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RECRUITING
NCT05435781
PHASE4

Effect of Supplemental Hydrocortisone During Stress in Prednisolone-induced Adrenal Insufficiency

Sponsor: Marianne Christina Klose

View on ClinicalTrials.gov

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

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/GCA , prednisolone is not part of the intervention.

DRUG

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