EUCTR2015-000939-33-ES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
适应症
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 6 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 or is naïve to TNF-alpha antagonist therapy but is failing current treatment.
- •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 638
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •1.Clinical evidence of abdominal abscess or toxic megacolon at Screening.
- •2.The subject has had an extensive colonic resection, subtotal or total colectomy.
- •3.The subject has had ileostomy, colostomy, or known fixed symptomatic stenosis of the intestine.
- •4.The subject has a diagnosis of Crohn's colitis or indeterminate colitis, ischemic colitis, radiation colitis, diverticular disease associated with colitis, or microscopic colitis.
- •5.The subject has received any of the following within 30 days of screening:
- •a.Non-biologic therapies other than those specifically listed in Section Permitted Medications For Treatment of UC.
- •b.An approved non-biologic therapy in an investigational protocol.
- •6.The subject has received any investigational or approved biologic or biosimilar agent within 60 days or 5 half lives prior to the screening (whichever is longer).
- •7.The subject has previously received natalizumab, efalizumab, adalimumab, or rituximab.
- •8.The subject has history or evidence of adenomatous colonic polyps that have not been removed, or colonic mucosal dysplasia.
- •9.Evidence of an active infection during Screening.
- •10.Evidence of, or treatment for, C. difficile or other intestinal pathogen within 28 days prior to the 1st dose of study drug.
- •11.The subject has chronic HBV or HCV infection.
- •12.The subject has active or latent TB, regardless of treatment history.
- •13.The subject has used a topical (rectal) treatment with (5-ASA) or corticosteroid enemas/suppositories within 2 weeks of the administration of the 1st dose of study drug.
- •14.The subject has a history of hypersensitivity or allergies to vedolizumab or adalimumab.
- •15.The subject has a positive PML subjective symptom checklist prior to the administration of the first dose of study drug.
研究者
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