Actively Recruiting
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.
Led by Marianne Christina Klose · Updated on 2026-03-16
250
Participants Needed
3
Research Sites
87 weeks
Total Duration
On this page
Sponsors
M
Marianne Christina Klose
Lead Sponsor
A
Aarhus University Hospital
Collaborating Sponsor
AI-Summary
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 mg/day and up to 5 mg/day) will have a Synacthen test to assess adrenal function. Those with adrenal insufficiency (cortisol response below 420 nmol/l) 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.
CONDITIONS
Brief Title
Effect of Supplemental Hydrocortisone During Stress in Prednisolone-induced Adrenal Insufficiency
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 50 years or older
- Women must be postmenopausal (FSH measured at screening)
- Diagnosis of polymyalgia rheumatica, giant cell arteritis, or both
- Treatment with prednisolone for at least 12 weeks
- Ongoing daily prednisolone dose greater than 0 mg and up to 5 mg, maintained for at least 2 weeks before screening
You will not qualify if you...
- Known primary or secondary adrenal insufficiency
- Known Cushing's Syndrome
- Allergy to any study medication ingredients
- Severe heart failure (NYHA class IV)
- Kidney failure with estimated glomerular filtration rate below 30 mL/min (chronic kidney disease stage 4-5)
- Liver cirrhosis
- Active cancer
- Known severe immune deficiency
- Psychiatric disease requiring treatment by a psychiatric department within the last year (for affective disorders)
- Alcohol consumption over 21 units per week
- Planned major surgery during the study period
- Use of drugs interfering with cortisol metabolism or measurements, including recent systemic estrogen treatment, strong CYP3A4 inhibitors or inducers, and certain glucocorticoid formulations
- Inability to provide written informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - Up to 6 months or until prednisolone treatment stops, with possible extension if prednisolone dose increases due to disease flare
Participants receive supplemental hydrocortisone or placebo in situations of stress while continuing their prednisolone treatment according to current clinical guidelines for polymyalgia rheumatica or giant cell arteritis.
Daily end-of-day assessments throughout the study period; monthly ecological momentary assessments for 3 days each month
Duration - Up to 6 months
Participants are followed up through medical records to monitor prednisolone treatment characteristics and hospitalizations after the treatment period.
No additional visits; follow-up via medical records
Trial Site Locations
Total: 3 locations
1
Department of Endocrinology, Aarhus University Hospital
Aarhus, Denmark
Actively Recruiting
2
Department of Medical Endocrinology, Copenhagen University Hospital, Rigshospitalet
Copenhagen, Denmark, 2100
Actively Recruiting
3
Department of Endocrinology, Odense University Hospital
Odense, Denmark
Actively Recruiting
Research Team
M
Marianne Klose, MD, PhD
S
Stina W. Borresen, MD, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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