ravulizumab. Naïve patients who initiate ravulizumab at enrolment, should have been prescribed ravulizumab, but not yet initiated treatment, according to the label and local market reimbursement criteria.\n5. Vaccinated against N. meningitidis (for serogroups A, C, W, Y and B) a) within 3 years and at least 2 weeks prior to the first dose of ravulizumab, or b) at the time of the first dose of ravulizumab provided that antibacterial drug prophylaxis is administered as per National Vaccination Guidelines and Summary of Product Characteristics of ravulizumab.\n\n   Weight\n6. Body weight ≥ 40 kg.\n\n   Sex\n7. Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those receiving each immunotherapy.\n\n   Informed Consent\n8. Capable of giving signed informed consent as described in Section 10.1.3, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.\n\nExclusion Criteria\n\nPatients are excluded from the study if any of the following criteria apply:\n\nMedical Conditions\n\n1. History of N. meningitidis infection.\n2. Human immunodeficiency virus (HIV) infection (evidenced by HIV-1 or HIV-2 antibody titer)\n3. History of unexplained infections.\n4. Active systemic bacterial, viral, or fungal infection within 14 days prior to screening.\n5. Presence of fever ≥ 38°C (100.4°F) within 7 days prior to screening\n6. NMOSD pregnant women will be excluded according to the local clinical practice. '\n7. History of implanted medical devices which are incompatible with strong magnetic fields used for MRI.\n\nPrior\u002FConcomitant Therapy 6. Use of inebilizumab within 6 months prior to Enrollment in patients switching to another therapy i.e. ravulizumab or the off-label ISTs.\n\n7\\. Use of satralizumab within 3 months prior to Enrollment. 8. Pregnant, breastfeeding, or intending to conceive during the course of the study",{"count":179,"type":21},"24 Months","This is a nationwide observational study looking at how ravulizumab, a complement C5 inhibitor, affects blood biomarkers o sNfL and sGFAP in people with AQP4-antibody positive NMOSD. The study does not change your treatment-only regular blood samples are collected to monitor these markers",[27],"2025-06-30",{"date":236,"type":32},"2025-07-01",{"date":238,"type":21},"2025-09-01",{"date":240,"type":21},"2028-06-01",{"name":242,"class":39},"National and Kapodistrian University of Athens",{"id":244,"slug":245,"hasResults":11,"nctId":246,"briefTitle":247,"officialTitle":248,"acronym":4,"eligibilityCriteria":249,"healthyVolunteers":157,"sex":250,"minAge":18,"maxAge":251,"enrollmentInfo":252,"targetDuration":4,"studyType":80,"phases":4,"briefSummary":254,"conditions":255,"keywords":4,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":259,"lastUpdatePostDateStruct":260,"startDateStruct":262,"completionDateStruct":264,"leadSponsor":266,"locationsCount":150},"100588355","pregnancy-registry-infants-serummilk-analysis-prisma-100588355","NCT06940323","Pregnancy Registry, Infants, Serum\u002FMilk Analysis (PRISMA)","Pregnancy Registry, Infants, Serum\u002FMilk Analysis (PRISMA): Pregnancy Registry for Women With Chronic Conditions","Inclusion Criteria:\n\n* Pregnant or contemplating pregnancy\n* Female, aged 18 to 64 years\n* Diagnosis of one of the following conditions:\n* Clinically Isolated Syndrome (CIS) or Multiple Sclerosis (MS), based on the 2010 McDonald Criteria\n* Neuromyelitis Optica Spectrum Disorder (NMOSD)\n* Inflammatory Bowel Disease (IBD)\n* Rheumatoid Arthritis (RA)\n* Myasthenia Gravis\n* Lupus\n* Other chronic neurological conditions\n* Willing to provide biosamples and\u002For complete surveys at specified timepoints\n* Women without a chronic condition who are pregnant or contemplating pregnancy (as part of the control group)\n\nExclusion Criteria:\n\n\\- Unwillingness to provide informed consent","FEMALE","64 Years",{"count":253,"type":21},250,"PRISMA, is a pregnancy registry study, focused on comprehensively collecting information about pregnancy in women with chronic neurological conditions from across the United States and internationally.\n\nDepending on their specific condition (MS, CIS, NMOSD, or other) and their specific treatment, participants will be asked to contribute to different aspects of the study. (1) The biosamples will be blood, breast milk, infant stool, maternal stool and vaginal swab samples, collected at specific time points. (2) The online surveys will be collected at specific time points. All study activities will be discussed with participants upon enrollment.\n\nBy collecting this information, the investigators hope to gain deeper insights into the relationship between pregnancy, the neurological condition, and maternal and infant health. For example, one of the sub-studies focuses on breast milk collection for women planning postpartum treatment with Ocrevus, Rituxan, Briumvi or Kesimpta.\n\nThis study is fully remote and all sample collection is optional, so participants can choose which types of samples they wish to provide. For blood draws, participants can schedule a home visit through ExamOne, making participation even more convenient.\n\nThe investigators aim to enroll women with chronic neurological conditions who are planning pregnancy, currently pregnant, or within one year postpartum.",[256,257,27,258],"Multiple Sclerosis","Clinically Isolated Syndrome","Myasthenia Gravis","2025-04-30",{"date":261,"type":32},"2025-05-04",{"date":263,"type":32},"2017-03-21",{"date":265,"type":21},"2035-06",{"name":267,"class":39},"University of California, San Francisco"]