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The purpose of this multi-center study of is to evaluate use of vedolizumab as a maintenance therapy for children and teens with ulcerative colitis, a long-term disease that causes lower abdominal pain and diarrhea. Standard treatments include medicines, such as steroids, and biologic therapies that work in different ways to reduce inflammation. The study drug has been approved for treatment of ulcerative colitis in adults and is still being tested with pediatric patients to determine best dosing levels, effectiveness, and side effects.
Subject to certain exclusion criteria, this study is open to pediatric patients with moderately to severely active Crohn’s disease, whose condition was not treatable through the current standard of care.
Boys and Girls: Ages 2 through 17 years
About 13 visits will be required for the various study stages, screening, induction, maintenance, and follow-up. During visits, physical exams and tests will be provided, including up to 3 colonoscopies during the study period, and the study drug will be given intravenously at specified visits 3 times during the 10-week induction period and 5 times during the 44-week maintenance period. Participants who show improvement in clinical response at 54 weeks, may be invited by their study doctor to continue in a separate extension study for up to 5 years.
Visits: About 13
Duration: About 14 months, with follow-up phone calls every 6 months for 2 years after the last dose of the study drug
Takeda Development Center Americas
Study Description at the National Institutes of Health
Whitney Sunseri, MD
For more information about the study or enrollment, please contact:
Susan Richey, RN, Clinical Research Nurse Coordinator
Children's Hospital's main campus is located in the Lawrenceville neighborhood. Our main hospital address is:
UPMC Children’s Hospital of Pittsburgh
One Children’s Hospital Way
4401 Penn Ave.
Pittsburgh, PA 15224
In addition to the main hospital, Children's has many convenient locations in other neighborhoods throughout the greater Pittsburgh region.
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