NL-OMON36415尚未招募3 期
A 52 week Randomised, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Maintenance of Remission in Subjects with Crohnâ¤*s Disease - CCX114157
适应症
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 30
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
- 18 至 99（—）
入选标准
- •Subjects achieving clinical response (CDAI decrease >= 100points) and/or remission (CDAI <150) upon completion of treatment in Study CCX114151.
- •Safe contraception for women of childbearing potential.
- •Any medications being currently received for Crohn*s disease must remain stable throughout the study period with the exception of tapering of corticosteroids.
- •Subjects on corticosteroids at entry must be willing to undergo corticosteroid dose tapering
排除标准
- •Breastfeeding, pregnancy.
- •Known coeliac disease, those who follow a gluten-free diet to manage symptoms of suspected coeliac disease and subjects with a positive screening test for celiac disease.
- •Known or suspected small bowel stricture
- •Enterocutaneous, abdominal or pelvic fistulae with abscesses or fistulae likely to require surgery during the study period.
研究者
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