Study on Supplemental Hydrocortisone During Stress for Patients Aged 50 and Older With Polymyalgia Rheumatica or Giant Cell Arteritis Taking Low-Dose Prednisolone

What this Trial Is About

Researchers are evaluating 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 or giant cell arteritis GCA who are on ongoing low-dose prednisolone and have glucocorticoid-induced adrenal insufficiency. The main focus is on reducing fatigue and understanding the daily variation of fatigue during stress. This is a phase 4, multicenter, randomized, double-blinded, placebo-controlled clinical trial. Participants with PMR or GCA on low-dose prednisolone greater than 0 mgday and up to 5 mgday will have a Synacthen test to assess adrenal function. Those with adrenal insufficiency cortisol response below 420 nmoll will be randomized to receive either supplemental hydrocortisone or placebo during stress, while continuing prednisolone treatment and tapering according to clinical guidelines. Severe stress situations requiring urgent care will be treated openly with hydrocortisone. The study duration is 6 months, but may end earlier if prednisolone treatment stops sooner or be extended if prednisolone dosage increases due to disease flare. During the study, participants will undergo screening, baseline assessments, and report health-related quality of life for 3 months using ecological momentary assessments and patient-reported outcomes via an app. Follow-up includes medical record review on prednisolone treatment and hospitalizations. Multiple secondary assessments include body composition, muscle strength tests, bone quality scans, metabolic and cardiovascular risk markers, and integrated cortisol status measured at baseline, 3 months, and 6 months. The primary outcome is fatigue measured multiple times daily in stress situations.

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