JPRN-jRCT2080222598已完成3 期
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]
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- AbbVie GK
- 入组人数
- 101
研究概览
简要总结
Safety and efficacy of adalimumab in pediatric patients were evaluated.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 4age old 至 <= 17age old（—）
- 性别
- All
入选标准
- •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.
排除标准
- •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).
研究者
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