Clinical Research Directory
Browse clinical research sites, groups, and studies.
Effect of Supplemental Hydrocortisone During Stress in Prednisolone-induced Adrenal Insufficiency
Sponsor: Marianne Christina Klose
Summary
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)/giant 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.
Official title: 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/Giant Cell Arteritis Receiving Ongoing Low-dose Prednisolone Treatment.
Key Details
Gender
All
Age Range
50 Years - Any
Study Type
INTERVENTIONAL
Enrollment
250
Start Date
2022-06-07
Completion Date
2028-03-01
Last Updated
2026-03-16
Healthy Volunteers
No
Interventions
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/GCA , prednisolone is not part of the intervention.
Placebo for 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/GCA , prednisolone is not part of the intervention.
Locations (3)
Department of Endocrinology, Aarhus University Hospital
Aarhus, Denmark
Department of Medical Endocrinology, Copenhagen University Hospital, Rigshospitalet
Copenhagen, Denmark
Department of Endocrinology, Odense University Hospital
Odense, Denmark