Pesquisa de Pacientes
Entrar
Todos os estudos
RecrutamentoFASE3INTERVENCIONISTA

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.

Em resumo

Status
Recrutamento
Fase
FASE3
Patrocinador
Eli Lilly and Company
Meta de inscrição
190
Iniciar
05 Apr 2019
Conclusão estimada
01 Jul 2031
Artrite Idiopática Juvenil

Sobre o que é este estudo?

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.

Pontos principais

  • 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.

Quem pode ser elegível?

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.

Este estudo pode ser adequado para você?

Responda a estas perguntas rápidas para ver se você pode ser elegível. Este é apenas um guia — a decisão final é da equipe de pesquisa.

  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?
Responda a todas as perguntas para ver o seu resultado.

O que envolve a participação?

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.

Riscos e benefícios potenciais

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
    Código postal verificado
    Rosario, Argentina· Ativo, mas não recrutando
  • Centro de Investigaciones Médicas Tucuman
    Não verificado
    SAN M. de Tucuman, Argentina· Ativo, mas não recrutando
  • Royal Children's Hospital
    Código postal verificado
    Melbourne, Austrália· Ainda não recrutando
  • Hospital Infantil de Perth
    Código postal verificado
    Perth, Australia· Ainda não recrutando
  • The Children's Hospital at Westmead
    Código postal verificado
    Westmead, Australia· Ativo, mas não recrutando
  • Landeskrankenhaus Bregenz
    Código postal verificado
    Bregenz, Austria· Concluído
  • Cliniques universitaires Saint-Luc
    Código postal verificado
    Bruxelas, Bélgica· Concluído
  • UZ Gent
    Código postal verificado
    Gante, Bélgica· Recrutamento
  • UZ Leuven
    Código postal verificado
    Leuven, Bélgica· Recrutamento
  • Faculdade de Medicina da UNESP
    Código postal verificado
    Botucatu, Brazil· Recrutamento
  • Universidade Federal de Sao Paulo
    Código postal verificado
    São Paulo, Brazil· Recrutamento
  • Instituto da Crianca do Hospital das Clinicas da FMUSP
    Código postal verificado
    São Paulo, Brazil· Recrutamento

Perguntas frequentes

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.

Quem pode participar deste estudo?

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

Is this study safe?

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.

Como saber mais

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

lillytrials@lilly.com 1-317-615-4559 Registro oficial do julgamento

Sempre consulte seu médico ou especialista antes de decidir participar de um estudo.

Interessado em participar?

Registre seu interesse

Compartilhe seus detalhes e a equipe de pesquisa para "A Study of Baricitinib in Participants From 1 Year to Less T…" entrará em contato com você se você for elegível. Sempre fale com seu médico antes de concordar em participar.

Discussão

Discussão da comunidade

Desenvolvido pelo nosso fórum em community.patient.info. Por favor, seja respeitoso — isto não é um conselho médico.