सभी अध्ययन
भर्तीचरण3हस्तक्षेपात्मक

A Study of Baricitinib in Participants From 1 Year to Less Than 18 Years Old With Juvenile Idiopathic Arthritis

This study is about a medicine called baricitinib for children and young people aged 1 to 17 who have Juvenile Idiopathic Arthritis (JIA). JIA is a condition where a child's immune system mistakenly attacks their joints, causing pain and swelling. The study aims to see if baricitinib is safe and effective in treating JIA in this age group. All participants in this study would have already taken part in a previous study testing baricitinib for JIA. This means researchers already have some information about how the medicine might work for them. The goal is to gather more details about the long-term safety and benefits of baricitinib for children and teenagers with JIA.

एक नजर में

स्थिति
भर्ती
चरण
चरण3
प्रायोजक
एली लिली एंड कंपनी
नामांकन लक्ष्य
190
प्रारंभ
05 Apr 2019
अनुमानित पूर्णता
01 Jul 2031

यह अध्ययन किस बारे में है?

This study is designed to understand more about a medicine called baricitinib for children and young people with Juvenile Idiopathic Arthritis (JIA). JIA is a type of arthritis that affects children, causing their joints to become swollen, painful, and stiff. It's a long-term condition that can make everyday activities difficult for children.

The researchers want to make sure that baricitinib is both safe to use and effective in helping to treat JIA in young patients between 1 and 17 years old. This is a very important step in finding the best ways to manage JIA and improve the lives of children affected by it.

What makes this study a bit different is that all the children taking part have already been involved in an earlier study looking at baricitinib for JIA. This follow-up study allows the doctors and scientists to continue observing how baricitinib works over a longer time. They can gather more information on its effects and how well children tolerate the medicine. This is known as a "Phase 3" study, which means it's one of the final steps before a new medicine might become widely available.

मुख्य निष्कर्ष

  • This study is for children aged 1-17 with JIA.
  • It's testing a medicine called baricitinib for safety and effectiveness.
  • Participants must have already been in a previous baricitinib study for JIA.
  • The study helps gather more information on long-term treatment.
  • Your child will have regular check-ups during the study.

कौन पात्र हो सकता है?

To be able to join this study, a child must have already taken part in a previous study investigating baricitinib for their JIA. This is an important requirement, as the researchers are looking to continue gathering information on participants who have already started treatment.

There are also some reasons why a child couldn't join. For instance, if they had to stop taking baricitinib permanently during the earlier study, they wouldn't be able to participate. Also, if a child developed an allergic reaction to baricitinib in the previous study, they would not be able to join this one.

क्या यह अध्ययन आपके लिए उपयुक्त हो सकता है?

यह देखने के लिए इन त्वरित प्रश्नों का उत्तर दें कि क्या आप पात्र हो सकते हैं। यह केवल एक मार्गदर्शिका है — अंतिम निर्णय शोध टीम द्वारा लिया जाता है।.

  1. Is your child aged between 1 and 17 years old?
  2. Has your child previously taken part in a study for baricitinib for JIA?
  3. Did your child continue taking baricitinib throughout that previous study (not permanently stopped)?
  4. Has your child not developed an allergy to baricitinib?
अपने परिणाम देखने के लिए हर प्रश्न का उत्तर दें।.

भागीदारी में क्या शामिल है?

If you decide to take part in this study, your child will continue to receive the study medicine, baricitinib. You would need to attend regular clinic visits where doctors and nurses will check how your child is doing, how the medicine is affecting their JIA, and if they are experiencing any side effects. These visits might include physical examinations, blood tests, and discussions about your child's health.

The exact number and timing of visits will be explained by the study team, but they are designed to closely monitor your child's health and the effects of the treatment. The total length of your child's participation in the study will depend on the study plan and will be fully explained before you make any decisions.

संभावित जोखिम और लाभ

Taking part in this study might offer some potential benefits, such as continuing access to the study medicine, baricitinib, and close medical monitoring. However, as with any medicine, there are potential risks and side effects that will be discussed in detail by the study team. You always have the right to withdraw your child from the study at any time, for any reason, without it affecting their ongoing medical care.

स्थान (78)

  • Instituto CAICI SRL
    सत्यापित पोस्टकोड
    Rosario, Argentina· सक्रिय लेकिन भर्ती नहीं
  • Centro de Investigaciones Médicas Tucuman
    असत्यापित
    SAN M. de Tucuman, Argentina· सक्रिय लेकिन भर्ती नहीं
  • Royal Children's Hospital
    सत्यापित पोस्टकोड
    मेलबर्न, ऑस्ट्रेलिया· अभी भर्ती नहीं हो रही है
  • Perth Children's Hospital
    सत्यापित पोस्टकोड
    Perth, Australia· अभी भर्ती नहीं हो रही है
  • The Children's Hospital at Westmead
    सत्यापित पोस्टकोड
    वेस्टमीड, ऑस्ट्रेलिया· सक्रिय लेकिन भर्ती नहीं
  • Landeskrankenhaus Bregenz
    सत्यापित पोस्टकोड
    Bregenz, Austria· पूर्ण
  • Cliniques universitaires Saint-Luc
    सत्यापित पोस्टकोड
    ब्रुसेल्स, बेल्जियम· पूर्ण
  • UZ Gent
    सत्यापित पोस्टकोड
    घेंट, बेल्जियम· भर्ती
  • UZ Leuven
    सत्यापित पोस्टकोड
    ल्यूवेन, बेल्जियम· भर्ती
  • Faculdade de Medicina da UNESP
    सत्यापित पोस्टकोड
    Botucatu, Brazil· भर्ती
  • Universidade Federal de Sao Paulo
    सत्यापित पोस्टकोड
    साओ पाउलो, ब्राज़ील· भर्ती
  • Instituto da Crianca do Hospital das Clinicas da FMUSP
    सत्यापित पोस्टकोड
    साओ पाउलो, ब्राज़ील· भर्ती

सामान्य प्रश्न

What is Juvenile Idiopathic Arthritis (JIA)?

JIA is a type of arthritis that affects children, causing joint pain, swelling, and stiffness.

What is baricitinib?

Baricitinib is a medicine being studied to see if it can help treat JIA.

इस अध्ययन में कौन शामिल हो सकता है?

Children aged 1 to 17 who have already been in a previous baricitinib JIA study and tolerated the medicine well.

क्या यह अध्ययन सुरक्षित है?

All medicines have potential side effects. The study team will monitor your child closely, and any risks will be explained in full.

Can I stop my child's participation at any time?

Yes, you can withdraw your child from the study at any time without affecting their medical care.

और अधिक जानने के लिए कैसे पता करें

परीक्षण प्रश्न या भागीदारी प्रश्न: 1-877-CTLILLY (1-877-285-4559) या

किसी अध्ययन में भाग लेने का निर्णय लेने से पहले हमेशा अपने जीपी या विशेषज्ञ से बात करें।.

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अपने विवरण साझा करें और अनुसंधान टीम के लिए "A Study of Baricitinib in Participants From 1 Year to Less T…यदि आप पात्र हो सकते हैं तो आपसे संपर्क करेंगे। भाग लेने के लिए सहमति देने से पहले हमेशा अपने जीपी से बात करें।.

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