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).
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab in Pediatric Subjects With Moderate to Severe Ulcerative Colitis
You can join if…
Open to people ages 4–17
Diagnosis of Ulcerative Colitis (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.
You CAN'T join if...
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).
University of California, San Francisco /ID# 120901accepting new patients San Francisco, California, 94158, United States
Childrens Hospital Los Angeles (USC) /ID# 147452accepting new patients Los Angeles, California, 90027, United States
Clinical and Translational Research Center at UCLA /ID# 120909not yet accepting patients Los Angeles, California, 90095, United States
Children's Hospital of Orange County /ID# 120903accepting new patients Orange, California, 92868, United States