An Observational Study to Assess Change in Disease Activity and Treatment Patterns of Upadacitinib When Given Alone or Co-Administered With Methotrexate in Adult Participants With Active Psoriatic Arthritis
This study is observing how a medicine called upadacitinib (RINVOQ) works in real-world settings for adults with active psoriatic arthritis. This condition causes joint pain and swelling. Upadacitinib is already approved in Europe for this condition. Around 450 people in France, Germany, Greece, and Italy will take part. Participants will receive upadacitinib as their doctor normally prescribes it, not as part of an experiment. The study will watch their progress for up to two years. There will be no additional tests or hospital visits beyond what a patient would normally have for their care. This helps to understand how the medicine works in typical patient care.
At a glance
What is this study about?
If you have psoriatic arthritis, you might be interested in a study looking at a treatment called upadacitinib (known as RINVOQ).
Psoriatic arthritis is a condition where your body's immune system mistakenly attacks your joints, causing pain, swelling, and stiffness. It can affect people who also have psoriasis, a skin condition. This study isn't testing whether upadacitinib works – it's already an approved medicine in Europe for adults with active psoriatic arthritis. Instead, it's an 'observational study'. This means researchers will simply watch and record how upadacitinib is used in everyday medical practice when prescribed by doctors.
The study aims to understand how effective upadacitinib is in real-life situations, either when used on its own or together with another medicine called methotrexate. It will also track how doctors decide to use the medicine. About 450 adult patients across France, Germany, Greece, and Italy will take part. They will receive their usual care, and researchers will gather information about their treatment and how their condition changes over time for up to two years. Your involvement wouldn't change your medical care or add extra appointments.
Key takeaways
- The study watches how upadacitinib (RINVOQ) is used in real life for psoriatic arthritis.
- It's for adults whose doctor has already decided to prescribe upadacitinib.
- Participation means no extra doctor visits or changes to your treatment.
- You'll be followed for up to 24 months, with researchers gathering information from your normal appointments.
- Your contribution helps improve understanding of the medicine's effectiveness.
Who may be eligible?
To be considered for this study, you must be an adult with psoriatic arthritis that your doctor has confirmed is 'active,' meaning it's causing symptoms that need treatment. Your doctor must have already decided that upadacitinib is the right treatment for you before they even consider you for this study. This is important because the study is observing real-world treatment decisions, not influencing them.
Your doctor must be prescribing upadacitinib according to the official guidelines and rules for its use in your country. You also need to be able to understand the study information and communicate with the study team to follow the study's requirements.
However, you cannot take part if you are currently involved in another study that is testing a new or experimental medicine, or if you have been in such a study within the last 30 days. You also can't join if you have already been treated with upadacitinib 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.
- Are you an adult (18 years or older)?
- Have you been diagnosed with active psoriatic arthritis?
- Has your doctor already prescribed upadacitinib for your psoriatic arthritis?
- Are you able to understand study information and communicate with the study team?
- Have you NOT taken part in a study for an experimental medicine in the last 30 days?
- Have you NOT been treated with upadacitinib before?
What does participation involve?
If you join this study, you will receive upadacitinib exactly as your doctor has prescribed it for you. There will be no extra tests, procedures, or hospital visits beyond what you would normally have as part of your regular care for psoriatic arthritis. You will continue to have your routine check-ups at your hospital or clinic. The research team will simply collect information from these visits about your condition and how your treatment is progressing. The study will follow you for up to two years.
Potential risks and benefits
Locations (88)
- Centre Hospitalier Universitaire de Nice - Hôpital Pasteur /ID# 252536Verified postcodeNice, France
- CH Troyes - Hopital Simone Veil /ID# 252625Verified postcodeTroyes, France
- CHU de Besancon - Jean Minjoz /ID# 252537Verified postcodeBesançon, France
- CHU Limoges - Dupuytren 1 /ID# 252432Verified postcodeLimoges, France
- CHU Toulouse - Hopital Purpan /ID# 252077Verified postcodeToulouse, France
- CHU Montpellier - Hopital Saint Eloi /ID# 252078Verified postcodeMontpellier, France
- CHU Grenoble - Hopital Michallon /ID# 252601Verified postcodeLa Tronche, France
- CHU Bordeaux - Hopital Pellegrin /ID# 252532Verified postcodeBordeaux, France
- Ch Beauvais /Id# 252464Verified postcodeBeauvais, France
- Hopitaux Universitaires Henri Mondor - Hopital Henri Mondor /ID# 245194Verified postcodeCréteil, France
- Infirmerie Protestante /ID# 252075Verified postcodeCaluire-et-Cuire, France
- CHU Amiens-Picardie Site Sud /ID# 252527Verified postcodeAmiens, France
Common questions
What is psoriatic arthritis?
Psoriatic arthritis is a type of arthritis that affects some people who have psoriasis. It causes joint pain, stiffness, and swelling.
What is upadacitinib (RINVOQ)?
Upadacitinib (brand name RINVOQ) is a medicine approved to treat active psoriatic arthritis in adults.
Will I get a new medicine if I join this study?
No, you will receive upadacitinib only if your doctor has already decided it's the right treatment for you, independently of this study.
Will I have extra appointments or tests?
No, there are no additional appointments or tests beyond your usual medical care for psoriatic arthritis.
How long will I be in the study?
The study will follow your progress for up to two years as part of your routine care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.