Last updated on October 2020

A Study to Assess the Efficacy and Safety of Golimumab in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis

Brief description of study

The purpose of this study is to evaluate efficacy of golimumab in inducing clinical remission as assessed by the Mayo score, in pediatric participants with moderately to severely active ulcerative colitis (UC). In addition, the safety profile of golimumab, in pediatric participants with moderately to severely active UC will be assessed.

Detailed Study Description

This is a multicenter study in pediatric participants aged 2 to 17 years with moderately to severely active UC, defined as a baseline Mayo score of 6 through 12, inclusive, with an endoscopy subscore of greater than or equal to (>=)2. This 54-week study will consist of a 6-week short-term phase and a 48-week long-term phase followed by a study extension (Week 54 to end of study). At Week 58, participants who are eligible will continue receiving golimumab in the study extension. The primary hypothesis is that golimumab is an effective therapy in pediatric UC relative to historical placebo control as assessed by clinical remission based on Mayo score. Safety will be monitored throughout the study.

Clinical Study Identifier: NCT03596645

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Mayo Clinic

Rochester, MN United States
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Cook Childrens Medical Center

Fort Worth, TX United States
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DHAT Research Institute

Garland, TX United States
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UZ Brussel

Jette, Belgium
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Asan Medical Center

Seoul, Korea, Republic of
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Samsung Medical Center

Seoul, Korea, Republic of
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Isala Kliniek

Zwolle, Netherlands
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GI For Kids

Knoxville, TN United States
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Digestive Disease Specialists Inc

Oklahoma City, OK United States
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Recruitment Status: Open

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