EUCTR2008-002782-32-CZ
进行中（未招募）
不适用
A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by Vedolizumab (MLN0002) in Patients with Moderate to Severe Ulcerative Colitis
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- 未指定
- 发起方
- Millennium Pharmaceuticals, Inc.
- 入组人数
- 826
- 状态
- 进行中（未招募）
- 最后更新
- 11年前
概览
简要总结
暂无简介。
研究者
入排标准
入选标准
- •1\. Age 18 to 80
- •2\. Male or female patient who is voluntarily able to give informed consent
- •3\. Female patients must:
- •be post\-menopausal for at least 1 year before the screening visit, OR
- •be surgically sterile, OR
- •(if they are of childbearing potential) agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent form through 6 months after the last dose of study drug, OR
- •agree to completely abstain from heterosexual contact.
- •Male patients, even if surgically sterilized (ie, status post\-vasectomy), must:
- •agree to practice effective barrier contraception during the entire study treatment period and through 6 months after the last dose of study drug, OR
- •agree to completely abstain from heterosexual contact.
排除标准
- •The exclusion criteria are divided into 3 categories: gastrointestinal exclusion criteria, infectious disease exclusion criteria, and general exclusion criteria. Patients meeting any of the following exclusion criteria are not to be enrolled in the study.
- •Gastrointestinal Exclusion Criteria
- •1\. Evidence of abdominal abscess or toxic megacolon at the initial screening visit
- •2\. Extensive colonic resection, subtotal or total colectomy
- •3\. Ileostomy, colostomy, or known fixed symptomatic stenosis of the intestine
- •4\. Within 30 days prior to enrollment, have received any of the following for the treatment of underlying disease:
- •Non\-biologic therapies (eg, cyclosporine, thalidomide) other than those
- •permitted in Section 6\.2
- •A non\-biologic investigational therapy
- •An approved non\-biologic therapy in an investigational protocol
结局指标
主要结局
未指定
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