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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.

Auf einen Blick

Status
Rekrutierung
Phase
PHASE3
Sponsor
Eli Lilly und Unternehmen
Einschreibeziel
190
Starten
05 Apr 2019
Geschätzte Fertigstellung
01 Jul 2031
Juvenile Idiopathische Arthritis

Worum geht es in dieser Studie?

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.

Wichtige Erkenntnisse

  • 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.

Wer könnte berechtigt sein?

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.

Könnte diese Studie für Sie geeignet sein?

Beantworten Sie diese kurzen Fragen, um zu sehen, ob Sie möglicherweise berechtigt sind. Dies ist nur ein Leitfaden – das Forschungsteam trifft die endgültige Entscheidung.

  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?
Beantworten Sie jede Frage, um Ihr Ergebnis zu sehen.

Was beinhaltet die Teilnahme?

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.

Potenzielle Risiken und Vorteile

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.

Locations (78)

  • Instituto CAICI SRL
    Verifizierte Postleitzahl
    Rosario, Argentinien· Aktiv, aber nicht rekrutierend
  • Centro de Investigaciones Médicas Tucuman
    Unbestätigt
    SAN M. de Tucuman, Argentina· Aktiv, aber nicht rekrutierend
  • Royal Children's Hospital
    Verifizierte Postleitzahl
    Melbourne, Australia· Noch nicht rekrutiert
  • Perth Children's Hospital
    Verifizierte Postleitzahl
    Perth, Australien· Noch nicht rekrutiert
  • The Children's Hospital at Westmead
    Verifizierte Postleitzahl
    Westmead, Australia· Aktiv, aber nicht rekrutierend
  • Landeskrankenhaus Bregenz
    Verifizierte Postleitzahl
    Bregenz, Austria· Abgeschlossen
  • Cliniques universitaires Saint-Luc
    Verifizierte Postleitzahl
    Brüssel, Belgien· Abgeschlossen
  • UZ Gent
    Verifizierte Postleitzahl
    Gent, Belgien· Rekrutierung
  • UZ Leuven
    Verifizierte Postleitzahl
    Leuven, Belgien· Rekrutierung
  • Faculdade de Medicina da UNESP
    Verifizierte Postleitzahl
    Botucatu, Brazil· Rekrutierung
  • Universidade Federal de Sao Paulo
    Verifizierte Postleitzahl
    São Paulo, Brazil· Rekrutierung
  • Instituto da Crianca do Hospital das Clinicas da FMUSP
    Verifizierte Postleitzahl
    São Paulo, Brazil· Rekrutierung

Häufige Fragen

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.

Wer kann an dieser Studie teilnehmen?

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

Ist diese Studie sicher?

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.

Wie Sie mehr erfahren können

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

lillytrials@lilly.com 1-317-615-4559 Offizielles Gerichtsprotokoll

Sprechen Sie immer mit Ihrem Hausarzt oder Spezialisten, bevor Sie sich entscheiden, an einer Studie teilzunehmen.

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