JPRN-jRCT1031190056已完成未知
Research for medicinal predictive marker on Crohn's disease - E6011-CS1 study
Mikami Yohei0 个研究点目标入组 32 人开始时间: 2019年7月17日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 32
研究概览
简要总结
In Crohn's disease patients treated with anti-TNF and anti-IL-12/23p40 agents, CD16+ monocytes/monocytes [FCM] correlated better than CRP for predicting drug response during the treatment induction phase. (endpoint 1) and CRP correlated better at 1 year (endpoint 2). The AUC in ROC analysis for predicting drug efficacy for endpoint 1 and 2 ranged from 0.482 to 0.750. DNA methylation analysis using the loci may be an alternative method to FCM for measuring CD16+ monocytes/monocytes.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 16age old 至 ot applicable（—）
- 性别
- All
入选标准
- •(1)Patients aged 16 or older when the written agreements made.(Need agreement for deputy for patients under 20 years old)
- •(2)Patients diagnosed as definitive Crohn's disease according to the Policy Research business for Health and Labor Sciences Research Grant for Intractable diseases and etc. [ Diagnostic criteria and treatment policy for Crohn's disease, Ulcerative colitis](revised in 2017)
- •(3)Active Crohn's disease.(only Study1)
- •(4)The patients who are indicated of Biologics(adalimumab,infliximab,ustekinumab) treatment on Crohn's disease.(only Study1)
- •(5)Patients who voluntarily provided written informed consent to participate in the study.
- •(6)Patients who are fully explained about the rules of this research and have the will and ability to abide by them.
排除标准
- •(1)Patients with history of following intestinal surgery, or patients who are scheduled for following intestinal surgery.
- •Enterectomy within 12 weeks prior to the beginning of the study, stoma or ileal pouch. (except rectostomy)
- •(2)Patients who have received cytapheresis (granulocyte apheresis/granulocyte monocyte apheresis[GCAP/GMA], leukocytopheresis[LCAP]) within 2 weeks prior to the beginning of the study.
- •(3)Patients who tested positive for the following viruses in screening test.
- •HBV, HCV, HIV and HTLV-1
研究者
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