RecruitingPhase 4NCT05435781

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/Giant Cell Arteritis Receiving Ongoing Low-dose Prednisolone Treatment.

Sponsor

Marianne Christina Klose

Enrollment

250 participants

Start Date

Jun 7, 2022

Study Type

INTERVENTIONAL

Conditions

Adrenal Insufficiency Giant Cell Arteritis Polymyalgia Rheumatica

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

Min Age: 50 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Hydrocortisone and a drug called Placebo for hydrocortisone for people with adrenal insufficiency, giant cell arteritis, and other related conditions. The study is currently recruiting participants at 3 locations. People eligible for this study include aged 50 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGHydrocortisone

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.

DRUGPlacebo for hydrocortisone