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

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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
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550 16th Street
San Francisco, California 94158
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Adelaide, South Australia
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300 Longwood Avenue
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Los Angeles, California 90027
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Morristown, New Jersey 07960
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New Hyde Park, New York 11040
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92 West Miller Street
Orlando, Florida 32806
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Rochester, Minnesota 55905
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601 Elmwood Avenue
Rochester, New York 14642
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Saint Paul, Minnesota 55114
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315 Martin Luther King Jr Way
Tacoma, Washington 98405
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