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.
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|
|Sponsor||Janssen Research & Development, LLC|
|Last Modified on||5 November 2020|
Select a piece of text and start making personal notes.
You have contacted , on
Your message has been sent to the study team at ,
Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.Learn more
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.Learn more
Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.Learn more
Congrats! You have your own personal workspace now.