[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Banu Aji Dibyasakti\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":53},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":31,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":42,"lastUpdatePostDateStruct":43,"startDateStruct":46,"completionDateStruct":48,"leadSponsor":50,"locationsCount":5},"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":21,"type":22},64,"ESTIMATED","INTERVENTIONAL",[25],"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.",[28,29,30],"Thyroid Eye Disease","Graves Ophthalmopathy","Graves Orbitopathy",[32,33,34,35,36,37,38,39,40],"graves orbitopapathy","thyroid eye disease","atorvastatin","statins","methylprednisolone","randomised controlled trial","orbital computed tomography","microRNA","graves ophthalmopathy","NOT_YET_RECRUITING","2026-08-07",{"date":44,"type":45},"2026-08-13","ACTUAL",{"date":47,"type":22},"2026-08-30",{"date":49,"type":22},"2027-09-30",{"name":51,"class":52},"Banu Aji Dibyasakti","OTHER",""]