Condition: Ulcerative Colitis · Crohn's Disease · Sponsor: Takeda
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.
This description comes directly from the study's public registry record.
Takeda Contact · +1-877-825-3327 · medinfoUS@takeda.com
Always discuss trial participation with your own doctor first.
| Phoenix Childrens Hospital | Phoenix, Arizona, United States | Not Yet Recruiting |
| Loma Linda University | Loma Linda, California, United States | Not Yet Recruiting |
| Children's Hospital of Orange County | Orange, California, United States | Not Yet Recruiting |
| Stanford Children's Health | Palo Alto, California, United States | Not Yet Recruiting |
| Advocate Children's Hospital Park Ridge | Park Ridge, Illinois, United States | Not Yet Recruiting |
| Childrens Hospital of Michigan | Detroit, Michigan, United States | Not Yet Recruiting |
| Atlantic Health - Morristown Medical Center | Morristown, New Jersey, United States | Not Yet Recruiting |
| New York Presbyterian Hospital | New York, New York, United States | Not Yet Recruiting |
| University Children's Clinic | Cleveland, Ohio, United States | Not Yet Recruiting |
| Cleveland Clinic | Cleveland, Ohio, United States | Not Yet Recruiting |
| The University of Oklahoma Health Sciences Center | Oklahoma City, Oklahoma, United States | Recruiting |
| Penn State Health Milton South Hershey Medical Center | Hershey, Pennsylvania, United States | Not Yet Recruiting |
+ 42 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT06405087