Special Investigation in Patients With Crohn's Disease (All Patients Investigation)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01298648
First received: January 26, 2011
Last updated: March 19, 2014
Last verified: March 2014
Results First Received: January 31, 2014  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Condition: Crohn's Disease

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Humira Participants who were prescribed Humira per approved prescribing information of Humira in Japan.

Participant Flow:   Overall Study
    Humira  
STARTED     1716  
COMPLETED     1693  
NOT COMPLETED     23  
Withdrawal by Subject                 2  
Lost to Follow-up                 21  



  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.
Safety analysis set: Excluding 21 patients who were transferred to other institutions during the surveillance period and 2 patients who made no visit after the first administration, 1693 patients were included in the safety analysis set.

Reporting Groups
  Description
Humira Participants who were prescribed Humira per approved prescribing information of Humira in Japan.

Baseline Measures
    Humira  
Number of Participants  
[units: participants]
  1693  
Age  
[units: years]
Mean ± Standard Deviation
  35.5  ± 11.7  
Gender  
[units: participants]
 
Female     584  
Male     1109  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants With Adverse Events (AEs)   [ Time Frame: 24 weeks ]

2.  Primary:   Crohn's Disease Activity Index (CDAI) at Baseline and Week 4   [ Time Frame: Baseline, Week 4 ]

3.  Primary:   Crohn's Disease Activity Index (CDAI) at Baseline and Week 8   [ Time Frame: Baseline, Week 8 ]

4.  Primary:   Crohn's Disease Activity Index (CDAI) at Baseline and Week 24   [ Time Frame: Baseline, Week 24 ]

5.  Secondary:   Improvement Rating by Investigator at Week 24   [ Time Frame: Week 24 ]

6.  Secondary:   Remission Rate at Week 4, Week 8, and Week 24   [ Time Frame: Baseline, Week 4, Week 8, and Week 24 ]


  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
No text entered.


  More Information
  Hide More Information

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 Services
Organization: AbbVie (prior sponsor, Abbott)
phone: 800-633-9110


No publications provided


Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT01298648     History of Changes
Other Study ID Numbers: P12-706
Study First Received: January 26, 2011
Results First Received: January 31, 2014
Last Updated: March 19, 2014
Health Authority: Japan: Ministry of Health, Labor and Welfare