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Study to Evaluate Efficacy and Safety of Certolizumab Pegol for Induction of Remission in Patients With Crohn's Disease

2018年7月10日 更新者：UCB Pharma

Phase IIIb, Multinational, Randomized, Double-blind, Placebo-controlled Trial to Assess the Efficacy and Safety of Certolizumab Pegol, a Pegylated Fab' Fragment of a Humanized Anti-Tumor Necrosis Factor(TNF)-Alpha Monoclonal Antibody, Administered in Subjects With Moderately to Severely Active Crohn's Disease.

The primary objective of the study is to evaluate efficacy of certolizumab pegol in inducing clinical remission in patients with moderate to severe Crohn's disease as compared with placebo based on Crohn's Disease Activity Index (CDAI) score at Week 6.

研究概览

地位

完全的

条件

干预/治疗

研究类型

介入性

注册 (实际的)

439

阶段

  • 第三阶段

扩展访问

可用的 查看扩展访问记录。

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 乌克兰
      • Dniepropetrovsk、乌克兰
      • Donetsk、乌克兰
      • Kiev、乌克兰
      • Kyiv、乌克兰
      • Lviv、乌克兰
      • Simferopol、乌克兰
  • 以色列
      • Beer Sheva、以色列
      • Haifa、以色列
      • Holon、以色列
      • Jerusalem、以色列
      • Kfar Saba、以色列
      • Petha Tikva、以色列
      • Rehovot、以色列
      • Tel Aviv、以色列
      • Zerifin、以色列
  • 俄罗斯联邦
      • Kazan、俄罗斯联邦
      • Moscow、俄罗斯联邦
      • St. Petersburg、俄罗斯联邦
  • 加拿大
      • Calgary、加拿大
    • Alberta
      • Edmonton、Alberta、加拿大
    • British Columbia
      • Kelowna、British Columbia、加拿大
    • Manitoba
      • Winnipeg、Manitoba、加拿大
    • Ontario
      • Hamilton、Ontario、加拿大
      • Kingston、Ontario、加拿大
      • London、Ontario、加拿大
      • Toronto、Ontario、加拿大
  • 匈牙利
      • Budapest、匈牙利
      • Gyor、匈牙利
      • Nagykanizsa、匈牙利
      • Szeged、匈牙利
      • Szombathely、匈牙利
  • 奥地利
      • Wien、奥地利
  • 巴西
      • Curitiba、巴西
      • Goiania、巴西
      • Porto Alegre、巴西
      • Rio de Janeiro、巴西
      • Santo-Andre、巴西
      • Santos、巴西
      • Sao Paulo、巴西
    • MG
      • Belo-Horizonte、MG、巴西
  • 德国
      • Berlin、德国
      • Frankfurt、德国
      • Freiburg、德国
      • Homburg、德国
      • Jena、德国
      • Kiel、德国
      • Munchen、德国
      • Ulm、德国
      • Wilhelmshaven、德国
  • 意大利
      • Bologna、意大利
      • Padova、意大利
      • Roma、意大利
  • 拉脱维亚
      • Riga、拉脱维亚
      • Valmiera、拉脱维亚
  • 捷克语
      • Hradec Kralove、捷克语
      • Hradek Kralove、捷克语
      • Praha 7、捷克语
      • Usti Nad Orlici、捷克语
      • Zlin、捷克语
  • 新西兰
      • Auckland、新西兰
      • Christchurch、新西兰
      • Hamilton、新西兰
    • Auckland
      • Milford、Auckland、新西兰
    • Wellington
      • Newton、Wellington、新西兰
  • 智利
      • Santiago、智利
      • Vina del Mar、智利
  • 比利时
      • Bonheiden、比利时
      • Brussels、比利时
      • Gent、比利时
      • Leuven、比利时
      • Liege、比利时
      • Roeselare、比利时
  • 波兰
      • Czestochowa、波兰
      • Lodz、波兰
      • Warszawa、波兰
      • Wroclaw、波兰
  • 澳大利亚
      • Adelaide、澳大利亚
      • Bankstown、澳大利亚
      • Clayton、澳大利亚
      • Fitzroy、澳大利亚
      • Fremantle、澳大利亚
      • Garran、澳大利亚
    • New South Wales
      • Concord、New South Wales、澳大利亚
    • Victoria
      • Box Hill、Victoria、澳大利亚
      • Footscray、Victoria、澳大利亚
      • Parkville、Victoria、澳大利亚
  • 爱沙尼亚
      • Tallin、爱沙尼亚
      • Tartu、爱沙尼亚
  • 罗马尼亚
      • Bucharest、罗马尼亚
      • Cluj Napoca、罗马尼亚
      • Constanta、罗马尼亚
  • 美国
    • Alabama
      • Pell City、Alabama、美国
    • Colorado
      • Colorado Springs、Colorado、美国
      • Lakewood、Colorado、美国
      • Littleton、Colorado、美国
    • Florida
      • Hollywood、Florida、美国
      • Jacksonville、Florida、美国
      • New Port Richey、Florida、美国
      • Winter Park、Florida、美国
    • Illinois
      • Chicago、Illinois、美国
    • Kentucky
      • Louisville、Kentucky、美国
    • Louisiana
      • Metairie、Louisiana、美国
      • Monroe、Louisiana、美国
    • Maryland
      • Annapolis、Maryland、美国
      • Towson、Maryland、美国
    • Michigan
      • Chesterfield、Michigan、美国
      • West Bloomfield、Michigan、美国
    • Minnesota
      • Rochester、Minnesota、美国
    • North Carolina
      • Raleigh、North Carolina、美国
    • Ohio
      • Cincinnati、Ohio、美国
      • Cleveland、Ohio、美国
    • Pennsylvania
      • Lancaster、Pennsylvania、美国
    • Tennessee
      • Germantown、Tennessee、美国
    • Virginia
      • Norfolk、Virginia、美国
    • Washington
      • Seattle、Washington、美国
  • 芬兰
      • Mikkeli、芬兰

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 75年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • male/female
  • 18 - 75 years inclusive
  • diagnosis of Crohn's disease confirmed
  • moderate to severe disease activity (Crohn's Disease Activity Index (CDAI) 225 - 450)
  • no previous treatment with anti-tumor necrosis factor (anti-TNF) medications

Exclusion Criteria:

  • previous participation in a certolizumab pegol study
  • general exclusion criteria as common for studies in this indication

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：四人间

武器和干预

参与者组/臂
干预/治疗
实验性的：Certolizumab pegol
Certolizumab pegol 400 mg for subcutaneous (sc) injection
生物：certolizumab pegol (CDP870, CZP)
Certolizumab Pegol 400 mg CZP sc injection 2 x 1 mL CZP (200 mg/mL) at Week 0, 2, and 4
其他名称：
  • CZP
  • CDP870
  • CIMZIA ®
安慰剂比较：Placebo
Placebo, saline solution for sc injection
其他：Placebo
Saline 0.9% sc injection 2 x 1 mL Placebo at Week 0, 2 and 4

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Percentage of Subjects in Clinical Remission at Week 6
大体时间：Week 6
The percentage of subjects in clinical remission at Week 6 (clinical remission is defined as a total Crohn's Disease Activity Index (CDAI) score of 150 points or less). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 points or below indicates clinical remission and a score above 450 points indicates extremely severe disease.
Week 6

次要结果测量

结果测量
措施说明
大体时间
Percentage of Subjects Achieving a Clinical Response at Week 6
大体时间：Week 0, Week 6
The percentage of subjects achieving a clinical response at Week 6 (clinical response is defined as at least a 100-point decrease from the Week 0 Crohn's Disease Activity Index (CDAI) score). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates clinical remission and a score above 450 points indicates extremely severe disease.
Week 0, Week 6
Percentage of Subjects in Inflammatory Bowel Disease Questionnaire (IBDQ) Remission at Week 6
大体时间：Week 6
The percentage of subjects in Inflammatory Bowel Disease Questionnaire (IBDQ) remission at Week 6 (IBDQ remission is defined as a total IBDQ score of 170 points or more). The IBDQ Global Score is the sum of 32 responses, each ranging from 0 to 7, thus the Global Score ranges from 0 to 224; a higher score indicating a better quality of life.
Week 6
Change in Total Crohn's Disease Activity Index (CDAI) Score From Week 0 to Week 6
大体时间：Week 0 to Week 6
The change in total Crohn's Disease Activity Index (CDAI) score from Week 0 to Week 6. CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 points or below indicates clinical remission and a score above 450 points indicates extremely severe disease.
Week 0 to Week 6
Change in Harvey Bradshaw Index (HBI) Score From Week 0 to Week 6
大体时间：Week 0 to Week 6
The change in Harvey Bradshaw Index (HBI) score from Week 0 to Week 6. HBI score consists of clinical parameters of general well-being (0 to 4), abdominal pain (0 to 3), number of liquid stools per day, abdominal mass (0 to 3), and complications (score 1 per item). The first three items are scored for the previous day. Lower scores indicated better well being.
Week 0 to Week 6
Percentage of Subjects in Clinical Remission at Week 2
大体时间：Week 2
The percentage of subjects in clinical remission at Week 2 (clinical remission is defined as a total Crohn's Disease Activity Index (CDAI) score of 150 points or less). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 points or below indicates clinical remission and a score above 450 points indicates extremely severe disease.
Week 2
Percentage of Subjects in Clinical Remission at Week 4
大体时间：Week 4
The percentage of subjects in clinical remission at Week 4 (clinical remission is defined as a total Crohn's Disease Activity Index (CDAI) score of 150 points or less). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 points or below indicates clinical remission and a score above 450 points indicates extremely severe disease.
Week 4
Percentage of Subjects Achieving a Clinical Response at Week 2
大体时间：Week 0, Week 2
The percentage of subjects achieving a clinical response at Week 2 (clinical response is defined as at least a 100-point decrease from the Week 0 Crohn's Disease Activity Index (CDAI) score). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 points or below indicates clinical remission and a score above 450 points indicates extremely severe disease.
Week 0, Week 2
Percentage of Subjects Achieving a Clinical Response at Week 4
大体时间：Week 0, Week 4
The percentage of subjects achieving a clinical response at Week 4 (clinical response is defined as at least a 100-point decrease from the Week 0 Crohn's Disease Activity Index (CDAI) score). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 points or below indicates clinical remission and a score above 450 points indicates extremely severe disease.
Week 0, Week 4
Change in Total Crohn's Disease Activity Index (CDAI) Score From Week 0 to Week 2
大体时间：Week 0 to Week 2
The change in total Crohn's Disease Activity Index (CDAI) score from Week 0 to Week 2. CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 points or below indicates clinical remission and a score above 450 points indicates extremely severe disease.
Week 0 to Week 2
Change in Total Crohn's Disease Activity Index (CDAI) Score From Week 0 to Week 4
大体时间：Week 0, Week 4
The change in total Crohn's Disease Activity Index (CDAI) score from Week 0 to Week 4. CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 points or below indicates clinical remission and a score above 450 points indicates extremely severe disease.
Week 0, Week 4
Percentage of Subjects in Inflammatory Bowel Disease Questionnaire (IBDQ) Remission at Week 2
大体时间：Week 2
The percentage of subjects in Inflammatory Bowel Disease Questionnaire (IBDQ) remission at Week 2 (IBDQ remission is defined as a total IBDQ score of 170 points or more). The IBDQ Global Score is the sum of 32 responses, each ranging from 0 to 7, thus the Global Score ranges from 0 to 224; a higher score indicating a better quality of life.
Week 2
Percentage of Subjects in Inflammatory Bowel Disease Questionnaire (IBDQ) Remission at Week 4
大体时间：Week 4
The percentage of subjects in Inflammatory Bowel Disease Questionnaire (IBDQ) remission at Week 4 (IBDQ remission is defined as a total IBDQ score of 170 points or more). The IBDQ Global Score is the sum of 32 responses, each ranging from 0 to 7, thus the Global Score ranges from 0 to 224; a higher score indicating a better quality of life.
Week 4
Percentage of Subjects in Subgroup With Less Than 10 mg/L C-reactive Protein (CRP) at Entry Who Are in Clinical Remission at Week 6
大体时间：Week 6
The percentage of subjects in the subgroup with less than 10 mg/L of C-reactive Protein (CRP) at Entry who are in clinical remission at Week 6 (clinical remission is defined as a total Crohn's Disease Activity Index (CDAI) score of 150 points or less). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 points or below indicates clinical remission and a score above 450 points indicates extremely severe disease.
Week 6
Percentage of Subjects in Subgroup With 10 mg/L or Greater C-reactive Protein (CRP) at Entry Who Are in Clinical Remission at Week 6
大体时间：Week 6
The percentage of subjects in the subgroup with 10 mg/L or greater C-reactive Protein (CRP) at Entry in clinical remission at Week 6 (clinical remission is defined as a total Crohn's Disease Activity Index (CDAI) score of 150 points or less). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 points or below indicates clinical remission and a score above 450 points indicates extremely severe disease.
Week 6
Percentage of Subjects in Subgroup With Less Than 10 mg/L C-reactive Protein (CRP) at Entry Achieving a Clinical Response at Week 6
大体时间：Week 0, Week 6
The percentage of subjects in the subgroup with less than 10 mg/L C-reactive Protein (CRP) at Entry achieving a clinical response at Week 6 (clinical response is defined as at least a 100-point decrease from the Week 0 Crohn's Disease Activity Index (CDAI) score). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 points or below indicates clinical remission and a score above 450 points indicates extremely severe disease.
Week 0, Week 6
Percentage of Subjects in Subgroup With 10 mg/L or Greater C-reactive Protein (CRP) at Entry Achieving a Clinical Response at Week 6
大体时间：Week 0, Week 6
The percentage of subjects in the subgroup with 10 mg/L or greater C-reactive Protein (CRP) at Entry achieving a clinical response at Week 6 (clinical response is defined as at least a 100-point decrease from the Week 0 Crohn's Disease Activity Index (CDAI) score). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 points or below indicates clinical remission and a score above 450 points indicates extremely severe disease.
Week 0, Week 6

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

UCB Pharma

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

有用的网址

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2008年3月1日

初级完成 (实际的)

2009年10月1日

研究完成 (实际的)

2009年11月1日

研究注册日期

首次提交

2007年10月18日

首先提交符合 QC 标准的

2007年10月31日

首次发布 (估计)

2007年11月1日

研究记录更新

最后更新发布 (实际的)

2018年8月9日

上次提交的符合 QC 标准的更新

2018年7月10日

最后验证

2011年10月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • C87085
  • 2007-001913-41 (EudraCT编号)

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

certolizumab pegol (CDP870, CZP)的临床试验

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赞助者和合作者

医疗条件

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条件

罕见疾病

药物干预

膳食补充剂

赞助者/合作者

地点

3
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