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RecrutamentoUso terapêutico (Fase IV)Intervencionista

Investigating the role of JAK inhibition in achieving and maintaining disease remission in psoriatic arthritis (PsA).

This study is investigating a medicine called XELJANZ for people with psoriatic arthritis, a condition that causes sore joints and skin problems. Researchers want to see if XELJANZ can help patients achieve remission, meaning their symptoms significantly improve or disappear. They're also interested in whether people can stay in remission, even after stopping the medicine. The study will track various aspects of the condition, including joint pain, swelling, skin issues, and overall quality of life over two years. This is a Phase IV study, meaning the medicine is already approved for use, and researchers are gathering more information about its long-term effects and how it helps patients in real-world settings.

Em resumo

Status
Recrutamento
Fase
Uso terapêutico (Fase IV)
Patrocinador
UZ Leuven
Meta de inscrição
20
Iniciar
03 Apr 2024

Sobre o que é este estudo?

This study is all about understanding how a medicine called XELJANZ works for people living with psoriatic arthritis (PsA). PsA is a type of arthritis that can cause painful and swollen joints, as well as skin problems like psoriasis. The main goal of this research is to see if XELJANZ can help people with PsA get into remission, which means their symptoms are much better or have even gone away. They also want to understand if people can stay in remission after they stop taking the medication.

To do this, the research team will carefully track different things over more than two years. They'll look at how your joints, fingers and toes (dactylitis), and areas where tendons attach to bone (enthesitis) are doing. They'll also check your skin. Beyond physical symptoms, the study will ask about your everyday life and how you feel, for example, your ability to do daily activities and your overall well-being. This helps them understand the full impact of the medicine on your life.

This is called a 'Phase IV' study. This means that XELJANZ is already a medication approved for use, but doctors want to learn more about how it works in real-world situations for many different patients. By doing this research, they hope to get a clearer picture of its long-term benefits and how it can best help people with psoriatic arthritis manage their condition.

Pontos principais

  • This study explores how XELJANZ helps psoriatic arthritis.
  • It aims to see if the medicine can lead to and maintain remission.
  • Researchers will track joint, skin, and overall well-being for over two years.
  • Participation involves taking XELJANZ and attending regular check-ups.
  • It's a Phase 4 study, gathering more information on an already approved medicine.

Quem pode ser elegível?

To be part of this study, you need to be at least 18 years old. Both men and women can take part.

You would likely be considered if you have psoriatic arthritis and meet other specific requirements related to your health and treatment history. These details would be checked by the study team to ensure the study is right for you, and that you meet the necessary health criteria for safe participation.

It's important to remember that these are just the basic age and gender rules. There will be other medical criteria to check if this study is a good fit for you. Your doctor will discuss all of these with you carefully.

Este estudo pode ser adequado para você?

Responda a estas perguntas rápidas para ver se você pode ser elegível. Este é apenas um guia — a decisão final é da equipe de pesquisa.

  1. Tenho 18 anos ou mais?
  2. Do I have a diagnosis of psoriatic arthritis?
  3. Am I able to attend regular clinic visits for about two years?
  4. Am I comfortable taking study medication and filling out questionnaires?
Responda a todas as perguntas para ver o seu resultado.

O que envolve a participação?

If you decide to take part in this study, you would be taking XELJANZ film-coated tablets as prescribed by the study doctors. Over the course of the study, which lasts for about two years (104 weeks), you would have regular visits to the clinic. These visits would happen at specific times, like at week 4, 12, 24, 28, 52, 76, and 104.

During these visits, the study team would check your health in several ways. This might include checking your joints, measuring any swelling in your fingers or toes, and looking at your skin. You would also be asked to fill out questionnaires about how you are feeling and how your condition affects your daily life. They will also collect information to track how your disease changes over time, including looking at your bone health.

The study aims to see if you can achieve remission and potentially stay in remission even after stopping the medication. The total duration of active follow-up would be until week 104.

Riscos e benefícios potenciais

Taking part in this study might offer you a chance to see if XELJANZ could help improve your psoriatic arthritis symptoms and potentially achieve remission. However, like all medicines, XELJANZ can have side effects, and the study will carefully monitor your health. You will be told about all known potential risks before you decide to join. It's very important to know that taking part in any clinical study is entirely your choice, and you have the right to withdraw at any time, for any reason, without it affecting your usual medical care.

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Perguntas frequentes

O que é artrite psoriática?

Psoriatic arthritis is a long-term condition that causes painful, swollen joints and can also affect the skin, causing psoriasis rashes.

O que significa 'remissão' neste estudo?

Remission means that the symptoms of your psoriatic arthritis have significantly improved or are no longer present.

What is XELJANZ?

XELJANZ is a medicine that is already approved for use, but this study wants to learn more about how it helps people with psoriatic arthritis over time.

How long will I need to be in the study?

The study will last for about two years, with regular check-ups at the clinic during that time.

Can anyone join this study?

You need to be at least 18 years old. Beyond that, the study team will check other health details to see if it's the right fit for you.

Como saber mais

Sempre consulte seu médico ou especialista antes de decidir participar de um estudo.

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