Study on Hydrocortisone for Stress in Patients with Polymyalgia Rheumatica or Giant Cell Arteritis and Adrenal Insufficiency

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What is this study about?

This clinical trial is focused on patients with polymyalgia rheumatica and giant cell arteritis, who are experiencing a condition known as glucocorticoid-induced adrenal insufficiency. This condition can occur in individuals who are taking a medication called prednisolone, which is a type of steroid used to reduce inflammation. The study aims to explore the effects of an additional treatment with hydrocortisone, a medication that helps the body manage stress, compared to a placebo. The main goal is to see how this treatment affects the quality of life, particularly focusing on feelings of tiredness, during times of physical or mental stress.

Participants in the study will receive either hydrocortisone or a placebo in the form of tablets. The study will monitor how these treatments impact their daily life, especially during stressful situations. The trial will also look at other aspects of health, such as the duration of prednisolone treatment and any changes in symptoms related to adrenal insufficiency. The study will use various questionnaires and assessments to gather information on the participants’ experiences and health status.

The trial is designed to be double-blinded, meaning neither the participants nor the researchers will know who is receiving the hydrocortisone or the placebo, to ensure unbiased results. The study will continue for a set period, during which participants will be asked to report their symptoms and any stress they experience. This information will help researchers understand the potential benefits of hydrocortisone in managing symptoms related to adrenal insufficiency in patients with polymyalgia rheumatica and giant cell arteritis.

1 joining the study

Upon joining the study, eligibility is confirmed based on criteria such as age, diagnosis, and current treatment with prednisolone.

Participants must be 50 years or older, women must be postmenopausal, and have a diagnosis of polymyalgia rheumatica or giant cell arteritis.

2 medication administration

Participants receive either hydrocortisone or a placebo in the form of 10 mg tablets for oral use.

The medication is administered during periods of mild to moderate physical or mental stress.

3 monitoring and assessments

Participants use a smartphone application to report stress and complete the Multidimensional Fatigue Inventory (MFI-20) General Fatigue questions five times daily for three days during stress.

A paper version of the assessment is available for those unable to use a smartphone.

4 monthly evaluations

Monthly assessments include the MFI-20 General Fatigue scale and the SF-36v2 questionnaire.

Participants report daily symptoms of adrenal insufficiency and stress using a smartphone app.

5 safety and health evaluations

Safety outcomes are monitored, including the incidence of adrenal crises and hospitalizations.

Body composition, bone quality, and metabolic and cardiovascular risks are assessed through various tests and questionnaires.

6 completion of the study

The study is estimated to conclude by December 31, 2026.

Participants’ health-related quality of life and treatment characteristics are evaluated throughout the study duration.

Who Can Join the Study?

  • Must be 50 years old or older.
  • Women must be postmenopausal, which means they have stopped having menstrual periods.
  • Must have a diagnosis of polymyalgia rheumatica (PMR), giant cell arteritis (GCA), or both. These are conditions that cause inflammation and pain.
  • Must have been treated with prednisolone for at least 12 weeks. Prednisolone is a type of medication used to reduce inflammation.
  • Must currently be taking prednisolone every day, with a dose greater than 0 mg and up to 5 mg. The dose should have been 5 mg or less for at least 2 weeks before the screening visit.

Who Cannot Join the Study?

  • Patients who do not have glucocorticoid-induced adrenal insufficiency. This is a condition where the body does not produce enough of a hormone called cortisol because of the use of certain medications.
  • Patients who are not currently being treated with low-dose prednisolone. Prednisolone is a type of medication used to reduce inflammation in the body.
  • Patients who are not diagnosed with polymyalgia rheumatica (PMR) or giant cell arteritis (GCA). PMR is a condition that causes muscle pain and stiffness, while GCA is a condition that causes inflammation of blood vessels.
  • Patients who are not within the specified age range for the study.
  • Patients who are part of a vulnerable population, meaning they might need special protection or care.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name City Country Status
Odense University Hospital Odense Denmark
Rigshospitalet Copenhagen Denmark
Amamey Ucmxisplwq Hzkcnbyg Aarhus Denmark

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Denmark Denmark
Not recruiting
01.06.2022

Trial locations

Investigated drugs:

Hydrocortisone is a medication used in this trial to see if it can help improve the quality of life for patients experiencing stress. It is being tested to see if it can reduce fatigue and help manage symptoms in patients with adrenal insufficiency caused by long-term use of another medication, prednisolone.

Prednisolone is a medication that patients in this trial are already taking for conditions like polymyalgia rheumatica and giant cell arteritis. It is a type of steroid used to reduce inflammation and suppress the immune system. The trial is investigating the effects of adding hydrocortisone to their treatment during times of stress.

Investigated diseases:

Glucocorticoid-Induced Adrenal Insufficiency – This condition occurs when the adrenal glands do not produce enough hormones due to the prolonged use of glucocorticoid medications. These medications can suppress the normal function of the adrenal glands, leading to a deficiency in cortisol production. Symptoms may include fatigue, muscle weakness, and weight loss. The condition can develop gradually and may become apparent during periods of stress when the body requires more cortisol. It is important to monitor for signs of adrenal insufficiency in patients who are on long-term glucocorticoid therapy.

Trial ID:
2024-518272-30-00
NCT ID:
NCT05435781
Trial Phase:
Therapeutic confirmatory (Phase III)

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