Last updated on July 2019
Efficacy and Safety of Adalimumab in Pediatric Subjects With Moderate to Severe Ulcerative Colitis
Are you eligible to participate in this study?
You may be eligible for this study if you meet the following criteria:
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Conditions: Ulcerative Colitis
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Age: Between 4 - 17 Years
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Gender: Male or Female
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).
