The purpose of the study is to demonstrate the efficacy and safety, and to assess the pharmacokinetics of adalimumab administered subcutaneously (SC) in pediatric subjects with moderate to severe ulcerative colitis (UC).
Diagnosis of UC for at least 12 weeks prior to screening, confirmed by endoscopy with biopsy.
Active ulcerative colitis with a Mayo Score of 6 - 12 points and endoscopy subscore of 2 - 3 despite concurrent treatment with oral corticosteroids or immunosuppressants or both.
Subject with Crohn's disease (CD) or indeterminate colitis (IC).
Current diagnosis of fulminant colitis and/or toxic megacolon.
Subjects with disease limited to the rectum (ulcerative proctitis) during the screening endoscopy.
Chronic recurring infections or active tuberculosis (TB).
October 5, 2020
Primary Contact Information
For more information on this trial, visit clinicaltrials.gov.
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