A Phase 2b, Extension Study to Determine the Long-term Safety of Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease Long-term Safety With Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease.
This study is a continuation of previous research, focusing on the long-term safety of a drug named Entyvio (vedolizumab IV) in children and teenagers who have either ulcerative colitis or Crohn's disease. Researchers want to understand if there are any side effects that appear over a longer period of treatment. They will be closely monitoring participants for any new or existing health issues that might be linked to the medicine. The study will also track how well the treatment continues to manage their disease symptoms and support healthy growth and development, helping us learn more about using Entyvio safely for young people with these conditions.
At a glance
What is this study about?
This study is looking at a medicine called Entyvio (which you might also hear called vedolizumab) in children and teenagers who have either ulcerative colitis or Crohn's disease. Both of these are types of inflammatory bowel disease, where the gut becomes inflamed and causes symptoms like tummy pain, diarrhoea, and tiredness. Researchers want to understand if Entyvio is safe to use over a long time in young people.
This isn't the very first time Entyvio has been studied, but this particular study is designed to follow patients for longer. The main thing the researchers are looking for is whether participants have any unwanted side effects when taking the medicine. They will also be checking to see how well the medicine continues to help with the symptoms of ulcerative colitis or Crohn's disease.
By carefully watching how children and teenagers react to Entyvio over time, doctors can learn more about its long-term safety and how it affects their growth and development. This information is very important to help make sure that young people with these conditions can get the best and safest treatment possible in the future.
Key takeaways
- This study is for children and teenagers with ulcerative colitis or Crohn's disease.
- It aims to understand the long-term safety of the medicine Entyvio.
- Participants will have regular check-ups and monitoring for side effects.
- The study tracks how well Entyvio manages disease symptoms and supports healthy development.
- Participation involves ongoing doctor visits and receiving the study medication.
Who may be eligible?
To be part of this study, you would need to be a child or teenager who has already been diagnosed with either ulcerative colitis or Crohn's disease. This study is open to both boys and girls of any age who meet the other specific health requirements set out by the researchers.
You would also need to have been part of an earlier study involving Entyvio, as this is an 'extension' study. This means it's for people who have already started treatment with this medication and the researchers want to continue to follow them.
Before joining, the research team would carefully review your medical history and current health to make sure this study is right for you and that you meet all the necessary criteria.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you a child or teenager?
- Do you have a diagnosis of ulcerative colitis or Crohn's disease?
- Have you been part of an earlier study involving Entyvio?
- Are you able to attend regular clinic visits and appointments?
What does participation involve?
If you decide to take part, you would continue to receive the study medication, Entyvio, which is given by infusion (into a vein). During your time in the study, you would have regular visits to the clinic. At these visits, doctors and nurses would check your health, ask about any symptoms you're experiencing, and monitor for any side effects.
They might do examinations, blood tests, and sometimes other tests like endoscopies (looking inside your gut with a small camera) to see how your condition is responding and how your body is handling the medication. Your growth (height and weight) will also be measured regularly. The total duration of your participation in this long-term study would depend on the study design, but it is meant to follow participants for an extended period to gather important safety information.
Potential risks and benefits
Locations (2)
- —UnverifiedHungary
- —UnverifiedPoland
Common questions
What is Entyvio?
Entyvio is a medicine designed to treat inflammatory bowel diseases like ulcerative colitis and Crohn's disease by calming the inflammation in your gut.
What does 'long-term safety' mean?
It means the doctors want to see if there are any side effects or health changes that only show up after someone has been taking the medicine for a long time.
Will I know if the medicine is helping my condition?
Yes, the doctors will regularly check your symptoms and do tests to see how well the treatment is working for your ulcerative colitis or Crohn's disease.
Is this a new medicine?
While this is a research study, Entyvio is an approved medication. This study is specifically looking at its long-term use in children and teenagers.
Can I stop being in the study if I change my mind?
Yes, you can choose to leave the study at any time, and this will not affect your future medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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