Vedolizumab for Children and Teenagers with Crohn's Disease
This study is testing vedolizumab, a medicine that helps reduce inflammation in the digestive system, for children and teenagers with moderate to severe Crohn's disease (CD). You may be able to join if you are between 2 and 17 years old, weigh at least 10 kg, and your CD has not responded well to other treatments. The main goal is to see if participants achieve remission (when symptoms improve or disappear and an endoscopy shows no inflammation) after 54 weeks of treatment. Participants will receive three initial infusions of vedolizumab, and then those who respond will receive either a high or low dose every eight weeks. The study plans to enroll about 120 participants, but its current status is unclear.
- Study design
- This is an interventional study with approximately 120 participants. After an initial treatment period, participants who respond will be randomly assigned to receive either a high or low dose of vedolizumab.
- What's involved
- You will receive three infusions of vedolizumab over six weeks. If you respond, you will then receive infusions every eight weeks for an unspecified duration, with remission checked at Week 54.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary endpoints are measured at Week 54, indicating follow-up for at least this duration.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
A Study of Vedolizumab in Children and Teenagers With Moderate to Severe Crohn's Disease (CD)
At a glance
Conditions
Where it's being run
96 sites across 72 statesWho to contact
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Do you actually qualify for this trial?
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Exclusion
What this trial measures
- Percentage of Participants With Clinical Remission at Week 54 Based on Pediatric Crohn's Disease Activity Index (PCDAI) Score ≤10Week 54
Clinical remission is defined by PCDAI score ≤10. The PCDAI was specifically designed for use in children. The PCDAI includes a child-specific item: the height velocity variable as well as three laboratory parameters: hematocrit (HCT) (adjusted for age and sex), erythrocyte sedimentation rate (ESR), and albumin level. The PCDAI score ranges from 0 to 100, with higher scores indicating more active disease. A score of \<10 will be consistent with inactive disease, 11 to 30 will indicate mild disease, and \>30 will indicate moderate to severe disease. A decrease of 12.5 points is taken as evidence of improvement.
- Percentage of Participants With Endoscopic Response at Week 54 Based on Simple Endoscopic Score for Crohn's Disease [SES-CD] ScoreWeek 54
Endoscopic response is defined as at least a 50% reduction in SES-CD score from Baseline. The overall SES-CD score ranges from 0 to 56 and is the sum of 4 variables (ie, size of ulcers \[cm\], ulcerated surface, affected surface \[%\], and presence of narrowing) across 5 bowel segments (ie, rectum, descending and sigmoid colon, transverse colon, ascending colon, and ileum). Each variable is coded from 0 to 3 based on severity, where 0 is none or not severe and 3 is the most severe case, with the sum of the scores for each variable ranging from 0 to 15, except for presence of narrowing. Presence of narrowing ranges from 0 to 11 since a severity of 3 represents a narrowing which a colonoscope cannot be passed and, thus, can only be observed once among the bowel segments. The segmental SES-CD score is the sum of the 4 variables for each bowel segment and can range from 0 to 12, where each individual variable score ranges from 0 to 3.