Supplemental hydrocortisone for adrenal insufficiency during stress
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.
This study is testing if adding hydrocortisone can help people with polymyalgia rheumatica or giant cell arteritis who have low adrenal function feel better during stressful times compared to a placebo.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 250 (estimated) |
| Ages | 50 Years and up |
| Sex | All |
| Sponsor | Rigshospitalet, Denmark Academic / other |
| Locations | 3 sites (Aarhus and 2 other locations) |
| Trial ID | NCT05435781 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of supplemental hydrocortisone compared to a placebo in patients with polymyalgia rheumatica (PMR) or giant cell arteritis (GCA) who are experiencing glucocorticoid-induced adrenal insufficiency while on low-dose prednisolone. The study is double-blinded and randomized, focusing on health-related quality of life, particularly fatigue, during periods of mild to moderate stress. Participants will be monitored for their cortisol levels and will receive either hydrocortisone or placebo during stressful situations over a duration of six months. The trial also includes a reference group of patients with normal adrenal function for comparison.
Who should consider this trial
Good fit: Ideal candidates are postmenopausal women and men aged 50 and older with PMR or GCA on low-dose prednisolone treatment.
Not a fit: Patients with known primary or secondary adrenal insufficiency or severe comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the management of adrenal insufficiency in patients undergoing treatment for PMR and GCA, enhancing their quality of life during stress.
How similar studies have performed: Other studies have shown promising results with similar approaches in managing adrenal insufficiency, suggesting potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥ 50 years * Women must be postmenopausal (FSH is measured at the screening visit) * A diagnosis of PMR/GCA, or both conditions combined. * Treatment with prednisolone ≥12 weeks * Ongoing prednisolone treatment, with current daily prednisolone dose \> 0 mg and ≤5 mg. The dose must have been ≤5 mg for minimum 2 weeks at the time of the screening visit. Exclusion Criteria: * Known primary or secondary adrenal insufficiency * Known Cushing's Syndrome * Known allergy towards study medication ingredients * Severe comorbidity: Heart failure (New York Heart Association class IV); Kidney failure with an estimated glomerular filtration rate \<30 mL/min (Chronic kidney disease stage 4-5); Liver disease in the form of cirrhosis; Active cancer; Known severe immune deficiency; A history of psychiatric disease requiring treatment by a psychiatric department (for affective disorders only if within the last year before study entry) * Alcohol consumption \>21 units per week * Planned major surgery during the study period at study entry. * Use of drugs that interfere with cortisol metabolism/measurements: Systemic oestrogen treatment (discontinued \< 1 month before inclusion), Treatment with strong CYP3A4 inhibitors or inducers, Use of other glucocorticoid formulations (Inhaled corticosteroids, intraarticular or intramuscular injections, steroid creams European steroid group IV-V used in the genital area. Note: Permitted glucocorticoid formulations: Eye-drops, nasal spray, glucocorticoid creams European steroid group I-III, and European steroid group IV-V used in the non-genital area only.) * Inability to provide written informed consent.
Where this trial is running
Aarhus and 2 other locations
- Department of Endocrinology, Aarhus University Hospital — Aarhus, Denmark (Recruiting)
- Department of Medical Endocrinology, Copenhagen University Hospital, Rigshospitalet — Copenhagen, Denmark (Recruiting)
- Department of Endocrinology, Odense University Hospital — Odense, Denmark (Recruiting)
Study contacts
- Principal investigator: Ulla Feldt-Rasmussen, Professor — Rigshospitalet, Denmark
- Study coordinator: Marianne Klose, MD, PhD
- Email: marianne.christina.klose.01@regionh.dk
- Phone: +4530237532
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.