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RecruitingOBSERVATIONAL

Clinical and Immunogenetic Characterization of Giant Cell Arteritis (GCA) and Polymyalgia Rheumatica (PMR)

This research is focused on two conditions: Giant Cell Arteritis (GCA) and Polymyalgia Rheumatica (PMR). The main goal is to identify genetic factors that might make someone more likely to develop GCA or PMR. By understanding these genetic links, scientists hope to gain new insights into what causes these diseases. This is an observational study, meaning researchers will collect information from people already diagnosed with GCA or PMR, or those suspected of having GCA, rather than testing new treatments. The study also looks at how these conditions and their treatments affect patients' quality of life. Participants must be 50 years or older and have a confirmed diagnosis or strong suspicion of GCA or PMR.

At a glance

Status
Recruiting
Sponsor
University of Leeds
Enrolment target
4,500
Start
10 Jun 2005
Estimated completion
31 Mar 2028

What is this study about?

Giant Cell Arteritis (GCA) and Polymyalgia Rheumatica (PMR) are conditions that cause inflammation in the body. GCA mainly affects people over 50 and involves inflammation of blood vessels, particularly in the head. If not treated quickly, GCA can lead to serious problems like vision loss or stroke. PMR causes widespread muscle pain and stiffness, especially in the mornings.

This study, run by the UK GCA Consortium, is an 'observational' study. This means researchers will collect information from people who already have GCA or PMR, or are suspected of having GCA, to learn more about their conditions. They won't be testing new medications. The main focus is to look for genetic factors that might make someone more susceptible to developing GCA and PMR. By identifying these genetic links, the researchers hope to understand the underlying causes of these diseases better, which could eventually lead to improved ways to diagnose and treat them.

Beyond genetics, the study also aims to understand how different types of GCA and PMR present, using clinical information, imaging, and lab tests. Another important aspect is to assess how these conditions and their treatments impact patients' daily lives and overall quality of life, using information provided directly by patients.

Key takeaways

  • This study aims to understand the causes of Giant Cell Arteritis (GCA) and Polymyalgia Rheumatica (PMR).
  • It focuses on finding genetic links that might make someone more likely to get these conditions.
  • This is an observational study, meaning no new treatments will be given.
  • Researchers will collect information from patient records and some samples.
  • The study also looks at how GCA and PMR affect patients' quality of life.
  • Participants must generally be 50 or over with a diagnosis or strong suspicion of GCA or PMR.

Who may be eligible?

To be considered for this study, you generally need to be 50 years of age or older. You must also have a clear diagnosis of Giant Cell Arteritis (GCA) or Polymyalgia Rheumatica (PMR). If you are joining the study when you are first suspected of having GCA, your doctor must believe GCA is the most likely reason for your symptoms.

It's important that you are willing and able to give your informed consent, which means you understand what the study involves and agree to take part voluntarily. You also need to be willing to share information about your ethnic background.

If you are under 50, you might still be considered for the study but only if your GCA has been confirmed by a biopsy and it's a very clear-cut case. The main reason someone would not be able to participate is if they are unable or unwilling to give their full informed consent.

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.

  1. Are you 50 years old or over?
  2. Do you have a diagnosis of Giant Cell Arteritis (GCA) or Polymyalgia Rheumatica (PMR)?
  3. Are you able to understand the study and willing to give your permission to take part?
  4. Are you willing to share your ethnic group information?
  5. If you're suspected of having GCA, is it the most likely explanation for your symptoms?
Answer every question to see your result.

What does participation involve?

This is an observational study, so you won't be given any new treatments. Instead, researchers will collect information from your existing medical records and potentially some new samples like blood. They will also ask you to provide information about your symptoms and how the condition affects your daily life.

The study involves categorising your GCA or PMR based on clinical features, imaging results, and lab tests. In some cases, genetic analysis (like looking at your DNA) might be performed. The researchers will also use patient-reported questionnaires to understand the impact of the disease and its treatments on your quality of life. The exact number of visits or duration of your participation isn't specified, but it will involve researchers collecting data at various points related to your condition.

Potential risks and benefits

Potential benefits of taking part include contributing to a better understanding of Giant Cell Arteritis and Polymyalgia Rheumatica. This research may lead to new insights into the causes of these conditions and, in the long term, could help develop improved treatments for future patients. As this is an observational study, there are generally very few direct risks beyond those associated with routine medical assessments or providing blood samples, which are common for these conditions. You always have the right to withdraw from the study at any time without giving a reason, and this will not affect the medical care you receive.

Locations (76)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Queen Elizabeth The Queen Mother Hospital
    Verified postcode
    Canterbury, United Kingdom· Recruiting
  • Whiston Hospital
    Verified postcode
    Prescot, United Kingdom· Recruiting
  • Nevill Hall Hospital, Aneurin Bevan University Health Board
    Verified postcode
    Abergavenny, United Kingdom· Recruiting
  • Stoke Mandeville Hospital, Buckinghamshire Healthcare NHS Trust
    Verified postcode
    Aylesbury, United Kingdom· Recruiting
  • Betsi Cadwaladr University Health Board
    Verified postcode
    Bangor, United Kingdom· Recruiting
  • Barnsley Hospital, Barnsley Hospital NHS Foundation Trust
    Verified postcode
    Barnsley, United Kingdom· Completed
  • Basildon University Hospital, Basildon and Thurrock University Hospitals NHS Foundation Trust
    Verified postcode
    Basildon, United Kingdom· Recruiting
  • Basingstoke and North Hampshire Hospital, Hampshire Hospitals NHS Foundation Trust
    Verified postcode
    Basingstoke, United Kingdom· Recruiting
  • Royal National Hospital for Rheumatic Diseases, Royal United Hospitals Bath NHS Foundation Trust
    Verified postcode
    Bath, United Kingdom· Recruiting
  • Birmingham Heartlands Hospital, University Hospitals Birmingham NHS Foundation Trust
    Verified postcode
    Birmingham, United Kingdom· Recruiting
  • Queen Elizabeth Hospital Birmingham, University Hospitals Birmingham NHS Foundation Trust
    Verified postcode
    Birmingham, United Kingdom· Recruiting
  • Bristol Royal Infirmary, University Hospitals Bristol NHS Foundation Trust
    Verified postcode
    Bristol, United Kingdom· Recruiting

Common questions

What is an 'observational study'?

An observational study means researchers watch and collect information about people who already have a condition; they don't test new treatments or medicines.

Why is genetic information important for this study?

By looking at genes, researchers hope to find clues about why some people get GCA or PMR and others don't, which can help understand the diseases better.

Will I receive any new treatment if I join this study?

No, this study is about understanding the conditions, not testing new treatments. Your current medical care will not be affected by taking part.

Does taking part affect my regular medical care?

No, your participation in this study will not change the medical care and treatment you currently receive for your condition.

What if I change my mind about participating?

You are free to withdraw from the study at any time, for any reason, without it affecting your ongoing medical care.

How to find out more

Louise Sorensen

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "Clinical and Immunogenetic Characterization of Giant Cell Ar…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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