Ulcerative Colitis - Vedolizumab- With/Without Prior Exposure to Anti-TNF（Tumor Necrosis Factor）Therapy
2020年12月17日 更新者：Aida Habtezion、Stanford University
A Case-control Study to Evaluate the Immunoinflammatory Effect of Prior Exposure to Anti-TNF Therapy in Patients With Ulcerative Colitis Starting Vedolizumab Therapy
A case-control study to evaluate the immunoinflammatory effect of prior exposure to anti-TNF therapy in patients with ulcerative colitis starting vedolizumab therapy
研究概览
详细说明
Inflammatory bowel disease (IBD)- ulcerative colitis (UC) and Crohn's disease (CD)- are chronic conditions of the gastrointestinal tract.
Treatment generally consists of immunosuppression to modify the dysregulated immune responses.
Vedolizumab, an inhibitor of α4β7, is a highly effective therapy for treating IBD, that minimized adverse effects through its gut selective inhibition of lymphocyte trafficking.
However, the mechanism of action remains incompletely characterized especially in those previously treated to other biologics and why some patients are either vedolizumab non-responders or fail to respond over time.
We would like to address the question whether anti-TNF non-responders as well as those that either do not respond or fail overtime to respond to vedolizumab identifies a specific population with difficult to treat disease that have alternate trafficking patterns and whether prior exposure to anti-TNF alters the mucosal immune responses, and/or trafficking patterns when compared to anti-TNF naive patients that may help explain impaired response to vedolizumab induction therapy.
研究类型
观察性的
注册 (实际的)
1
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
取样方法
非概率样本
研究人群
clinical indication for biologic therapy, adult patients (>18) with the diagnosis of inflammatory bowel disease (Ulcerative Colitis) who are naive or failed anti-TNF therapy previously.
描述
Inclusion Criteria:
- adult patients (>18 years old)
- clinical diagnosis of inflammatory bowel disease (Ulcerative Colitis)
- clinical indication for biologic therapy
- naive or failed anti-TNF therapy previously
Exclusion Criteria:
- patients allergic or intolerant to vedolizumab,
- past use of vedolizumab;
- patient unable to give consent to enter the study
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
vedolizumab-UC-naïve to TNF-antagonist
standard vedolizumab induction therapy for ulcerative colitis patients who are naïve to TNF-antagonist therapy
|
standard vedolizumab induction (300mg IV at week 0, 2, 6)
其他名称：
|
|
vedolizumab-UC- previous TNF-antagonist
standard vedolizumab induction therapy for ulcerative colitis patients with previous TNF-antagonist exposure
|
standard vedolizumab induction (300mg IV at week 0, 2, 6)
其他名称：
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Analysis of blood and tissue leukocytes (T cells, B cells and Dendritic cells)
大体时间：changes from enrollment to end of treatment (week 14)
|
Analysis of blood and tissue leukocytes (T cells, B cells and Dendritic cells) in patients with and without prior anti-TNF exposure
|
changes from enrollment to end of treatment (week 14)
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Analysis of the serum and tissue concentrations of inflammatory markers (interleukins)
大体时间：changes from enrollment to end of treatment (week 14)
|
Analysis of the serum and tissue concentrations of inflammatory markers (interleukins) in vedolizumab responders versus non-responders
|
changes from enrollment to end of treatment (week 14)
|
|
Analysis of the serum and tissue concentrations of vedolizumab
大体时间：changes from enrollment to end of treatment (week 14)
|
Analysis of the serum and tissue concentrations of vedolizumab in patients with and without prior anti-TNF exposure
|
changes from enrollment to end of treatment (week 14)
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Aida Habtezion, MD、Stanford University
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Feagan BG, Rutgeerts P, Sands BE, Hanauer S, Colombel JF, Sandborn WJ, Van Assche G, Axler J, Kim HJ, Danese S, Fox I, Milch C, Sankoh S, Wyant T, Xu J, Parikh A; GEMINI 1 Study Group. Vedolizumab as induction and maintenance therapy for ulcerative colitis. N Engl J Med. 2013 Aug 22;369(8):699-710. doi: 10.1056/NEJMoa1215734.
- Sandborn WJ, Feagan BG, Rutgeerts P, Hanauer S, Colombel JF, Sands BE, Lukas M, Fedorak RN, Lee S, Bressler B, Fox I, Rosario M, Sankoh S, Xu J, Stephens K, Milch C, Parikh A; GEMINI 2 Study Group. Vedolizumab as induction and maintenance therapy for Crohn's disease. N Engl J Med. 2013 Aug 22;369(8):711-21. doi: 10.1056/NEJMoa1215739.
- Schmitt H, Billmeier U, Dieterich W, Rath T, Sonnewald S, Reid S, Hirschmann S, Hildner K, Waldner MJ, Mudter J, Hartmann A, Grutzmann R, Neufert C, Munster T, Neurath MF, Atreya R. Expansion of IL-23 receptor bearing TNFR2+ T cells is associated with molecular resistance to anti-TNF therapy in Crohn's disease. Gut. 2019 May;68(5):814-828. doi: 10.1136/gutjnl-2017-315671. Epub 2018 May 30.
- Boden EK, Shows DM, Chiorean MV, Lord JD. Identification of Candidate Biomarkers Associated with Response to Vedolizumab in Inflammatory Bowel Disease. Dig Dis Sci. 2018 Sep;63(9):2419-2429. doi: 10.1007/s10620-018-4924-8. Epub 2018 Jan 25.
- Suzawa K, Kobayashi M, Sakai Y, Hoshino H, Watanabe M, Harada O, Ohtani H, Fukuda M, Nakayama J. Preferential induction of peripheral lymph node addressin on high endothelial venule-like vessels in the active phase of ulcerative colitis. Am J Gastroenterol. 2007 Jul;102(7):1499-509. doi: 10.1111/j.1572-0241.2007.01189.x. Epub 2007 Apr 24.
- Kobayashi M, Hoshino H, Masumoto J, Fukushima M, Suzawa K, Kageyama S, Suzuki M, Ohtani H, Fukuda M, Nakayama J. GlcNAc6ST-1-mediated decoration of MAdCAM-1 protein with L-selectin ligand carbohydrates directs disease activity of ulcerative colitis. Inflamm Bowel Dis. 2009 May;15(5):697-706. doi: 10.1002/ibd.20827.
- Rosario M, Dirks NL, Gastonguay MR, Fasanmade AA, Wyant T, Parikh A, Sandborn WJ, Feagan BG, Reinisch W, Fox I. Population pharmacokinetics-pharmacodynamics of vedolizumab in patients with ulcerative colitis and Crohn's disease. Aliment Pharmacol Ther. 2015 Jul;42(2):188-202. doi: 10.1111/apt.13243. Epub 2015 May 20. Erratum In: Aliment Pharmacol Ther. 2015 Nov;42(9):1135.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2020年10月29日
初级完成 (实际的)
2020年12月11日
研究完成 (实际的)
2020年12月11日
研究注册日期
首次提交
2018年12月10日
首先提交符合 QC 标准的
2019年1月9日
首次发布 (实际的)
2019年1月14日
研究记录更新
最后更新发布 (实际的)
2020年12月21日
上次提交的符合 QC 标准的更新
2020年12月17日
最后验证
2020年12月1日
更多信息
与本研究相关的术语
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
不
IPD 计划说明
We will share the data through the publication of results.
Individual participant data was not promised to be shared.
药物和器械信息、研究文件
研究美国 FDA 监管的药品
是的
研究美国 FDA 监管的设备产品
不
在美国制造并从美国出口的产品
是的
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
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Fondazione IRCCS Policlinico San Matteo di Pavia招聘中
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Second Affiliated Hospital of Wenzhou Medical University完全的
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Sixth Affiliated Hospital, Sun Yat-sen University招聘中
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University Medical Center Groningen完全的
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Odyssey Therapeutics招聘中溃疡性结肠炎 (UC) | UC - 溃疡性结肠炎澳大利亚, 奥地利, 约旦, 波兰, 乌克兰, 新西兰, 加拿大, 捷克语, 立陶宛, 摩尔多瓦
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TakedaTakeda Development Center Americas, Inc.完全的