[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100472738":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":34,"centralContacts":40,"locations":49,"responsibleParty":90,"collaborators":94,"id":99,"slug":100,"hasResults":101,"nctId":102,"briefTitle":103,"officialTitle":104,"acronym":105,"eligibilityCriteria":106,"healthyVolunteers":101,"sex":107,"minAge":108,"maxAge":24,"enrollmentInfo":109,"targetDuration":24,"studyType":112,"phases":113,"briefSummary":115,"conditions":116,"keywords":120,"overallStatus":52,"whyStopped":24,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":126,"startDateStruct":129,"completionDateStruct":131,"leadSponsor":133,"locationsCount":134},{"fullName":5,"class":6},"Rigshospitalet, Denmark","OTHER",[8,14,20],{"label":9,"type":10,"description":11,"interventionNames":12},"RCT group - hydrocortisone","ACTIVE_COMPARATOR","Patients with polymyalgia rheumatica\u002Fgiant cell arteritis with glucocorticoid-induced adrenal insufficiency (Synacthen test response \\\u003C420 nmol\u002Fl) that are randomised to receive hydrocortisone",[13],"Drug: Hydrocortisone",{"label":15,"type":16,"description":17,"interventionNames":18},"RCT group - placebo","PLACEBO_COMPARATOR","Patients with polymyalgia rheumatica\u002Fgiant cell arteritis with glucocorticoid-induced adrenal insufficiency (Synacthen test response \\\u003C420 nmol\u002Fl) that are randomised to receive placebo",[19],"Drug: Placebo for hydrocortisone",{"label":21,"type":22,"description":23,"interventionNames":24},"Control group","NO_INTERVENTION","Patients with polymyalgia rheumatica\u002Fgiant cell arteritis with normal adrenal function (Synacthen test response ≥420 nmol\u002Fl)",null,[26,31],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":24},"DRUG","Hydrocortisone","Patients are randomised to either placebo or hydrocortisone supplemental doses in situations of stress. Patients will continue prednisolone treatment and tapering hereof according to current clinical guidelines for PMR\u002FGCA , prednisolone is not part of the intervention.",[9],{"type":27,"name":32,"description":29,"armGroupLabels":33,"otherNames":24},"Placebo for hydrocortisone",[15],[35,38],{"name":36,"affiliation":5,"role":37},"Ulla Feldt-Rasmussen, Professor","PRINCIPAL_INVESTIGATOR",{"name":39,"affiliation":5,"role":37},"Marianne Klose, MD, PhD",[41,45],{"name":39,"role":42,"phone":43,"phoneExt":24,"email":44},"CONTACT","+4530237532","marianne.christina.klose.01@regionh.dk",{"name":46,"role":42,"phone":47,"phoneExt":24,"email":48},"Stina W. Borresen, MD, PhD","+4525347551","stina.borresen@regionh.dk",[50,65,79],{"facility":51,"status":52,"city":53,"state":24,"zip":24,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":62},"Department of Endocrinology, Aarhus University Hospital","RECRUITING","Aarhus","Denmark","DK",{"type":57,"coordinates":58},"Point",[59,60],10.21076,56.15674,{"lat":60,"lon":59},[63],{"name":64,"role":42,"phone":24,"phoneExt":24,"email":24},"Jens Otto L. Jørgensen, Professor",{"facility":66,"status":52,"city":67,"state":24,"zip":68,"country":54,"countryCode":55,"cosmosGeoPoint":69,"geoPoint":73,"contacts":74},"Department of Medical Endocrinology, Copenhagen University Hospital, Rigshospitalet","Copenhagen","2100",{"type":57,"coordinates":70},[71,72],12.56553,55.67594,{"lat":72,"lon":71},[75,77,78],{"name":36,"role":42,"phone":24,"phoneExt":24,"email":76},"ufeldt@rh.dk",{"name":46,"role":42,"phone":24,"phoneExt":24,"email":24},{"name":36,"role":37,"phone":24,"phoneExt":24,"email":24},{"facility":80,"status":52,"city":81,"state":24,"zip":24,"country":54,"countryCode":55,"cosmosGeoPoint":82,"geoPoint":86,"contacts":87},"Department of Endocrinology, Odense University Hospital","Odense",{"type":57,"coordinates":83},[84,85],10.38831,55.39594,{"lat":85,"lon":84},[88],{"name":89,"role":42,"phone":24,"phoneExt":24,"email":24},"Marianne S. Andersen, professor",{"type":91,"investigatorFullName":92,"investigatorTitle":93,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"SPONSOR_INVESTIGATOR","Marianne Christina Klose","MD, PhD",[95,97],{"name":96,"class":6},"Aarhus University Hospital",{"name":98,"class":6},"Odense University Hospital","100472738","phase-4-effect-of-supplemental-hydrocortisone-during-stress-in-prednisolone-induced-adrenal-insufficiency-100472738",false,"NCT05435781","Effect of Supplemental Hydrocortisone During Stress in Prednisolone-induced Adrenal Insufficiency","RESCUE - Effect of Supplemental Hydrocortisone During Stress in Prednisolone-induced Adrenal Insufficiency; A Multicentre, Randomised, Double Blinded, Placebo-controlled Clinical Trial on Health-related Quality of Life in Patients With Polymyalgia Rheumatica\u002FGiant Cell Arteritis Receiving Ongoing Low-dose Prednisolone Treatment.","RESCUE","Inclusion Criteria:\n\n* Age ≥ 50 years\n* Women must be postmenopausal (FSH is measured at the screening visit)\n* A diagnosis of PMR\u002FGCA, or both conditions combined.\n* Treatment with prednisolone ≥12 weeks\n* Ongoing prednisolone treatment, with current daily prednisolone dose \\> 0 mg and ≤5 mg. The dose must have been ≤5 mg for minimum 2 weeks at the time of the screening visit.\n\nExclusion Criteria:\n\n* Known primary or secondary adrenal insufficiency\n* Known Cushing's Syndrome\n* Known allergy towards study medication ingredients\n* Severe comorbidity: Heart failure (New York Heart Association class IV); Kidney failure with an estimated glomerular filtration rate \\\u003C30 mL\u002Fmin (Chronic kidney disease stage 4-5); Liver disease in the form of cirrhosis; Active cancer; Known severe immune deficiency; A history of psychiatric disease requiring treatment by a psychiatric department (for affective disorders only if within the last year before study entry)\n* Alcohol consumption \\>21 units per week\n* Planned major surgery during the study period at study entry.\n* Use of drugs that interfere with cortisol metabolism\u002Fmeasurements: Systemic oestrogen treatment (discontinued \\\u003C 1 month before inclusion), Treatment with strong CYP3A4 inhibitors or inducers, Use of other glucocorticoid formulations (Inhaled corticosteroids, intraarticular or intramuscular injections, steroid creams European steroid group IV-V used in the genital area. Note: Permitted glucocorticoid formulations: Eye-drops, nasal spray, glucocorticoid creams European steroid group I-III, and European steroid group IV-V used in the non-genital area only.)\n* Inability to provide written informed consent.","ALL","50 Years",{"count":110,"type":111},250,"ESTIMATED","INTERVENTIONAL",[114],"PHASE4","In this double-blinded randomised placebo-controlled clinical trial, the aim is to determine the effect of supplemental hydrocortisone compared with placebo during mild to moderate physical or mental stress on health related quality of life in patients with polymyalgia rheumatica (PMR)\u002Fgiant cell arteritis (GCA) on ongoing low-dose prednisolone diagnosed with glucocorticoid-induced adrenal insufficiency. The main emphasis is on fatigue (primary outcome) and daily variation hereof during periods of stress.",[117,118,119],"Adrenal Insufficiency","Polymyalgia Rheumatica","Giant Cell Arteritis",[121,122,123,124],"Glucocorticoid-induced adrenal insufficiency","Prednisolone","Glucocorticoids","Hypothalamic-pituitary-adrenal axis","2026-03-12",{"date":127,"type":128},"2026-03-16","ACTUAL",{"date":130,"type":128},"2022-06-07",{"date":132,"type":111},"2028-03-01",{"name":92,"class":6},3]