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Mucosal Healing Study in Crohn's Disease (CD) (MUSIC)

2011年8月30日更新者：UCB Pharma

A Phase IIIB Multicentre Open Label 54 Weeks Clinical Trial Evaluating Certolizumab Pegol, a PEGylated Fab Fragment of Humanized Antibody to Tumor Necrosis Factor Alpha (TNFα) on Endoscopic and Mucosal Healing in Patients Suffering From Active Crohn's Disease.

The aim of the study will be to investigate the effect of certolizumab pegol on the intestinal mucosa in active Crohn's disease.

研究概览

地位

完全的

条件

克罗恩病

干预/治疗

生物：Certolizumab pegol

研究类型

介入性

注册 (实际的)

阶段

第三阶段

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

德国
- - Berlin、德国
  - Bonn、德国
比利时
- - Bonheiden、比利时
  - Brussels、比利时
  - Edegem、比利时
  - Leuven、比利时
法国
- - Amiens、法国
  - Besancon、法国
  - Chambray-Les-Tours、法国
  - Clichy、法国
  - Grenoble、法国
  - Lille、法国
  - Marseille、法国
  - Nice、法国
  - Paris、法国
  - Reims、法国
  - Rouen、法国
  - Strasbourg、法国
  - Vandoeuvre Les Nancy、法国

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:

Patients suffering from active Crohn's disease [Crohn's Disease Activity Index(CDAI) ≥ 220 and ≤ 450] and at least 2 segments with endoscopic ulcerative lesions with Baseline Crohn's Disease Endoscopic Index of Severity (CDEIS) ≥ 8
Patients who need to be treated by anti-tumor necrosis factor (anti-TNF) therapy

Exclusion Criteria:

Obstructive intestinal strictures, bowel resection, proctocolectomy or total colectomy, current total parenteral nutrition, short bowel syndrome
History of tuberculosis or positive tests for tuberculosis at screening
All the concomitant diseases or pathological conditions that could interfere with Crohn's disease assessment or to be harmful for the well being of the patient
Previous clinical trials and previous biological therapy that could interfere with the results in the present clinical trial

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：不适用
介入模型：单组作业
屏蔽：无（打开标签）

手臂数量

武器和干预

参与者组/臂	干预/治疗
实验性的：CDP870 400 mg Certolizumab pegol (CDP870) 400 mg	生物：Certolizumab pegol Certolizumab pegol (CDP870) 400 mg administered subcutaneously (sc) at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug end, either Q4W or Q2W, according to their administration frequency at Week 52. 其他名称：西姆齐亚 CZP CDP870

参与者组/臂

干预/治疗

实验性的：CDP870 400 mg

Certolizumab pegol (CDP870) 400 mg

生物：Certolizumab pegol

Certolizumab pegol (CDP870) 400 mg administered subcutaneously (sc) at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug end, either Q4W or Q2W, according to their administration frequency at Week 52.

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
Mean Change From Baseline in CDEIS (Crohn's Disease Endoscopic Index of Severity) Score at Week 10 Using Local Non-blinded Assessments 大体时间：Baseline, Week 10	The CDEIS (Crohn's Disease Endoscopic Index of Severity) score provides a measure of mucosal inflammation. Generally, scores range from 0-30. A higher score indicates more severe mucosal inflammation, thus a negative change from Baseline (i.e., Week 10 score minus Baseline score) indicates improvement.	Baseline, Week 10
Mean Change From Baseline in CDEIS (Crohn's Disease Endoscopic Index of Severity) Score at Week 10 Using Central Blinded Assessments 大体时间：Baseline, Week 10	The CDEIS (Crohn's Disease Endoscopic Index of Severity) score provides a measure of mucosal inflammation. Generally, scores range from 0-30. A higher score indicates more severe mucosal inflammation, thus a negative change from Baseline (i.e., Week 10 score minus Baseline score) indicates improvement.	Baseline, Week 10

次要结果测量

结果测量	措施说明	大体时间
Percentage of Patients Achieving Mucosal Healing at Week 10 Using Local Non-blinded Assessments 大体时间：Week 10	Mucosal healing is defined as complete absence of ulceration contribution in the CDEIS (Crohn's Disease Endoscopic Index of Severity) score	Week 10
Percentage of Patients Achieving Mucosal Healing at Week 10 Using Central Blinded Assessments 大体时间：Week 10	Mucosal healing is defined as complete absence of ulceration contribution in the CDEIS (Crohn's Disease Endoscopic Index of Severity) score	Week 10
Percentage of Patients Achieving Mucosal Healing at Week 54 Using Local Non-blinded Assessments 大体时间：Week 54	Mucosal healing is defined as complete absence of ulceration contribution in the CDEIS (Crohn's Disease Endoscopic Index of Severity) score	Week 54
Percentage of Patients Achieving Mucosal Healing at Week 54 Using Central Blinded Assessments 大体时间：Week 54	Mucosal healing is defined as complete absence of ulceration contribution in the CDEIS (Crohn's Disease Endoscopic Index of Severity) score	Week 54
Percentage of Patients With Endoscopic Response (Crohn's Disease Endoscopic Index of Severity (CDEIS) Decrease From Baseline of More Than 5 Points) at Week 10 Using Local Non-blinded Assessments 大体时间：Baseline, Week 10	The CDEIS (Crohn's Disease Endoscopic Index of Severity) score provides a measure of mucosal inflammation. Generally, scores range from 0-30. A higher score indicates more severe mucosal inflammation.	Baseline, Week 10
Percentage of Patients With Endoscopic Response (Crohn's Disease Endoscopic Index of Severity (CDEIS) Decrease From Baseline of More Than 5 Points) at Week 10 Using Central Blinded Assessments 大体时间：Baseline, Week 10	The CDEIS (Crohn's Disease Endoscopic Index of Severity) score provides a measure of mucosal inflammation. Generally, scores range from 0-30. A higher score indicates more severe mucosal inflammation.	Baseline, Week 10
Percentage of Patients With Endoscopic Response (Crohn's Disease Endoscopic Index of Severity (CDEIS) Decrease From Baseline of More Than 5 Points) at Week 54 Using Local Non-blinded Assessments 大体时间：Baseline, Week 54	The CDEIS (Crohn's Disease Endoscopic Index of Severity) score provides a measure of mucosal inflammation. Generally, scores range from 0-30. A higher score indicates more severe mucosal inflammation.	Baseline, Week 54
Percentage of Patients With Endoscopic Response (Crohn's Disease Endoscopic Index of Severity (CDEIS) Decrease From Baseline of More Than 5 Points) at Week 54 Using Central Blinded Assessments 大体时间：Baseline, Week 54	The CDEIS (Crohn's Disease Endoscopic Index of Severity) score provides a measure of mucosal inflammation. Generally, scores range from 0-30. A higher score indicates more severe mucosal inflammation.	Baseline, Week 54
Percentage of Patients With Endoscopic Remission (Crohn's Disease Endoscopic Index of Severity (CDEIS) Score Below 6) at Week 10 Using Local Non-blinded Assessments 大体时间：Week 10	The CDEIS (Crohn's Disease Endoscopic Index of Severity) score provides a measure of mucosal inflammation. Generally, scores range from 0-30. A higher score indicates more severe mucosal inflammation.	Week 10
Percentage of Patients With Endoscopic Remission (Crohn's Disease Endoscopic Index of Severity (CDEIS) Score Below 6) at Week 10 Using Central Blinded Assessments 大体时间：Week 10	The CDEIS (Crohn's Disease Endoscopic Index of Severity) score provides a measure of mucosal inflammation. Generally, scores range from 0-30. A higher score indicates more severe mucosal inflammation.	Week 10
Percentage of Patients With Endoscopic Remission (Crohn's Disease Endoscopic Index of Severity (CDEIS) Score Below 6) at Week 54 Using Local Non-blinded Assessments 大体时间：Week 54	The CDEIS (Crohn's Disease Endoscopic Index of Severity) score provides a measure of mucosal inflammation. Generally, scores range from 0-30. A higher score indicates more severe mucosal inflammation.	Week 54
Percentage of Patients With Endoscopic Remission (Crohn's Disease Endoscopic Index of Severity (CDEIS) Score Below 6) at Week 54 Using Central Blinded Assessments 大体时间：Week 54	The CDEIS (Crohn's Disease Endoscopic Index of Severity) score provides a measure of mucosal inflammation. Generally, scores range from 0-30. A higher score indicates more severe mucosal inflammation.	Week 54
Percentage of Patients With Endoscopic Complete Remission (Crohn's Disease Endoscopic Index of Severity (CDEIS) Score Below 3) at Week 10 Using Local Non-blinded Assessments 大体时间：Week 10	The CDEIS (Crohn's Disease Endoscopic Index of Severity) score provides a measure of mucosal inflammation. Generally, scores range from 0-30. A higher score indicates more severe mucosal inflammation.	Week 10
Percentage of Patients With Endoscopic Complete Remission (Crohn's Disease Endoscopic Index of Severity (CDEIS) Score Below 3) at Week 10 Using Central Blinded Assessments 大体时间：Week 10	The CDEIS (Crohn's Disease Endoscopic Index of Severity) score provides a measure of mucosal inflammation. Generally, scores range from 0-30. A higher score indicates more severe mucosal inflammation.	Week 10
Percentage of Patients With Endoscopic Complete Remission (Crohn's Disease Endoscopic Index of Severity (CDEIS) Score Below 3) at Week 54 Using Local Non-blinded Assessments 大体时间：Week 54	The CDEIS (Crohn's Disease Endoscopic Index of Severity) score provides a measure of mucosal inflammation. Generally, scores range from 0-30. A higher score indicates more severe mucosal inflammation.	Week 54
Percentage of Patients With Endoscopic Complete Remission (Crohn's Disease Endoscopic Index of Severity (CDEIS) Score Below 3) at Week 54 Using Central Blinded Assessments 大体时间：Week 54	The CDEIS (Crohn's Disease Endoscopic Index of Severity) score provides a measure of mucosal inflammation. Generally, scores range from 0-30. A higher score indicates more severe mucosal inflammation.	Week 54
Change From Baseline in Histological Crohn's Disease Score at Week 10 Using Central Blinded Assessment 大体时间：Baseline, Week 10	The histological Crohn's disease score combines active inflammatory changes: infiltration of mononuclear cells, polymorphonuclear cells, presence of erosions and/or ulcers, and chronic architectural changes. Scores range from 0 to 44, with higher scores indicating greater disease.	Baseline, Week 10
Change From Baseline in Histological Crohn's Disease Score at Week 54 Using Central Blinded Assessment 大体时间：Baseline, Week 54	The histological Crohn's disease score combines active inflammatory changes: infiltration of mononuclear cells, polymorphonuclear cells, presence of erosions and/or ulcers, and chronic architectural changes. Scores range from 0 to 44, with higher scores indicating greater disease.	Baseline, Week 54
Percentage of Patients Achieving Crohn's Disease Activity Index (CDAI) Response (Defined as a Decrease of at Least 100 Points in CDAI Score From Baseline) at Week 10 大体时间：Baseline, Week 10	Crohn's disease activity index (CDAI) responders are patients achieving clinical response (a reduction in CDAI score of at least 100 points from Baseline). CDAI is used to quantify the symptoms of Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.	Baseline, Week 10
Percentage of Patients Achieving Crohn's Disease Activity Index (CDAI) Response (Defined as a Decrease of at Least 100 Points in CDAI Score From Baseline) at Week 54 大体时间：Baseline, Week 54	Crohn's disease activity index (CDAI) responders are patients achieving clinical response (a reduction in CDAI score of at least 100 points from Baseline). CDAI is used to quantify the symptoms of Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.	Baseline, Week 54
Percentage of Patients Achieving Crohn's Disease Activity Index (CDAI) Remission (Defined as a CDAI Score Less Than or Equal to 150) at Week 10 大体时间：Week 10	Crohn's disease activity index (CDAI) responders are patients achieving clinical response (a reduction in CDAI score of at least 100 points from Baseline). CDAI is used to quantify the symptoms of Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.	Week 10
Percentage of Patients Achieving Crohn's Disease Activity Index (CDAI) Remission (Defined as a CDAI Score Less Than or Equal to 150) at Week 54 大体时间：Week 54	Crohn's disease activity index (CDAI) responders are patients achieving clinical response (a reduction in CDAI score of at least 100 points from Baseline). CDAI is used to quantify the symptoms of Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.	Week 54
Geometric Mean C-Reactive Protein (CRP) Level (mg/L) at Week 10 大体时间：Week 10		Week 10
Ratio to Baseline of C-Reactive Protein (CRP) Level (mg/L) at Week 10 大体时间：Baseline, Week 10	Ratio is calculated as the Week 10 value divided by the Baseline value for patients with data at both timepoints.	Baseline, Week 10
Geometric Mean C-Reactive Protein (CRP) Level (mg/L) at Week 52 大体时间：Week 52		Week 52
Ratio to Baseline of C-Reactive Protein (CRP) Level (mg/L) at Week 52 大体时间：Baseline, Week 52	The ratio is calculated as the Week 52 value divided by Baseline value for patients with data at both timepoints.	Baseline, Week 52
Correlation Between Mean C-Reactive Protein (CRP) Plasma Level and Crohn's Disease Activity Index (CDAI) Score at Week 10 大体时间：Week 10	Crohn's disease activity index (CDAI) responders are patients achieving clinical response (a reduction in CDAI score of at least 100 points from Baseline). CDAI is used to quantify the symptoms of Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.	Week 10
Correlation Between Mean C-Reactive Protein (CRP) Plasma Level and Crohn's Disease Endoscopic Index of Severity (CDEIS) Score at Week 10 Using Local Non-blinded Assessment 大体时间：Week 10	The CDEIS (Crohn's Disease Endoscopic Index of Severity) score provides a measure of mucosal inflammation. Generally, scores range from 0-30. A higher score indicates more severe mucosal inflammation.	Week 10
Correlation Between Mean C-Reactive Protein (CRP) Plasma Level and Crohn's Disease Endoscopic Index of Severity (CDEIS) Score at Week 10 Using Central Blinded Assessment 大体时间：Week 10	The CDEIS (Crohn's Disease Endoscopic Index of Severity) score provides a measure of mucosal inflammation. Generally, scores range from 0-30. A higher score indicates more severe mucosal inflammation.	Week 10
Correlation Between Mean C-Reactive Protein (CRP) Plasma Level and Histological Crohn's Disease Score at Week 10 Using Central Blinded Assessment 大体时间：Week 10	The histological Crohn's disease score combines active inflammatory changes: infiltration of mononuclear cells, polymorphonuclear cells, presence of erosions and/or ulcers, and chronic architectural changes. Scores range from 0 to 44, with higher scores indicating greater disease	Week 10
Change From Baseline in Crohn's Disease Endoscopic Index of Severity (CDEIS) Score at Week 54 Using Local Non-blinded Assessment 大体时间：Baseline, Week 54	The CDEIS (Crohn's Disease Endoscopic Index of Severity) score provides a measure of mucosal inflammation. Generally, scores range from 0-30. A higher score indicates more severe mucosal inflammation.	Baseline, Week 54
Change From Baseline in Crohn's Disease Endoscopic Index of Severity (CDEIS) Score at Week 54 Using Central Blinded Assessment 大体时间：Baseline, Week 54	The CDEIS (Crohn's Disease Endoscopic Index of Severity) score provides a measure of mucosal inflammation. Generally, scores range from 0-30. A higher score indicates more severe mucosal inflammation.	Baseline, Week 54
Change From Baseline in Crohn's Disease Activity Index (CDAI) Score at Week 10 大体时间：Baseline, Week 10	Crohn's disease activity index (CDAI) responders are patients achieving clinical response (a reduction in CDAI score of at least 100 points from Baseline). CDAI is used to quantify the symptoms of Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.	Baseline, Week 10
Change From Baseline in Crohn's Disease Activity Index (CDAI) Score at Week 54 大体时间：Baseline, Week 54	Crohn's disease activity index (CDAI) responders are patients achieving clinical response (a reduction in CDAI score of at least 100 points from Baseline). CDAI is used to quantify the symptoms of Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.	Baseline, Week 54

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

FDA Safety Alerts and Recalls

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2月1日

初级完成 (实际的)

2008年1月1日

研究完成 (实际的)

2009年12月1日

研究注册日期

首次提交

2006年2月27日

首先提交符合 QC 标准的

2006年2月27日

首次发布 (估计)

2006年2月28日

研究记录更新

最后更新发布 (估计)

2011年8月31日

上次提交的符合 QC 标准的更新

2011年8月30日

最后验证

2011年2月1日

Certolizumab pegol的临床试验

UCB Pharma

完全的

Cimzia® 再治疗慢性斑块状银屑病患者的疗效

银屑病

法国, 德国
Michael Schiff, MD
UCB Pharma

完全的

TNF-Alpha 不完全二级反应者能否获得安全有效的反应切换到 Cimzia

类风湿关节炎

美国
Nathan Wei, MD, FACP, FACR:
University of California, San Diego

完全的

类风湿性关节炎治疗和活检研究评估 Certolizumab Pegol (Cimzia)

类风湿关节炎

美国
Novo Nordisk A/S

完全的

Turoctocog Alfa Pegol (N8-GP) 预防和治疗既往接受过治疗的中国 A 型血友病患者出血事件的疗效和安全性（探路者 10） (Pathfinder10)

血友病A

中国
Novo Nordisk A/S

招聘中

服用药物 Esperoct 对血友病患者关节健康的观察性研究

血友病A

加拿大
Bayer

主动，不招人

旨在了解更多关于接受 Damoctocog Alfa Pegol 治疗的 A 型血友病患者身体活动水平的研究（LIFE ACTIVE 研究） (LIFE-ACTIVE)

甲型血友病

加拿大, 西班牙, 美国, 比利时, 意大利, 台湾, 斯洛文尼亚
Novo Nordisk A/S

邀请报名

一项针对患有 A 型血友病的男性患者使用 Esperoct® 进行预防的研究 (pathfinder9)

血友病A

奥地利, 西班牙, 保加利亚, 克罗地亚, 爱沙尼亚, 匈牙利, 意大利, 立陶宛, 葡萄牙, 希腊, 德国, 捷克语, 斯洛文尼亚, 瑞士, 斯洛伐克
RenJi Hospital

尚未招聘

妊娠类风湿性关节炎的治疗

类风湿关节炎 | 怀孕相关

中国
Queen Mary University of London

完全的

评估 RA 患者对 TNFα 抑制剂的 Th17 反应 (THERAPIST)

类风湿关节炎

英国
Bayer

主动，不招人

研究以了解更多关于药物 Jivi 在长期接受治疗的 A 型血友病（缺乏 FVIII 导致的出血性疾病）患者的安全性，这些患者定期接受治疗医生的 Jivi 预防出血 (HA-SAFE)

甲型血友病

西班牙, 德国, 奥地利, 希腊, 意大利, 斯洛文尼亚

Mucosal Healing Study in Crohn's Disease (CD) (MUSIC)

A Phase IIIB Multicentre Open Label 54 Weeks Clinical Trial Evaluating Certolizumab Pegol, a PEGylated Fab Fragment of Humanized Antibody to Tumor Necrosis Factor Alpha (TNFα) on Endoscopic and Mucosal Healing in Patients Suffering From Active Crohn's Disease.

研究概览

地位

条件

干预/治疗

研究类型

注册 (实际的)

阶段

联系人和位置

学习地点

参与标准

资格标准

适合学习的年龄

接受健康志愿者

有资格学习的性别

描述

学习计划

研究是如何设计的？

设计细节

手臂数量

武器和干预

参与者组/臂

干预/治疗

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

次要结果测量

结果测量

措施说明

大体时间

合作者和调查者

赞助

出版物和有用的链接

一般刊物

有用的网址

研究记录日期

研究主要日期

学习开始

初级完成 (实际的)

研究完成 (实际的)

研究注册日期

首次提交

首先提交符合 QC 标准的

首次发布 (估计)

研究记录更新

最后更新发布 (估计)

上次提交的符合 QC 标准的更新

最后验证

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

Certolizumab pegol的临床试验

搜索类似试验

赞助者和合作者

医疗条件

药物干预

CROs by country

CROs in Dominican Republic

条件

罕见疾病

药物干预

膳食补充剂

赞助者/合作者

地点