Efficacy and Safety of Adalimumab in Pediatric Subjects With Moderate to Severe Ulcerative Colitis

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).

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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).