A Long-Term Extension Study of Vedolizumab in Children and Teenagers With Ulcerative Colitis (UC) or Crohn's Disease (CD)

Condition(s) studied

Investigational drug(s) / intervention(s)

Vedolizumab SC: Vedolizumab subcutaneous injection.

No Intervention: As this is an observational cohort, no intervention will be administered.

Study summary

The main aim of this study is to learn about medical problems (adverse events) if vedolizumab subcutaneously (SC) is given to a child or teenager with UC or CD for a long time. Other aims are to understand if the long time use of vedolizumab SC has an impact on the time period until hospital visits because of bowel swelling (inflammation) are needed and has an impact on the quality of life of children and teenagers who received vedolizumab SC.

In this study, participants who responded well to the treatment with vedolizumab SC in the parent study (VedolizumabSC-3003 \[NCT06100289\]) will continue to be treated with vedolizumab SC. Participants who did not respond well to the treatment with vedolizumab SC in the parent study or who received corticosteroids in the last 4 weeks of the parent study will not receive vedolizumab SC in this study but will be followed for up to 2 years after the last treatment with vedolizumab SC in the parent study.

During the study, participants will visit their study clinic several times.

Eligibility

Primary outcome measure(s)

• 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 Events — Up to Week 86
  Prespecified safety events will include serious infections, malignancies, PML, concerns about growth and pubertal development, and bowel surgery.

Trial sites (54)

+ 14 more sites — see the full list on the official registry below.

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