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Effectiveness and Safety in Patients With Crohn´s Disease in Clinical Routine

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01083680
First Posted: March 10, 2010
Last Update Posted: April 4, 2017
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):
AbbVie ( AbbVie (prior sponsor, Abbott) )
Results First Submitted: December 13, 2016  
Study Type: Observational
Study Design: Observational Model: Case-Only;   Time Perspective: Prospective
Condition: Crohn's Disease

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
A total of 4107 participants were enrolled: 1621 in the full analysis set (FAS) population were analyzed for efficacy; 4107 were analyzed for safety.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Participants With Crohn's Disease (CD) Participants with Crohn's Disease treated with adalimumab in routine clinical practice.

Participant Flow:   Overall Study
    Participants With Crohn's Disease (CD)
STARTED   4107 
Full Analysis Set (FAS), Efficacy   1621 
COMPLETED   263 
NOT COMPLETED   3844 
Lost to Follow-up                2758 
Withdrawal by Subject                1086 



  Baseline Characteristics
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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.
Baseline analyses accounts for safety analysis set population (all participants who received at least 1 dose of study drug).

Reporting Groups
  Description
Participants With Crohn's Disease (CD) Participants with Crohn's Disease treated with adalimumab in routine clinical practice.

Baseline Measures
   Participants With Crohn's Disease (CD) 
Overall Participants Analyzed 
[Units: Participants]
 4107 
Age [1] 
[Units: Years]
Mean (Standard Deviation)
 
Participants Analyzed 
[Units: Participants]
 4076 
   36.6  (12.7) 
[1] Baseline analysis (age, continuous) accounts for safety analysis set population with available data. This information wasn't available for 31 participants.
Sex: Female, Male [1] 
[Units: Participants]
Count of Participants
 
Participants Analyzed 
[Units: Participants]
 4083 
Female      2500  61.2% 
Male      1583  38.8% 
[1] Baseline analysis (gender) accounts for safety analysis set population with available data. This information wasn't available for 24 participants.


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Mean Change From Baseline in Crohn's Disease Activity Index (CDAI) at Each Visit   [ Time Frame: Months 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54 and 60 ]

2.  Primary:   Percentage of Full Analysis Set (FAS) Participants in Each CDAI Disease Classification Over Time   [ Time Frame: Months 0, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54 and 60 ]

3.  Primary:   Mean Change From Baseline in Short Inflammatory Bowel Disease Questionnaire (SIBDQ) at Each Visit in FAS Participants   [ Time Frame: Months 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54 and 60 ]

4.  Primary:   Percentage of Participants With Adverse Events (Excluding Serious Adverse Events)   [ Time Frame: Months 0, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54 and 60 ]

5.  Secondary:   4.Mean Harvey Bradshaw Index (HBI) in Full Analysis Set (FAS) Participants Over Time   [ Time Frame: Months 0, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54 and 60 ]

6.  Secondary:   Compliance With the Self-injection Via the Humira®-PEN   [ Time Frame: Months 0, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54 and 60 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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: Global Medical Information
Organization: AbbVie
phone: 800-633-9110



Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT01083680     History of Changes
Other Study ID Numbers: P10-278
First Submitted: February 26, 2010
First Posted: March 10, 2010
Results First Submitted: December 13, 2016
Results First Posted: April 4, 2017
Last Update Posted: April 4, 2017