Hydrocortisone vs. placebo for adrenal insufficiency symptoms after stopping glucocorticoids

A Multi-centre, Randomised, Double-blinded, Placebo Controlled 16-weeks Study to Compare the Effect of Hydrocortisone and Placebo in Patients With Giant Cell Arteritis (GCA)/ Polymyalgia Rheumatica (PMR) With Patient-reported Symptoms of Adrenal Insufficiency After Cessation of Glucocorticoid Treatment.

This study is testing if hydrocortisone can help people over 50 feel better after stopping glucocorticoids and dealing with adrenal insufficiency symptoms.

Quick facts

• Phase: PHASE4
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 50 Years and up
• Sex: All
• Sponsor: Odense University Hospital (other)
• Locations: 3 sites (Aarhus and 2 other locations)
• Trial ID: NCT05193396 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effects of hydrocortisone compared to a placebo in patients experiencing symptoms of adrenal insufficiency after discontinuing glucocorticoid treatment. The study focuses on individuals aged 50 and older who have been in remission from polymyalgia rheumatica or giant cell arteritis for a specified period after glucocorticoid therapy. The aim is to assess the incidence of glucocorticoid-induced adrenal insufficiency and determine the efficacy of hydrocortisone in alleviating symptoms. Participants will be monitored for their response to treatment over the course of the trial.

Who should consider this trial

Good fit: Ideal candidates are individuals aged 50 and older with a diagnosis of polymyalgia rheumatica or giant cell arteritis who are in glucocorticoid-free remission.

Not a fit: Patients with known primary or secondary adrenal insufficiency or other significant health issues may not benefit from this study.

Why it matters

Potential benefit: If successful, this trial could provide a new treatment option for patients suffering from adrenal insufficiency symptoms after glucocorticoid cessation.

How similar studies have performed: Other studies have explored glucocorticoid-induced adrenal insufficiency, but this specific approach to treatment with hydrocortisone is relatively novel.

Eligibility criteria

Inclusion Criteria:

* Age ≥ 50 years
* A diagnosis of PMR or GCA in GC free remission for \>2 week and \<12 weeks after treatment with prednisolone (any dosage) for ≥12 weeks

Exclusion Criteria:

* Known primary or secondary adrenal insufficiency
* Known Cushing´s syndrome
* Heart failure (New York Heart Association class IV)
* Kidney failure with an estimated glomerular filtration rate \<30 mL/min
* Liver 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 within 1 month before study inclusion
* Strong CYP3A4 inhibitors or inducers
* Use of other glucocorticoid formulations: inhaled, intra-articular or intramuscular injections, creams European steroid group IV applied in genital area
* Permitted glucocorticoid formulations: eye-drops, nasal spray, creams European group I-III, and European group IV applied in non-genital area
* Inability to provide written informed consent

Where this trial is running

Aarhus and 2 other locations

• Department of Endocrinology and Internal Medicine, Aarhus University Hospital — Aarhus, Denmark (RECRUITING)
• Department of Nephrology and Endocrinology, Rigshospitalet — Copenhagen, Denmark (RECRUITING)
• Department of Endocrinology, Odense University Hospital — Odense, Denmark (RECRUITING)

Study contacts

• Principal investigator: Marianne S Andersen — Odense University Hospital
• Study coordinator: Marianne S Andersen

Conditions: Adrenal Insufficiency, Polymyalgia Rheumatica, Giant Cell Arteritis, tertiary adrenal insufficiency