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Study on Hydrocortisone and Placebo for Patients with Giant Cell Arteritis or Polymyalgia Rheumatica Experiencing Adrenal Insufficiency Symptoms

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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 studying the effects of a medication called hydrocortisone in patients who have been diagnosed with Giant Cell Arteritis (GCA) or Polymyalgia Rheumatica (PMR). These are conditions that cause inflammation in the body, leading to symptoms like pain and stiffness. The study is particularly interested in patients who have stopped taking a type of medication called glucocorticoids, which are often used to treat these conditions. After stopping glucocorticoids, some patients may experience symptoms of adrenal insufficiency, a condition where the body does not produce enough of certain hormones.

The purpose of this study is to compare the effects of hydrocortisone with a placebo in managing these symptoms. Hydrocortisone is a medication that can help replace the hormones that the adrenal glands are not producing enough of. The study will last for 16 weeks, during which participants will receive either hydrocortisone or a placebo. The study is designed to be double-blinded, meaning neither the participants nor the researchers will know who is receiving the actual medication or the placebo, to ensure unbiased results.

Throughout the study, participants will be monitored for symptoms of adrenal insufficiency, as well as other health indicators such as fatigue, blood pressure, and muscle strength. The goal is to provide evidence-based guidance for managing adrenal insufficiency in patients who have stopped glucocorticoid treatment, addressing an important need for many patients with GCA or PMR. This study aims to improve the quality of life for these patients by finding effective ways to manage their symptoms after glucocorticoid treatment has ended.

The research process

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

Step 1
Joining the study
Upon joining the study, participation is confirmed based on age (50 years or older) and a diagnosis of polymyalgia rheumatica or giant cell arteritis. The condition must be in remission without glucocorticoids for more than 2 weeks but less than 12 weeks after treatment with prednisolone for at least 12 weeks.
Step 2
Randomization
Participants are randomly assigned to receive either hydrocortisone or a placebo. This process is double-blinded, meaning neither the participant nor the researchers know which treatment is being administered.
Step 3
Medication administration
The medication is taken orally in the form of tablets. The specific dosage and frequency are determined by the study protocol and are administered consistently throughout the trial period.
Step 4
16-week treatment period
The study lasts for 16 weeks. During this time, participants continue taking their assigned medication and attend regular check-ups to monitor their health and any symptoms of adrenal insufficiency.
Step 5
Symptom monitoring
Participants report symptoms of adrenal insufficiency using the AddiQoL-30 questionnaire. Other symptoms such as fatigue, blood pressure, muscle strength, and bone status are also monitored.
Step 6
End of study assessments
At the end of the 16-week period, a comprehensive assessment is conducted. This includes evaluating metabolic and cardiovascular risk, body composition, and biological cortisol status.

Who can join the trial?

6 criteria

Must be **50 years old** or older.
Must have been diagnosed with **polymyalgia rheumatica** or **giant cell arteritis**. These are conditions that cause inflammation and pain in certain parts of the body.
Must be in a state called **glucocorticoid-free remission** for more than 2 weeks but less than 12 weeks. This means you have stopped taking a type of medication called glucocorticoids, like prednisolone, and your symptoms are not active.
Must have been treated with **prednisolone** for at least 12 weeks. Prednisolone is a medication used to reduce inflammation.
Both **men and women** can participate.
Participants should not belong to a **vulnerable population**. This means they should not be in a group that might need special protection or care.

Who cannot join the trial?

1 criterion

Patients with **tertiary adrenal insufficiency** cannot participate. This is a condition where the adrenal glands do not produce enough hormones due to a problem with the pituitary gland or hypothalamus in the brain.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

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Aarhus University Hospital
Aarhus, Denmark
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Odense University Hospital
Odense, Denmark
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Rigshospitalet
Copenhagen, Denmark

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Investigated drugs

Hydrocortisone is a medication used in this trial to help manage symptoms in patients with Giant Cell Arteritis (GCA) and Polymyalgia Rheumatica (PMR). It is a type of steroid that can help reduce inflammation and relieve symptoms associated with these conditions. The trial aims to assess the effects of hydrocortisone in patients who have reported symptoms of adrenal insufficiency after stopping glucocorticoid treatment.

What is already known about the treatment

Hydrocortisone – Hydrocortisone is typically administered orally or intravenously, depending on the specific medical condition being treated. It is currently being studied in clinical trials for its effects on patients with conditions like Giant Cell Arteritis and Polymyalgia Rheumatica, particularly after stopping glucocorticoid treatment. The main therapeutic indication for hydrocortisone in this context is to manage symptoms of adrenal insufficiency. At the molecular level, hydrocortisone works by mimicking the action of cortisol, a natural hormone, helping to regulate inflammation and immune responses. It is classified pharmacologically as a glucocorticoid, which is a type of corticosteroid hormone.

Investigated diseases

Tertiary adrenal insufficiency – This condition occurs when the adrenal glands do not produce enough hormones due to a lack of stimulation from the pituitary gland, which itself is not receiving adequate signals from the hypothalamus. It often develops after long-term use of glucocorticoid medications, which suppress the hypothalamic-pituitary-adrenal (HPA) axis. As a result, the body struggles to produce cortisol, a hormone crucial for stress response, metabolism, and immune function. Symptoms may include fatigue, muscle weakness, weight loss, and low blood pressure. The condition can lead to an increased risk of adrenal crises, which are acute episodes of severe symptoms. Management typically involves careful monitoring and gradual reduction of glucocorticoid use to allow the HPA axis to recover.