ACTRN12607000003471尚未招募3 期
A Phase 3, Multi-Center, Randomized, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy with Abatacept in Subjects with Active Ulcerative Colitis (UC) who have had an Inadequate Clinical Response and/or Intolerance to Medical Therapy
Bristol-Myers Squibb0 个研究点目标入组 586 人开始时间: 2007年1月2日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 586
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 ot stated（—）
- 性别
- All
入选标准
- •*Ulcerative colitis for at lease 3 months *Moderate to severe active ulcerative colitis *Inadequate response or intolerance to standard ulcerative colitis treatment.
排除标准
- •*Women of child bearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 10 weeks after the study.
研究者
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A Phase 3, Multi-Center, Randomized, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy with Abatacept in Subjects with Active Crohn’s Disease (CD) who have had an Inadequate Clinical Response and/or Intolerance to Medical Therapy.Revised Protocol 04 incorporating Amendments 02, 03, 08 & 09 (v1.0, date 09-Mar-2009) + administrative letters 01 & 02. And Pharmacogenetics Blood Sample Amendment 01 - Site Specific (Version 2.0, Date: 26-Oct-2006).Crohn's disease, NOSMedDRA version: 8.1Level: LLTClassification code 10011401Term: Crohn's diseaseEUCTR2006-003371-13-DEBristol-Myers Squibb International Corporation709
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A Phase 3, Multi-Center, Randomized, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy with Abatacept in Subjects with Active Crohn’s Disease (CD) who have had an Inadequate Clinical Response and/or Intolerance to Medical Therapy.Revised Protocol 04 incorporating Amendments 02, 03, 08 & 09 (v1.0, date 09-Mar-2009) + administrative letters 01 & 02. And Pharmacogenetics Blood Sample Amendment 01 - Site Specific (Version 2.0, Date: 26-Oct-2006).Crohn's disease, NOSMedDRA version: 8.1Level: LLTClassification code 10011401Term: Crohn's diseaseEUCTR2006-003371-13-DKBristol-Myers Squibb International Corporation709
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A Phase 3, Multi-Center, Randomized, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy with Abatacept in Subjects with Active Crohn’s Disease (CD) who have had an Inadequate Clinical Response and/or Intolerance to Medical Therapy.Revised Protocol 03 incorporating Amendments 02, 03 & 08 + administrative letters 01 & 02.+ Pharmacogenetics Blood Sample Amendment 01 - Site Specific (Version 2.0, Date: 26-Oct-2006).EUCTR2006-003371-13-BEBristol-Myers Squibb International Corporation709
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