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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
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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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.
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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 
Overall Participants Analyzed 
[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 ]

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 ]

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 ]

4.  Secondary:   Number of Participants Who Had Extra-intestinal Manifestations (EIM) at Baseline and Resolution by Week 20.   [ Time Frame: Week 20 of treatment ]

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 ]

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 ]

7.  Secondary:   Mean Change in Percent Impairment While Working From Baseline to Week 20 of Treatment   [ Time Frame: Week 20 of treatment ]

8.  Secondary:   Mean Change in Overall Work Productivity and Activity Impairment Score From Baseline to Week 20   [ Time Frame: Week 20 of treatment ]

9.  Secondary:   Mean Change in Activity Impairment Score From Baseline to Week 20   [ Time Frame: Week 20 of treatment ]


  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 Services
Organization: Abbott
phone: 800-633-9110


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

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