EUCTR2018-004967-30-GB进行中（未招募）1 期
IBD Reference and Biosimilar adalimumab CroSS over Study - iBaSS
niversity Hospital Southampton NHS Foundation Trust0 个研究点目标入组 150 人开始时间: 2019年1月14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
- 150
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 with the following characteristics are eligible for this study:
- •18 years and over with a confirmed diagnosis of Crohn’s Disease
- •Stable dose of Humira over the 12 weeks prior to enrolment
- •mHBI < 8 at baseline
- •Anticipated to remain on the same adalimumab administration frequency for the duration of the study
- •Able to comply with study requirements
- •Able to provide informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 0
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •Subjects with the following characteristics are ineligible for this study:
- •Less than 18 years of age at enrolment
- •Not anticipated to remain on adalimumab therapy for more than 3 months after randomisation
- •Allergic to any of the known excipients of Humira or Imraldi
- •Scheduled for a surgical procedure or planned hospitalisation within 12 months of randomisation
- •Unable to comply with study requirements
- •Inability to provide consent
- •Pregnant or lactating women
研究者
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