Long-Term Study of Vedolizumab for Crohn's Disease and Ulcerative Colitis in Children
This study is looking at the long-term safety of vedolizumab SC (a medicine given by injection under the skin) in children and teenagers with ulcerative colitis (UC) or Crohn's disease (CD). It also aims to see if long-term use of vedolizumab SC affects how often hospital visits are needed due to bowel inflammation and how it impacts quality of life. You may be able to join if you are 2 to 17 years old, have UC or CD, and have already responded well to vedolizumab SC in a previous study (VedolizumabSC-3003). The study will track any medical problems (adverse events) that occur. The current status of this study is unclear, and it plans to enroll about 70 participants.
- Study design
- This interventional study plans to enroll about 70 participants. It includes a treatment group and an observational group, with the treatment group being randomized to receive vedolizumab in different injection devices.
- What's involved
- If you are in the treatment group, you will continue to receive vedolizumab SC at the same dose and frequency as in the previous study. The overall time you would participate in this study is up to 2 years.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants in the treatment group will have a safety follow-up visit 18 weeks after their last dose of vedolizumab SC.
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A Long-Term Extension Study of Vedolizumab in Children and Teenagers With Ulcerative Colitis (UC) or Crohn's Disease (CD)
At a glance
Conditions
Where it's being run
54 sites across 30 statesStudy leadership
- Study Director · STUDY_DIRECTOR · Takeda
Who to contact
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What this trial measures
- Treatment Cohort: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)First dose of the study drug until 18 weeks of follow-up after last dose (up to Week 138)
An Adverse event (AE) is defined as any untoward medical occurrence in clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory value), symptom, or disease temporally associated with use of drug whether or not it is considered related to drug. SAE is defined as any untoward medical occurrence that at any dose: results in death, is life threatening.
- Treatment Cohort: Number of Participants With Adverse Events of Special Interests (AESIs)First dose of the study drug until 18 weeks of follow-up after last dose (up to Week 138)
AESI is defined as infections, including opportunistic infection, such as progressive multifocal leukoencephalopathy (PML), liver injury, malignancies, injection-related reactions or systemic reactions including anaphylaxis and hypersensitivity reactions.
- Observational Cohort: Number of Participants With Prespecified Safety EventsUp to Week 86
Prespecified safety events will include serious infections, malignancies, PML, concerns about growth and pubertal development, and bowel surgery.