REPLACE - 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 research trial, called REPLACE, is investigating a common issue for people in the UK who have Giant Cell Arteritis (GCA) or Polymyalgia Rheumatica (PMR). If you've had these conditions, you might have been treated with steroid medications such as prednisolone. When you stop taking these steroids, some people can experience symptoms of 'adrenal insufficiency,' which means your body isn't making enough natural steroids. This study aims to see if taking a low dose of hydrocortisone (a type of steroid) can help ease these symptoms. Participants will be given either hydrocortisone tablets or a dummy tablet (placebo) for 16 weeks. The main goal is to find out if hydrocortisone improves how patients feel, based on their own reports about their symptoms. It's a 'Phase IV' study, meaning the treatment being tested is already approved for other uses.
At a glance
What is this study about?
This study, called REPLACE, is looking into an important health concern for people who have conditions like Giant Cell Arteritis (GCA) or Polymyalgia Rheumatica (PMR). These conditions are often treated with steroid medications like prednisolone. While these steroids are very effective, when patients stop taking them, some can experience something called 'adrenal insufficiency'. This happens because the body has gotten used to the steroid medication doing the work, and it can take time for your own body to start producing enough of its natural steroids again. This can lead to symptoms like tiredness, weakness, and feeling generally unwell.
The REPLACE study wants to see if a specific type of steroid tablet, called hydrocortisone, can help people feel better if they have these symptoms after stopping their main steroid treatment for GCA or PMR. Hydrocortisone is a medication that's already approved and used for other health issues. In this study, some people will receive the hydrocortisone tablets, and others will receive a 'placebo' – which looks exactly like the hydrocortisone tablet but contains no active medicine. This helps researchers understand if the hydrocortisone is truly making a difference.
The trial will last for 16 weeks, and throughout this time, the research team will carefully track how participants are feeling. They will primarily use questionnaires to understand changes in symptoms related to adrenal insufficiency, but they will also look at other factors like tiredness, overall quality of life, blood pressure, and bone health. This research is important because it could help doctors find better ways to support patients who are recovering after stopping long-term steroid therapy.
Key takeaways
- Tests hydroonedicine for symptoms after stopping steroid treatment for GCA/PMR.
- Compares hydrocortisone to a dummy pill (placebo) over 16 weeks.
- Aims to improve symptoms like tiredness and overall well-being.
- Participation involves regular clinic visits and filling out questionnaires.
- You will be closely monitored by a medical team throughout the trial.
Who may be eligible?
To join this study, participants must be at least 18 years old – there's no upper age limit. The study is open to both men and women.
The most important criteria are that you have Giant Cell Arteritis (GCA) or Polymyalgia Rheumatica (PMR) and have recently stopped your main steroid treatment for these conditions. You should also be experiencing symptoms that suggest your body isn't producing enough of its natural steroids, which doctors call 'adrenal insufficiency'.
Your doctor will check your medical history and current health to make sure that taking part in the study would be safe and appropriate for you.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you 18 years old or older?
- Do you have Giant Cell Arteritis (GCA) or Polymyalgia Rheumatica (PMR)?
- Have you recently stopped steroid treatment for GCA or PMR?
- Are you experiencing symptoms suggestive of 'adrenal insufficiency' (e.g., unusual tiredness, weakness)?
- Are you able to attend regular clinic appointments?
What does participation involve?
If you decide to take part, you'll be involved in the study for 16 weeks. During this time, you'll be asked to take either the hydrocortisone tablet or a dummy tablet every day. Neither you nor your study doctor will know which one you are receiving – this is called 'double-blinded' and helps ensure the results are fair.
You'll have regular visits to the clinic so the medical team can monitor your health and how you're feeling. These visits will involve answering questionnaires about your symptoms, especially how you feel regarding your adrenal insufficiency and overall quality of life. They might also check your blood pressure, measure your muscle strength, and sometimes take blood samples to assess your body's steroid levels and general health. The research team will explain all procedures in detail before you agree to participate.
Potential risks and benefits
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Common questions
What are Giant Cell Arteritis (GCA) and Polymyalgia Rheumatica (PMR)?
These are inflammatory conditions that can cause pain, stiffness, and other symptoms. They are often treated with steroid medications.
What is 'adrenal insufficiency symptoms'?
It means your body isn't making enough natural steroids, often after you've stopped taking steroid medications. This can cause tiredness, weakness, and feeling unwell.
What is hydrocortisone?
It's a type of steroid medication, similar to the natural steroids your body makes. It's used to replace these natural steroids when your body isn't making enough.
What is a 'placebo'?
A placebo is a dummy pill that looks exactly like the real medication but contains no active drug. It helps researchers fairly compare the active treatment.
How long will the study last for each person?
If you join, you'll be in the study for about 16 weeks.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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