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.
Status: Recruiting
Location: See all (3) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 50
Healthy Volunteers: f
View:
• Age ≥ 50 years
• Women must be postmenopausal (FSH is measured at the screening visit)
• A diagnosis of PMR/GCA, or both conditions combined.
• Treatment with prednisolone ≥12 weeks
• 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.
Locations
Other Locations
Denmark
Department of Endocrinology, Aarhus University Hospital
NOT_YET_RECRUITING
Aarhus
Department of Medical Endocrinology, Copenhagen University Hospital, Rigshospitalet
RECRUITING
Copenhagen
Department of Endocrinology, Odense University Hospital
NOT_YET_RECRUITING
Odense
Contact Information
Primary
Ulla Feldt-Rasmussen, Professor
ufeldt@rh.dk
+4523829869
Backup
Stina W. Borresen, MD, PhD
stina.borresen@regionh.dk
+4525347551
Time Frame
Start Date:2022-06-07
Estimated Completion Date:2028-03-01
Participants
Target number of participants:250
Treatments
Active_comparator: RCT group - hydrocortisone
Patients with polymyalgia rheumatica/giant cell arteritis with glucocorticoid-induced adrenal insufficiency (Synacthen test response \<420 nmol/l) that are randomised to receive hydrocortisone
Placebo_comparator: RCT group - placebo
Patients with polymyalgia rheumatica/giant cell arteritis with glucocorticoid-induced adrenal insufficiency (Synacthen test response \<420 nmol/l) that are randomised to receive placebo
No_intervention: Control group
Patients with polymyalgia rheumatica/giant cell arteritis with normal adrenal function (Synacthen test response ≥420 nmol/l)