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

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What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 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. Step 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. Step 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. Step 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. Step 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. Step 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 trial?

5 criteria

  • 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 trial?

5 criteria

  • 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.
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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.

What is already known about the treatment

Hydrocortisone – Hydrocortisone is administered orally or intravenously, depending on the specific needs of the patient. It is currently being studied in clinical trials for its effects on health-related quality of life in patients with glucocorticoid-induced adrenal insufficiency, particularly those with polymyalgia rheumatica or giant cell arteritis. The main therapeutic indication is to manage adrenal insufficiency caused by long-term glucocorticoid use. At the molecular level, hydrocortisone works by mimicking the action of cortisol, a natural hormone, helping to regulate metabolism and immune response. It is classified as a glucocorticoid, a type of steroid hormone.

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 detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-518272-30-00Estimated enrolment345 patientsSponsorRegion Hovedstaden

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