[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100476093":3},{"organization":4,"armGroups":7,"interventions":8,"overallOfficials":21,"centralContacts":26,"locations":31,"responsibleParty":52,"collaborators":54,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":65,"acronym":7,"eligibilityCriteria":66,"healthyVolunteers":63,"sex":67,"minAge":68,"maxAge":7,"enrollmentInfo":69,"targetDuration":7,"studyType":72,"phases":7,"briefSummary":73,"conditions":74,"keywords":77,"overallStatus":33,"whyStopped":7,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},{"fullName":5,"class":6},"University Hospital, Basel, Switzerland","OTHER",null,[9,12,15,18],{"type":6,"name":10,"description":11,"armGroupLabels":7,"otherNames":7},"Data collection for cellular analyses (Immune subset composition, GCR expression, in vitro steroid responsiveness)","Biological material will be sampled at three time-points. The first time-point will be when patients have been treated with 15 mg of prednisone per day for at least 5 days. A second time-point will be after prednisone was successfully tapered and maintained at 5 mg per day for at least 5 days, a third time point will be 4 weeks after the stop of prednisone. Biosampling is done for cellular analyses, pharmacokinetics and hormone measurements.",{"type":6,"name":13,"description":14,"armGroupLabels":7,"otherNames":7},"Data collection for exploratory analyses of endogenous steroid hormones","Concentrations of GC, MC, androgens and progestins will be determined and the suppression of cortisol and cortisone upon prednisone treatment will be analyzed.",{"type":6,"name":16,"description":17,"armGroupLabels":7,"otherNames":7},"Data collection for correlation between clinical defined and lab defined GC responsivness","The time to first relapse, the cumulative steroid dose at 1 year after diagnosis, the need for treatment with steroid sparing agents and the GTI after 1 year will be correlated to the percentage of in vitro inhibition of cytokine concentration by dexamethasone treatment, to the prednisone\u002Fprednisolone ratio in plasma, to the percentage of endogenous GC suppression (plasma and urinary cortisol and cortisone) by prednisone treatment. Furthermore, correlations of steroid sensitivity with Mineralocorticoid (MC) and androgens will be investigated.",{"type":6,"name":19,"description":20,"armGroupLabels":7,"otherNames":7},"Data collection for Prednisone metabolism","Plasma concentrations of prednisone and its active metabolite prednisolone will be quantified by liquid chromatography-tandem mass spectrometry (LC-MS\u002FMS). If changes on prednisone\u002Fprednisolone are observed, the quantification of the 6-hydroxylated prednisone\u002Fprednisolone metabolites in 24 h urine samples will be performed to estimate their metabolism as well as the ratio of inactive to active GC.",[22],{"name":23,"affiliation":24,"role":25},"Thomas Daikeler, Prof. Dr. med.","Department of Rheumatology University Hospital Basel","PRINCIPAL_INVESTIGATOR",[27],{"name":23,"role":28,"phone":29,"phoneExt":7,"email":30},"CONTACT","+41 61 265 27 09","Thomas.Daikeler@usb.ch",[32],{"facility":24,"status":33,"city":34,"state":7,"zip":35,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"RECRUITING","Basel","4031","Switzerland","CH",{"type":39,"coordinates":40},"Point",[41,42],7.57327,47.55839,{"lat":42,"lon":41},[45,46,47,50],{"name":23,"role":28,"phone":29,"phoneExt":7,"email":30},{"name":23,"role":25,"phone":7,"phoneExt":7,"email":7},{"name":48,"role":49,"phone":7,"phoneExt":7,"email":7},"Alex Odermatt, Prof. Dr. med.","SUB_INVESTIGATOR",{"name":51,"role":49,"phone":7,"phoneExt":7,"email":7},"Christoph Berger, Prof. Dr. med.",{"type":53,"investigatorFullName":7,"investigatorTitle":7,"investigatorAffiliation":7,"oldNameTitle":7,"oldOrganization":7},"SPONSOR",[55,58],{"name":56,"class":57},"Schweizerische Stiftung für die Erforschung der Muskelkrankheiten","UNKNOWN",{"name":59,"class":60},"Novartis","INDUSTRY","100476093","predictive-factors-for-treatment-response-in-patients-with-newly-diagnosed-polymyalgia-rheumatica-and-giant-cell-arteritis-100476093",false,"NCT05479448","Predictive Factors for Treatment Response in Patients With Newly-diagnosed Polymyalgia Rheumatica and Giant Cell Arteritis","Inclusion Criteria:\n\n* Patients with diagnosis of PMR according to the 2012 provisional classification criteria and GCA according to published criteria\n* Consent to participate in the SCQM database\n* Treatment according to our standardized regimes\n\nExclusion Criteria:\n\n* Treatment with Tocilizumab, MTX or other disease modifying medications at inclusion\n* History of GCA and PMR in the past\n* Inability to give informed consent","ALL","18 Years",{"count":70,"type":71},30,"ESTIMATED","OBSERVATIONAL","This prospective study is to explore different predictive factors for response to steroid treatment in patients with PMR and\u002For GCA. It evaluates the association of endogenous GC suppression (plasma and urinary cortisol and cortisone) to the responsiveness of PMR\u002FGCA to GCs.",[75,76],"Polymyalgia Rheumatica (PMR)","Giant Cell Arteritis (GCA)",[78,79,80,81,82,83,84,85,86,87,88],"Large vessel vasculitis (LVV)","Glucocorticoid receptor (GCR)","glucocorticoid (GC)","steroid-response","GCR expression levels","GCR sensitivity\u002Fresponsiveness","prednisolone","prednisone","Swiss Clinical Quality Management in Rheumatic Diseases (SCQM)","Glucocorticoid resistance","endogenous GC suppression","2025-03-31",{"date":91,"type":92},"2025-04-01","ACTUAL",{"date":94,"type":92},"2022-06-03",{"date":96,"type":71},"2028-12",{"name":5,"class":6},1]