Active not recruitingOBSERVATIONAL

Investigating Genes in Patients With Polymyositis and Dermatomyositis

This research is investigating the genes in people who have inflammatory muscle conditions such as polymyositis (PM) and dermatomyositis (DM). These conditions cause muscle weakness and can be very challenging. Current treatments don't always work fully and can have side effects. The study aims to find out if changes in our genes play a part in causing PM and DM, similar to what's been found in other inflammatory diseases like rheumatoid arthritis. By understanding these genetic links, scientists hope to create more effective and targeted treatments in the future. Participants will be asked to give a small blood sample and share some health information.

At a glance

Status

Active not recruiting

Sponsor

Northern Care Alliance NHS Foundation Trust

Enrolment target

1,000

Start

01 Jan 2001

Estimated completion

01 Dec 2030

Myositis

What is this study about?

This research is trying to understand why certain inflammatory muscle conditions like polymyositis (PM) and dermatomyositis (DM) develop. These conditions lead to muscle weakness and can be long-lasting and difficult to live with. The treatments we have now, such as steroids, often don't fully get rid of the symptoms and can have unpleasant side effects, limiting how useful they are.

The researchers believe that by looking closely at people's genes, they might find clues about what causes these conditions. In other similar health problems, like arthritis, specific genetic changes are known to play a role. Because PM and DM share some similarities with these conditions, it's thought that genes might also be important in causing and shaping PM and DM.

To do this, the study will ask patients with PM, DM, or a related condition called inclusion body myositis (IBM) to give a small blood sample. This blood, along with some important information about their condition, will be sent to a special lab at The University of Manchester. There, scientists will carefully examine the genes. The hope is that by finding the genetic causes, they can develop much more specific and effective treatments for these muscle conditions in the future.

Key takeaways

Aims to find genetic causes of muscle conditions like polymyiositis.
Hopes to lead to better, more targeted treatments in the future.
Participation involves giving one blood sample.
No new medications are given as part of the study.
Eligibility includes specific age and diagnosis criteria.
You can withdraw from the study at any time.

Who may be eligible?

To be part of this study, you need to be aged between 18 and 70 years old. You must have a confirmed diagnosis of polymyositis, dermatomyositis, or inclusion body myositis, based on specific medical guidelines.

There are some reasons why you might not be able to join. For example, if your myositis is caused by alcohol, drugs (even prescribed ones like statins), or a recent viral illness. You also need to be able to give your clear agreement to take part and communicate well in English.

If you have a condition that affects your thinking or if you are not willing to provide a blood sample, you would not be able to participate in this particular genetic study.

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 between 18 and 70 years old?
Do you have a diagnosis of polymyositis, dermatomyositis, or inclusion body myositis?
Is your muscle condition NOT caused by alcohol, drugs, or a recent infection?
Are you able to provide your consent to take part and communicate in English?
Are you willing to give a blood sample?

Answer every question to see your result.

What does participation involve?

If you decide to take part, your own specialist doctor (a rheumatologist or neurologist) will ask you to provide a single blood sample, which is a bit like having a normal blood test. This involves taking about four teaspoons (20 ml) of blood from your arm. Your doctor will also fill out a form with some details about your muscle condition, like when it started and how it affects you.

There are no extra hospital visits or follow-up appointments specifically for this study. You will not be given any new medication as part of this research. The blood sample and your health information will be sent to a special research centre for genetic analysis. The study aims to collect blood samples from around 1000 patients across the UK, but your involvement will only require this one blood sample and the sharing of your anonymised clinical details.

Potential risks and benefits

The main benefit of taking part is contributing to research that aims to improve future treatments for muscle conditions like yours. By understanding the genetic causes, scientists hope to develop more targeted medicines that work better and have fewer side effects. The risks associated with giving a blood sample are generally very small, such as slight bruising or discomfort at the injection site. You are completely free to withdraw from the study at any time without giving a reason, and this will not affect your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Salford Royal NHS Foundation Trust
Verified postcode
Manchester, United Kingdom

Common questions

What is the main goal of this study?

The main goal is to understand the genetic reasons behind muscle conditions like polymyositis and dermatomyositis, hoping to develop better treatments in the future.

What will I have to do if I join?

You will be asked to provide one blood sample, just like a regular blood test, and your doctor will share some details about your health condition with the researchers.

Will I get any new medicine in this study?

No, this study is about collecting blood samples and health information to understand genetics, not about testing new medicines on participants.

Will my personal details be kept private?

Yes, your personal details will be handled with care. Your clinical details will be stored securely on a password-protected computer at the NHS trust.

What if I change my mind about taking part?

You can withdraw from the study at any time, for any reason, and it will not affect the medical care you receive.