RecruitingOBSERVATIONAL

Advanced Sensor Based Functional ASsessmenTs in Axial Spondyloarthritis

This study is about a type of arthritis called axial spondyloarthritis (axSpA), which mainly affects the spine. We want to see how a new kind of treatment, called biologic therapy, helps with movement and stiffness in the back. To do this, we'll use small, wearable sensors to measure how well people can move their spine. We'll also take MRI scans of the spine before and after treatment to look for signs of inflammation. By comparing the sensor readings with the MRI scans, we hope to understand better how these treatments work and if they can improve the lives of people with axSpA. This information could help doctors make better choices for future patients.

At a glance

Status

Recruiting

Sponsor

Western Health and Social Care Trust

Enrolment target

Start

01 Jul 2019

Estimated completion

07 Feb 2026

Axial Spondyloarthritis

What is this study about?

This study is looking at a condition called axial spondyloarthritis, or axSpA for short. This is a type of arthritis that mainly causes pain and stiffness in the spine and the joints where your spine connects to your pelvis. For some people, these symptoms can get worse over time. This research aims to understand how a specific kind of modern medicine, called biologic therapy, helps people with axSpA.

We're particularly interested in how these treatments affect movement in the back. To measure this, we'll be using special small sensors, called IMU sensors, which are worn on the body. These sensors can accurately track how you move. We'll also use MRI scans, which are detailed pictures of the inside of your body, to see if the treatment reduces inflammation in your spine. By comparing the information from the sensors and the MRI scans, we hope to learn if there's a link between how much inflammation you have and how well you can move.

The main idea behind this study is to find better ways to measure how well treatments for axSpA are working. The information we gather could help doctors and researchers understand more about axSpA and how to give the best care to patients in the future. It's an observational study, which means we're watching and measuring what happens as people go about their usual treatment, rather than trying out a new, untested drug.

Key takeaways

This study looks at how biologic treatments affect back movement in axial spondyloarthritis.
Small sensors and MRI scans will be used to measure changes in spinal movement and inflammation.
Participation involves assessments before and after starting your prescribed biologic therapy.
You will receive your usual, approved biologic treatment, not an experimental drug.
The study aims to improve understanding of treatment effectiveness and patient care for axSpA.

Who may be eligible?

To be able to take part in this study, you need to have been diagnosed with axial spondyloarthritis (axSpA) and be aged between 18 and 80 years old. You also need to be planning to start biologic therapy as part of your regular treatment, and your doctor must agree that this treatment is suitable for you. It's important that you can understand and fill out questionnaires as part of the study.

There are also some reasons why you might not be able to join. For example, if your doctor thinks biologic therapy might be unsafe for you, or if you've had certain back or hip surgeries in the past. People with very limited hip movement or a significant curve in their spine (scoliosis) might also not be suitable. You also can't take part if you've recently had another biologic treatment, or if you are pregnant or breastfeeding.

Before you join, you will need to read and sign a consent form. This form explains everything about the study, and by signing it, you confirm that you understand what's involved and are happy to take part.

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 diagnosed with axial spondyloarthritis (axSpA)?
Are you between 18 and 80 years old?
Are you about to start biologic therapy for axSpA?
Can you understand and complete questionnaires?
Do you have any severe hip problems or spinal surgery history?
Are you pregnant or breastfeeding?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would be one of 20 people with axial spondyloarthritis who are about to start biologic therapy. You won't be given any new or experimental medications; you'll receive the biologic therapy your doctor usually prescribes for you.

Before you start your biologic therapy, and then again after you've been on it for a while, you will have several assessments. These include:

* **MRI scans:** You will have detailed MRI scans of your spine and the joints at the base of your spine (sacroiliac joints). These scans help us look for signs of inflammation. * **Sensor tests:** In the clinic, you'll do a series of movements while wearing small sensors (IMU sensors) that measure how much you can move your neck and back. You'll also take some of these sensors home to perform standard function tests there. * **Questionnaires:** You'll complete several questionnaires about your pain, daily activities, quality of life, and work productivity. These help us understand how your condition is affecting you. * **Blood tests:** You'll have blood tests to check for signs of inflammation such as ESR and CRP levels.

The exact number of visits and the total duration of your participation will depend on your treatment plan, but it generally involves assessments before and after your biologic therapy begins.

Potential risks and benefits

Taking part in this study may offer a potential benefit by closely monitoring your response to biologic therapy, which might give you and your doctors more detailed information about your treatment's effectiveness. There are no new or experimental treatments involved; you will receive the standard care biologic therapy prescribed by your doctor. The main risks are those associated with standard medical procedures: slight discomfort from blood tests and the MRI scans. For safety reasons, people with certain metal implants cannot have an MRI. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

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

Department of Rheumatology, Altnagelvin Hospital
Verified postcode
Londonderry, United Kingdom· Recruiting

Common questions

What is 'axial spondyloarthritis'?

It's a type of arthritis that mainly causes long-term pain and stiffness in your spine and the joints connecting your spine to your pelvis.

What are 'biologic therapies'?

These are advanced medicines that target specific parts of the immune system to reduce inflammation in conditions like axial spondyloarthritis.

What is an 'IMU sensor'?

It's a small wearable device, like a fitness tracker, that can measure movement very accurately. In this study, it helps us see how well you move your back.

Will I receive a new medicine as part of this study?

No, you will receive the biologic therapy that your doctor has already decided is best for your condition, as part of your usual care.

Is this study safe?

Yes, this is an observational study, meaning we are just observing your response to your usual treatment. The procedures like MRI scans and blood tests are standard and used in routine care, with usual safety precautions.

How to find out more

Dawn Small

dawn.small@westerntrust.hscni.net 02871345171 Official trial record

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