An Open-label Study to Evaluate the Pharmacokinetics and Safety of Bimekizumab in Pediatric Study Participants With Active Juvenile Idiopathic Arthritis Subtypes Enthesitis-related Arthritis (Including Juvenile-onset Ankylosing Spondylitis) and Juvenile Psoriatic Arthritis
This study is investigating a medicine called Bimekizumab for young people aged 2 to 18 years old who have active enthesitis-related arthritis (including a form called juvenile-onset ankylosing spondylitis) or juvenile psoriatic arthritis. The main goal is to understand how the body processes the medicine after it's given as an injection under the skin. We also want to check how safe it is for children and teenagers. This is a Phase 3 study, meaning it's one of the final steps before a medicine might be approved for wider use, and it's 'open-label,' so everyone involved will know they are receiving Bimekizumab.
במבט חטוף
על מה המחקר הזה?
This study is designed for children and young people between the ages of 2 and 18 who are living with specific types of arthritis: enthesitis-related arthritis (including a form called juvenile-onset ankylosing spondylitis) or juvenile psoriatic arthritis. These conditions can cause pain, swelling, and stiffness in joints and where tendons and ligaments attach to bone. The new medicine being looked at is called Bimekizumab.
The main purpose of this study is quite scientific – we want to understand how the body absorbs, distributes, breaks down, and removes Bimekizumab after it's given as an injection under the skin. This information, called pharmacokinetics, helps scientists work out the best dose and how often the medicine should be given to children and young people. We will also be carefully monitoring how safe the medicine is for them.
By taking part, children and their families can help us learn more about Bimekizumab. If it's found to be safe and effective, it could potentially offer a new treatment option for young people with these types of arthritis in the future. Your involvement is incredibly valuable in advancing medical knowledge.
נקודות עיקריות
- This study is for children aged 2-18 with specific types of arthritis.
- It tests a new medicine called Bimekizumab.
- The main aim is to understand how the medicine works in the body and if it's safe.
- Participants will receive the medicine via injection.
- Close medical monitoring is provided throughout the study.
- אתה יכול לפרוש מהמחקר בכל עת.
מי עשוי להיות זכאי?
This study is looking for children and young people between 2 and 18 years old who have been diagnosed with enthesitis-related arthritis (including juvenile-onset ankylosing spondylitis) or juvenile psoriatic arthritis for at least three months. Importantly, their arthritis needs to be 'active,' meaning they currently have at least three joints affected and, for enthesitis-related arthritis, at least one area where tendons or ligaments attach to bone is inflamed.
Participants should also have tried at least one anti-inflammatory painkiller (NSAID) for at least a month without enough improvement, or have found it too difficult to take. It's okay if they are already taking certain other medications like methotrexate or sulfasalazine, as long as the dose has been stable for a while. However, they can't be taking most other types of strong arthritis medications.
There are also requirements about body weight (at least 10kg), and for girls, it's important that they are not pregnant or breastfeeding. If they are old enough to potentially become pregnant, they would need to agree to use effective contraception during the study and for several months afterwards.
האם מחקר זה יכול להתאים לך?
ענה על השאלות המהירות הללו כדי לבדוק אם אתה עשוי להיות זכאי. זהו מדריך בלבד — צוות המחקר מקבל את ההחלטה הסופית.
- Is your child between 2 and 18 years old?
- Does your child have enthesitis-related arthritis or juvenile psoriatic arthritis for at least 3 months?
- Is their arthritis currently active (at least 3 affected joints)?
- Have they tried an anti-inflammatory painkiller (NSAID) that didn't work well or they couldn't tolerate?
- Does your child weigh at least 10 kilograms?
- For girls, are they not pregnant or breastfeeding, and willing to use contraception if needed?
מה כרוך בהשתתפות?
If you decide to take part, your child would receive regular injections of Bimekizumab under the skin. The study team would closely monitor your child through various clinic visits, which would likely include physical examinations, blood tests, and potentially other assessments to check their arthritis activity and overall health. You would need to attend these visits regularly during the treatment period.
The initial treatment period would be followed by an 'Open-label Extension' where treatment continues, and then a 'Safety Follow-up' period to check on your child's health after the last dose of the medicine. The total length of time your child would be involved in the study, including follow-up after the last dose, could be quite long – potentially over a year or more. You would be fully informed about the schedule of visits and what each visit involves before making a decision.
סיכונים ותועלות פוטנציאליים
Locations (23)
- Ja0005 50646מיקוד מאומתקלגרי, קנדה· גיוס
- Ja0005 50644מיקוד מאומתמונטריאול, קנדה· גיוס
- Ja0005 50645מיקוד מאומתSaskatoon, Canada· גיוס
- Ja0005 40777לא מאומתIndre-et-Loire, France· גיוס
- Ja0005 40510מיקוד מאומתLe Kremlin-Bicêtre, France· גיוס
- Ja0005 40778מיקוד מאומתפריז, צרפת· גיוס
- Ja0005 40776מיקוד מאומתPoitiers, France· גיוס
- Ja0005 40369מיקוד מאומתברלין, גרמניה· גיוס
- Ja0005 40356מיקוד מאומתDresden, Germany· גיוס
- Ja0005 40072מיקוד מאומתפרייבורג אים ברייסגאו, גרמניה· גיוס
- Ja0005 40852מיקוד מאומתהמבורג, גרמניה· גיוס
- Ja0005 40787מיקוד מאומתSankt Augustin, Germany· גיוס
שאלות נפוצות
What is enthesitis-related arthritis?
It's a type of arthritis that mainly affects children and causes inflammation where tendons and ligaments attach to bones, often in the spine, hips, or feet.
What is juvenile psoriatic arthritis?
This is a type of arthritis that can affect children and is often linked with a skin condition called psoriasis.
מה המשמעות של 'תווית פתוחה'?
It means that everyone involved in the study – the doctors, nurses, and you – will know that your child is receiving the study medicine, Bimekizumab.
Will my child still take their usual arthritis medicines?
They may be able to continue some medications like methotrexate or sulfasalazine, but usually not other strong arthritis medicines. The study doctor will discuss this with you.
How is Bimekizumab given?
It's given as an injection under the skin.
כיצד לגלות עוד
UCB אכפת
תמיד התייעץ עם רופא המשפחה או המומחה שלך לפני שתחליט להשתתף במחקר.
מעוניינים להשתתף?
דיון
דיון קהילתי
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