JPRN-jRCT2080222598
Completed
Phase 3
A Multicenter, Randomized, Double-Blind Study of the Human Anti-TNF Monoclonal Antibody Adalimumab in Pediatric Subjects With Moderate to Severe Ulcerative Colitis [M11-290]
Conditionslcerateive Colotis
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- lcerateive Colotis
- Sponsor
- AbbVie GK
- Enrollment
- 101
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
Safety and efficacy of adalimumab in pediatric patients were evaluated.
Investigators
Eligibility Criteria
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).
Outcomes
Primary Outcomes
Not specified
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