Vedolizumab is a medication that helps reduce inflammation and pain in the digestive system. This study is for children and teenagers who have moderate to severe Crohn's disease (CD), a condition where the digestive tract becomes inflamed, causing pain and diarrhea. The goal of this study is to see if the medication can help improve or completely stop these symptoms.
Participants will get three infusions of vedolizumab over six weeks. If they respond well, they will continue to receive either a high or low dose every eight weeks for several months. The study is worldwide and includes about 120 participants.
- Duration: Up to 54 weeks, with possible extension.
- Visits: Regular infusions every 8 weeks after the initial 6-week period.
- Risks: Potential side effects and the need for regular medical check-ups.
Participants must have tried other treatments without success and meet certain health criteria. They should be at least 10 kg in weight and have been diagnosed with CD for more than one month. It's important to discuss with your doctor to see if this study is a good fit for you.