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Study of Vedolizumab in Patients With Moderate to Severe Crohn's Disease (GEMINI III)

2014年6月19日 更新者：Millennium Pharmaceuticals, Inc.

A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction of Clinical Response and Remission by Vedolizumab in Patients With Moderate to Severe Crohn's Disease

This study in patients with moderately to severely active Crohn's disease is designed to establish the efficacy and safety of vedolizumab for the induction of clinical response and remission.

研究概览

地位

完全的

条件

干预/治疗

详细说明

After completing the study, patients were eligible to enroll in a long term safety study with continued access to vedolizumab (study C13008; NCT00790933) if study drug was well tolerated, and no major surgical intervention for Crohn's disease occurred or was required.

Participants who did not enroll in Study C13008 were to complete the Final Safety visit (16 weeks after the last dose of study drug) for a maximum time on study of 22 weeks.

研究类型

介入性

注册 (实际的)

416

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

  • 加拿大
    • Alberta
      • Edmonton、Alberta、加拿大、T6G2X8
        • Zeidler Ledcor Center-Univerisity of Alberta
  • 美国
    • Colorado
      • Lafayette、Colorado、美国、80026
        • Gastroenterology of the Rockies
    • Connecticut
      • Hamden、Connecticut、美国、65180
        • Gastroenterology Center of Connecticut P.C.
    • Florida
      • Gainesville、Florida、美国、32610
        • University of Florida
      • Miami、Florida、美国、33136
        • University of Miami Miller School of Medicine
      • Winter Park、Florida、美国、32789
        • Shafran Gastroenterology Center
    • Georgia
      • Atlanta、Georgia、美国、30342
        • Atlanta Gastroenterology Associates
      • Macon、Georgia、美国、31201
        • Gastroenterology Associates of Central Georgia
      • Suwanee、Georgia、美国、30024
        • Atlanta Gastroenterology Specialist PC
    • Illinois
      • Chicago、Illinois、美国、60637
        • University of Chicago Medical Center
    • Kansas
      • Topeka、Kansas、美国、66606
        • Cotton O'Neil Digestive Health Center
    • Kentucky
      • Lexington、Kentucky、美国、40536
        • University of Kentucky Medical Center
      • Louisville、Kentucky、美国、40402
        • University of Louisville
    • Louisiana
      • Baton Rouge、Louisiana、美国、70809
        • Gastroenterology Associates
      • Hammond、Louisiana、美国、70403
        • Gastroenterology Research Of New Orleans
    • Maryland
      • Chevy Chase、Maryland、美国、20815
        • Metropolitan Gastroenterology Group P.C.
      • Hollywood、Maryland、美国、20636
        • Mid-Atlantic Medical Research Center
    • Massachusetts
      • Boston、Massachusetts、美国、02114
        • Massachusetts General Hospital Crohn's and Colitis Center
    • Michigan
      • Ann Arbor、Michigan、美国、48109
        • University of Michigan
      • Troy、Michigan、美国、48098
        • Center for Digestive Health
      • Ypsilanti、Michigan、美国、48197
        • Huron Gastroenterology Associates
    • Minnesota
      • Plymouth、Minnesota、美国、55446
        • Minnesota Gastroenterology P.A.
      • Rochester、Minnesota、美国、55905
        • Mayo Clinic
    • Missouri
      • St. Louis、Missouri、美国、63110
        • Washington University
    • New Hampshire
      • Lebanon、New Hampshire、美国、03756
        • Dartmouth-Hitchcock Medical Center
    • New York
      • Great Neck、New York、美国、11021
        • Long Island Clinical Research Associates
      • New York、New York、美国、10021
        • New York Presbyterian Hospital
      • Rochester、New York、美国、14642
        • University of Rochester
    • North Carolina
      • Chapel Hill、North Carolina、美国、27599
        • University of North Carolina at Chapel Hill
      • Charlotte、North Carolina、美国、28207
        • Charlotte Gastroenterology and Hepatology P.L.L.C
    • Ohio
      • Cincinnati、Ohio、美国、45219
        • Consultants for Clinical Research Inc.
    • Oklahoma
      • Tulsa、Oklahoma、美国、74104
        • Options Health Research
    • Oregon
      • Portland、Oregon、美国、97225
        • The Oregon Clinic-West Hills Gastroenterology
    • South Carolina
      • Columbia、South Carolina、美国、29203
        • Consultants in Gastroenterology
    • Tennessee
      • Germantown、Tennessee、美国、38138
        • Gastroenterology Center of the MidSouth PC
    • Texas
      • San Antonio、Texas、美国、78229
        • Gastroenterology Clinic of San Antonio
      • Tyler、Texas、美国、75701
        • Digestive Health Specialists of Tyler
    • Virginia
      • Charlottesville、Virginia、美国、22908
        • University of Virginia Health System
    • Washington
      • Seattle、Washington、美国、98195
        • University of Washington School of Medicine
    • Wisconsin
      • Milwaukee、Wisconsin、美国、53226
        • Medical College of Wisconsin
      • Milwaukee、Wisconsin、美国、53215
        • Wisconsin Center for Advanced Research

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 80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:

  • Age 18 to 80
  • Diagnosis of moderately to severely active Crohn's disease
  • Crohn's Disease involvement of the ileum and/or colon
  • Demonstrated, over the previous 5 year period, an inadequate response to, loss of response to, or intolerance of at least one conventional therapy as defined by the protocol
  • May be receiving a therapeutic dose of conventional therapies for inflammatory bowel disease (IBD) as defined by the protocol

Exclusion Criteria

  • Evidence of abdominal abscess at the initial screening visit
  • Extensive colonic resection, subtotal or total colectomy
  • History of >3 small bowel resections or diagnosis of short bowel syndrome
  • Ileostomy, colostomy, or known fixed symptomatic stenosis of the intestine
  • Have received non permitted therapies within either 30 or 60 days, depending on the medication, as stated in the protocol
  • Chronic hepatitis B or C infection; human immunodeficiency virus (HIV) infection
  • Active or latent tuberculosis

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：三倍

武器和干预

参与者组/臂
干预/治疗
安慰剂比较：Placebo
Participants received placebo intravenous infusion at Weeks 0, 2 and 6.
其他：安慰剂
安慰剂静脉输注
实验性的：Vedolizumab
Participants received 300 mg intravenous vedolizumab at Weeks 0, 2, and 6.
药品：维多珠单抗
维多珠单抗用于静脉输注
其他名称：
  • 恩蒂维奥
  • MLN0002
  • MLN02
  • LDP-02

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 Participants in Clinical Remission in the Tumor Necrosis Factor Alpha (TNFα) Antagonist Failure Subpopulation
大体时间：Week 6

Clinical remission is defined as a Crohn's Disease Activity Index (CDAI) score ≤ 150 points.

The CDAI is used to quantify the symptoms of patients with Crohn's disease and consists of eight factors, each summed after adjustment with a weighting factor. The components of the CDAI are:

  • Number of liquid or soft stools each day for 7 days;
  • Abdominal pain (graded from 0-3 on severity) each day for 7 days;
  • General well-being, subjectively assessed from 0 (well) to 4 (terrible) each day for 7 days;
  • Presence of complications;
  • Taking Lomotil or opiates for diarrhea;
  • Presence of an abdominal mass (0 as none, 2 as questionable, 5 as definite);
  • Hematocrit of < 0.47 in men and < 0.42 in women;
  • Percentage deviation from standard weight.

The total score ranges from 0 to approximately 600 and with higher scores indicating greater disease activity.

All participants who prematurely discontinued for any reason were considered as not achieving clinical remission.
Week 6

次要结果测量

结果测量
措施说明
大体时间
Percentage of Participants in Clinical Remission at Week 6 in the Overall Population
大体时间：Week 6

Clinical remission is defined as a Crohn's Disease Activity Index (CDAI) score ≤ 150 points.

The CDAI is used to quantify the symptoms of patients with Crohn's disease and consists of eight factors, each summed after adjustment with a weighting factor. The components of the CDAI are:

  • Number of liquid or soft stools each day for 7 days;
  • Abdominal pain (graded from 0-3 on severity) each day for 7 days;
  • General well-being, subjectively assessed from 0 (well) to 4 (terrible) each day for 7 days;
  • Presence of complications;
  • Taking Lomotil or opiates for diarrhea;
  • Presence of an abdominal mass (0 as none, 2 as questionable, 5 as definite);
  • Hematocrit of < 0.47 in men and < 0.42 in women;
  • Percentage deviation from standard weight.

The total score ranges from 0 to approximately 600 and with higher scores indicating greater disease activity.

All participants who prematurely discontinued for any reason were considered as not achieving clinical remission.
Week 6
Percentage of Participants in Clinical Remission at Week 10 in the TNFα Antagonist Failure Subpopulation
大体时间：Week 10

Clinical remission is defined as a Crohn's Disease Activity Index (CDAI) score ≤ 150 points.

The CDAI is used to quantify the symptoms of patients with Crohn's disease and consists of eight factors, each summed after adjustment with a weighting factor. The components of the CDAI are:

  • Number of liquid or soft stools each day for 7 days;
  • Abdominal pain (graded from 0-3 on severity) each day for 7 days;
  • General well-being, subjectively assessed from 0 (well) to 4 (terrible) each day for 7 days;
  • Presence of complications;
  • Taking Lomotil or opiates for diarrhea;
  • Presence of an abdominal mass (0 as none, 2 as questionable, 5 as definite);
  • Hematocrit of < 0.47 in men and < 0.42 in women;
  • Percentage deviation from standard weight.

The total score ranges from 0 to approximately 600 and with higher scores indicating greater disease activity.

All participants who prematurely discontinued for any reason were considered as not achieving clinical remission.
Week 10
Percentage of Participants in Clinical Remission at Week 10 in the Overall Population
大体时间：Week 10

Clinical remission is defined as a Crohn's Disease Activity Index (CDAI) score ≤ 150 points.

The CDAI is used to quantify the symptoms of patients with Crohn's disease and consists of eight factors, each summed after adjustment with a weighting factor. The components of the CDAI are:

  • Number of liquid or soft stools each day for 7 days;
  • Abdominal pain (graded from 0-3 on severity) each day for 7 days;
  • General well-being, subjectively assessed from 0 (well) to 4 (terrible) each day for 7 days;
  • Presence of complications;
  • Taking Lomotil or opiates for diarrhea;
  • Presence of an abdominal mass (0 as none, 2 as questionable, 5 as definite);
  • Hematocrit of < 0.47 in men and < 0.42 in women;
  • Percentage deviation from standard weight.

The total score ranges from 0 to approximately 600 and with higher scores indicating greater disease activity.

All participants who prematurely discontinued for any reason were considered as not achieving clinical remission.
Week 10
Percentage of Participants With Sustained Clinical Remission in the TNFα Antagonist Failure Population
大体时间：Week 6 and Week 10

Sustained clinical remission is defined as a CDAI score ≤ 150 points at both Week 6 and Week 10. The CDAI is used to quantify the symptoms of patients with Crohn's disease and consists of eight factors, each summed after adjustment with a weighting factor. The components of the CDAI are:

  • Number of liquid or soft stools each day for 7 days;
  • Abdominal pain (graded from 0-3 on severity) each day for 7 days;
  • General well-being, subjectively assessed from 0 (well) to 4 (terrible) each day for 7 days;
  • Presence of complications;
  • Taking Lomotil or opiates for diarrhea;
  • Presence of an abdominal mass (0 as none, 2 as questionable, 5 as definite);
  • Hematocrit of < 0.47 in men and < 0.42 in women;
  • Percentage deviation from standard weight.

The total score ranges from 0 to approximately 600 and with higher scores indicating greater disease activity.

All participants who prematurely discontinued for any reason were considered as not achieving sustained clinical remission.
Week 6 and Week 10
Percentage of Participants With Sustained Clinical Remission in the Overall Population
大体时间：Week 6 and Week 10

Sustained clinical remission is defined as a CDAI score ≤ 150 points at both Week 6 and Week 10. The CDAI is used to quantify the symptoms of patients with Crohn's disease and consists of eight factors, each summed after adjustment with a weighting factor. The components of the CDAI are:

  • Number of liquid or soft stools each day for 7 days;
  • Abdominal pain (graded from 0-3 on severity) each day for 7 days;
  • General well-being, subjectively assessed from 0 (well) to 4 (terrible) each day for 7 days;
  • Presence of complications;
  • Taking Lomotil or opiates for diarrhea;
  • Presence of an abdominal mass (0 as none, 2 as questionable, 5 as definite);
  • Hematocrit of < 0.47 in men and < 0.42 in women;
  • Percentage deviation from standard weight.

The total score ranges from 0 to approximately 600 and with higher scores indicating greater disease activity.

All participants who prematurely discontinued for any reason were considered as not achieving sustained clinical remission.
Week 6 and Week 10
Percentage of Participants With Enhanced Clinical Response at Week 6 in the TNFα Antagonist Failure Subpopulation
大体时间：Baseline and Week 6

Enhanced clinical response is defined as a ≥ 100-point decrease in CDAI score from Baseline.

The CDAI is used to quantify the symptoms of patients with Crohn's disease and consists of eight factors, each summed after adjustment with a weighting factor. The components of the CDAI are:

  • Number of liquid or soft stools each day for 7 days;
  • Abdominal pain (graded from 0-3 on severity) each day for 7 days;
  • General well-being, subjectively assessed from 0 (well) to 4 (terrible) each day for 7 days;
  • Presence of complications;
  • Taking Lomotil or opiates for diarrhea;
  • Presence of an abdominal mass (0 as none, 2 as questionable, 5 as definite);
  • Hematocrit of < 0.47 in men and < 0.42 in women;
  • Percent deviation from standard weight.

The total score ranges from 0 to approximately 600 and with higher scores indicating greater disease activity.

All participants who prematurely discontinued for any reason were considered as not achieving enhanced clinical response.
Baseline and Week 6
Number of Participants With Adverse Events (AEs)
大体时间：From the date of first study drug administration to Week 22, through the 14 March 2012 database lock date. At the time of this database lock, 7 patients had completed Week 10 or early termination assessments but not Week 22 assessments.

An AE was defined as any untoward medical occurrence in a patient administered a pharmaceutical product, which did not necessarily have a causal relationship with the treatment. A serious adverse event (SAE) was any AE, occurring at any dose and regardless of causality that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was an important medical event based upon appropriate medical judgment that may have jeopardized the patient and may have required medical or surgical intervention to prevent 1 of the outcomes listed above, or any diagnosis of progressive multifocal leukoencephalopathy (PML).

Relationship to study drug administration was determined by the investigator responding yes or no to the question: Is there a reasonable possibility that the AE is associated with the study drug?
From the date of first study drug administration to Week 22, through the 14 March 2012 database lock date. At the time of this database lock, 7 patients had completed Week 10 or early termination assessments but not Week 22 assessments.

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

Millennium Pharmaceuticals, Inc.

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

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

2010年11月1日

初级完成 (实际的)

2012年2月1日

研究完成 (实际的)

2012年4月1日

研究注册日期

首次提交

2010年10月18日

首先提交符合 QC 标准的

2010年10月18日

首次发布 (估计)

2010年10月19日

研究记录更新

最后更新发布 (估计)

2014年7月21日

上次提交的符合 QC 标准的更新

2014年6月19日

最后验证

2014年6月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • C13011
  • U1111-1158-2581 (注册表标识符：WHO)
  • 2009-016488-12 (EudraCT编号)
  • NL34356.078.10 (注册表标识符：CCMO)

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

在美国制造并从美国出口的产品

不

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.

安慰剂的临床试验

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赞助者和合作者

医疗条件

药物干预

CROs by country

CROs in Cyprus

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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