JPRN-jRCT2080220712未知2 期
A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis
试验速览
- 阶段
- 2 期
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 ot applicable（—）
- 性别
- All
入选标准
- •Have a biopsy consistent with the diagnosis of moderately to severely active ulcerative colitis (UC) prior to the beginning of the trial
- •Must either be currently receiving treatment with, or have a history of having failed to respond to, or tolerate, at least 1 of the following therapies: oral 5-ASAs, oral corticosteroids, 6-mercaptopurine(6MP) and azathioprine (AZA )
- •Have or have had a history of corticosteroid dependency (i.e. an inability to successfully taper corticosteroids without a return of the symptoms of UC)
排除标准
- •Have severe extensive ulcerative colitis that is likely to require a colectomy within 12 weeks of study entry
- •Have UC limited to the rectum only or to < 20 cm of the colon
- •Presence of a stoma
- •Presence or history of a fistula
- •Previous exposure to anti-TNF therapies
研究者
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