Active not recruitingOBSERVATIONAL

A Study of Guselkumab and Interleukin-17 (IL-17) Inhibitor Therapies in Participants With Psoriatic Arthritis in Routine Clinical Practice

This study, called PsABIOnd, is looking at treatments for Psoriatic Arthritis (PsA), a condition that causes painful, swollen joints and skin patches. The focus is on two types of medicine: guselkumab and IL-17 inhibitors. Researchers want to see how well these treatments work in a real-world setting, rather than in strict lab conditions. They will observe people starting one of these medicines for their PsA to understand how long they continue using it and its effects on their daily lives. The study will also collect extra information on things like mood, sleep, and physical activity for some participants, using wearable devices. It's a long-term study, lasting about six years.

At a glance

Status

Active not recruiting

Sponsor

Janssen Pharmaceutica N.V., Belgium

Enrolment target

1,314

Start

25 Aug 2021

Estimated completion

02 Aug 2027

Arthritis, Psoriatic

What is this study about?

This study is about Psoriatic Arthritis, or PsA for short. PsA is a type of arthritis linked to psoriasis, a skin condition that causes red, scaly patches. PsA can make your joints painful and swollen, and can affect other parts of your body too, like your fingers and toes, or where your muscles and tendons attach to bones. The study wants to understand more about two types of modern medicines used to treat PsA: guselkumab and IL-17 inhibitors.

These medicines work by targeting specific natural substances in your body that play a role in inflammation, which is what causes the symptoms of PsA. Guselkumab, for example, blocks a substance called IL-23, while IL-17 inhibitors block another substance called IL-17. By doing this, they can help reduce the inflammation and the painful symptoms of PsA.

Researchers want to see how these medicines work when used in a normal clinic setting, rather than in a strict research environment. They will follow people who are starting one of these treatments for their PsA. The main goal is to find out how long people continue to use these medicines. For some participants, the study will also collect extra details about how these treatments affect their mood, sleep, physical activity, and overall PsA symptoms. This will help doctors understand the real-life benefits and challenges of these treatments over a long period.

Key takeaways

The study observes how well new and existing PsA medicines (guselkumab and IL-17 inhibitors) work in real life.
It aims to understand how long people stay on these treatments.
You'll be taking a medicine your doctor has already prescribed.
The study helps improve understanding of PsA treatments for future patients.
Participation involves filling out electronic forms and potentially using wearable devices.
You can leave the study at any time without affecting your medical care.

Who may be eligible?

To join the main part of this study, you need to have a confirmed diagnosis of Psoriatic Arthritis from your rheumatologist. You must be starting either guselkumab or an IL-17 inhibitor as your first, second, third, or fourth biologic treatment for your PsA, as part of your regular medical care. You also need to be able to read and understand the study information and fill out forms on a computer or tablet.

There are also some reasons why you might not be able to join. For example, if you are starting guselkumab or an IL-17 inhibitor as your fifth or later biologic treatment, you wouldn't be eligible. Also, if you've already taken a specific IL-17 or IL-23 blocking medicine and plan to start that exact same one again, you couldn't participate. Finally, if you've recently taken part in another experimental drug study within the last month, you might also be excluded.

For a smaller part of the study, you would also need to be willing to use wearable devices (like a smartwatch or fitness tracker) or apps to help track your health and activity as part of your daily routine.

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.

Do you have a diagnosis of Psoriatic Arthritis from a specialist?
Are you about to start guselkumab or an IL-17 inhibitor treatment for your PsA?
Is this your first, second, third, or fourth 'biologic' medicine for PsA?
Are you 18 years old or older?
Can you read and understand study materials and use electronic questionnaires?
For the optional extra part, are you willing to use a wearable device or app to track your health?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be observed as you start your new PsA medicine (either guselkumab or an IL-17 inhibitor) as part of your usual care. The study aims to follow participants for up to six years, including the time it takes to sign up and the follow-up period. You won't be given any experimental medicines; you'll receive your PsA treatment as prescribed by your own doctor.

During the study, you'll be asked to provide information through electronic questionnaires (ePROs). These will ask about your symptoms and how you're feeling. For some participants, there's also an option to join a smaller part of the study. If you choose this, you might be asked to use wearable devices or apps to help collect extra information about your mood, physical activity, sleep, and how your PsA is affecting you. This extra data collection might happen more often than for those in the main study. There won't be extra clinic visits specifically for the study; the data will be collected around your routine appointments.

Potential risks and benefits

Participating in this study involves minimal direct risks beyond what you would experience with your standard PsA treatment. You will receive your prescribed medication as usual, and the study mainly involves collecting information about your health and how well the treatment is working in your daily life. A potential benefit is that your information will help doctors and researchers better understand the real-world effectiveness of these PsA treatments, which could improve care for others in the future. You have the right to withdraw from the study at any time without affecting your medical care.

Locations (155)

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

OMI
Verified postcode
Buenos Aires, Argentina
Hospital Italiano de Buenos Aires
Verified postcode
Buenos Aires, Argentina
Hospital J. M. Ramos Mejía
Verified postcode
Buenos Aires, Argentina
Hospital Cordoba
Verified postcode
Córdoba, Argentina
MR Medicina Reumatologica
Verified postcode
San Fernando, Argentina
The Queen Elizabeth Hospital
Verified postcode
Adelaide, Australia
Footscray Hospital, Western Health
Verified postcode
Footscray, Australia
Royal North Shore Hospital
Verified postcode
St Leonards, Australia
LKH-Univ. Klinikum Graz
Verified postcode
Graz, Austria
Kepler Universitatsklinikum GmbH
Verified postcode
Linz, Austria
Medizinische Universitaet Wien
Verified postcode
Vienna, Austria
Evang. Krankenhaus Gemein. Betriebgesm. Mbh
Verified postcode
Vienna, Austria

Common questions

What is Psoriatic Arthritis?

Psoriatic Arthritis is a type of arthritis linked to psoriasis, causing joint pain, swelling, and sometimes affects fingers, toes, and where tendons attach to bone.

What are guselkumab and IL-17 inhibitors?

These are modern medicines for Psoriatic Arthritis that work by blocking specific natural substances in your body that cause inflammation and symptoms.

Will I receive new medicine in this study?

No, you will receive the PsA medicine (guselkumab or an IL-17 inhibitor) that your doctor has already decided is best for you, as part of your regular care.

How long will I be in the study?

The study expects to follow participants for about six years in total, including the time it takes to join and the follow-up tracking.

Do I have to use a wearable device?

Using a wearable device is only for a smaller, optional part of the study; it's not required for everyone.