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Study of Adalimumab Treatment for Induction and Maintenance of Clinical Remission in Subjects With Crohn's Disease

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Abbott
ClinicalTrials.gov Identifier:
NCT00409617
First received: December 8, 2006
Last updated: October 6, 2011
Last verified: October 2011
History of Changes
Results First Received: July 24, 2009  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Crohn's Disease
Intervention: Biological: adalimumab

  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
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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
Open Label Adalimumab 40 mg Every Other Week or Every Week Participants received adalimumab 160 mg by subcutaneous injection at Week 0 and adalimumab 80 mg by subcutaneous injection at Week 2. Beginning at Week 4 of the study, participants received adalimumab 40 mg every other week. Beginning at Week 12, participants who experienced a disease flare (increase in Harvey Bradshaw Index of 3 or more compared to Week 4 and a total Index score of 7 or higher) and participants who did not respond to every other week treatment (non-response defined as a decrease in HBI by fewer than 3 points compared to Baseline) could switch to adalimumab 40 mg every week.

Participant Flow:   Overall Study
    Open Label Adalimumab 40 mg Every Other Week or Every Week  
STARTED     945  
COMPLETED     785  
NOT COMPLETED     160  
Adverse Event                 57  
Lack of Efficacy                 54  
Lost to Follow-up                 2  
Protocol Violation                 24  
Withdrawal by Subject                 8  
Administrative reasons                 1  
Not described                 14  



  Baseline Characteristics
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Reporting Groups
  Description
Open Label Adalimumab 40 mg Every Other Week or Every Week Participants received adalimumab 160 mg by subcutaneous injection at Week 0 and adalimumab 80 mg by subcutaneous injection at Week 2. Beginning at Week 4 of the study, participants received adalimumab 40 mg every other week. Beginning at Week 12, participants who experienced a disease flare (increase in Harvey Bradshaw Index of 3 or more compared to Week 4 and a total Index score of 7 or higher) and participants who did not respond to every other week treatment (non-response defined as a decrease in HBI by fewer than 3 points compared to Baseline) could switch to adalimumab 40 mg every week.

Baseline Measures
    Open Label Adalimumab 40 mg Every Other Week or Every Week  
Number of Participants  
[units: participants]
 		  945  
Age  
[units: participants]
 		 
<=18 years     12  
Between 18 and 65 years     919  
>=65 years     14  
Age  
[units: years]
Mean ± Standard Deviation 		  35.3  ± 11.29  
Gender  
[units: participants]
 		 
Female     568  
Male     377  
Region of Enrollment  
[units: participants]
 		 
Portugal     19  
Slovakia (Slovak Republic)     18  
Greece     25  
Finland     5  
Spain     47  
Ireland     11  
Austria     47  
United Kingdom     73  
Switzerland     15  
Italy     64  
France     141  
Czech Republic     37  
Belgium     72  
Denmark     43  
Germany     266  
Norway     27  
Sweden     35  



  Outcome Measures
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1.  Primary:   Number of Participants in Clinical Remission at Treatment Week 20. Clinical Remission Defined as Harvey Bradshaw Index (HBI) Score Less Than 5.   [ Time Frame: Week 20 of treatment ]
  Show Outcome Measure 1

2.  Secondary:   Number of Participants Who Were Responders at Week 20 of Treatment. A Responder Was Defined as a Participant Who Had a Decrease of 3 or More on the HBI.   [ Time Frame: Week 20 of treatment ]
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Measure Type Secondary
Measure Title Number of Participants Who Were Responders at Week 20 of Treatment. A Responder Was Defined as a Participant Who Had a Decrease of 3 or More on the HBI.
Measure Description 5-items that assess general well-being, abdominal pain, diarrhea, abdominal mass, and complications. Score is total of 1) subject well-being (0=very well; 4=terrible); 2) abdominal pain (0=none; 3=severe); 3) diarrhea (number of time per day); 4) abdominal mass (0=none; 3=definite and tender); 5) complications (number). Participants who had a decrease from Baseline of at least 3 points in HBI total score were considered responders. Missing data were imputed using non-responder imputation (NRI).
Time Frame Week 20 of treatment  
Safety Issue No  

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.
ITT Population, defined as all participants who received at least 1 injection of adalimumab. Missing data were imputed using non-responder imputation; participants who discontinued the study prior to Week 20 and participants with no score on the Harvey-Bradshaw Index (missing value) at Week 20 were counted as "no" for response.

Reporting Groups
  Description
Open Label Adalimumab 40 mg Every Other Week or Every Week Participants received adalimumab 160 mg by subcutaneous injection at Week 0 and adalimumab 80 mg by subcutaneous injection at Week 2. Beginning at Week 4 of the study, participants received adalimumab 40 mg every other week. Beginning at Week 12, participants who experienced a disease flare (increase in Harvey Bradshaw Index of 3 or more compared to Week 4 and a total Index score of 7 or higher) and participants who did not respond to every other week treatment (non-response defined as a decrease in HBI by fewer than 3 points compared to Baseline) could switch to adalimumab 40 mg every week.

Measured Values
    Open Label Adalimumab 40 mg Every Other Week or Every Week  
Number of Participants Analyzed  
[units: participants]
 		  945  
Number of Participants Who Were Responders at Week 20 of Treatment. A Responder Was Defined as a Participant Who Had a Decrease of 3 or More on the HBI.  
[units: Participants]
 		  658  

No statistical analysis provided for Number of Participants Who Were Responders at Week 20 of Treatment. A Responder Was Defined as a Participant Who Had a Decrease of 3 or More on the HBI.



3.  Secondary:   Number of Participants Who Had a Reduction in Number of Draining Fistulas of at Least 50% From Baseline to Week 20   [ Time Frame: Week 20 of treatment ]
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4.  Secondary:   Number of Participants Who Had Extra-intestinal Manifestations (EIM) at Baseline and Resolution by Week 20.   [ Time Frame: Week 20 of treatment ]
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5.  Secondary:   Mean Change in Total Score of Short Inflammatory Bowel Disease Questionnaire (SIBDQ) From Baseline to Week 20   [ Time Frame: Week 20 of treatment ]
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6.  Secondary:   Mean Change in Percent Work Time Missed Due to Crohn's Disease From Baseline to Week 20 of Treatment   [ Time Frame: Week 20 of treatment ]
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7.  Secondary:   Mean Change in Percent Impairment While Working From Baseline to Week 20 of Treatment   [ Time Frame: Week 20 of treatment ]
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8.  Secondary:   Mean Change in Overall Work Productivity and Activity Impairment Score From Baseline to Week 20   [ Time Frame: Week 20 of treatment ]
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9.  Secondary:   Mean Change in Activity Impairment Score From Baseline to Week 20   [ Time Frame: Week 20 of treatment ]
  Show Outcome Measure 9


  Serious Adverse Events
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  Other Adverse Events
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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.


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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Results Point of Contact:  
Name/Title: Global Medical Services
Organization: Abbott
phone: 800-633-9110


No publications provided by Abbott

Publications automatically indexed to this study:


Responsible Party: Abbott
ClinicalTrials.gov Identifier: NCT00409617     History of Changes
Other Study ID Numbers: M06-829, EudraCT:2006-002078-23
Study First Received: December 8, 2006
Results First Received: July 24, 2009
Last Updated: October 6, 2011
Health Authority: Austria: Agency for Health and Food Safety