Ulcerative Colitis or Crohn’s Disease
Conditions
Brief summary
Observational Cohort: Incidence of safety events (SAEs, serious infections, malignancies, PML, bowel surgery, and delay in growth or pubertal development)., Treatment Cohort: The primary endpoints for this study are the incidence of adverse events (AEs), serious adverse events (SAEs), and adverse events of special interest (AESIs) (ie, infections including opportunistic infection, such as PML; liver injury; malignancies; injection-related reactions or systemic reactions including anaphylaxis and hypersensitivity reactions)
Detailed description
Treatment Cohort: Time to major IBD-related events (eg, hospitalizations, surgeries, or procedures) from Day 1 of Study VedolizumabSC-3004., Changes from baseline of Study VedolizumabSC-3003 in IMPACT-III total and subscale scores for subjects aged 9 to 17 years
Interventions
Sponsors
Takeda Development Center Americas Inc.
Eligibility
Sex/Gender
All
Age
0 Years to 17 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Observational Cohort: Incidence of safety events (SAEs, serious infections, malignancies, PML, bowel surgery, and delay in growth or pubertal development)., Treatment Cohort: The primary endpoints for this study are the incidence of adverse events (AEs), serious adverse events (SAEs), and adverse events of special interest (AESIs) (ie, infections including opportunistic infection, such as PML; liver injury; malignancies; injection-related reactions or systemic reactions including anaphylaxis and hypersensitivity reactions) | — |
Secondary
| Measure | Time frame |
|---|---|
| Treatment Cohort: Time to major IBD-related events (eg, hospitalizations, surgeries, or procedures) from Day 1 of Study VedolizumabSC-3004., Changes from baseline of Study VedolizumabSC-3003 in IMPACT-III total and subscale scores for subjects aged 9 to 17 years | — |
Countries
Belgium, Bulgaria, Denmark, Ireland, Italy, Netherlands, Poland, Portugal, Romania, Spain
Outcome results
None listed