Long-Term Safety of Vedolizumab in Children with Ulcerative Colitis or Crohn's Disease
This study is looking at the long-term safety of vedolizumab in children with ulcerative colitis (UC) or Crohn's disease (CD). Vedolizumab is a drug given through an IV (intravenous infusion). You can join this study if you are 2 years old or older and have already participated in one of two previous studies (MLN0002-3024 or MLN0002-3025) and met certain health improvements. The main goal is to track any side effects (adverse events) that happen while taking vedolizumab or in an observational group. This study plans to enroll up to 240 children worldwide, but the current recruitment status is unclear.
- Study design
- This is an interventional study, meaning participants will receive a treatment. It is an extension of two previous studies, enrolling up to 240 participants into either a treatment group or an observational group.
- What's involved
- If in the Treatment Cohort, you would receive vedolizumab IV every 8 weeks. Safety events will be monitored for up to approximately 5 years in the Treatment Cohort and up to approximately 2 years in the Observational Cohort.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants in the Treatment Cohort will be followed for up to approximately 5 years for adverse events. Participants in the Observational Cohort will be followed for up to approximately 2 years for safety events.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
A Study of Vedolizumab in Children With Ulcerative Colitis (UC) or Crohn's Disease (CD)
At a glance
Conditions
Where it's being run
98 sites across 74 statesStudy leadership
- Study Director · STUDY_DIRECTOR · Takeda
Who to contact
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What this trial measures
- Treatment Cohort: Number of Participants With at Least One Adverse Event (AE)From first dose of study drug up to approximately 5 years
An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have causal relationship with this treatment. AE can be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a drug whether or not it is considered related to drug.
- Observational Cohort: Number of Participants With Prespecified Safety EventsUp to approximately 2 years
Prespecified safety events will include serious infections, malignancies, progressive multifocal leukoencephalopathy (PML), concerns about growth and pubertal development, and bowel surgery.