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

Status:	Recruiting
Conditions:	Colitis, Colitis, Gastrointestinal
Therapuetic Areas:	Gastroenterology
Healthy:	No
Age Range:	4 - 17
Updated:	3/10/2019
Start Date:	October 13, 2014
End Date:	September 4, 2020
Contact:	ABBVIE CALL CENTER
Email:	abbvieclinicaltrials@abbvie.com
Phone:	847.283.8955

A Multicenter, Randomized, Double-Blind Study of the Human Anti-TNF Monoclonal Antibody 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 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.

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).

We found this trial at

sites

Womens and Childrens Hospital /ID# 127538

Adelaide, South Australia

from

Adelaide,