EUCTR2013-003032-77-PL进行中（未招募）1 期
A Multicenter, Randomized, Double-Blind Study of the Human Anti-TNF Monoclonal Antibody Adalimumab in PediatricSubjects with Moderate to Severe Ulcerative Colitis.
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 93
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •? Subjects from the ages of 4 to 17 prior to baseline dosing.
- •? Diagnosis of 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
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 93
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
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 TB
研究者
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