EUCTR2019-002038-35-BE进行中（未招募）1 期
A prospective study investigating ustekinumab concentrations through dried blood spot sampling in Crohn’s disease patients - DUST
Z Leuven0 个研究点目标入组 30 人开始时间: 2019年6月7日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 30
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
- •At least 18 years old at inclusion
- •Established diagnosis of Crohn’s disease with clinical disease activity (Harvery-Bradshaw index (HBI) > 4) and endoscopic activity (Simple Endoscopic Score for Crohn’s disease (SES-CD)= 6 or SES-CD = 4 in patients with ileitis only)
- •Adequate contraception in female of reproductive age (oral contraception, intra uterine device, sterilisation or barrier method)
- •Participants must sign an informed consent form indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study.
- •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 25
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 5
排除标准
- •Patients who previously received ustekinumab or an anti-IL23 antibody
- •Patients with ostomies
- •Women that are pregnant, nursing, or planning pregnancy
研究者
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