A Repeated Dose-finding Study of Sarilumab in Children and Adolescents With Systemic Juvenile Idiopathic Arthritis (SKYPS)
This study is investigating a new medicine, sarilumab, for children and teenagers aged 1 to 17 who have systemic Juvenile Idiopathic Arthritis (sJIA). This type of arthritis affects joints and can cause inflammation throughout the body. The main goal is to figure out the best dose of sarilumab for this age group to help manage their condition effectively. Researchers will also look at how the medicine works in the body, if it helps to improve symptoms, and if it's safe over a longer period. It's for young people who haven't fully responded to their current treatments and whose doctors think a different approach might be helpful.
نظرة سريعة
ما هو موضوع هذه الدراسة؟
This research study, called SKYPS, is all about finding a better way to treat children and teenagers who have a type of arthritis known as systemic Juvenile Idiopathic Arthritis, or sJIA. "Systemic" means the condition can affect the whole body, not just the joints. It's different from other types of arthritis because it can cause symptoms like fevers, rashes, and swelling in various organs, as well as painful, stiff joints.
The study is focusing on a specific medicine called sarilumab. This medicine works by targeting a particular part of the body's immune system that can contribute to the inflammation seen in sJIA. The main aim is to find the most suitable dose of sarilumab for young patients, from 1 to 17 years old. We need to understand how the medicine behaves in their bodies to make sure it's both effective and safe.
Beyond finding the right dose, the researchers will also be looking closely at how effective sarilumab is at controlling the symptoms of sJIA and if it can improve the overall health and well-being of the young participants. They will also be carefully monitoring for any side effects to understand the long-term safety of the treatment. This study is important because it could lead to a new treatment option for young people living with sJIA who haven't found enough relief from their current medications.
النقاط الرئيسية
- This study is testing a new medicine, sarilumab, for children aged 1-17 with systemic JIA.
- The main goal is to find the best dose and check its safety and effectiveness.
- It's for young people whose current sJIA treatments aren't working well enough.
- The study involves regular visits and will last over three years.
- Participants will receive close medical monitoring.
- You can stop taking part at any time without affecting your normal care.
من قد يكون مؤهلاً؟
This study is looking for children and teenagers between the ages of 1 and 17 who have been diagnosed with systemic Juvenile Idiopathic Arthritis (sJIA). Your doctor will need to confirm your specific diagnosis meets the study's requirements.
To be considered, your current treatment for sJIA shouldn't be working well enough, and your doctor should believe that a different type of medicine, like the one being studied, might be beneficial for you.
There are also some reasons why someone might not be able to join. For example, if you weigh less than 10kg (around 22 lbs) or more than 60kg (around 132 lbs) at the very start of the study, or if you have certain other health issues like serious lung problems or a condition called Macrophage Activation Syndrome within the last 6 months. Also, if you've recently changed doses of other medicines for your arthritis, or if you've previously been treated with similar medicines to sarilumab, you might not be eligible.
هل يمكن أن تناسبك هذه الدراسة؟
أجب عن هذه الأسئلة السريعة لترى ما إذا كنت مؤهلاً. هذا دليل فقط - الفريق البحثي هو الذي يتخذ القرار النهائي.
- هل عمرك بين 1 و 17 سنة؟
- Have you been diagnosed with systemic Juvenile Idiopathic Arthritis (sJIA)?
- Is your current sJIA treatment not fully controlling your symptoms?
- Do you weigh at least 10kg (around 22 lbs) and no more than 60kg (around 132 lbs) at the very start of the study?
- Have you *not* had Macrophage Activation Syndrome (MAS) within the last six months?
- Have you *not* previously used similar medications to sarilumab (like tocilizumab) for your sJIA?
ماذا يتضمن المشاركة؟
If you decide to take part in this study, the total time commitment will be about 166 weeks, which is just over three years. It starts with a four-week period where tests will be done to check if you are suitable for the study. After that, you'll enter the main treatment phase, which lasts for 12 weeks, where you'll receive the study medication.
Following the main treatment, there's a much longer 'extension phase' of 144 weeks. During this time, you'll continue to be monitored and receive treatment to see the long-term effects. Finally, there will be a 6-week period after the treatment ends where doctors will follow up on your health. Throughout the study, you'll have regular visits to the clinic for check-ups, blood tests, and to see how you're responding to the medication.
المخاطر والفوائد المحتملة
المواقع (40)
- Investigational Site Number : 0320004الرمز البريدي المؤكدSan Miguel de Tucumán, Argentina· التوظيف
- Investigational Site Number : 0320005الرمز البريدي المؤكدبوينس آيرس، الأرجنتين· التوظيف
- Investigational Site Number : 1240110الرمز البريدي المؤكدكالجاري، كندا· التوظيف
- Investigational Site Number : 2460040الرمز البريدي المؤكدهلسنكي، فنلندا· التوظيف
- Investigational Site Number : 2500041الرمز البريدي المؤكدBron, France· التوظيف
- Investigational Site Number : 2500042الرمز البريدي المؤكدمونبلييه، فرنسا· التوظيف
- Investigational Site Number : 2500040الرمز البريدي المؤكدباريس، فرنسا· التوظيف
- Investigational Site Number : 2760064الرمز البريدي المؤكدبرلين، ألمانيا· التوظيف
- Investigational Site Number : 2760065الرمز البريدي المؤكدبرلين، ألمانيا· التوظيف
- Investigational Site Number : 2760062الرمز البريدي المؤكدهامبورغ، ألمانيا· التوظيف
- Investigational Site Number : 2760060الرمز البريدي المؤكدSankt Augustin, Germany· التوظيف
- Investigational Site Number : 2760063الرمز البريدي المؤكدSendenhorst, Germany· مكتمل
أسئلة شائعة
What is systemic Juvenile Idiopathic Arthritis (sJIA)?
It's a type of arthritis in young people that affects joints and can also cause inflammation throughout the body, leading to symptoms like fever and rash.
What is sarilumab?
Sarilumab is a medicine being tested in this study. It works by targeting a specific part of the immune system to help reduce inflammation caused by sJIA.
كم ستستغرق مدة الدراسة؟
The study will last for approximately 166 weeks in total for each participant, which is just over three years.
Will I know if I'm taking the actual medicine or a dummy medicine?
The information provided doesn't specify if this is a blinded study, meaning whether participants will know if they're receiving sarilumab or a placebo (dummy medicine).
هل يمكنني التوقف عن المشاركة في الدراسة إذا أردت؟
Yes, you have the right to withdraw from the study at any time, for any reason, without it affecting your regular medical care.
كيفية معرفة المزيد
البريد الإلكتروني للشفافية التجريبية موصى به (مجاني للولايات المتحدة وكندا)
تحدث دائمًا إلى طبيبك العام أو الأخصائي قبل اتخاذ قرار بالمشاركة في دراسة.
هل أنت مهتم بالمشاركة؟
نقاش
مناقشة المجتمع
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