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

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.

Timeline

Start

2022-06-07

Primary completion

2026-06-30

Completion

2028-03-01

Publications

• Borresen SW, Hansen SB, Al-Jorani H, Tei R, Dreyer AF, Boesen VB, Bislev LS, Jorgensen NT, Jensen RC, Bjergstrom MLL, Christensen LL, Frederiksen JSS, Glintborg D, Bjorner JB, Feldt-Rasmussen U, Jorgensen JOL, Andersen MS, Klose M. Effect of supplemental hydrocortisone during stress in prednisolone-induced adrenal insufficiency: a study protocol for a multicentre, randomised, double-blinded, placebo-controlled clinical trial on health-related quality of life in patients with polymyalgia rheumatica/giant cell arteritis on low-dose prednisolone treatment (the RESCUE study). BMJ Open. 2026 Jun 11;16(6):e113110. doi: 10.1136/bmjopen-2025-113110.

Drugs

Indications