[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100444432":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":26,"centralContacts":31,"locations":39,"responsibleParty":132,"collaborators":25,"id":134,"slug":135,"hasResults":136,"nctId":137,"briefTitle":138,"officialTitle":139,"acronym":140,"eligibilityCriteria":141,"healthyVolunteers":136,"sex":142,"minAge":143,"maxAge":144,"enrollmentInfo":145,"targetDuration":25,"studyType":148,"phases":149,"briefSummary":151,"conditions":152,"keywords":154,"overallStatus":75,"whyStopped":25,"lastUpdateSubmitDate":156,"lastUpdatePostDateStruct":157,"startDateStruct":160,"completionDateStruct":162,"leadSponsor":164,"locationsCount":165},{"fullName":5,"class":6},"Tang-Du Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Tocilizumab","EXPERIMENTAL","Participants will receive tocilizumab administered intravenously (IV) on weeks 1,5,9 and 13 of the randomized controlled period.",[13],"Drug: Tocilizumab Injectable Product",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","Participants will receive placebo administered intravenously (IV) on weeks 1,5,9 and 13 of the randomized controlled period.",[13],[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Tocilizumab Injectable Product","Participants will receive IV tocilizumab",[15,9],null,[27],{"name":28,"affiliation":29,"role":30},"Ting Chang, MD,PHD","The Second Affiliated Hospital of Air Force Military Medical University","STUDY_DIRECTOR",[32,36],{"name":28,"role":33,"phone":34,"phoneExt":25,"email":35},"CONTACT","+86-29-84778845","changting1981@163.com",{"name":37,"role":33,"phone":34,"phoneExt":25,"email":38},"Zhe Ruan","ruanzhe573291596@126.com",[40,59,73,89,104,118],{"facility":41,"status":42,"city":43,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"Beijing Tiantan Hospital, Capital Medical University","NOT_YET_RECRUITING","Beijing","Beijing Municipality","100050","China","CN",{"type":49,"coordinates":50},"Point",[51,52],116.39723,39.9075,{"lat":52,"lon":51},[55],{"name":56,"role":33,"phone":57,"phoneExt":25,"email":58},"Fudong Shi, MD,PHD","+86-22-60817429","fshi@tmu.edu.cn",{"facility":60,"status":42,"city":61,"state":62,"zip":63,"country":46,"countryCode":47,"cosmosGeoPoint":64,"geoPoint":68,"contacts":69},"Xiangya Hospital Central South University","Changsha","Hunan","410008",{"type":49,"coordinates":65},[66,67],112.97087,28.19874,{"lat":67,"lon":66},[70],{"name":71,"role":33,"phone":25,"phoneExt":25,"email":72},"Huan Yang, MD,PHD","yxyx69@gahoo.com.cn",{"facility":74,"status":75,"city":76,"state":77,"zip":78,"country":46,"countryCode":47,"cosmosGeoPoint":79,"geoPoint":83,"contacts":84},"Tangdu Hospital, The Fourth Military Medical University","RECRUITING","Xi'an","Shaanxi","710038",{"type":49,"coordinates":80},[81,82],108.92861,34.25833,{"lat":82,"lon":81},[85,88],{"name":86,"role":33,"phone":87,"phoneExt":25,"email":35},"Ting Chang","02984778845",{"name":37,"role":33,"phone":25,"phoneExt":25,"email":38},{"facility":90,"status":42,"city":91,"state":92,"zip":93,"country":46,"countryCode":47,"cosmosGeoPoint":94,"geoPoint":98,"contacts":99},"Huashan Hospital","Shanghai","Shanghai Municipality","200040",{"type":49,"coordinates":95},[96,97],121.45806,31.22222,{"lat":97,"lon":96},[100],{"name":101,"role":33,"phone":102,"phoneExt":25,"email":103},"Chongbo Zhao, MD,PHD","86-21-52889999","zhao_chongbo@fudan.edu.cn",{"facility":105,"status":42,"city":106,"state":107,"zip":108,"country":46,"countryCode":47,"cosmosGeoPoint":109,"geoPoint":113,"contacts":114},"West China Hospital of Sichuan University","Chengdu","Sichuan","610041",{"type":49,"coordinates":110},[111,112],104.06667,30.66667,{"lat":112,"lon":111},[115],{"name":116,"role":33,"phone":25,"phoneExt":25,"email":117},"Hongyu Zhou, MD,PHD","zhouhy@scu.edu.cn",{"facility":119,"status":42,"city":120,"state":121,"zip":122,"country":46,"countryCode":47,"cosmosGeoPoint":123,"geoPoint":127,"contacts":128},"Tianjin medical university general hospital","Tianjin","Tianjin Municipality","300052",{"type":49,"coordinates":124},[125,126],117.17667,39.14222,{"lat":126,"lon":125},[129],{"name":130,"role":33,"phone":131,"phoneExt":25,"email":25},"Chao Zhang, MD,PHD","+86-22-60362255",{"type":133,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100444432","phase-2-efficacy-and-safety-of-tocilizumab-in-the-treatment-of-generalized-myasthenia-gravis-100444432",false,"NCT05067348","Efficacy and Safety of Tocilizumab in the Treatment of Generalized Myasthenia Gravis","A Multi-center, Randomized, Double-blind, Placebo-controlled Clinical Trial of the Efficacy and Safety of Tocilizumab in the Treatment of Generalized Myasthenia Gravis","tMG","Inclusion Criteria:\n\n1. Diagnosis of MG with anti-AChRantibody.\n2. MGFA Clinical Classification Class II, III, or IV.\n3. MG-ADL score of 5 or greater at screening and at randomization with \\> 50% of this score attributed to non-ocular items.\n4. QMG score of 11 or greater.\n5. Subjects must be on:\n\n   1. Cholinesterase inhibitor, with no dose increase within 4 weeks prior to randomization;\n   2. Corticosteroids, with no dose increase within 4 weeks prior to randomization; or\u002Fand c. non-steroidal IST (including azathioprine, mycophenolate mofetil, tacrolimus, cyclosporine A), with continuous use for at least 6 months prior to randomization and no dose increase within 4 months prior to randomization.\n\nExclusion Criteria:\n\n1. Participants had clinically relevant active infections (such as sepsis, pneumonia, or abscess) or severe infections (resulting in hospitalization or requiring antibiotic treatment) in the 4 weeks before randomization;\n2. Those with a history of high-risk tuberculosis infection, acquired tuberculosis infection, and chronic hepatitis;\n3. Human immunodeficiency virus (HIV) infection;\n4. Thymomas that have received thymectomy or planned thymectomy during RCP within 6 months before randomization, or require chemotherapy and\u002For radiotherapy at any time;\n5. Received rituximab treatment in the past 6 months before randomization;\n6. Received tocilizumab or eculizumab treatment within 3 months before randomization;\n7. Received IVIG or plasma exchange within 4 weeks before randomization;\n8. Unresected thymoma.\n9. History of other tumor diseases.","ALL","18 Years","80 Years",{"count":146,"type":147},64,"ESTIMATED","INTERVENTIONAL",[150],"PHASE2","Randomized, double-blind, placebo-controlled, parallel-group study with optional open-label extension.",[153],"Myasthenia Gravis, Generalized",[155,9],"Generalized Myasthenia Gravis","2025-04-28",{"date":158,"type":159},"2025-05-01","ACTUAL",{"date":161,"type":159},"2022-07-21",{"date":163,"type":147},"2026-03-30",{"name":5,"class":6},6]