EUCTR2017-001225-41-IE进行中（未招募）1 期
A Multicenter, Randomized, Double-Blind, Placebo- Controlled Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Crohn's Disease who Completed the Studies M14-431 or M14-433
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 747
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
- •For Substudy 1:
- •- Subject who receive double-blind treatment in Study M14- 431 or Study M14-433 and achieve clinical response.
- •- Subject completes Week 12 or Week 24 study procedures in study M14-431 or study M14-433. The final endoscopy for studies M14-431 or M14-433 may be missing, if the endoscopy cannot be performed during the coronavirus SARS-CoV-2 pandemic.
- •For Substudy 2:
- •- Subject completes Substudy 1 of Study M14-430. The week 52 endoscopy may be missing, if the endoscopy cannot be performed during the coronavirus SARS-CoV-2 pandemic.
- •- Subject achieved clinical response at Week 24 and completed Week 24 visit and procedures in Part 3/Cohort 3 of Study M14-431.
- •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 710
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 37
排除标准
- •For Sub-studies 1 and 2:
- •- Subject is considered by the investigator, for any reason, to be an unsuitable candidate for the study.
- •- Subject who has a known hypersensitivity to upadacitinib or its excipients, or had an adverse event during Study M14-431, M14-433,or Substudy 1 of Study M14-430 that in the investigator's judgment makes the subject unsuitable for this study.
- •- Subject with any active or chronic recurring infections based on the investigator's assessment that makes the subject an unsuitable candidate for the study. Subjects with serious infections undergoing treatment may be enrolled BUT NOT dosed until the infection treatment has been completed and the infection is resolved, based on the investigator's assessment.
- •- Subject with high grade colonic dysplasia or malignancy diagnosed at the endoscopy performed at the final visit of Study M14-431, M14-433,or Substudy 1 of Study M14-430 (Week 52).
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