[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100630113":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":27,"centralContacts":31,"locations":38,"responsibleParty":189,"collaborators":36,"id":191,"slug":192,"hasResults":193,"nctId":194,"briefTitle":195,"officialTitle":196,"acronym":36,"eligibilityCriteria":197,"healthyVolunteers":193,"sex":198,"minAge":199,"maxAge":200,"enrollmentInfo":201,"targetDuration":36,"studyType":204,"phases":205,"briefSummary":207,"conditions":208,"keywords":36,"overallStatus":41,"whyStopped":36,"lastUpdateSubmitDate":211,"lastUpdatePostDateStruct":212,"startDateStruct":215,"completionDateStruct":217,"leadSponsor":219,"locationsCount":220},{"fullName":5,"class":6},"Hoffmann-La Roche","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"RMS Cohort","EXPERIMENTAL","Participants with RMS will receive ocrelizumab, 300 milligrams (mg), intravenous (IV) infusions on Days 1 and 15 of Cycle 1 and thereafter as a single infusion of 600 mg, IV, for all subsequent cycles every 24 weeks (Q24W) (1 Cycle=24 weeks).",[13],"Drug: Ocrelizumab",{"label":15,"type":10,"description":16,"interventionNames":17},"PPMS Cohort","Participants with PPMS will receive ocrelizumab, 300 mg, IV infusions on Days 1 and 15 of Cycle 1 and thereafter as a single infusion of 600 mg, IV, at Week 24 (1 Cycle=24 weeks).",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"DRUG","Ocrelizumab","Ocrelizumab will be administered as per the schedule specified in the respective arms.",[15,9],[25,26],"OCREVUS®","RO4964913",[28],{"name":29,"affiliation":5,"role":30},"Clinical Trials","STUDY_DIRECTOR",[32],{"name":33,"role":34,"phone":35,"phoneExt":36,"email":37},"Reference Study ID Number: YN44938 https:\u002F\u002Fforpatients.roche.com\u002F","CONTACT","888-662-6728",null,"global-roche-genentech-trials@gene.com",[39,53,62,68,74,83,92,101,110,116,125,134,143,152,162,171,180],{"facility":40,"status":41,"city":42,"state":43,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":36},"The First Affiliated Hospital of Nanchang University","RECRUITING","Nanchang","Jiangxi","330209","China","CN",{"type":48,"coordinates":49},"Point",[50,51],115.85306,28.68396,{"lat":51,"lon":50},{"facility":54,"status":41,"city":55,"state":36,"zip":56,"country":45,"countryCode":46,"cosmosGeoPoint":57,"geoPoint":61,"contacts":36},"Peking Union Medical College Hospital","Beijing","100032",{"type":48,"coordinates":58},[59,60],116.39723,39.9075,{"lat":60,"lon":59},{"facility":63,"status":41,"city":55,"state":36,"zip":64,"country":45,"countryCode":46,"cosmosGeoPoint":65,"geoPoint":67,"contacts":36},"Peking University First Hospital","100034",{"type":48,"coordinates":66},[59,60],{"lat":60,"lon":59},{"facility":69,"status":41,"city":55,"state":36,"zip":70,"country":45,"countryCode":46,"cosmosGeoPoint":71,"geoPoint":73,"contacts":36},"Beijing Hospital of Ministry of Health","100730",{"type":48,"coordinates":72},[59,60],{"lat":60,"lon":59},{"facility":75,"status":41,"city":76,"state":36,"zip":77,"country":45,"countryCode":46,"cosmosGeoPoint":78,"geoPoint":82,"contacts":36},"Xiangya Hospital Central South University","Changsha","410008",{"type":48,"coordinates":79},[80,81],112.97087,28.19874,{"lat":81,"lon":80},{"facility":84,"status":41,"city":85,"state":36,"zip":86,"country":45,"countryCode":46,"cosmosGeoPoint":87,"geoPoint":91,"contacts":36},"West China Hospital of Sichuan University","Chengdu","610041",{"type":48,"coordinates":88},[89,90],104.06667,30.66667,{"lat":90,"lon":89},{"facility":93,"status":41,"city":94,"state":36,"zip":95,"country":45,"countryCode":46,"cosmosGeoPoint":96,"geoPoint":100,"contacts":36},"The First Affiliated Hospital, Chongqing Medical University","Chongqing","400016",{"type":48,"coordinates":97},[98,99],106.55771,29.56026,{"lat":99,"lon":98},{"facility":102,"status":41,"city":103,"state":36,"zip":104,"country":45,"countryCode":46,"cosmosGeoPoint":105,"geoPoint":109,"contacts":36},"The First Affiliated Hospital of Sun Yat-sen University","Guangzhou","510080",{"type":48,"coordinates":106},[107,108],113.25,23.11667,{"lat":108,"lon":107},{"facility":111,"status":41,"city":103,"state":36,"zip":112,"country":45,"countryCode":46,"cosmosGeoPoint":113,"geoPoint":115,"contacts":36},"The Third Affiliated Hospital of Sun Yat-Sen University","510630",{"type":48,"coordinates":114},[107,108],{"lat":108,"lon":107},{"facility":117,"status":41,"city":118,"state":36,"zip":119,"country":45,"countryCode":46,"cosmosGeoPoint":120,"geoPoint":124,"contacts":36},"The First Affiliated Hospital of College of Medicine, Zhejiang University","Hangzhou","310003",{"type":48,"coordinates":121},[122,123],120.16142,30.29365,{"lat":123,"lon":122},{"facility":126,"status":41,"city":127,"state":36,"zip":128,"country":45,"countryCode":46,"cosmosGeoPoint":129,"geoPoint":133,"contacts":36},"Inner Mongolia Autonomous Region People's Hospital","Hohhot","010011",{"type":48,"coordinates":130},[131,132],111.65222,40.81056,{"lat":132,"lon":131},{"facility":135,"status":41,"city":136,"state":36,"zip":137,"country":45,"countryCode":46,"cosmosGeoPoint":138,"geoPoint":142,"contacts":36},"Lanzhou University Second Hospital","Lanzhou","730030",{"type":48,"coordinates":139},[140,141],103.83987,36.05701,{"lat":141,"lon":140},{"facility":144,"status":41,"city":145,"state":36,"zip":146,"country":45,"countryCode":46,"cosmosGeoPoint":147,"geoPoint":151,"contacts":36},"The First Hospital of China Medical University","Shenyang","DUMMY_VALUE",{"type":48,"coordinates":148},[149,150],123.43278,41.79222,{"lat":150,"lon":149},{"facility":153,"status":154,"city":155,"state":36,"zip":156,"country":45,"countryCode":46,"cosmosGeoPoint":157,"geoPoint":161,"contacts":36},"The Second Hospital of Hebei Medical University","ACTIVE_NOT_RECRUITING","Shijiazhuang","050000",{"type":48,"coordinates":158},[159,160],114.47861,38.04139,{"lat":160,"lon":159},{"facility":163,"status":41,"city":164,"state":36,"zip":165,"country":45,"countryCode":46,"cosmosGeoPoint":166,"geoPoint":170,"contacts":36},"1st Affiliated Hospital of Shanxi Medical University","Taiyuan","030000",{"type":48,"coordinates":167},[168,169],112.56028,37.86944,{"lat":169,"lon":168},{"facility":172,"status":41,"city":173,"state":36,"zip":174,"country":45,"countryCode":46,"cosmosGeoPoint":175,"geoPoint":179,"contacts":36},"Xinjiang People Hospital","Ürümqi","830000",{"type":48,"coordinates":176},[177,178],87.60046,43.80096,{"lat":178,"lon":177},{"facility":181,"status":41,"city":182,"state":36,"zip":183,"country":45,"countryCode":46,"cosmosGeoPoint":184,"geoPoint":188,"contacts":36},"Tongji Hospital Tongji Medical College Huazhong University of Science and Technology","Wuhan","430030",{"type":48,"coordinates":185},[186,187],114.26667,30.58333,{"lat":187,"lon":186},{"type":190,"investigatorFullName":36,"investigatorTitle":36,"investigatorAffiliation":36,"oldNameTitle":36,"oldOrganization":36},"SPONSOR","100630113","phase-4-a-study-to-evaluate-the-efficacy-safety-pharmacokinetics-and-pharmacodynamics-of-ocrelizumab-in-participants-with-relapsing-multiple-sclerosis-and-primary-progressive-multiple-sclerosis-100630113",false,"NCT07483450","A Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Ocrelizumab in Participants With Relapsing Multiple Sclerosis and Primary Progressive Multiple Sclerosis","A Multicenter, Open-label, Single-arm Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Ocrelizumab in Chinese Patients With Relapsing Multiple Sclerosis and Primary Progressive Multiple Sclerosis","Inclusion Criteria:\n\n* Diagnosis of RMS\u002FPPMS in accordance with the revised 2017 McDonald Criteria\n* EDSS score from 0-5.5 (RMS) or 3.0-6.5 (PPMS), inclusive, at screening and baseline\n* Documented MRI of brain with abnormalities consistent with MS before screening\n\nExclusion Criteria:\n\n* Diagnosis of PPMS or non-active secondary progressive multiple sclerosis (SPMS) (only for RMS cohort)\n* History of relapsing remitting multiple sclerosis (RRMS) or SPMS at screening (only for PPMS cohort)\n* Disease duration of more than 10 years in participants with an EDSS ≤ 2.0 at screening (only for RMS cohort)\n* History of confirmed or suspected progressive multifocal leukoencephalopathy (PML)\n* Inability to complete an MRI scan or contraindication to Gd administration\n* Contraindications to mandatory pre-medications (i.e., corticosteroids and antihistamines)\n* Known presence of other neurologic disorders if they could interfere with the diagnosis of MS or assessments of efficacy and\u002For safety during the study\n* Any concomitant disease that may require chronic treatment with systemic corticosteroids or immunosuppressants during the course of the study\n* Known history of human immunodeficiency virus (HIV) infection\n* Lack of peripheral venous access\n* Previous treatment with B-cell targeted therapies (i.e., rituximab, ocrelizumab, atacicept, belimumab, or ofatumumab), unless the last infusion was at least 6 months prior to screening\n* Positive screening tests for hepatitis B virus (HBV) and\u002For hepatitis C virus (HCV)","ALL","18 Years","55 Years",{"count":202,"type":203},60,"ESTIMATED","INTERVENTIONAL",[206],"PHASE4","The main purpose of this study is to evaluate the efficacy of ocrelizumab in participants with relapsing multiple sclerosis (RMS) and to characterize the ocrelizumab pharmacodynamic (PD) profile in Chinese participants with primary progressive multiple sclerosis (PPMS).",[209,210],"Relapsing Multiple Sclerosis","Primary Progressive Multiple Sclerosis","2026-05-22",{"date":213,"type":214},"2026-05-27","ACTUAL",{"date":216,"type":214},"2025-07-04",{"date":218,"type":203},"2027-04-23",{"name":5,"class":6},17]