Study of vedolizumab for kids with ulcerative colitis or Crohn's disease
Treatments studied
Part of Digestive system clinical trials.
This trial tests vedolizumab, a biologic medicine that reduces inflammation, in children and teenagers who have moderate to severe ulcerative colitis or Crohn's disease and have not responded well to other treatments.
Summary written for real people, not researchers, by Clin2.
Who can take part
- Must weigh at least 22 pounds (10 kg) at study start
- Must have a diagnosis of ulcerative colitis or Crohn's disease for at least 1 month
- Must have moderate to severe disease activity as determined by specific scores and endoscopy
- Must have tried and failed, lost response to, or been unable to tolerate corticosteroids, immunomodulators, or a TNF inhibitor (like infliximab or adalimumab)
- For ulcerative colitis, the inflammation must extend beyond the rectum (not just proctitis)
- Must be up to date on all childhood vaccines
- Cannot have had prior treatment with vedolizumab or similar integrin blockers (e.g., natalizumab, etrolizumab)
- No active or untreated infections, including tuberculosis, hepatitis B, or HIV
Quick eligibility check
Answer a few plain-language questions, based on this study's own requirements, to get a preliminary sense of fit.
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This study tests a medication called vedolizumab for people with moderate to severe ulcerative colitis or Crohn's disease. The goal is to see how well it works in a regular community setting, and it may help control symptoms if other treatments haven't worked.
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This study compares two biologic medicines, vedolizumab and infliximab, to see which works better for children with moderate to severe ulcerative colitis. It aims to find a more effective treatment to reduce symptoms and improve quality of life.
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