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.

Glucocorticoid induced adrenal insufficiency

Ecological momentary assessments (EMA) of the Multidimensional Fatigue Inventory (MFI-20), the General Fatigue scale, in situations of stress (Stress EMA). Details: EMA reporting will be done using a study smartphone applica-tion. When patients report stress, the app prompts participants to answer the four momentary MFI-20 General Fatigue questions five time daily at semi ran-domized timepoints for three days. A paper version is available for patients who cannot use a smartphone.

Key secondary outcome: EMA version of the MFI-20 General Fatigue scale at baseline (baseline EMA) and at fixed timepoints monthly (unstressed EMA), Key secondary outcome: SF-36v2 questionnaire, Key secondary outcome: Daily ‘end-of-day’ smartphone app facilitated patient reported symptoms of adrenal insufficiency and intercurrent illness and stress. The questions about symptoms originate from the Danish version of the PRO-CTCAE questionnaire., Key secondary outcome: AddiQol-30 questionnaire, Key secondary outcome: PMR/GCA treatment characteristics: Duration of prednisolone tapering from 5 mg to complete withdrawal; Accumulated dose of glucocorticoid treatment; Duration of prednisolone treatment for PMR/GCA., Key secondary outcome: Number of ‘sick days’, Key secondary outcome: ACTH test results depending on the length of the prednisolon pause: ACTH test results (basal and stimulated plasma cortisol) after 0, 1, or 2 days prednisolone pause; Prednisolone cross reactivity in Roche Elecsys cortisol II immunoassay in plasma 2 hours, 4 hours, 1 day and 2 days after last prednisolone intake; ACTH concentrations (central HPA axis recovery)., Safety outcomes: Adrenal insufficiency: Incidence rate and grade of adrenal crises; Number of hospitalisations, Safety outcome: Exogenous Cushing’s Syndrome - Body composition and muscle strength: Dual-energy X-ray absorptiometry (DXA) scan (fat percentage, body composition, bone mineral density); Waist- and hip circumference, weight, height, body mass index (BMI); Timed up and go; Handgrip strength; Short Physical Performance Battery and chair rising test., Safety outcome: Exogenous Cushing’s Syndrome - Bone quality: Bone markers in blood and urine, Safety outcome: Exogenous Cushing’s Syndrome - Metabolic and cardiovascular risk: Automated office blood pressure; Coagulation and Inflammation markers in blood; Metabolic and cardiovascular markers in blood and urine., Safety outcome: Exogenous Cushing’s Syndrome - Patient reported symptoms: CushingQol questionnaire; Single item Sleep Quality Scale (SQS) questionnaire, Exploratory outcome: PMR/GCA treatment characteristics: Number of PMR/GCA disease flare up/relapse, and disease activity of the PMR/GCA., Exploratory outcome: Biological integrated cortisol status assessment: ACTH test for normalization of adrenal function; 24h urine; Salivary cortisol and cortisone during ACTH tests (determined by Roche immunoassay and LC-MS); Cortisol binding globulin (CBG) in plasma to calculate Free Cortisol Index (total P-cortisol concentration (nmol/l)/serum CBG (in mg/L). Circulating biomarkers of glucocorticoid effects and adverse effects (incl. glucocorticoid receptor gene polymorphisms).

Denmark