Last updated on June 2019

Long-term Safety With Vedolizumab Intravenous (IV) in Pediatric Participants With Ulcerative Colitis (UC) or Crohn's Disease (CD)

Brief description of study

The purpose of this study is to determine the safety profile of long-term vedolizumab IV treatment in pediatric participants with UC or CD.

Detailed Study Description

The drug being tested in this study is called Vedolizumab. Vedolizumab is being tested to treat pediatric participants who have moderately to severely active UC or CD.

This study will look at the long-term safety profile in participants who take vedolizumab IV. Participants will be randomly assigned (by chance, like flipping a coin) which will remain undisclosed to the participant and investigator during this double blind study (up to Week 40) maintaining the dose at study entry and escalating the dose at disease worsening.

The dosing regimen selected for the long-term study is intended to maintain clinical response at the lowest possible exposure.

At the discretion of the investigator, participants receiving the low dose (150 or 100 mg) of vedolizumab IV may be escalated to the high dose (300 or 200 mg) if the participants demonstrate disease worsening at 2 consecutive visits (scheduled or unscheduled).

Participants who experience continued disease worsening during the study despite being administered vedolizumab 300 or 200 mg every 8 weeks (Q8W) will be discontinued from the study.

Study duration is expected to be up to 5 years, depending on the enrollment rate in the previous randomized double blind study (MLN0002-2003).

Clinical Study Identifier: NCT03196427

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Cedars-Sinai Medical Center

Los Angeles, CA United States
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Mount Sinai Medical Center

Chicago, IL United States
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Northwell Health

Lake Success, NY United States
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Children's Medical Center Dallas

Chapel Hill, NC United States
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Mayo Clinic - Rochester

Houston, TX United States
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Texas Children's Hospital

Houston, TX United States
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Seattle Children's Hospital

Seattle, WA United States
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Hopital Robert Debre

Paris Cedex 19, France
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Hopital de la Timone

Marseille Cedex 5, France
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King's College Hospital

Hartford, United Kingdom
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