[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100297555":3},{"organization":4,"outcomesModule":7,"designInfo":37,"detailedDescription":50,"studyPopulation":36,"armGroups":51,"interventions":64,"overallOfficials":74,"centralContacts":79,"locations":84,"responsibleParty":286,"collaborators":288,"id":298,"slug":299,"hasResults":300,"nctId":301,"briefTitle":302,"officialTitle":303,"acronym":304,"eligibilityCriteria":305,"healthyVolunteers":300,"sex":306,"minAge":307,"maxAge":36,"enrollmentInfo":308,"targetDuration":36,"studyType":311,"phases":312,"briefSummary":314,"conditions":315,"keywords":36,"overallStatus":87,"whyStopped":36,"lastUpdateSubmitDate":318,"lastUpdatePostDateStruct":319,"startDateStruct":322,"completionDateStruct":324,"leadSponsor":326,"locationsCount":327},{"fullName":5,"class":6},"University Hospital, Basel, Switzerland","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":36},[9],{"measure":10,"description":11,"timeFrame":12},"Time to any incidence","Time to first occurrence of hospitalization, death, initiation of unplanned systemic glucocorticoid therapy, or adrenal crisis (defined as glucocorticoid-responsive hypotension or shock with or without accompanying symptoms and signs such as weakness, apathy, nausea, vomiting, abdominal pain, hypothermia, hyponatremia \\[serum sodium \\\u003C 135 millimole (mM)\\], hyperkalemia \\[serum potassium \\> 5 mM\\], hypoglycemia \\[plasma glucose \\\u003C 3.5 mM\\]); whichever occurs first.","up to 6 months",[14,17,19,21,24,28,31,34],{"measure":15,"description":16,"timeFrame":12},"Time to specific incidence","Time to first occurrence of individual components of the primary outcome;",{"measure":18,"description":18,"timeFrame":12},"Cumulative overall systemic glucocorticoid dose",{"measure":20,"description":20,"timeFrame":12},"Cumulative systemic glucocorticoid dose administered to treat or prevent adrenal failure",{"measure":22,"description":23,"timeFrame":12},"Cumulative systemic glucocorticoid dose administered to treat relapse","Cumulative systemic glucocorticoid dose administered to treat relapse of disease, specified for each disease",{"measure":25,"description":26,"timeFrame":27},"General health status","General health status as self-assessed by the participant on a visual analog scale (VAS) from 0 to 100","assessed at days 1, 7, 28, 35, 90,180",{"measure":29,"description":30,"timeFrame":12},"Score of symptoms and signs of hypocortisolism","Score of symptoms and signs of hypocortisolism: weakness, hypothermia, nausea, vomiting, abdominal pain, fatigue, dizziness, Blood pressure, serum Na and serum glucose concentrations.",{"measure":32,"description":33,"timeFrame":12},"Performance in 250 mcg Synacthen® test","Performance in 250 mcg Synacthen® test: test assessed day 1 in all participants, plus days 7 and 35 in those followed in centers Bruderholz, Luzern, Aarau",{"measure":35,"description":35,"timeFrame":12},"In patients hospitalized at study entry: length of hospital stay",null,{"allocation":38,"interventionModel":39,"interventionModelDescription":40,"primaryPurpose":41,"observationalModel":36,"timePerspective":36,"maskingInfo":42},"RANDOMIZED","PARALLEL","Standard treatment arm: Prednisone, a synthetic glucocorticoid with intermediate duration of action (biological half-life 18-35 hrs). The detailed characteristics of the compound, marketed under several brand names, can be found at www.swissmedicinfo.ch: Prednison Streuli (Swissmedic registration number: 29349); Prednison Axapharm (Swissmedic registration number: 58761); Prednison Galepharm (Swissmedic registration number: 50821).\n\nInterventional treatment arm: matching placebo.","TREATMENT",{"masking":43,"maskingDescription":44,"whoMasked":45},"QUADRUPLE","Blinding of trial participants, treating physicians, study doctors, study nurses, outcome assessors and data analysts will be ensured by using identical-looking placebo, packaged in identical vials as the prednisone verum. Vials will be labeled with \"Prednisone or Placebo\" in an identical fashion.",[46,47,48,49],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR","In total, 530 patients will be enrolled. Patients will be randomly assigned in a 1:1 ratio to either prednisone in decreasing doses over 4 weeks or placebo.\n\nPatients, treating physicians, and study personnel will be blinded to treatment allocation to either prednisone or matching placebo. At inclusion, we will perform a 250 micrograms Synacthen® stimulation test. The results of the test will be blinded to treating physicians and investigators, and its value to predict clinical outcome will only be assessed after completion of the trial. As a safety measure, all patients will be instructed about stress coverage as well as signs and symptoms of hypocortisolism and will be provided with emergency medication. Patients will be randomized to the standard (tapering) or the experimental (matching placebo) arm. Follow-up will be for six months. In order to improve adherence to the study and ensure feasibility, follow-up visits in most study centers will be by telephone only. Visits will be performed early after stopping glucocorticoids in both arms (i.e. at days 7 and 35) to ensure safety; the other two visits will be on days 90 and 180.\n\nAmendment approved in 1-2018: former exclusion criterion 'status post organ transplantation' was revised and deleted",[52,58],{"label":53,"type":54,"description":55,"interventionNames":56},"Placebo arm (intervention arm)","PLACEBO_COMPARATOR","Stop glucocorticoid treatment; administer placebo matching the verum preparation in weekly intervals.",[57],"Other: Placebo Arm",{"label":59,"type":60,"description":61,"interventionNames":62},"Verum group (control\u002Fstandard arm)","ACTIVE_COMPARATOR","If patient is on \\> 7.5 mg prednisone-equivalent daily: administer 7.5 mg q.d. for 7 days, then 5 mg q.d. for 7 days, then 2.5 mg q.d. for 7 days, then 2.5 mg q.d. every second day, then stop. If patient on 7.5 mg q.d.: maintain for 7 days, then taper as above.",[63],"Drug: Prednisone",[65,70],{"type":66,"name":67,"description":68,"armGroupLabels":69,"otherNames":36},"DRUG","Prednisone","The control intervention (standard treatment) consists of prednisone treatment in decreasing doses, starting with 7.5 mg q.d. and reducing the dose every 7 days, such that prednisone treatment is stopped after a total of 4 weeks.",[59],{"type":6,"name":71,"description":72,"armGroupLabels":73,"otherNames":36},"Placebo Arm","The experimental intervention consists of stopping glucocorticoid treatment abruptly and administering matching placebo over 4 weeks.",[53],[75],{"name":76,"affiliation":77,"role":78},"Jonas Rutishauser, Prof MD","Departement Medizin, Kantonsspital Baden","PRINCIPAL_INVESTIGATOR",[80],{"name":76,"role":81,"phone":82,"phoneExt":36,"email":83},"CONTACT","+41-56-486 25 14","j.rutishauser@unibas.ch",[85,104,122,138,150,160,172,181,190,205,219,228,238,254,263,277],{"facility":86,"status":87,"city":88,"state":36,"zip":36,"country":89,"countryCode":90,"cosmosGeoPoint":91,"geoPoint":96,"contacts":97},"University Hospital Frankfurt","RECRUITING","Frankfurt","Germany","DE",{"type":92,"coordinates":93},"Point",[94,95],10.53333,49.68333,{"lat":95,"lon":94},[98,100,101],{"name":99,"role":81,"phone":36,"phoneExt":36,"email":36},"Jörg Bojunga, Prof. Dr. med.",{"name":99,"role":78,"phone":36,"phoneExt":36,"email":36},{"name":102,"role":103,"phone":36,"phoneExt":36,"email":36},"Gesine Meyer, PD Dr. med.","SUB_INVESTIGATOR",{"facility":105,"status":87,"city":106,"state":36,"zip":107,"country":89,"countryCode":90,"cosmosGeoPoint":108,"geoPoint":112,"contacts":113},"University Hospital Würzburg","Würzburg","97080",{"type":92,"coordinates":109},[110,111],9.95121,49.79391,{"lat":111,"lon":110},[114,116,120,121],{"name":115,"role":81,"phone":36,"phoneExt":36,"email":36},"Irina Chifu, Dr. med.",{"name":117,"role":81,"phone":118,"phoneExt":36,"email":119},"Martin Fassnacht, Prof Dr. med.","+49-931-201-39201","Fassnacht_M@ukw.de",{"name":117,"role":103,"phone":36,"phoneExt":36,"email":36},{"name":115,"role":78,"phone":36,"phoneExt":36,"email":36},{"facility":123,"status":87,"city":124,"state":36,"zip":125,"country":126,"countryCode":127,"cosmosGeoPoint":128,"geoPoint":132,"contacts":133},"Departement of Internal Medicine, Kantonsspital Aarau","Aarau","5001","Switzerland","CH",{"type":92,"coordinates":129},[130,131],8.04422,47.39254,{"lat":131,"lon":130},[134],{"name":135,"role":81,"phone":136,"phoneExt":36,"email":137},"Philip Schuetz, Prof Dr med","+41 62 838 95 24","schuetzph@gmail.com",{"facility":139,"status":87,"city":140,"state":36,"zip":141,"country":126,"countryCode":127,"cosmosGeoPoint":142,"geoPoint":146,"contacts":147},"Kantonsspital Baden","Baden","5404",{"type":92,"coordinates":143},[144,145],8.30592,47.47333,{"lat":145,"lon":144},[148],{"name":149,"role":81,"phone":82,"phoneExt":36,"email":83},"Jonas Rutishauser, Prof. Dr. MD",{"facility":151,"status":152,"city":153,"state":36,"zip":154,"country":126,"countryCode":127,"cosmosGeoPoint":155,"geoPoint":159,"contacts":36},"Endocrinology\u002FDiabetology\u002FMetabolism; University Hospital Basel","TERMINATED","Basel","4031",{"type":92,"coordinates":156},[157,158],7.57327,47.55839,{"lat":158,"lon":157},{"facility":161,"status":87,"city":153,"state":36,"zip":162,"country":126,"countryCode":127,"cosmosGeoPoint":163,"geoPoint":165,"contacts":166},"St. Claraspital Basel","4058",{"type":92,"coordinates":164},[157,158],{"lat":158,"lon":157},[167,171],{"name":168,"role":81,"phone":169,"phoneExt":36,"email":170},"Matthias Hepprich","+41 61 685 89 40","matthias.hepprich@claraspital.ch",{"name":168,"role":78,"phone":36,"phoneExt":36,"email":36},{"facility":173,"status":152,"city":174,"state":36,"zip":175,"country":126,"countryCode":127,"cosmosGeoPoint":176,"geoPoint":180,"contacts":36},"Department of Rheumatology, Immunology, and Allergology, Inselspital","Bern","3010",{"type":92,"coordinates":177},[178,179],7.44744,46.94809,{"lat":179,"lon":178},{"facility":182,"status":152,"city":183,"state":36,"zip":184,"country":126,"countryCode":127,"cosmosGeoPoint":185,"geoPoint":189,"contacts":36},"Division of Gastroenterology, Spital Bülach AG","Bülach","8180",{"type":92,"coordinates":186},[187,188],8.54049,47.52197,{"lat":188,"lon":187},{"facility":191,"status":87,"city":192,"state":36,"zip":193,"country":126,"countryCode":127,"cosmosGeoPoint":194,"geoPoint":198,"contacts":199},"Kantonsspital Frauenfeld","Frauenfeld","8501",{"type":92,"coordinates":195},[196,197],8.89893,47.55776,{"lat":197,"lon":196},[200,204],{"name":201,"role":81,"phone":202,"phoneExt":36,"email":203},"Andreas Kistler, PD Dr. med.","+41 52 723 76 43","andreas.kistler@stgag.ch",{"name":201,"role":78,"phone":36,"phoneExt":36,"email":36},{"facility":206,"status":87,"city":207,"state":36,"zip":208,"country":126,"countryCode":127,"cosmosGeoPoint":209,"geoPoint":213,"contacts":214},"Geneva University Hospitals","Geneva","1205",{"type":92,"coordinates":210},[211,212],6.14569,46.20222,{"lat":212,"lon":211},[215,218],{"name":216,"role":81,"phone":217,"phoneExt":36,"email":36},"Jean-Luc Reny, Prof. Dr. med.","+41 22 372 90 52",{"name":216,"role":78,"phone":36,"phoneExt":36,"email":36},{"facility":220,"status":152,"city":221,"state":36,"zip":222,"country":126,"countryCode":127,"cosmosGeoPoint":223,"geoPoint":227,"contacts":36},"Center for Primary Health Care,University of Basel, Kantonsspital Baselland","Liestal","4410",{"type":92,"coordinates":224},[225,226],7.73446,47.48455,{"lat":226,"lon":225},{"facility":229,"status":87,"city":221,"state":36,"zip":222,"country":126,"countryCode":127,"cosmosGeoPoint":230,"geoPoint":232,"contacts":233},"Internal Medicine, Kantonsspital Baselland\u002FLiestal",{"type":92,"coordinates":231},[225,226],{"lat":226,"lon":225},[234],{"name":235,"role":81,"phone":236,"phoneExt":36,"email":237},"Jörg Leuppi, Prof Dr med","+41-61-925 21 80","joerg.leuppi@ksbl.ch",{"facility":239,"status":87,"city":240,"state":36,"zip":241,"country":126,"countryCode":127,"cosmosGeoPoint":242,"geoPoint":246,"contacts":247},"Department of Internal Medicine, Kantonsspital Münsterlingen","Münsterlingen","8596",{"type":92,"coordinates":243},[244,245],9.23271,47.63197,{"lat":245,"lon":244},[248,252],{"name":249,"role":81,"phone":250,"phoneExt":36,"email":251},"Robert Thurnheer","+41 71 686 21 75","robert.thurnheer@stgag.ch",{"name":253,"role":78,"phone":36,"phoneExt":36,"email":36},"Robert Thurnheer, Prof. Dr. med",{"facility":255,"status":152,"city":256,"state":36,"zip":257,"country":126,"countryCode":127,"cosmosGeoPoint":258,"geoPoint":262,"contacts":36},"Stoffwechselzentrum, Kantonsspital Olten","Olten","4600",{"type":92,"coordinates":259},[260,261],7.90329,47.34999,{"lat":261,"lon":260},{"facility":264,"status":87,"city":265,"state":36,"zip":266,"country":126,"countryCode":127,"cosmosGeoPoint":267,"geoPoint":271,"contacts":272},"Department of Internal Medicine, Kantonsspital St. Gallen","Sankt Gallen","9007",{"type":92,"coordinates":268},[269,270],9.37477,47.42391,{"lat":270,"lon":269},[273],{"name":274,"role":81,"phone":275,"phoneExt":36,"email":276},"Michael Brändle, Prof Dr med","+41-71-494 61 21","michael.braendle@kssg.ch",{"facility":278,"status":152,"city":279,"state":36,"zip":280,"country":126,"countryCode":127,"cosmosGeoPoint":281,"geoPoint":285,"contacts":36},"Dept. of Endocrinology, Diabetology and Clinical Nutrition, University Hospital","Zurich","8091",{"type":92,"coordinates":282},[283,284],8.55,47.36667,{"lat":284,"lon":283},{"type":287,"investigatorFullName":36,"investigatorTitle":36,"investigatorAffiliation":36,"oldNameTitle":36,"oldOrganization":36},"SPONSOR",[289,291,293,296],{"name":290,"class":6},"Kantonsspital Baselland Bruderholz",{"name":292,"class":6},"Swiss National Science Foundation",{"name":294,"class":295},"HEMMI Stiftung Switzerland","UNKNOWN",{"name":297,"class":295},"Gebauer Stiftung Zurich","100297555","phase-4-taper-or-abrupt-steroid-stop-toassttrial-100297555",false,"NCT03153527","Taper Or Abrupt Steroid Stop: TOASSTtrial","Glucocorticoid Withdrawal and Glucocorticoid-induced Adrenal Insufficiency: a Randomized Controlled Multicenter Trial","TOASST","Inclusion Criteria:\n\n* Informed Consent as documented by signature (Appendix Informed Consent Form)\n* Age ≥ 18 years\n* Daily glucocorticoid dose ≥ 7.5 mg prednisone-equivalent at the time of inclusion\n* Therapy over ≥ 28 days, ≥ 7.5 mg average daily dose, with a cumulative glucocorticoid dose ≥ 420 mg prednisone-equivalent prior to inclusion\n* Tapering not or no longer mandatory to treat underlying disease\n\nExclusion Criteria:\n\n* Primary adrenal failure\n* Treatment with systemic depot glucocorticoids (e.g. intramuscular, epidural)\n* Incapability to administer glucocorticoid cover treatment in situations of stress\n* Inability or unwillingness to provide informed consent\n* Women who are pregnant or breast feeding,\n* Intention to become pregnant during the course of the study,\n* Lack of safe contraception, defined as: Female participants of childbearing potential, not using and not willing to continue using a medically reliable method of contraception for the entire study duration, such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices, or who are not using any other method considered sufficiently reliable by the investigator in individual cases.\n* Known or suspected non-compliance\n* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant,\n* Participation in another study with investigational drug within the 30 days preceding and during the present study,\n* Previous enrolment into the current study,\n* Enrolment of the investigator, his\u002Fher family members, employees and other dependent persons","ALL","18 Years",{"count":309,"type":310},530,"ESTIMATED","INTERVENTIONAL",[313],"PHASE4","This study is an Investigator-initiated, placebo-controlled, multicenter noninferiority trial, comparing rapid termination of systemic glucocorticoid treatment with a tapering regime over 4 weeks.",[316,317],"Inflammatory Disorder","Autoimmune","2026-04-20",{"date":320,"type":321},"2026-04-22","ACTUAL",{"date":323,"type":321},"2017-05-31",{"date":325,"type":310},"2027-06",{"name":5,"class":6},16]