Ongoing, recruitingTherapeutic use (Phase IV)Interventional

U3P study - Upadacitinib in Psoriatic Arthritis Pain Processing

The U3P study is a research project focusing on people who have psoriatic arthritis. This condition causes joint pain and skin problems. The study is investigating a specific medicine called RINVOQ, given as a 15 mg tablet that releases slowly in the body. Researchers want to understand how this medicine affects the way our brains process pain. They will use a special type of brain scan to measure changes in pain signals at the start of the study, and again after one week and twelve weeks. This is a "Phase IV" study, which means the medicine is already approved for use, and researchers are now gathering more information about its effects in real-world settings.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic use (Phase IV)

Sponsor

Universitaetsklinikum Erlangen AöR

Enrolment target

Start

20 Mar 2024

Psoriatic arthritis

What is this study about?

The U3P study is all about understanding how a medicine called RINVOQ (upadacitinib) helps people with psoriatic arthritis. Psoriatic arthritis is a long-term condition that affects your joints, causing pain, stiffness, and swelling, and it's often linked to a skin condition called psoriasis. While RINVOQ is already a recognised treatment, researchers want to look more closely at how it helps reduce pain by studying changes in the brain.

To do this, they will use a special type of brain scan. This scan looks at how much activity there is in different parts of your brain when you're experiencing pain. The study will compare these brain activity scans at the beginning, then after one week, and again after twelve weeks of taking RINVOQ. By doing this, the researchers hope to learn exactly how this medicine works inside your body to make your pain feel better.

Understanding these pain pathways in the brain is really important. It could help doctors better predict who might benefit most from this treatment and even lead to new ways to help manage psoriatic arthritis pain in the future, improving the quality of life for many people.

Key takeaways

The study is investigating how RINVOQ helps psoriatic arthritis pain.
It uses special brain scans to see changes in pain processing.
RINVOQ is given as a 15 mg slow-release tablet.
The study lasts about 12 weeks for active participation.
It’s open to adults aged 18 and over, of any gender.
This research helps understand how medicines work in the brain to reduce pain.

Who may be eligible?

To take part in this study, you generally need to be an adult, aged 18 years or older. There are no specific restrictions based on whether you are male or female; anyone can potentially join if they meet the other requirements.

However, it's important to remember that this is just a very general overview. While the study is open to both men and women over 18, there will be other specific health checks and criteria that determine if this study is right for you. For example, you might need to have a confirmed diagnosis of psoriatic arthritis and meet certain health standards that the study team will explain.

The best way to find out if you could be part of this research is to speak directly with your doctor or the study team. They can go through all the details and assess whether you fit the full list of requirements for this particular 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 18 years old or older?
Do you have a diagnosis of psoriatic arthritis?
Are you able to attend regular clinic appointments and brain scans?
Are you able to take the study medicine as prescribed?
Are you comfortable with the potential risks and benefits explained by the study team?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would be taking the medicine RINVOQ as a 15 mg tablet once a day. The study involves regular visits to the clinic, where you would have brain scans to measure how your pain processing changes. These scans will happen at the very beginning of the study, again after one week, and then one final time after twelve weeks.

Throughout the study, you'll have specific medical checks and assessments during your clinic visits to monitor your health and how the treatment is affecting you. You'll also be asked about your pain levels and general well-being. The total length of your active involvement in the study, taking the medicine and having the brain scans, would be around 12 weeks. After this period, there will likely be follow-up appointments to check on your long-term progress and health.

Potential risks and benefits

Participating in this study might offer potential benefits, such as receiving a specific medicine (RINVOQ) that could help manage your psoriatic arthritis pain, and close monitoring of your health by medical professionals. On the other hand, all medicines have potential risks and side effects, which the study team will explain fully. These can range from mild to more serious, and some people may not experience any benefit from the treatment. 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 psoriatic arthritis?

It's a type of arthritis that affects some people with psoriasis, causing painful and swollen joints, and sometimes affecting other parts of the body too.

What is RINVOQ?

RINVOQ is a medicine used to treat certain inflammatory conditions, including psoriatic arthritis. It comes in a tablet form.

Why are they looking at brain scans?

Researchers are using brain scans to understand how RINVOQ helps reduce pain by looking at how brain activity related to pain changes after taking the medicine.

How long does the study last?

The main part of the study, where you take the medicine and have scans, lasts for about 12 weeks, with follow-up appointments afterwards.

Is RINVOQ a new medicine?

RINVOQ is already approved for use in conditions like psoriatic arthritis (this is a Phase IV study), but this study aims to learn even more about how it works.