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Corticosteroid Sparing Effect of Certolizumab in Crohn's Disease (COSPAR1)

2018年7月10日 更新者：UCB Pharma

A Phase IIIb Multicenter, Double-blind, Placebo-controlled,Randomized Trial to Examine the Corticosteroid-sparing Effect of Certolizumab Pegol in Patients With Moderate to Severe Crohn's Disease.

The current study is designed to measure the corticosteroid-sparing effect of certolizumab pegol using a defined schedule of corticosteroid tapering in subjects with moderate to severe Crohn's disease. Subjects had to be in remission (CDAI<=150) and receiving corticosteroids at a dose no higher than 30 mg/day prednisone or equivalent during the week prior to randomization.

研究概览

地位

终止

条件

干预/治疗

研究类型

介入性

注册 (实际的)

174

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

  • 加拿大
    • Alberta
      • Calgary、Alberta、加拿大
      • Edmonton、Alberta、加拿大
    • British Columbia
      • Abbotsford、British Columbia、加拿大
      • Vancouver、British Columbia、加拿大
    • Manitoba
      • Winnipeg、Manitoba、加拿大
    • Nova Scotia
      • Halifax、Nova Scotia、加拿大
    • Ontario
      • London、Ontario、加拿大
      • Toronto、Ontario、加拿大
    • Saskatchewan
      • Saskatoon、Saskatchewan、加拿大
  • 德国
      • Frankfurt、德国
      • Heidleberg、德国
      • Jena、德国
      • Magdeburg、德国
      • Ulm、德国
  • 美国
    • Alabama
      • Birmingham、Alabama、美国
      • Montgomery、Alabama、美国
    • Arizona
      • Tucson、Arizona、美国
    • California
      • La Jolla、California、美国
      • Oceanside、California、美国
      • Orange、California、美国
      • Palo Alto、California、美国
      • Roseville、California、美国
    • Colorado
      • Golden、Colorado、美国
    • Florida
      • Clearwater、Florida、美国
      • Gainesville、Florida、美国
      • Hialeah、Florida、美国
      • Jacksonville、Florida、美国
      • North Miami Beach、Florida、美国
      • Sarasota、Florida、美国
      • Winter Park、Florida、美国
    • Georgia
      • Marietta、Georgia、美国
      • Savannah、Georgia、美国
    • Illinois
      • Chicago、Illinois、美国
    • Indiana
      • Bloomington、Indiana、美国
    • Kansas
      • Topeka、Kansas、美国
    • Kentucky
      • Bowling Green、Kentucky、美国
      • Louisville、Kentucky、美国
    • Louisiana
      • Metairie、Louisiana、美国
    • Maryland
      • Annapolis、Maryland、美国
    • Massachusetts
      • Newton、Massachusetts、美国
    • Michigan
      • Chesterfield、Michigan、美国
      • Dearborn、Michigan、美国
      • Troy、Michigan、美国
    • Minnesota
      • Rochester、Minnesota、美国
    • Mississippi
      • Ocean Springs、Mississippi、美国
    • Missouri
      • Kansas City、Missouri、美国
      • Mexico、Missouri、美国
    • New York
      • New York、New York、美国
      • Syracuse、New York、美国
    • North Carolina
      • Chapel Hill、North Carolina、美国
      • Charlotte、North Carolina、美国
      • Raleigh、North Carolina、美国
    • Ohio
      • Cincinnati、Ohio、美国
      • Cleveland、Ohio、美国
      • Dayton、Ohio、美国
    • Oklahoma
      • Tulsa、Oklahoma、美国
    • South Carolina
      • Columbia、South Carolina、美国
    • Tennessee
      • Germantown、Tennessee、美国
    • Texas
      • Austin、Texas、美国
      • Irving、Texas、美国
    • Utah
      • Salt Lake City、Utah、美国
    • Vermont
      • Burlington、Vermont、美国
    • Virginia
      • Chesapeake、Virginia、美国
      • Richmond、Virginia、美国
    • Washington
      • Seattle、Washington、美国
    • Wisconsin
      • Madison、Wisconsin、美国
      • Milwaukee、Wisconsin、美国
      • Monroe、Wisconsin、美国

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 及以上 (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:

  • Men and women
  • Age 18 years or older with moderate to severe Crohn's disease (Crohn's Disease Activity Index (CDAI) score of ≥ 220 ≤450)

Exclusion Criteria:

  • Active or draining fistula present at screening
  • Lactating and/or pregnant female subjects
  • A history of any health condition that could potentially interfere with the disease and/or the treatment
  • A history of an adverse reaction to polyethylene glycol (PEG) or a protein medicinal product
  • Any other condition which in the Investigator's judgment would make the patient unsuitable for inclusion in the study
  • History of drug or alcohol abuse in the prior year
  • Receipt of any experimental therapy within or outside a clinical trial in the 3 months prior to Visit 0

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：双倍的

武器和干预

参与者组/臂
干预/治疗
安慰剂比较：安慰剂
其他：Placebo
Placebo (commercially available sodium chloride 0.9% (preservative free)) provided for subcutaneous injection in single-use vials for administration at Weeks 0, 2, 4 and then every 4 weeks until Week 36. Two vials will be required for each dosing.
实验性的：Certolizumab pegol 400 mg
生物：certolizumab pegol 400 mg
Certolizumab pegol 400 mg provided in solution for subcutaneous injection (2 x 200 mg/mL) in single-use vials for administration at Weeks 0, 2, 4 and then every 4 weeks until Week 36. Two vials will be required for each dosing.
其他名称：
  • 西姆齐亚
  • CZP
  • CDP870

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 Who Have Been Withdrawn From Prednisone or Prednisolone Therapy According to the Corticosteroid Tapering Schedule and Have Remained Off Corticosteroids and in Disease Remission at Week 38
大体时间：Week 38
The Crohn's Disease Activity Index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A CDAI score of 150 or below indicates disease remission and a score above 450 indicates extremely severe disease.
Week 38

次要结果测量

结果测量
措施说明
大体时间
Percentage of Subjects With Continuous Remission Off Steroids at Week 38
大体时间：Week 38
The Crohn's Disease Activity Index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A CDAI score of 150 or below indicates disease remission and a score above 450 indicates extremely severe disease. A subject with continuous remission off steroids at Week 38 is a subject in remission (CDAI =< 150) from the visit when he stops taking steroids to Week 38 and is off corticosteroids until Week 38.
Week 38
Cumulative Percentage of Subjects With Relapse/Treatment Failure at Week 38
大体时间：Week 38
A subject with relapse/ treatment failure has a Crohn's Disease Activity Index (CDAI) > 150 and an increase in CDAI of >= 70 points versus Week 0. [The CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates disease remission and a score above 450 indicates extremely severe disease.]
Week 38
Time to Relapse/Treatment Failure During the 38-week Double-blind Treatment Period
大体时间：During the 38-week double-blind treatment period
A subject with relapse/ treatment failure has a Crohn's Disease Activity Index (CDAI) > 150 and an increase in CDAI of >= 70 points versus Week 0. [The CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates disease remission and a score above 450 indicates extremely severe disease.]
During the 38-week double-blind treatment period
Per-subject Median Weekly Dose of Corticosteroids Over the 38-week Double-blind Treatment Period
大体时间：Over the 38-week double-blind treatment period
The median weekly dose of corticosteroids is calculated for each subject, and these per-subject median values are further summarized by treatment group. The mean of the per-subject median doses in each treatment group is presented here.
Over the 38-week double-blind treatment period
Per-subject Cumulative Dose of Corticosteroids Over the 48-week Study Period
大体时间：Over the 48-week study period
The cumulative dose of corticosteroids over the 48-week study period is calculated for each subject individually. The mean of these values for each treatment group is presented here.
Over the 48-week study period
Change From the 6-week run-in Period in Per-subject Median Weekly Dose of Corticosteroids Over the 38-week Double-blind Treatment Period
大体时间：6-week run-in period, 38-week double-blind treatment period
The run in period lasted a minimum of 1 week and a maximum of 6 weeks. During this period subjects were treated with any dose or type of systemic corticosteroids the Investigator felt was appropriate. To be eligible for study randomization, subjects must have been in remission (CDAI ≤150 points) and receiving corticosteroids at a dose no higher than 30 mg/day prednisone or equivalent during the week prior to randomization. Subjects who did not meet these criteria were not randomized and were withdrawn from the study.
6-week run-in period, 38-week double-blind treatment period
Crohn's Disease Activity Index (CDAI) Score at Week 38
大体时间：Week 38
The Crohn's Disease Activity Index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates disease remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
Week 38
Change From Baseline in CDAI Score at Week 38
大体时间：Week 0, Week 38
The Crohn's Disease Activity Index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates disease remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
Week 0, Week 38
Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score at Week 38
大体时间：Week 38
The total IBDQ score will be derived as the sum of the responses (each ranging from 1 to 7) to all 32 questions on the IBDQ and can therefore range from 32 to 224. A higher score indicates a better quality of life. IBDQ remission is defined as a subject having an IBDQ total score >= 170 points.
Week 38
Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score at Week 38
大体时间：Week 0, Week 38
The total IBDQ score will be derived as the sum of the responses (each ranging from 1 to 7) to all 32 questions on the IBDQ and can therefore range from 32 to 224. A higher scores indicates a better quality of life. IBDQ response is defined as an increase from baseline in the IBDQ total score >= 16 points.
Week 0, Week 38

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。

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

2006年11月1日

初级完成 (实际的)

2009年7月1日

研究完成 (实际的)

2009年7月1日

研究注册日期

首次提交

2006年6月30日

首先提交符合 QC 标准的

2006年7月6日

首次发布 (估计)

2006年7月10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

2010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

  • C87059
  • 2006-003870-88 (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.

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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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