ISRCTN11094929进行中（未招募）4 期
IBD Reference and Biosimilar adalimumab CroSS over Study
niversity Hospital Southampton NHS Foundation Trust0 个研究点目标入组 150 人开始时间: 2019年7月24日最近更新:
适应症
试验速览
- 阶段
- 4 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
入排标准
- 性别
- All
入选标准
- •1. 18 years and over with a confirmed diagnosis of Crohn’s Disease
- •2. Stable dose of Humira over the 12 weeks prior to enrolment
- •3. mHBI < 8 at baseline
- •4. Anticipated to remain on the same adalimumab administration frequency for the duration of the study
- •5. Able to comply with study requirements
- •6. Able to provide informed consent
排除标准
- •1. Less than 18 years of age at enrolment
- •2. Not anticipated to remain on adalimumab therapy for more than 3 months after randomisation
- •3. Allergic to any of the known excipients of Humira or Imraldi
- •4. Scheduled for a surgical procedure or planned hospitalisation within 12 months of randomisation
- •5. Unable to comply with study requirements
- •6. Inability to provide consent
- •7. Pregnant or lactating women
研究者
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