EUCTR2015-000481-58-IT进行中（未招募）1 期
A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Vedolizumab Subcutaneous as MaintenanceTherapy in Subjects With Moderately to Severely Active Crohn's Disease Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy - Efficacy and Safety of Vedolizumab SC as Maintenance Therapy in Crohn's Disease
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
- 644
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
- •1. The subject has a diagnosis of Crohn's disease (CD) established at least 3 months prior to screening, by clinical and endoscopic evidence
- •and corroborated by a histopathology report.
- •2. The subject has moderately to severely active CD.
- •3. The subject has CD involvement of the ileum and/or colon, at a minimum.
- •4. The subject has extensive colitis or pancolitis of >8 years duration or limited colitis of >12 years duration must have documented evidence
- •that a surveillance colonoscopy was performed within 12 months of the initial screening visit.
- •5. Subjects with a family history of colorectal cancer, personal history of increased colorectal cancer risk, age >50 years, or other known risk factors must be up-to-date on colorectal cancer surveillance at
- •6. The subject has demonstrated an inadequate response to, loss of response to, or intolerance of at least 1 of the following agents: immunomodulators, corticosteroids, or TNF-alpha antagonists.
- •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 799
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 25
排除标准
- •1. The subject has evidence of abdominal abscess at the initial Screening
- •2. The subject has had extensive colonic resection, subtotal or total
- •3. The subject has a history of >3 small bowel resections or diagnosis of
- •short bowel syndrome.
- •4. The subject has received tube feeding, defined formula diets, or
- •parenteral alimentation within 21 days prior to the administration of the
- •first dose of study drug.
- •5. The subject has had ileostomy, colostomy, or known fixed
- •symptomatic stenosis of the intestine.
- •6. The subject has received any of the investigational or approved nonbiologic
- •therapies (eg, cyclosporine, tacrolimus, thalidomide,
- •methotrexate, or tofacitinib except for those specifically listed in the
- •protocol) for the treatment of underlying disease within 30 days or 5
- •half-lives of screening (which ever is longer).
- •7. The subject has received any investigational or approved biologic or
- •biosimilar agent within 60 days or 5 half-lives of screening (which ever
- •is longer).
- •8. The subject has used topical (rectal) treatment with 5-ASA or
- •corticosteroid enemas/suppositories within 2 weeks of the
- •administration of the first dose of study drug.
- •9. The subject requires currently or is anticipated to require surgical
- •intervention for CD during the study.
- •10. The subject has a history or evidence of adenomatous colonic polyps
- •that have not been removed.
- •11. The subject has a history or evidence of colonic mucosal dysplasia.
- •12. The subject has a suspected or confirmed diagnosis of ulcerative
- •colitis, indeterminate colitis, ischaemic colitis, radiation colitis,
- •diverticular disease associated with colitis, or microscopic colitis.
- •13. The subject has evidence of an active infection during the Screening
- •14. The subject has evidence of, or treatment for, C. difficile infection or
- •other intestinal pathogen with 28 days prior to first dose of study drug.
- •15. The subject has chronic hepatitis B virus (HBV) or hepatitis C virus
- •(HCV) infection.
- •16. The subject has active or latent TB, regardless of treatment history,
- •as evidenced by any of the following:
- •17. The subject has any identified congenital or acquired
- •immunodeficiency (eg, common variable immunodeficiency, human
- •immunodeficiency virus [HIV] infection, organ transplantation).
- •18. The subject has received any live vaccinations within 30 days prior to
- •19. The subject has clinically significant infection (eg, pneumonia,
- •pyelonephritis) within 30 days prior to screening, or ongoing chronic
研究者
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