ENTERPRET study to treat Moderately to Severely Active Ulcerative Colitis
Brief description of study
This is a Phase 4, open-label study to test whether vedolizumab IV at higher (optimized) doses as compared to standard dose is safe and effective on mucosal healing in adults with moderate-severe UC.
Detailed description of study
All subjects will get induction dose of vedolizumab.
Those who are responders (respond to treatment) or have low clearance will receive treatment per physician discretion.
Those with high drug clearance and are nonresponders will be randomized to receive either standard or optimized doses. All randomized subjects will receive vedolizumab IV either 300mg or 600mg every 4 or 8 weeks.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
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Conditions:
Ulcerative Colitis
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Age: Between 18 Years - 75 Years
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Gender: All
Updated on
26 Jun 2019.
Study ID: 829190
