A Study of Vedolizumab in Children and Teenagers With Moderate to Severe Crohn's Disease (CD)
This study is testing a medicine called vedolizumab for children and teenagers aged 2 to 17 who have moderate to severe Crohn's disease. Vedolizumab helps reduce gut inflammation and pain. The main goal is to see if participants go into remission, meaning their symptoms improve or disappear and a check of their gut shows no inflammation. Participants first receive three doses of vedolizumab. If their condition improves, they then get either a high or low dose every eight weeks. This study hopes to find a new way to help young people manage their Crohn's disease.
Em resumo
Sobre o que é este estudo?
This study is looking into a medicine called vedolizumab for children and teenagers aged 2 to 17 years old who have Crohn's disease that is moderate to severe. Crohn's disease is a condition that causes swelling and irritation in the digestive system, which can lead to pain, diarrhoea, and other uncomfortable symptoms. Medicines like vedolizumab are designed to help calm this inflammation and ease these symptoms. Vedolizumab is already used and approved for adults in many countries.
The main thing this study wants to find out is if vedolizumab can help young people with Crohn's disease go into remission. Remission means that their symptoms get much better or even disappear, and when doctors look at their gut (for example, with a small camera), they see that the inflammation has settled down. For people with Crohn's disease, reaching remission can mean a much better quality of life.
This study is important because it could lead to new ways of treating Crohn's disease in young people when other treatments haven't worked well enough. By understanding how vedolizumab works in children and teenagers, doctors can make more informed decisions about the best care for them.
Pontos principais
- This study is for children and teenagers with moderate to severe Crohn's disease.
- It tests a medicine called vedolizumab, which is already used in adults.
- The main goal is to see if the medicine can achieve remission (symptom improvement and gut healing).
- Medicine is given through a drip, initially 3 times, then every 8 weeks if it helps.
- Participants will receive either a high or low dose, assigned by chance.
- Taking part involves regular check-ups and observations.
Quem pode ser elegível?
To join this study, children and teenagers generally need to be aged between 2 and 17 years old and weigh at least 10 kg (about 1 stone 8 pounds). They must have Crohn's disease that is moderately to severely active, which means their symptoms are significantly affecting them. Importantly, they should have already tried and not responded well to, or couldn't tolerate, at least one other standard treatment for Crohn's disease, such as certain medicines or special diets.
There are also some reasons why someone might not be able to join. For example, if they have certain serious brain or spinal cord conditions, or if they have recently received other experimental study medicines. All participants must have had their Crohn's disease diagnosed at least one month before starting the study.
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.
- Você tem entre 2 e 17 anos?
- Do you weigh at least 10 kg (about 1 stone 8 pounds)?
- Do you have moderate to severe Crohn's disease?
- Have you tried at least one other Crohn's treatment that didn't work well or you couldn't tolerate?
- Was your Crohn's disease diagnosed at least one month ago?
- Are your routine childhood vaccinations up to date?
O que envolve a participação?
If you join this study, here’s what you can expect:
**Medicine:** You will receive the study medicine, vedolizumab, through a drip into a vein (IV infusion).
**Initial Treatment:** For the first six weeks, you will have three infusions: one at the very beginning, one after two weeks, and another after six weeks. The amount of medicine you get will depend on your weight.
**Continuing Treatment:** After these initial doses, if your condition has improved, you will then be randomly assigned (like flipping a coin) to receive either a high or a low dose of vedolizumab. You’ll get an infusion of this dose once every eight weeks until Week 46 of the study. Neither you nor your study doctor will know if it’s the high or low dose, unless there's a medical reason to find out.
**Assessments:** Throughout the study, you’ll have regular check-ups with the study team. These visits will likely include blood tests, physical examinations, and possibly endoscopies (where a small camera looks into your gut) to see how your Crohn's disease is responding. The total duration of active treatment in the study will be about 46 weeks.
Riscos e benefícios potenciais
Locations (96)
- Phoenix Childrens HospitalCódigo postal verificadoPhoenix, Estados Unidos· Ainda não recrutando
- Centro Médico Cedars SinaiCódigo postal verificadoLos Angeles, Estados Unidos· Retirado
- Rady Childrens Hospital San Diego - PINCódigo postal verificadoSan Diego, Estados Unidos· Ainda não recrutando
- Universidade da Califórnia, São FranciscoCódigo postal verificadoSão Francisco, Estados Unidos· Retirado
- I.H.S Health LLCCódigo postal verificadoKissimmee, United States· Retirado
- Childrens Center For Digestive HealthcareCódigo postal verificadoAtlanta, Estados Unidos· Recrutamento
- Advocate Children's Hospital Park RidgeCódigo postal verificadoPark Ridge, United States· Recrutamento
- Riley Hospital For ChildrenCódigo postal verificadoIndianápolis, Estados Unidos· Retirado
- Johns Hopkins UniversityCódigo postal verificadoBaltimore, Estados Unidos· Ainda não recrutando
- Hospital Infantil de BostonCódigo postal verificadoBoston, Estados Unidos· Ainda não recrutando
- MNGI Digestive Health, PACódigo postal verificadoMinneapolis, Estados Unidos· Recrutamento
- Mayo Clinic - PINCódigo postal verificadoRochester, Estados Unidos· Ainda não recrutando
Perguntas frequentes
O que é a doença de Crohn?
Crohn's disease is a long-term condition that causes inflammation in your digestive system, leading to symptoms like tummy pain, diarrhoea, and tiredness.
What is remission?
Remission means your Crohn's symptoms have significantly improved or disappeared, and signs of inflammation in your gut have reduced.
Como o medicamento é administrado?
The medicine, vedolizumab, is given directly into a vein through a drip (an IV infusion).
Will I know if I'm getting the high or low dose?
No, during the later part of the study, neither you nor your doctor will usually know if you're receiving the high or low dose, to keep the study fair.
Posso sair do estudo se mudar de ideia?
Yes, you can leave the study at any time without having to give a reason, and it won't affect your future medical care.
Como saber mais
Contato Takeda
Sempre consulte seu médico ou especialista antes de decidir participar de um estudo.
Interessado em participar?
Discussão
Discussão da comunidade
Desenvolvido pelo nosso fórum em community.patient.info. Por favor, seja respeitoso — isto não é um conselho médico.