EUCTR2015-000481-58-HU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 Maintenance Therapy 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
- 824
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 screening.
- •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 Visit.
- •2. The subject has had extensive colonic resection, subtotal or total colectomy.
- •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 28 days prior to the administration of the first dose of study drug.
- •5. The subject has ileostomy, colostomy, or known fixed symptomatic stenosis of the intestine.
- •6. The subject has received any of the investigational or approved non-biologic 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 Period.
- •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) infection* or chronic hepatitis C virus (HCV) infection. * HBV immune subjects (ie, being hepatitis B surface antibody [HBsAb] negative and hepatitis B antibody positive) may, however, be included.
- •16. The subject has active or latent TB as evidenced by the following:
- •i. A positive diagnostic TB test within 30 days prior to screening or during the screening period, defined as: 1. A positive QuantiFERON test or 2 successive indeterminate QuantiFERON tests, (or, A positive T-SPOT TB test [Japan only]), OR, Vedolizumab SC 2. A tuberculin skin test reaction =5 mm.
- •Note: if subjects have received BCG vaccine then a QuantiFERON TB Gold text should be performed instead of the tuberculin skin text
- •ii. Chest X-ray within 3 months prior to Week 0 which is suspicious for pulmonary TB, and a positive or 2 successive indeterminate QuantiFERON tests (or, A positive T-SPOT TB test [Japan only]) within 30 days prior to Screening or during the Screening Period.
- •Note: subjects with documented previously treated TB with a negative QuantiFERON text can be included in the study.
- •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 screening.
- •19. The subject has clinically significant infection (eg, pneumonia, pyelonephritis) within 30 days prior to screening, or ongoing chronic infection.
研究者
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