Ongoing, recruitingTherapeutic use (Phase IV)Interventional

Rapid pain control in Ixekizumab targeted axial spondyloarthritis

This study is investigating a medicine called Taltz (ixekizumab) to see how quickly it can help people with axial spondyloarthritis manage their pain. Axial spondyloarthritis is a type of arthritis that mainly affects the spine and can cause ongoing pain and stiffness. The researchers are using a special type of brain scan, called an fMRI, to measure changes in brain activity related to pain very early in the treatment – specifically, comparing brain signals just a few days after starting Taltz to signals before treatment began. This late-stage study aims to understand the rapid effects of Taltz on pain signals.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic use (Phase IV)

Sponsor

Universitaetsklinikum Erlangen AöR

Enrolment target

Start

29 Jan 2024

axial spondyloarthritis

What is this study about?

This study is focusing on a medicine called Taltz (ixekizumab) and its effects on a condition known as axial spondyloarthritis. Axial spondyloarthritis is a long-term type of arthritis that mostly affects the joints in your spine and sometimes other joints and parts of the body. It can cause ongoing back pain, stiffness, and tiredness. Medicines like Taltz are designed to help reduce inflammation and improve symptoms.

The main aim of this research is to understand how quickly Taltz starts to reduce pain for people with this condition. Instead of just asking people about their pain directly, the scientists are using a special brain scanning technique called fMRI (functional Magnetic Resonance Imaging). This scan helps them see which parts of your brain are active when you feel pain. They will compare these brain signals very early in the treatment – looking at changes just a few days after taking Taltz versus before you started the medicine.

This is a 'Phase IV' study, which means the medicine Taltz is already approved and available for use. Researchers are now looking at more specific details, like how quickly it works on pain at a brain signal level. Understanding these rapid effects can help doctors and patients have a clearer picture of what to expect soon after starting treatment with Taltz for axial spondyloarthritis.

Key takeaways

This study is about how quickly Taltz helps reduce pain in axial spondyloarthritis.
It uses special brain scans (fMRI) to measure changes in pain signals.
Taltz is an approved medicine; this study is looking at its very early effects.
You must be 18 or older to participate; all genders are welcome.
The study involves receiving Taltz injections and having several fMRI scans.

Who may be eligible?

To be considered for this study, you would need to be an adult, 18 years old or older. There is no upper age limit, so people of all adult ages are welcome to inquire.

Both men and women are eligible to take part in this research study, so your gender does not affect whether you can join.

Beyond these basic requirements, there will be other specific health checks and criteria that a study doctor will discuss with you to make sure the study is a safe and suitable option 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?
Have you been diagnosed with axial spondyloarthritis?
Are you able to attend study visits for scans and assessments?
Are you able to receive injections of the study medicine?
Are you comfortable with undergoing fMRI brain scans?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive the study medicine, Taltz, which is given as an injection using a pre-filled pen. The study involves several visits where you will have fMRI brain scans to measure changes in your pain signals. These scans will happen at specific times: before you start any treatment (Day 0), a few days after your first dose (Day 3), and then again shortly after (Day 14 and Day 17). There will also be other health checks and assessments during your visits. You would be followed closely by the study team throughout the research. The exact total duration of your participation and the number of visits would be explained in full by the study team.

Potential risks and benefits

Taking part in a study like this may offer potential benefits, such as contributing to scientific knowledge and possibly receiving close medical attention. You may also find that the treatment helps your condition, though this is not guaranteed for everyone. However, there are also potential risks involved, including possible side effects from the medication (which would be fully explained), and the time commitment for study visits and tests. All procedures, including fMRI scans, are generally safe but have their own considerations. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

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

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Unverified
Germany

Common questions

What is axial spondyloarthritis?

It's a type of arthritis that mainly causes pain and stiffness in your spine, but can affect other joints and parts of the body too.

What is Taltz (ixekizumab)?

Taltz is a medicine used to treat inflammatory conditions like axial spondyloarthritis. It's given as an injection.

What is an fMRI scan?

An fMRI is a special type of brain scan that helps researchers see which parts of your brain are active, including areas linked to pain signals.

Is Taltz already an approved medicine?

Yes, Taltz is an approved medicine. This study is looking at more specific details about how it works.

Will taking part in this study cure my condition?

No, participating in a study doesn't guarantee a cure. It aims to help us understand the medicine better and potentially improve treatment.