[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100651537":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":41,"responsibleParty":57,"collaborators":26,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":67,"eligibilityCriteria":68,"healthyVolunteers":63,"sex":69,"minAge":70,"maxAge":71,"enrollmentInfo":72,"targetDuration":26,"studyType":75,"phases":76,"briefSummary":78,"conditions":79,"keywords":83,"overallStatus":93,"whyStopped":26,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},{"fullName":5,"class":6},"Gadjah Mada University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Methylprednisolone only","ACTIVE_COMPARATOR","Experimental group recieve methylprednisolone injection 500 mg per week for six weeks followed by methylprednisolone 250 mg per weeks for following six weeks",[13],"Drug: methylprednisolone (IVMP)",{"label":15,"type":16,"description":17,"interventionNames":18},"Methylprednisolone plus Atorvastatin","EXPERIMENTAL","Experimental group recieve methylprednisolone injection 500 mg per week for six weeks followed by methylprednisolone 250 mg combined per week for following six weeks combined atorvastatin 20 mg per weeks for six months",[19,13],"Drug: Atorvastatin",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Atorvastatin","Moderate-to-severe Graves' orbitopathy at a tertiary referral centre in Yogyakarta, Indonesia, will be allocated 1:1 to intravenous methylprednisolone (500 mg weekly for six weeks, then 250 mg weekly for six weeks) with oral atorvastatin 20 mg daily for 24 weeks.",[15],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"methylprednisolone (IVMP)","Moderate-to-severe Graves' orbitopathy at a tertiary referral centre in Yogyakarta, Indonesia, will be allocated 1:1 to intravenous methylprednisolone (500 mg weekly for six weeks, then 250 mg weekly for six weeks)",[9,15],[32,37],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"Banu Aji Dibyasakti, MD","CONTACT","+628112574789","bdibyasakti@gmail.com",{"name":38,"role":34,"phone":39,"phoneExt":26,"email":40},"Nikolaus Erik Darmawan, MD","+6281392133296","nikolauserikd7@gmail.com",[42],{"facility":43,"status":26,"city":44,"state":45,"zip":26,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"Universitas Gadjah Mada","Yogyakarta","Yogyakarta, Indonesia","Indonesia","ID",{"type":49,"coordinates":50},"Point",[51,52],110.36472,-7.80139,{"lat":52,"lon":51},[55,56],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},{"name":38,"role":34,"phone":39,"phoneExt":26,"email":40},{"type":58,"investigatorFullName":59,"investigatorTitle":60,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"SPONSOR_INVESTIGATOR","Banu Aji Dibyasakti","Principle investigator","100651537","phase-1-study-of-atorvastatin-and-its-effects-in-clinical-and-radiological-aspects-in-patients-with-moderate-to-severe-thyroid-eye-disease-100651537",false,"NCT07762105","Study of Atorvastatin and Its Effects in Clinical and Radiological Aspects in Patients With Moderate-to-Severe Thyroid Eye Disease","Adjunctive Atorvastatin in Moderate-to-severe Thyroid Eye Disease (SEMAR-TED: Structural, Biomarker Expression and Muscle Endpoints of Atorvastatin): Study Protocol for a Randomised, Open-label, Assessor-masked Controlled Trial","SEMAR-TED","Inclusion Criteria:\n\n* Age 18 to 75 years inclusive\n* Graves' orbitopathy graded moderate-to-severe by EUGOGO criteria\n* Active disease, clinical activity score ≥ 3 of 7\n* Rehabilitative orbital decompression anticipated after completion of glucocorticoid therapy, on the usual clinical grounds\n* Able to attend weekly infusion visits and complete follow-up to week 48\n* Written informed consent given\n* For women of childbearing potential, agreement to use effective contraception until week 24\n\nExclusion Criteria:\n\n* Sight-threatening disease at screening: dysthyroid optic neuropathy or corneal breakdown\n* Any other autoimmune disease requiring systemic immunosuppresion\n* Known hypersensitivity to atorvastatin or to any statin\n* Current or recent (within 3 months) use of any lipid-lowering drug\n* Any contraindication to orbital decompression\n* Any independent indication for lipid-lowering therapy: established atherosclerotic cardiovascular disease, more than one cardiovascular risk factor (diabetes mellitus, hypertension, obesity), or LDL cholesterol ≥ 190 mg\u002FdL\n* Systemic glucocorticoid or immunosuppressive treatment for orbitopathy within the preceding 3 months\n* Previous orbital irradiation or orbital surgery\n* Alanine or aspartate aminotransferase \\> 3 × upper limit of normal, or creatine kinase \\> 5 × upper limit of normal, at screening\n* Estimated glomerular filtration rate \\\u003C 30 mL\u002Fmin\u002F1.73 m²\n* Pregnancy at screening (confirmed by a negative test before randomisation) or breastfeeding\n* Concomitant treatment with a strong CYP3A4 inhibitor\n* Any condition that, in the opinion of the investigator, would prevent completion of the trial","ALL","18 Years","75 Years",{"count":73,"type":74},64,"ESTIMATED","INTERVENTIONAL",[77],"PHASE1","The trial tests the hypothesis that, in adults with active, moderate-to-severe Graves' orbitopathy, 24 weeks of oral atorvastatin 20 mg daily added to a standard 12-week course of intravenous methylprednisolone produces a greater reduction in extraocular muscle size than intravenous methylprednisolone alone, and that any such reduction is accompanied by lower expression of TSH receptor, IGF-1 receptor, PDGF receptor, PI3K\u002FAKT and miR-155 transcripts, and higher expression of miR-146a. The prespecified direction for miR-146a follows its reported suppression in CD4+ T cells in active disease \\[26\\]. Reported directions of change are compartment-specific and not unanimous, so the transcript analyses are exploratory.",[80,81,82],"Thyroid Eye Disease","Graves Ophthalmopathy","Graves Orbitopathy",[84,85,86,87,88,89,90,91,92],"graves orbitopapathy","thyroid eye disease","atorvastatin","statins","methylprednisolone","randomised controlled trial","orbital computed tomography","microRNA","graves ophthalmopathy","NOT_YET_RECRUITING","2026-08-07",{"date":96,"type":97},"2026-08-13","ACTUAL",{"date":99,"type":74},"2026-08-30",{"date":101,"type":74},"2027-09-30",{"name":59,"class":6},1]