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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.

Överblick

Status
Rekrytering
Fas
FAS3
Sponsor
Eli Lilly och Company
Inskrivningsmål
190
Starta
05 Apr 2019
Beräknad slutförande
01 Jul 2031
Juvenile Idiopathic Arthritis

Vad handlar denna studie om?

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.

Viktiga punkter

  • 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.

Vem kan vara berättigad?

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.

Kan denna studie passa dig?

Svara på dessa snabba frågor för att se om du kan vara berättigad. Detta är endast en vägledning — forskarteamet fattar det slutgiltiga beslutet.

  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?
Svara på varje fråga för att se ditt resultat.

Vad innebär deltagande?

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.

Potentiella risker och fördelar

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.

Platser (78)

  • Instituto CAICI SRL
    Verifierat postnummer
    Rosario, Argentina· Aktiv men inte rekryterande
  • Centro de Investigaciones Médicas Tucuman
    Obekräftad
    SAN M. de Tucuman, Argentina· Aktiv men inte rekryterande
  • Kungliga Barnsjukhuset
    Verifierat postnummer
    Melbourne, Australien· Rekryterar inte ännu
  • Perth Children's Hospital
    Verifierat postnummer
    Perth, Australia· Rekryterar inte ännu
  • The Children's Hospital at Westmead
    Verifierat postnummer
    Westmead, Australien· Aktiv men inte rekryterande
  • Landeskrankenhaus Bregenz
    Verifierat postnummer
    Bregenz, Austria· Avslutad
  • Cliniques universitaires Saint-Luc
    Verifierat postnummer
    Bryssel, Belgien· Avslutad
  • UZ Gent
    Verifierat postnummer
    Gent, Belgien· Rekrytering
  • UZ Leuven
    Verifierat postnummer
    Leuven, Belgien· Rekrytering
  • Faculdade de Medicina da UNESP
    Verifierat postnummer
    Botucatu, Brazil· Rekrytering
  • Universidade Federal de Sao Paulo
    Verifierat postnummer
    São Paulo, Brasilien· Rekrytering
  • Instituto da Crianca do Hospital das Clinicas da FMUSP
    Verifierat postnummer
    São Paulo, Brasilien· Rekrytering

Vanliga frågor

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.

Vem kan delta i denna studie?

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

Är denna studie säker?

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.

Hur du får reda på mer

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

lillytrials@lilly.com 1-317-615-4559 Officiell rättegångsprotokoll

Prata alltid med din läkare eller specialist innan du bestämmer dig för att delta i en studie.

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