NCT05435781 Effect of Supplemental Hydrocortisone During Stress in Prednisolone-induced Adrenal Insufficiency
| NCT ID | NCT05435781 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Marianne Christina Klose |
| Condition | Adrenal Insufficiency |
| Study Type | INTERVENTIONAL |
| Enrollment | 250 participants |
| Start Date | 2022-06-07 |
| Primary Completion | 2026-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 250 participants in total. It began in 2022-06-07 with a primary completion date of 2026-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility 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.
Contact & Investigator
Ulla Feldt-Rasmussen, Professor
PRINCIPAL INVESTIGATOR
Rigshospitalet, Denmark
Frequently Asked Questions
Who can join the NCT05435781 clinical trial?
This trial is open to participants of all sexes, aged 50 Years or older, studying Adrenal Insufficiency. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05435781 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT05435781 currently recruiting?
Yes, NCT05435781 is actively recruiting participants. Contact the research team at marianne.christina.klose.01@regionh.dk for enrollment information.
Where is the NCT05435781 trial being conducted?
This trial is being conducted at Aarhus, Denmark, Copenhagen, Denmark, Odense, Denmark.
Who is sponsoring the NCT05435781 clinical trial?
NCT05435781 is sponsored by Marianne Christina Klose. The principal investigator is Ulla Feldt-Rasmussen, Professor at Rigshospitalet, Denmark. The trial plans to enroll 250 participants.