[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100555286":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":33,"centralContacts":37,"locations":32,"responsibleParty":42,"collaborators":32,"id":44,"slug":45,"hasResults":46,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":32,"eligibilityCriteria":50,"healthyVolunteers":46,"sex":51,"minAge":52,"maxAge":53,"enrollmentInfo":54,"targetDuration":32,"studyType":57,"phases":58,"briefSummary":60,"conditions":61,"keywords":63,"overallStatus":66,"whyStopped":32,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":32},{"fullName":5,"class":6},"Third Affiliated Hospital, Sun Yat-Sen University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Group A","EXPERIMENTAL","The daily scheme was as follows: 0.5 g methylprednisolone i.v. daily for 5 consecutive days, followed by oral prednisone for 6 months. Oral prednisone started at 40 mg\u002Fday for 4 weeks and then the dose was tapered by 5 mg\u002Fday every 2-4 weeks.",[13],"Drug: methylprednisolone(daily scheme)",{"label":15,"type":16,"description":17,"interventionNames":18},"Group B","ACTIVE_COMPARATOR","The weekly protocol was as follows: 0.5 g methylprednisolone i.v. weekly for 6 weeks and then the dose was tapered by 0.25 g\u002Fweek over the following 6 weeks.",[19],"Drug: methylprednisolone(weekly scheme)",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","methylprednisolone(daily scheme)","0.5 g methylprednisolone i.v. daily for 5 consecutive days, followed by oral prednisone for 6 months. Oral prednisone started at 40 mg\u002Fday for 4 weeks and then the dose was tapered by 5 mg\u002Fday every 2-4 weeks.",[9],[27],"prednisone",{"type":22,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"methylprednisolone(weekly scheme)","0.5 g methylprednisolone i.v. weekly for 6 weeks and then the dose was tapered by 0.25 g\u002Fweek over the following 6 weeks.",[15],null,[34],{"name":35,"affiliation":5,"role":36},"Shuo Lin","PRINCIPAL_INVESTIGATOR",[38],{"name":35,"role":39,"phone":40,"phoneExt":32,"email":41},"CONTACT","020-85253408","linshuo3@mail.sysu.edu.cn",{"type":36,"investigatorFullName":35,"investigatorTitle":43,"investigatorAffiliation":5,"oldNameTitle":32,"oldOrganization":32},"Principal Investigator","100555286","phase-4-a-randomized-clinical-trial-of-intravenous-methylprednisolone-with-2-protocols-in-patients-with-graves-orbitopathy-100555286",false,"NCT06510114","A Randomized Clinical Trial of Intravenous Methylprednisolone With 2 Protocols in Patients With Graves Orbitopathy","Comparison of Two Intravenous Methylprednisolone Protocols in Patients With Graves Orbitopathy: a Randomized Clinical Trial","Inclusion Criteria:\n\n1. Age 18-65 years old;\n2. diagnosed as thyroid associated ophthalmopathy by using Bartley criteria，Moderate to severe (EUGOGO grade), with CAS≥3 points;\n3. Thyroid function normally lasts for more than 2 months, with oral antithyroid drugs or thyroid surgery, or six months after iodine-131 treatment;\n4. without receiving immunosuppressive therapy for thyroid eye disease before.\n\nExclusion Criteria:\n\n(1) severe cardiac, liver and renal insufficiency (2) acute or chronic viral hepatitis or tuberculosis (3) optic neuropathy (4) received immunosuppressive and glucocorticoid therapy for any reason within the past 3 months","ALL","18 Years","65 Years",{"count":55,"type":56},150,"ESTIMATED","INTERVENTIONAL",[59],"PHASE4","Intravenous glucocorticoid (IVGC) is an accessible and effective therapy for Graves orbitopathy (GO); the 4.5-g weekly protocol is well studied, but many details of treatment protocols need to be clarified. The goal of this trial is to compare the efficacy and safety of weekly and daily protocol of IVGC in GO. Researchers will compare daily protocol to weekly protocol to see if daily protocol works to treat GO.",[62],"Graves Ophthalmopathy",[64,62,65],"Hyperthyroidism","glucocorticoid","NOT_YET_RECRUITING","2024-07-15",{"date":69,"type":70},"2024-07-19","ACTUAL",{"date":72,"type":56},"2024-07",{"date":74,"type":56},"2026-12",{"name":5,"class":6}]