RecruitingPHASE4INTERVENTIONAL

A Study to Evaluate the Impact of Upadacitinib on Spondyloarthritis Outcomes in Patients With Active Psoriatic Arthritis

This research, called UP-SPOUT, is investigating a medicine named Upadacitinib, also known as Rinvoq, for people living with active psoriatic arthritis. The study focuses particularly on how this medicine impacts symptoms affecting the spine, a condition sometimes called spondyloarthritis or axial involvement. Researchers want to understand if Upadacitinib can improve the lives of those with psoriatic arthritis that affects the back and other joints. It's a phase 4 study, which means the medicine is already approved for some uses and doctors want to learn more about its effects. Participants will be randomly given either the active medicine or a 'dummy' pill (placebo) to fairly compare their effects. This study is taking place in multiple locations.

At a glance

Status

Recruiting

Phase

PHASE4

Sponsor

CARE ARTHRITIS LTD.

Enrolment target

100

Start

03 Dec 2024

Estimated completion

01 Oct 2028

Psoriatic Arthritis Spondyloarthritis, Axial

What is this study about?

This study, known as UP-SPOUT, is designed to learn more about how a medicine called Upadacitinib, also known by its brand name Rinvoq, works for people who have active psoriatic arthritis. Psoriatic arthritis is a type of arthritis that can cause joint pain, stiffness, and swelling in people who also have psoriasis, a skin condition. Sometimes, psoriatic arthritis can also affect the spine, causing back pain and stiffness. This specific involvement of the spine is sometimes called spondyloarthritis or axial involvement.

Upadacitinib is a type of medicine that helps to calm down the overactive immune system, which is what causes the inflammation in conditions like psoriatic arthritis. This study is trying to understand if Upadacitinib can help reduce the symptoms of psoriatic arthritis, especially when it affects the spine, and improve people's overall quality of life. It's a Phase 4 study, which means the medication is already available for some conditions, and this research aims to gather more information about its long-term effects and benefits in this specific group of patients.

The study is set up as a 'randomised, placebo-controlled' trial. This means that participants will be put into groups by chance – some will receive the active medicine (Upadacitinib), and others will receive a 'dummy' pill (placebo) that looks the same but contains no active medicine. This method helps researchers fairly compare the effects of the active drug against no treatment. It's also a 'multicenter' study, which means it is being conducted in several different hospitals or clinics, allowing more people to participate and providing a broader picture of the results.

Key takeaways

This study is testing Upadacitinib (Rinvoq) for psoriatic arthritis, especially when it affects the spine.
It's a large-scale study where some participants will receive the active medicine and others a dummy pill.
The main goal is to see if this medicine improves symptoms and quality of life.
You must be 18 or older and have a confirmed diagnosis of psoriatic arthritis with spinal involvement.
Your participation will involve regular clinic visits and close monitoring.
You can leave the study at any time if you change your mind.

Who may be eligible?

To be considered for this study, you must be 18 years old or older. You also need to have been diagnosed with psoriatic arthritis by a rheumatologist, which is a doctor specialising in joint conditions. This diagnosis needs to meet specific criteria, including evidence of psoriasis on your skin or a history of it in your family, certain nail changes, or a negative test for rheumatoid factor.

Crucially, your psoriatic arthritis must also show signs of affecting your spine. This could be through active inflammation or changes in your bones that have been picked up in previous tests. You'll also need to be willing to follow all the study instructions and understand what participating involves before you sign a consent form.

Both men and women are welcome to participate in this 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?
Have you been diagnosed with psoriatic arthritis by a specialist?
Does your psoriatic arthritis show signs of affecting your spine?
Are you willing and able to follow all study instructions?
Do you understand what participating in a research study involves?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will have regular visits to the clinic. At these visits, doctors will assess your health, symptoms, and how you are feeling. You will be given either the study medicine, Upadacitinib (Rinvoq), or a dummy pill (placebo), which you will take as instructed. The study team will monitor you closely for any changes in your condition or any side effects you might experience. There will be specific tests and questionnaires to understand how the treatment is affecting your psoriatic arthritis, especially your spine. The total duration of your participation in the study, including all follow-up, will be clearly explained to you before you join.

Potential risks and benefits

Participating in this study might offer you some potential benefits, such as receiving a medication that could improve your psoriatic arthritis symptoms, particularly those affecting your spine, or contributing to medical knowledge that helps others with the condition in the future. However, as with any medication, there are potential risks and side effects associated with Upadacitinib, which the study team will discuss with you in detail. There are also risks associated with participating in any research study, such as the inconvenience of clinic visits or the possibility of receiving a placebo instead of the active drug. It is very important to remember that you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (5)

University Hospitals Cleveland Medical Center
Verified postcode
Cleveland, United States· Recruiting
Oregon Health and Science University
Verified postcode
Portland, United States· Recruiting
University of Pennsylvania
Verified postcode
Philadelphia, United States· Recruiting
The Ottawa Hospital Research Institute
Verified postcode
Ottawa, Canada· Recruiting
Groupe de Recherche en Maladies Osseuses (G.R.M.O.) Inc.
Verified postcode
Québec, Canada· Recruiting

Common questions

What is psoriatic arthritis?

It's a type of arthritis that can cause joint pain, swelling, and stiffness in people who also have psoriasis, a skin condition.

What does 'axial' mean in this study?

It refers to symptoms of psoriatic arthritis that affect the spine, causing back pain and stiffness.

What is Upadacitinib (Rinvoq)?

It's a medicine being studied that aims to calm down the body's overactive immune system to reduce inflammation in joint conditions.

What is a 'placebo'?

A placebo is a 'dummy' pill that looks just like the study medicine but doesn't contain any active drug. It helps researchers compare effects fairly.

Can I stop participating in the study if I want to?

Yes, you have the right to withdraw from the study at any time without it affecting your right to receive your usual medical care.

How to find out more

Amanda Carapellucci

amanda.carapellucci@carearthritis.com 5874009524 Official trial record

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