EUCTR2013-001746-33-AT进行中（未招募）1 期
A Multicenter, Randomized, Double-Blind Study to Evaluate Higher Versus Standard Adalimumab Dosing Regimens for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Crohn's Disease and Evidence of Mucosal Ulceration
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
- 500
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 colonic, ileocolonic, or ileal Crohn´s disease for = 3 months prior Baseline and confirmed by endoscopy during the Screening Period or endoscopy performed within 45 days before Baseline.
- •3) Crohn's Disease Activity Index (CDAI) = 220 and = 450 at Baseline despite concurrent or prior treatment with oral corticosteroids and/or immunosuppressants
- •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 485
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 15
排除标准
- •1) Subject with ulcerative colitis or indeterminate colitis
- •2) Subject who has had surgical bowel resections within the past 6 months or is planning resection
- •3) Subject with an ostomy or ileoanal pouch
- •4) Subject with bowel stricture or abdominal or peri-anal abscess
- •5) Subject who has short bowel syndrome
- •6) Chronic recurring infections or active TB
研究者
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