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RecrutementConfirmatoire thérapeutique (Phase III)Interventionnel

A Multicenter, Open-Label Extension Study to Assess the Long-Term Safety, Tolerability, and Efficacy of Bimekizumab in the Treatment of Study Participants with Active Axial Spondyloarthritis, Ankylosing Spondylitis, and Nonradiographic Axial Spondyloarthritis

This research study is checking the long-term effects of a medicine called bimekizumab for people suffering from a condition called axial spondyloarthritis. This condition causes pain and stiffness, mainly in the spine. The study wants to see how safe the medicine is over time and if it continues to help people feel better. Researchers will carefully watch for any side effects and how much the medicine improves symptoms like pain and stiffness. It's a follow-up study for people who have already been taking bimekizumab in previous trials, giving us more information on its long-term use.

En un coup d'œil

Statut
Recrutement
Phase
Confirmatoire thérapeutique (Phase III)
Sponsor
UCB Biopharma
Objectif d'inscription
568
Démarrer
02 Jul 2024

De quoi parle cette étude ?

This study is a follow-up for people who have already been taking a medicine called bimekizumab in earlier research. The main goal is to understand how safe this medicine is over a longer period and if it continues to help people with axial spondyloarthritis. Axial spondyloarthritis is a type of arthritis that mainly affects the spine, causing pain, stiffness, and sometimes damage.

Researchers will be carefully tracking any unexpected effects (known as 'adverse events') that people experience while taking the medicine. They'll also be looking at how well the medicine continues to reduce symptoms like pain and stiffness, and if it helps people move more easily. This extended study is important because it gives doctors and patients a better idea of what to expect from bimekizumab if it's used for many months or even years.

By gathering this long-term information, the study aims to confirm whether bimekizumab is a good and lasting treatment option for axial spondyloarthritis. This helps doctors make informed decisions and gives people living with this condition more options for managing their symptoms and improving their quality of life.

Points clés

  • This study is for adults with axial spondyloarthritis.
  • It's a long-term follow-up for people already using bimekizumab.
  • The main goals are to check the medicine's safety and how well it continues to work.
  • You'll have regular medical checks and assessments if you join.
  • Both potential benefits and risks are considered.
  • You can leave the study at any time.

Qui peut être éligible ?

To be considered for this study, you must be an adult aged 18 years or older. This study is for people who have already taken part in earlier research studies involving the medicine bimekizumab.

Both men and women can join. The study is specifically for individuals who have been diagnosed with axial spondyloarthritis, which includes conditions like ankylosing spondylitis or non-radiographic axial spondyloarthritis.

Cet étude pourrait-elle vous convenir ?

Répondez à ces questions rapides pour voir si vous êtes éligible. Ceci est un guide uniquement — l'équipe de recherche prend la décision finale.

  1. Avez-vous 18 ans ou plus ?
  2. Have you been diagnosed with axial spondyloarthritis (including ankylosing spondylitis or non-radiographic axial spondyloarthritis)?
  3. Have you previously taken part in an earlier study with bimekizumab?
  4. Are you willing to attend regular clinic visits for check-ups and tests?
Répondez à chaque question pour voir votre résultat.

En quoi consiste la participation ?

If you take part in this study, you will continue to receive the medicine bimekizumab. You will need to attend regular visits to the study clinic for assessments. These visits will involve doctors checking your health, asking about any symptoms or side effects you might be having, and possibly taking blood samples or performing other tests.

Throughout the study, researchers will be carefully monitoring how well the medicine is working and how your body is reacting to it. The length of your participation can vary, as the study aims to gather long-term information. You should expect regular check-ups over an extended period, which could be for a few years, to track your progress and safety.

Risques et avantages potentiels

Participating in this study might offer potential benefits, such as continuing to receive a treatment that could help manage your axial spondyloarthritis symptoms under close medical supervision. However, like all medicines, bimekizumab can have side effects, and you might experience new or unexpected ones. Serious side effects, although rare, are possible. It's 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.

Emplacements (7)

Certains emplacements de site sont approximatifs. Nous améliorons cela — veuillez vérifier avec l'équipe d'essai avant de vous déplacer.
  • —
    Non vérifié
    Hongrie
  • —
    Non vérifié
    Pologne
  • —
    Non vérifié
    France
  • —
    Non vérifié
    Belgique
  • —
    Non vérifié
    Tchéquie
  • —
    Non vérifié
    Espagne
  • —
    Non vérifié
    Allemagne

Questions fréquentes

What is axial spondyloarthritis?

It's a type of arthritis that mainly causes long-lasting pain and stiffness in the spine and sometimes other joints.

What is bimekizumab?

Bimekizumab is a medicine being studied as a treatment for conditions like axial spondyloarthritis.

Que signifie 'sécurité à long terme' ?

It means the study will check if the medicine remains safe to use over many months or even years, and what side effects might show up over time.

Will taking part in this study cure my condition?

No, this study aims to see if the medicine helps manage symptoms and improves your condition, not to cure it.

Dois-je payer pour participer à l'étude ?

No, clinical trials usually cover the costs of study medicine and study-related visits.

Comment en savoir plus

Parlez toujours à votre médecin généraliste ou spécialiste avant de décider de participer à une étude.

Intéressé à participer ?

Inscrivez votre intérêt

Partagez vos coordonnées et l'équipe de recherche pour "A Multicenter, Open-Label Extension Study to Assess the Long… vous contactera si vous êtes éligible. Consultez toujours votre médecin avant d'accepter de participer.

Discussion

Discussion communautaire

Propulsé par notre forum à community.patient.info. Veuillez être respectueux — ceci n'est pas un avis médical.