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An Ex-US Study to Assess Treatment Persistence With Risankizumab in Adult Participants With Psoriatic Arthritis

This study is for people living with psoriatic arthritis, a condition where your immune system mistakenly attacks your joints, often alongside a skin condition called psoriasis. Doctors want to understand how a medicine called risankizumab works over a long time when compared to other treatments for psoriatic arthritis. This helps them see how effective it is in everyday medical care. The study will involve around 900 to 1200 people from various countries outside the United States. Participants will receive their medication as usual and have their check-ups during routine doctor visits for two years. The study aims to gather important real-world information without adding extra burdens for those taking part.

At a glance

Status
Recruiting
Sponsor
AbbVie
Enrolment target
1,200
Start
31 Jan 2025
Estimated completion
01 Feb 2029

What is this study about?

You might be interested in this study if you have psoriatic arthritis. This condition is a type of joint pain and stiffness, which often occurs in people who also have the skin condition psoriasis. It happens because your body's defence system, called the immune system, mistakenly attacks healthy parts of your body.

This study wants to learn more about how a medicine called risankizumab (pronounced riz-AN-ki-zoo-mab) helps people with psoriatic arthritis over a long period. They will compare it with other advanced medicines that doctors usually prescribe for this condition. The aim is to understand how well risankizumab works and how it's used in normal medical practice, rather than in strict experimental conditions.

Risankizumab is already approved for treating psoriatic arthritis. This study will take place in about 15 countries outside the U.S. and involve at least 900 to 1200 participants. Most participants will receive risankizumab, while others will receive different advanced treatments. Your treatment will be given in the usual way, just as your doctor would normally prescribe it, following current medical guidelines.

Key takeaways

  • This study evaluates risankizumab for psoriatic arthritis.
  • It aims to understand long-term effectiveness in real-world settings.
  • Participants will follow their usual medical treatment and appointments.
  • The study lasts for 24 months, with no extra patient burden.
  • It's open to adults aged 18-75 with inadequately controlled psoriatic arthritis.

Who may be eligible?

To be considered for this study, you would need to have been diagnosed with psoriatic arthritis for at least six months and have active symptoms of the condition at the start of the study. You also need to be between 18 and 75 years old.

Another important requirement is that your current psoriatic arthritis treatment, which might include certain medicines called DMARDs (Disease-modifying antirheumatic drugs), hasn't worked well enough for you. Alternatively, you might be eligible if you can't take certain standard DMARDs because of side effects or other medical reasons, as judged by your doctor.

However, you would not be able to join the study if three or more advanced biological or targeted synthetic DMARD medicines have not worked for you in the past.

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.

  1. Do you have a diagnosis of psoriatic arthritis?
  2. Have you had psoriatic arthritis symptoms for at least 6 months?
  3. Are you between 18 and 75 years old?
  4. Has your current psoriatic arthritis treatment not worked well enough, or can you not take certain standard medications?
  5. Have you not previously tried and failed three or more advanced biologic or targeted synthetic medications for psoriatic arthritis?
Answer every question to see your result.

What does participation involve?

If you join this study, you will receive your prescribed medication (either risankizumab or another advanced treatment) in the way your doctor usually gives it, following standard medical guidelines. You will attend your regular doctor's appointments and check-ups for your psoriatic arthritis. These visits will be counted as part of the study information gathering. There won't be any extra appointments or tests beyond what you would normally have.

The study will follow you for a total of two years (24 months). During this time, the researchers will collect information from your routine visits about how your treatment is working and how you are getting on. The idea is that taking part should not add any extra burden to your usual medical care.

Potential risks and benefits

Participating in this study might offer a benefit by allowing your doctors to gather important information about how your treatment works in real-world settings, which could help future patients. As your treatment will be given in the usual way, there are no expected additional risks beyond those associated with your standard medical care and the prescribed medications. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (132)

  • Cer Instituto Médico /ID# 274445
    Verified postcode
    Quilmes, Argentina· Recruiting
  • Instituto Medico de Alta Complejidad San Isidro S.A. /ID# 274417
    Verified postcode
    San Isidro, Argentina· Recruiting
  • Instituto Médico Río Cuarto /ID# 274421
    Verified postcode
    Río Cuarto, Argentina· Recruiting
  • Landesklinikum Stockerau /ID# 275618
    Verified postcode
    Stockerau, Austria· Recruiting
  • Rheuma-Zentrum Wien-Oberlaa GmbH /ID# 275617
    Verified postcode
    Vienna, Austria· Recruiting
  • Medizinische Universitaet Graz /ID# 273765
    Verified postcode
    Graz, Austria· Recruiting
  • Krankenhaus Der Barmherzigen Brueder Graz /ID# 273764
    Verified postcode
    Graz, Austria· Recruiting
  • Universite Libre de Bruxelles - Hopital Erasme /ID# 272763
    Verified postcode
    Anderlecht, Belgium· Recruiting
  • Rhumaconsult Sprl /ID# 272797
    Verified postcode
    Charleroi, Belgium· Recruiting
  • Reumacentrum Genk - Medisch Centrum Genk /ID# 272796
    Verified postcode
    Genk, Belgium· Recruiting
  • ReumaClinic /ID# 272782
    Verified postcode
    Genk, Belgium· Recruiting
  • OLV Ziekenhuis Aalst /ID# 274456
    Verified postcode
    Aalst, Belgium· Recruiting

Common questions

What is psoriatic arthritis?

Psoriatic arthritis is a type of arthritis that causes joint pain, swelling, and stiffness in people who often have the skin condition psoriasis. It happens when the body's immune system attacks healthy tissues by mistake.

What is risankizumab?

Risankizumab is a medicine that has been approved to treat psoriatic arthritis. This study wants to see how well it works over time in everyday use.

Will I have extra doctor appointments if I join?

No, you shouldn't have any extra appointments. All the study visits will happen during your normal, routine check-ups for your psoriatic arthritis.

How long will the study last if I take part?

If you join, you will be followed for two years (24 months) to observe how your treatment is working.

Will taking part in this study cost me anything?

The study aims to observe treatment in usual care, so there should be no additional costs or burdens for participants beyond your normal medical care.

How to find out more

Shari Chapman

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

Interested in taking part?

Register your interest

Share your details and the research team for "An Ex-US Study to Assess Treatment Persistence With Risankiz…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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