MLN0002-3025
A Randomized, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of Vedolizumab Intravenous as Maintenance Therapy in Pediatric Subjects with Moderately to Severely Active Crohn’s Disease Who Achieved Clinical Response Following Open–Label Vedolizumab Intravenous Therapy
- Sex at Birth: Any
- Age: Child (Birth - 17)
- Accepting Healthy People: No
- Type: Interventional / Therapeutic
- Trial Phase: Phase III
- Conditions Being Studied: Crohns Disease
Study Purpose
This study will help in collecting data for the dosing (amount of study medicine you get), effectiveness (how well the study medicine works for you), and safety (any side effects that you or other patients have) of vedolizumab in the treatment of moderate-to-severe CD in children.
Who Can Participate
Age: 2-17
Locations
UH Cleveland Medical Center
11100 Euclid Avenue
Cleveland OH, 44106
- UH IRB: STUDY20210527
- StudyID: 2020-0494
- ClinicalTrials.gov: NCT04779320
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