EUCTR2015-000852-12-GB进行中（未招募）1 期
A Randomized Double-Blind Phase 4 Study to Evaluate the Safety and Proportion of Subjects With Fistula Healing in 2 Dose Regimens of Entyvio (Vedolizumab IV) in the Treatment of Fistulizing Crohn’s Disease - ENTERPRISE
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 34
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
- •-Adult subjects, aged 18 to 80 years, inclusive, with moderately to severely active CD and 1 to 3 draining perianal fistula(e) of at least 2 weeks duration.
- •-Subjects who have historically had an inadequate response with, lost
- •response to, or were intolerant to either conventional therapy or a TNFalpha antagonist for their underlying CD (does not require treatment failure for currently active draining fistula); for subjects from France only: subjects who have historically failed (ie, had an inadequate response with, lost response to, or was intolerant to) infliximab for treatment of their underlying CD or fistulizing CD.
- •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 85
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 15
排除标准
- •-Subjects who have perianal abscesses greater than 2 cm or an abscess that the investigator feels requires drainage based on either clinical assessment or MRI.
- •-Subjects who have a CDAI score greater than 400.
- •-Subjects who have ileostomy, colostomy, or known fixed symptomatic stenosis of the intestine.
- •-Subjects who have significant anal or rectal stenosis.
- •-Subjects who have any evidence of an active infection (eg, sepsis, cytomegalovirus, or listeriosis) during Screening, other than related to the fistula(e).
- •-Subjects who have a positive progressive multifocal leukoencephalopathy (PML) subjective checklist.
- •-Subjects who have received any investigational or approved biologic or biosimilar agent within 60 days of randomization.
- •-Subjects who have had prior exposure to vedolizumab, natalizumab, efalizumab, or rituximab, etrolizumab, or anti- mucosal addressin cell adhesion molecule-1 (MAdCAM-1) therapy.
- •-Subjects who have active or latent tuberculosis.
- •-Subjects who have a known history of hepatitis B virus (HBV), hepatitis
- •C virus (HCV), acquired human immunodeficiency virus (HIV), or are
- •found to be seropositive at Screening.
研究者
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