OLE Study With Filgotinib in JIA
This study is an extension to previous trials, focusing on the long-term safety and how well a medicine called filgotinib works for children and young people with a type of arthritis called Juvenile Idiopathic Arthritis (JIA). It's specifically for those who have already been treated with filgotinib in earlier studies and whose doctors believe the medicine has been helping them. The trial aims to continue monitoring their health and how the medicine affects their arthritis over a longer period.
At a glance
What is this study about?
This study is about a medicine called filgotinib, and how it helps young people aged 8 to 18 who have a condition called Juvenile Idiopathic Arthritis (JIA). JIA is a type of arthritis that affects children and teenagers, causing joint pain, swelling, and stiffness.
This isn't the first time filgotinib has been studied for JIA. This particular study is an 'open-label extension' (OLE) which means it's a continuation for young people who have already been in other studies using filgotinib. The main goal is to understand the medicine's long-term effects, both in terms of safety and how well it continues to control their arthritis symptoms over a longer time.
Doctors want to make sure that filgotinib not only helps with the symptoms but also remains safe for long-term use in young people. By continuing to follow those who have already shown improvement, they can gather important information to help other young people with JIA in the future.
Key takeaways
- This study is for young people (8-18) with JIA who already take filgotinib.
- It aims to check the long-term safety and effectiveness of the medicine.
- Participants must have previously benefited from filgotinib.
- Regular health checks and study visits will be required.
- You can stop participating at any time.
- This is an important step to understand long-term treatment for JIA.
Who may be eligible?
To join this study, you must have already taken part in a previous study using filgotinib and your doctor must agree that the medicine has been helping your arthritis.
You also need to be aged between 8 and 18 years old. If you're under 16, your parent or guardian will need to give their permission too. Everyone involved needs to be able to follow the study's rules and attend appointments.
There are some reasons you wouldn't be able to join. For example, if you're pregnant or have an active infection. Also, if you have a known allergy to filgotinib or any part of the medication, or if your doctor thinks there's any other reason it wouldn't be safe for you to take part.
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 aged between 8 and 18 years old?
- Have you taken filgotinib in a previous study?
- Do you and your doctor agree that filgotinib has helped your arthritis?
- Are you able to attend regular study appointments?
- Are you free from active infections or known allergies to the study drug?
- If female and sexually active, are you able to use contraception as advised?
What does participation involve?
If you join this study, you'll continue to receive filgotinib. The study team will regularly check in with you to see how you're feeling and how your arthritis is progressing. This will involve regular visits to the clinic, where doctors and nurses will assess your health and take some blood or urine samples.
They'll monitor for any side effects and make sure the medicine is still working well for you. The exact number and frequency of visits, and the tests involved will be clearly explained by the study team. They will also let you know the total duration that your participation is expected to last.
Potential risks and benefits
Locations (4)
- Bicetre HospitalVerified postcodeLe Kremlin-Bicêtre, France· Not yet recruiting
- Hamburger Zentrum für Kinder- und JugendrheumatologieVerified postcodeHamburg, Germany· Recruiting
- Asklepios Klinik Sankt Augustin GmbHVerified postcodeSankt Augustin, Germany· Not yet recruiting
- Great Ormond Street Hospital for ChildrenVerified postcodeLondon, United Kingdom· Not yet recruiting
Common questions
What is Juvenile Idiopathic Arthritis (JIA)?
JIA is a type of arthritis that affects children and teenagers, causing joint pain, swelling, and stiffness.
What is filgotinib?
Filgotinib is a medication that helps to reduce inflammation and symptoms of conditions like JIA.
Why is this study only for people who have taken filgotinib before?
This study is an extension to previous trials, focusing on looking at the long-term safety and effects of filgotinib in people who have already shown benefit from the medicine.
What does 'long-term safety' mean?
It means the study will watch closely for any side effects or health issues that might appear when taking the medicine over a longer period of time.
Can I stop taking part in the study if I want to?
Yes, you or your parent/guardian can decide to withdraw from the study at any time without giving a reason, and it won't affect your future medical care.
How to find out more
Catherine Vincent
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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