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A Long-Term Registry of Humira® (Adalimumab) in Subjects With Moderately to Severely Active Crohn's Disease (CD)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00524537
First Posted: September 3, 2007
Last Update Posted: January 24, 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: November 18, 2016  
Study Type: Observational
Study Design: Observational Model: Cohort;   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 6 participants less than 18 years of age were enrolled in the study. Participants were permitted to re-enroll after discontinuing the study. Of the 2811 participants who discontinued study, 339 re-enrolled in the study; 102 participants discontinued from the study after re-enrollment.

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
Adalimumab (Humira) Treatment Adult patients with moderately to severely active CD treated with Humira in a routine clinical practice setting.

Participant Flow:   Overall Study
    Adalimumab (Humira) Treatment
STARTED   5025 [1] 
Discontinued   2811 [2] 
Re-enrolled   339 [3] 
Discontinued After Re-enrollment   102 [4] 
COMPLETED   2451 [5] 
NOT COMPLETED   2574 
[1] All Treated Population: All participants who received at least 1 injection of Humira in the registry
[2] Discontinued from study
[3] Discontinued from study and later re-enrolled in study
[4] Discontinued from study after re-enrollment
[5] Still enrolled in study at the end of study



  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.
All Treated Population: All participants who received at least 1 injection of Humira in the registry

Reporting Groups
  Description
Adalimumab (Humira) Treatment Adult patients with moderately to severely active CD treated with Humira in a routine clinical practice setting.

Baseline Measures
   Adalimumab (Humira) Treatment 
Overall Participants Analyzed 
[Units: Participants]
 5025 
Age 
[Units: Years]
Mean (Standard Deviation)
 37.8  (12.7) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      2869  57.1% 
Male      2156  42.9% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants With Registry Treatment-Emergent Adverse Events (AEs)   [ Time Frame: Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years). ]

2.  Secondary:   Short Inflammatory Bowel Disease Questionnaire (SIBDQ) Total Score: Change From Baseline to Each Visit   [ Time Frame: Baseline (Enrollment) and 12, 24, 36, 48, 60, and 72 Months ]

3.  Secondary:   Physician's Global Assessment of Disease Activity (PGA): Change From Baseline to Each Visit   [ Time Frame: Baseline (Enrollment) and 12, 24, 36, 48, 60, and 72 Months ]

4.  Secondary:   Work Productivity and Activity Impairment: Special Health Problem (WPAI:SHP): Change in Mean Percentage of Work Time Missed (Absenteeism) From Baseline to Each Visit   [ Time Frame: Baseline (Enrollment) and 12, 24, 36, 48, 60, and 72 Months ]

5.  Secondary:   WPAI:SHP: Change in Mean Percentage of Impairment While Working (Presenteeism) Due to Crohn’s Disease From Baseline to Each Visit   [ Time Frame: Baseline (Enrollment) and 12, 24, 36, 48, 60, and 72 Months ]

6.  Secondary:   WPAI:SHP: Change in Mean Percentage of Overall Work Impairment Due to Crohn’s Disease From Baseline to Each Visit   [ Time Frame: Baseline (Enrollment) and 12, 24, 36, 48, 60, and 72 Months ]

7.  Secondary:   WPAI:SHP: Change in Mean Percentage of Activity Impairment Due to Crohn’s Disease From Baseline to Each Visit   [ Time Frame: Baseline (Enrollment) and 12, 24, 36, 48, 60, and 72 Months ]

8.  Secondary:   Healthcare Resource Utilization (HCRU): Mean Number Of Visits At Physician's Office Due to CD at Each Study Visit   [ Time Frame: Baseline (Enrollment) and 12, 24, 36, 48, 60, and 72 Months ]

9.  Secondary:   Healthcare Resource Utilization (HCRU): Mean Number Of Visits At Emergency Room Due to CD at Each Study Visit   [ Time Frame: Baseline (Enrollment) and 12, 24, 36, 48, 60, and 72 Months ]

10.  Secondary:   Healthcare Resource Utilization (HCRU): Mean Number Of Admissions to Hospital Due to CD at Each Study Visit   [ Time Frame: Baseline (Enrollment) and 12, 24, 36, 48, 60, and 72 Months ]

11.  Secondary:   Healthcare Resource Utilization (HCRU): Mean Total Days In Hospital Due to CD at Each Study Visit   [ Time Frame: Baseline (Enrollment) and 12, 24, 36, 48, 60, and 72 Months ]


  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: NCT00524537     History of Changes
Other Study ID Numbers: P06-134
First Submitted: August 31, 2007
First Posted: September 3, 2007
Results First Submitted: November 18, 2016
Results First Posted: January 24, 2017
Last Update Posted: January 24, 2017