NL-OMON40329已完成不适用
A Phase 1b Open-Label Study to Assess the Safety and Pharmacokinetics of Subcutaneously Administered Golimumab, a Human anti-TNFa Antibody, in Pediatric Subjects With Moderately to Severely Active Ulcerative Colitis - PURSUIT PEDS PK
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 4
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 2 至 17（—）
入选标准
- •Moderate to severe Ulcerative Colitis (UC) defined by a Mayo score (a
- •score used to assess the treatment for UC) of 6 to 12 inclusive, including
- •an endoscopic subscore of 2 or more.
- •Must either be currently receiving treatment with, or have a history of
- •having failed to respond to, or have a medical contraindication to at least
- •1 of the following therapies: oral or intravenous corticosteroids, 6-
- •mercaptopurine and azathioprine OR
- •must either have or have had a history of corticosteroid dependency
- •(ie, an inability to successfully taper corticosteroids without a return of
- •the symptoms of UC) OR
- •required more than 3 courses of corticosteroids in the past year
- •No history of latent or active tuberculosis prior to screening
- •Positive protective antibody titers to varicella and measles prior to the
- •first administration of study agent
排除标准
- •Have severe extensive UC that is likely to require a colectomy (surgical
- •removal of the colon) within 12 weeks of study entry
- •Have UC limited to the rectum only or to less than 20 cm of the colon
- •Presence of a stoma
- •Presence or history of a fistula
- •Have evidence of Crohn's disease (an inflammatory large intestine
- •Previous exposure to anti-tumor necrosis factor therapy
研究者
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