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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01224171
First Posted: October 19, 2010
Last Update Posted: July 21, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Millennium Pharmaceuticals, Inc.
Results First Submitted: June 19, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition: Crohn's Disease
Interventions: Drug: vedolizumab
Other: Placebo

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants with moderately to severely active Crohn's Disease took part in the study at 107 sites worldwide from 24 November 2010 to 12 April 2012. Approximately 75% of participants were to have previously failed tumor necrosis factor alpha (TNFα) antagonist therapy and approximately 25% were to have been naïve to TNFα antagonist therapy.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants were randomized 1:1 to receive either 300 mg vedolizumab or placebo. Randomization to treatment assignment was stratified by the presence or absence of previous failure of TNFα antagonist therapy or naïve to TNFα antagonist therapy, concomitant use of oral corticosteroids and concomitant use of immunomodulators.

Reporting Groups
  Description
Placebo Participants received placebo intravenous infusion at Weeks 0, 2 and 6.
Vedolizumab Participants received 300 mg intravenous vedolizumab at Weeks 0, 2, and 6.

Participant Flow:   Overall Study
    Placebo   Vedolizumab
STARTED   207   209 
TNFα Antagonist Failure Population   157 [1]   158 [1] 
COMPLETED   192 [2]   196 [2] 
NOT COMPLETED   15   13 
Adverse Event                8                4 
Protocol Violation                0                1 
Lack of Efficacy                5                1 
Withdrawal of Consent                2                4 
Lost to Follow-up                0                3 
[1] Previously failed (inadequate response, loss of response, or intolerance) TNFα antagonist therapy
[2] Completed study is defined as patients who completed the Week 10 assessments.



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The Overall Intent-to-treat (ITT) Population consisted of all randomized participants who received any amount of blinded study drug.

Reporting Groups
  Description
Placebo Participants received placebo intravenous infusion at Weeks 0, 2 and 6.
Vedolizumab Participants received 300 mg intravenous vedolizumab at Weeks 0, 2, and 6.
Total Total of all reporting groups

Baseline Measures
   Placebo   Vedolizumab   Total 
Overall Participants Analyzed 
[Units: Participants]
 207   209   416 
Age 
[Units: Years]
Mean (Standard Deviation)
 37.1  (13.15)   38.6  (12.14)   37.9  (12.66) 
Age, Customized 
[Units: Participants]
     
< 35 years   105   88   193 
≥ 35 years   102   121   223 
Age, Customized 
[Units: Participants]
     
< 65 years   202   206   408 
≥ 65 years   5   3   8 
Gender 
[Units: Participants]
     
Female   118   118   236 
Male   89   91   180 
Ethnicity (NIH/OMB) 
[Units: Participants]
     
Hispanic or Latino   4   4   8 
Not Hispanic or Latino   199   204   403 
Unknown or Not Reported   4   1   5 
Race/Ethnicity, Customized 
[Units: Participants]
     
White   186   188   374 
Black   5   4   9 
Asian   9   9   18 
Other   7   6   13 
Not Reported   0   2   2 
Body Weight 
[Units: Kg]
Mean (Standard Deviation)
 71.3  (19.22)   69.5  (17.76)   70.4  (18.50) 
Body Mass Index 
[Units: Kg/m^2]
Mean (Standard Deviation)
 24.6  (6.13)   24.0  (5.13)   24.3  (5.65) 
Geographic Region 
[Units: Participants]
     
North America   95   102   197 
Western/Northern Europe   37   38   75 
Central Europe   46   41   87 
Eastern Europe   15   10   25 
Asia/Australia/Africa   14   18   32 
Duration of Crohn's Disease (CD) 
[Units: Years]
Mean (Standard Deviation)
 10.0  (7.98)   10.6  (8.75)   10.3  (8.37) 
Duration of Crohn's Disease - Categorical 
[Units: Participants]
     
< 1 year   12   11   23 
≥ 1 to < 3 years   25   28   53 
≥ 3 to < 7 years   52   52   104 
≥ 7 years   118   118   236 
Baseline Disease Activity – Crohn’s Disease Activity Index (CDAI) [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 301.3  (54.97)   313.9  (53.17)   307.7  (54.38) 
[1] Baseline disease activity represents the baseline CDAI score. The CDAI is a numerical calculation derived from the sum of products from a list of 8 disease variables: number of liquid stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to ~600 points with lower scores indicating disease remission and higher scores indicating disease worsening.
Baseline Disease Activity – Categorical 
[Units: Participants]
     
CDAI ≤ 330   148   132   280 
CDAI > 330   59   77   136 
C-reactive Protein (CRP) 
[Units: mg/L]
Mean (Standard Deviation)
 18.5  (21.98)   19.0  (23.17)   18.8  (22.56) 
CRP - Categorical 
[Units: Participants]
     
≤ 2.87 mg/L   41   46   87 
> 2.87 to ≤ 5 mg/L   19   14   33 
> 5 to ≤ 10 mg/L   42   48   90 
> 10 mg/L   105   101   206 
Fecal Calprotectin [1] 
[Units: μg/g]
Mean (Standard Deviation)
 1426.5  (2357.76)   1148.1  (1878.58)   1288.0  (2134.79) 
[1] Number of participants for whom baseline fecal calprotectin data were available were 206 and 204, respectively.
Fecal Calprotectin - Categorical 
[Units: Participants]
     
≤ 250 μg/g   47   52   99 
> 250 to ≤ 500 μg/g   35   35   70 
> 500 μg/g   124   117   241 
Missing   1   5   6 
Disease Localization 
[Units: Participants]
     
Ileum only   29   33   62 
Colon only   52   48   100 
Ileocolonic (both ileum and colon)   126   128   254 
History of Prior Surgery for Crohn's Disease 
[Units: Participants]
     
Yes   89   92   181 
No   118   117   235 
Smoking Status 
[Units: Participants]
     
Current Smoker   58   65   123 
Never Smoked   102   93   195 
Former Smoker   47   51   98 
History of Fistulizing Disease 
[Units: Participants]
     
Yes   77   71   148 
No   130   138   268 
Draining Fistula at Baseline 
[Units: Participants]
     
Yes   25   25   50 
All Closed   0   1   1 
No Fistula   182   183   365 
Extraintestinal Manifestations at Baseline 
[Units: Participants]
     
Yes   130   116   246 
No   77   93   170 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percentage of Participants in Clinical Remission in the Tumor Necrosis Factor Alpha (TNFα) Antagonist Failure Subpopulation   [ Time Frame: Week 6 ]

2.  Secondary:   Percentage of Participants in Clinical Remission at Week 6 in the Overall Population   [ Time Frame: Week 6 ]

3.  Secondary:   Percentage of Participants in Clinical Remission at Week 10 in the TNFα Antagonist Failure Subpopulation   [ Time Frame: Week 10 ]

4.  Secondary:   Percentage of Participants in Clinical Remission at Week 10 in the Overall Population   [ Time Frame: Week 10 ]

5.  Secondary:   Percentage of Participants With Sustained Clinical Remission in the TNFα Antagonist Failure Population   [ Time Frame: Week 6 and Week 10 ]

6.  Secondary:   Percentage of Participants With Sustained Clinical Remission in the Overall Population   [ Time Frame: Week 6 and Week 10 ]

7.  Secondary:   Percentage of Participants With Enhanced Clinical Response at Week 6 in the TNFα Antagonist Failure Subpopulation   [ Time Frame: Baseline and Week 6 ]

8.  Secondary:   Number of Participants With Adverse Events (AEs)   [ Time Frame: 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. ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Medical Director
Organization: Millennium Pharmaceuticals Inc.
phone: 800-778-2860
e-mail: clinicaltrialregistry@tpna.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Millennium Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01224171     History of Changes
Other Study ID Numbers: C13011
U1111-1158-2581 ( Registry Identifier: WHO )
2009-016488-12 ( EudraCT Number )
NL34356.078.10 ( Registry Identifier: CCMO )
First Submitted: October 18, 2010
First Posted: October 19, 2010
Results First Submitted: June 19, 2014
Results First Posted: July 21, 2014
Last Update Posted: July 21, 2014