EUCTR2013-001682-16-AT进行中（未招募）1 期
A Double-Blind, Randomized, Multicenter Study of Higher Versus Standard Adalimumab Dosing Regimens for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 840
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
- •1)Subject is between the ages of 18 to 75 years
- •2) Diagnosis of UC for at least 90 days, confirmed by endoscopy (colonoscopy or flexible sigmoidoscopy) during the Screening Period
- •3) 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? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 683
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 157
排除标准
- •1. Subject with Crohn's disease (CD) or indeterminate colitis (IC).
- •2. Current diagnosis of fulminant colitis and/or toxic megacolon.
- •3. Subjects with disease limited to the rectum (ulcerative proctitis) during the screening endoscopy.
- •4. Chronic recurring infections or active TB
研究者
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