Hydrocortisone and Placebo in Patients With Symptoms of Adrenal Insufficiency After Cessation of Glucocorticoid Treatment

Launched by MARIANNE ANDERSEN · Jan 2, 2022

Keywords

ClinConnect Summary

This clinical trial is studying the effects of hydrocortisone, a type of hormone, in patients who have recently stopped taking glucocorticoids (steroids) like prednisolone. These steroids are often prescribed for conditions such as polymyalgia rheumatica (PMR) and giant cell arteritis (GCA). The researchers want to see if giving hydrocortisone can help patients who are experiencing symptoms of adrenal insufficiency, which can happen after stopping steroid treatment. Adrenal insufficiency means the body isn't producing enough cortisol, a hormone that is important for managing stress and energy levels. The trial aims to provide better guidance for patients who may suffer from symptoms like fatigue after stopping steroids.

To participate in this trial, individuals must be at least 50 years old and have been diagnosed with PMR or GCA, having been off glucocorticoids for more than 2 weeks but less than 12 weeks after at least 12 weeks of treatment. Certain health conditions, like severe heart or kidney issues, active cancer, or a history of serious mental health problems, may exclude potential participants. Those who join the study can expect to be randomly assigned to receive either hydrocortisone or a placebo (a non-active treatment) and will be monitored for their symptoms. This study is important because it aims to fill a gap in understanding how to support patients after they stop taking glucocorticoids, helping thousands of individuals who may struggle with these symptoms.

Gender

ALL

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