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Sponsor: Takeda
Conditions: Ulcerative Colitis, Crohn's Disease
Interventions: Vedolizumab SC, No Intervention
Countries: United States, Belgium, Bulgaria, Denmark, Ireland, Italy, Japan, Netherlands
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.
Sex: ALL
Age: 2 Years to 17 Years
Healthy volunteers: No
Study type: INTERVENTIONAL
Inclusion Criteria for Treatment Cohort 1. Has completed Week 34 of Study VedolizumabSC-3003 (NCT06100289) and achieved clinical response at Week 34 and was corticosteroid-free for at least the last 4 weeks (Week 30 to Week 34). Clinical response for participants with UC is defined as a reduction of partial Mayo score of \>=2 points and \>= 25 percentage (%) from baseline (from VedolizumabSC-3003 \[NCT06100289\]), including a \>=1-point decrease in the Mayo stool frequency subscore and a \>=1-point reduction in the rectal bleeding subscore or absolute rectal bleeding subscore of less than or equal to (\<=) 1 point. Clinical response for participants with CD is defined as a pediatric Crohn's disease activity index (PCDAI) \<=30 with a reduction in the PCDAI of \>=15 points from baseline (from VedolizumabSC-3003 \[NCT06100289\]). Inclusion Criteria for Observational Cohort 1\. Has received at least 1 dose of vedolizumab during Study VedolizumabSC-3003 (NCT06100289) and early terminated OR completed the Week 34 clinic visit of Study VedolizumabSC-3003 (NCT06100289) but was not eligible to enroll in the treatment cohort of this study. Exclusion Criteria for Treatment Cohort 1. Has hypersensitivity or allergies to vedolizumab or any of its excipients. 2. The participant currently requires major surgical intervention for UC or CD (example, bowel resection), or is anticipated to require major surgical intervention for UC or CD during the study.
- Phoenix, Arizona, United States
- Loma Linda, California, United States
- Orange, California, United States
- Palo Alto, California, United States
- Park Ridge, Illinois, United States
- Detroit, Michigan, United States
- Morristown, New Jersey, United States
- New York, New York, United States
- Cleveland, Ohio, United States
- Cleveland, Ohio, United States
- Oklahoma City, Oklahoma, United States
- Hershey, Pennsylvania, United States
- Charleston, South Carolina, United States
- Tacoma, Washington, United States
- Brussels, Brussels Capital, Belgium
- Liège, Belgium
- Plovdiv, Bulgaria
- Hvidovre, Capital Region, Denmark
- Crumlin, Dublin, Ireland
- Messina, Italy
- Milan, Italy
- Pescara, Italy
- Roma, Italy
- Kurume-shi, Fukuoka, Japan
- Bunkyo-ku, Tokyo, Japan
- Setagaya-ku, Tokyo, Japan
- Nijmegen, Netherlands
- Rzeszów, Poland
- Warsaw, Poland
- Warsaw, Poland
- + 24 more on CT.gov