[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100603616":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":11,"centralContacts":20,"locations":11,"responsibleParty":26,"collaborators":11,"id":28,"slug":29,"hasResults":30,"nctId":31,"briefTitle":32,"officialTitle":33,"acronym":11,"eligibilityCriteria":34,"healthyVolunteers":30,"sex":35,"minAge":36,"maxAge":37,"enrollmentInfo":38,"targetDuration":11,"studyType":41,"phases":42,"briefSummary":44,"conditions":45,"keywords":11,"overallStatus":47,"whyStopped":11,"lastUpdateSubmitDate":48,"lastUpdatePostDateStruct":49,"startDateStruct":52,"completionDateStruct":54,"leadSponsor":56,"locationsCount":11},{"fullName":5,"class":6},"Qilu Pharmaceutical (Hainan) Co., Ltd.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Dimethyl Fumarate Group","EXPERIMENTAL",null,[13],"Drug: Dimethyl Fumarate Enteric-coated Capsules",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":11},"DRUG","Dimethyl Fumarate Enteric-coated Capsules","Eligible 50 RMS patients will orally take dimethyl fumarate enteric-coated capsules during treatment, with an initial dose of 120 mg twice daily for 7 days, followed by a maintenance dose of 240 mg twice daily for 48 weeks",[9],[21],{"name":22,"role":23,"phone":24,"phoneExt":11,"email":25},"Junwei Hao, doctor","CONTACT","010-83198082","haojunwei@vip.163.com",{"type":27,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100603616","phase-4-a-phase-iv-study-of-dimethyl-fumarate-enteric-coated-capsules-for-relapsing-multiple-sclerosis-rms-100603616",false,"NCT07138833","A Phase IV Study of Dimethyl Fumarate Enteric-coated Capsules for Relapsing Multiple Sclerosis (RMS)","A Multicenter, Open-label, Single Group, Phase 4 Study to Evaluate Dimethyl Fumarate Enteric-coated Capsules in Relapsing Multiple Sclerosis (RMS)","Inclusion Criteria:\n\n* Confirmed RMS per the 2017 McDonald criteria, including clinically isolated syndrome (CIS), relapsing-remitting MS (RRMS), or active secondary progressive MS (SPMS)\n* At least one documented relapse within 12 months prior to screening; plus evidence of MS-consistent lesions on prior brain MRI or gadolinium-enhancing (GdE) lesions on an MRI performed within 6 weeks before screening\n* Expanded Disability Status Scale (EDSS) score between 0.0 and 5.0 (inclusive) at screening\n\nExclusion Criteria:\n\n* History or current diagnosis of malignancy (except fully resected basal cell carcinoma), or uncontrolled severe diseases of major organ systems (e.g., cardiac, renal, hepatic, neurological \\[excluding multiple sclerosis\\]) that, in the investigator's assessment, pose a significant risk to the subject or could confound study results.\n* Protocol-defined multiple sclerosis (MS) relapse within 30 days prior to screening, or failure to achieve clinical stability from a prior relapse.\n* History of suicidal behavior within 5 years prior to screening. Suicidal ideation (indicated by a \"Yes\" response to Item 4 or 5 on the C-SSRS) within 6 months prior to screening.Subjects with a history of suicidal behavior occurring \\>5 years prior to screening require investigator assessment of eligibility.","ALL","18 Years","65 Years",{"count":39,"type":40},50,"ESTIMATED","INTERVENTIONAL",[43],"PHASE4","The goal of this clinical trial is to evaluate the efficacy and safety\\] in \\[subjects diagnosed with RMS according to the 2017 McDonald criteria, including clinically isolated syndrome (CIS), relapsing-remitting multiple sclerosis (RRMS), and active secondary progressive multiple sclerosis (SPMS).\n\nThe main questions it aims to answer are:\n\n\\[Question 1\\] The efficacy of dimethyl fumarate enteric-coated capsules in the treatment of RMS.\n\n\\[Question 2\\] The safety of dimethyl fumarate enteric-coated capsules in the treatment of RMS.\n\nParticipants will:\n\nEligible 50 RMS patients will orally take dimethyl fumarate enteric-coated capsules during treatment, with an initial dose of 120 mg twice daily for 7 days, followed by a maintenance dose of 240 mg twice daily for 48 weeks.\n\nThe annualized relapse rate (ARR) at Week 48 will be observed.",[46],"Relapsing Multiple Sclerosis","NOT_YET_RECRUITING","2025-08-17",{"date":50,"type":51},"2025-08-24","ACTUAL",{"date":53,"type":40},"2025-09",{"date":55,"type":40},"2028-08",{"name":5,"class":6}]