EUCTR2015-000939-33-BG进行中（未招募）1 期
A Randomized, Double-Blind, Double-Dummy, Multicenter, Active-Controlled Study to Evaluate the Efficacy and Safety of Vedolizumab IV Compared to Adalimumab SC in Subjects With Ulcerative Colitis - Efficacy and Safety of Vedolizumab IV Compared to Adalimumab SC in Subjects With Ulcerative Colitis
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 771
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
入选标准
- •1.Has a diagnosis of ulcerative colitis established at least 3 months prior to screening by clinical and endoscopic evidence and corroborated by a histopathology report.
- •2.Has moderately to severely active ulcerative colitis as determined by a Mayo score of 6 to 12 with an endoscopic subscore greater than or equal to >=2 within 14 days prior to the randomization.
- •3.Has evidence of ulcerative colitis proximal to the rectum (>=15 centimeter [cm] of involved colon).
- •4.With extensive colitis (up to the hepatic flexure) or pancolitis of >8 years duration or left-sided colitis of >12 years duration must have documented evidence that a surveillance colonoscopy was performed within 12 months of the initial screening visit (may be performed during the Screening Period).
- •5.Has had previous treatment with tumor necrosis factor- alpha (TNF-alpha) antagonists without documented clinical response to treatment (eg, due to lack of response [primary nonresponders], loss of response, or intolerance [secondary nonresponder], or
- •b. Has previously used a TNF-a antagonist (except adalimumab), and discontinued its use due to reasons other than safety
- •5. Is naïve to TNF-alpha antagonist therapy but is failing current treatment(ie, corticosteroids, 5-aminosalicylate, or immunomodulators)..
- •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 735
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 23
排除标准
- •1.The subject has had an extensive colonic resection, subtotal or total colectomy.
- •2.The subject has any evidence of an active infection during Screening.
- •3.The subject has a positive progressive multifocal leukoencephalopathy (PML) subjective symptom checklist at Screening or before the administration of study drug at Day 1.
- •4. The subject has received any investigational or approved biologic biosimilar agent (other than those listed below) within 60 days or 5 half lives prior to screening (whichever is longer)
- •5. The subject has had prior to vedolizumab, natalizumab, efalizumab, adalimumab, etrolizumab, AMG-181, anti-mucosal addressin cell adhesion molecule-1 (MAdCAM-1)-antibodies, or rituximab.
研究者
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