Active Ulcerative Colitis (UC) or Crohn's disease (CD)
Conditions
Brief summary
For the Treatment Cohort: The primary endpoint for this study is the incidence of adverse events (AEs)., For the Observational Cohort: Incidence of prespecified safety events (serious infections, malignancies, progressive multifocal leukoencephalopathy [PML], concerns about growth and pubertal development, and bowel surgery).
Detailed description
For the Treatment Cohort: • Time to major IBD-related events (eg, hospitalizations, surgeries, or procedures). • Changes from baseline of Studies MLN0002-3024 (UC) or MLN0002-3025 (CD) in IMPACT-III total and subscale scores for subjects aged 9 to 17 years as measured every 24 weeks.
Interventions
DRUGPREDNISONE
Sponsors
Takeda Development Center Americas Inc.
Eligibility
Sex/Gender
All
Age
0 Years to 17 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| For the Treatment Cohort: The primary endpoint for this study is the incidence of adverse events (AEs)., For the Observational Cohort: Incidence of prespecified safety events (serious infections, malignancies, progressive multifocal leukoencephalopathy [PML], concerns about growth and pubertal development, and bowel surgery). | — |
Secondary
| Measure | Time frame |
|---|---|
| For the Treatment Cohort: • Time to major IBD-related events (eg, hospitalizations, surgeries, or procedures). • Changes from baseline of Studies MLN0002-3024 (UC) or MLN0002-3025 (CD) in IMPACT-III total and subscale scores for subjects aged 9 to 17 years as measured every 24 weeks. | — |
Countries
Belgium, Croatia, Greece, Hungary, Italy, Poland
Outcome results
None listed