Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

A Study of Adalimumab for the Induction of Clinical Remission in Japanese Subjects With Crohn's Disease

This study has been completed.
Sponsor:
Collaborators:
Abbott Japan Co.,Ltd
Eisai Co., Ltd.
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT00445939
First received: March 7, 2007
Last updated: June 20, 2011
Last verified: June 2011
Results First Received: December 23, 2008  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Crohn's Disease
Interventions: Biological: adalimumab
Biological: placebo

  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
Subjects with moderate to severe Crohn's Disease (Crohn's Disease Activity Index [CDAI] >= 220 and <= 450) were enrolled into study. The period from the first dose of study drug to the evaluation at Week 4 is Period A. The period from the study drug injection at Week 4 to the evaluation at Week 8 is Period B.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
All subjects were evaluated at Week 4. If responders (CDAI decrease >= 70 points compared to Baseline), rolled over to a maintenance study. If non-responders (CDAI decrease of < 70 points compared to Baseline), continued in study and received: adalimumab 160/80 mg + 40/40 mg, or adalimumab 80/40 mg + 40/40 mg or placebo + adalimumab 160/80 mg.

Reporting Groups
  Description
Adalimumab 160 mg/80 mg Adalimumab 160 mg at Week 0, 80 mg at Week 2
Adalimumab 80 mg/40 mg Adalimumab 80 mg at Week 0, 40 mg at Week 2
Placebo Placebo at Week 0, placebo at Week 2
Adalimumab 40mg /40 mg Non-responders continued after 4 weeks, Adalimumab 160 at Week 0, 80 mg at Week 2, 40 mg at Week 4, 40 mg at Week 6; Adalimumab 80 mg at Week 0, 40 mg at Week 2, 40 mg at Week 4, 40 mg at Week 6.

Participant Flow for 2 periods

Period 1:   Period A - Week 0 - Week 4
    Adalimumab 160 mg/80 mg     Adalimumab 80 mg/40 mg     Placebo     Adalimumab 40mg /40 mg  
STARTED     33     34     23     0  
COMPLETED     32 [1]   32 [2]   23 [3]   0  
NOT COMPLETED     1     2     0     0  
Adverse Event                 1                 2                 0                 0  
[1] 23 rated as responders and 9 rated as non-responders in evaluation on Week 4.
[2] 20 rated as responders and 12 rated as non-responders in evaluation on Week 4.
[3] 7 rated as responders and 16 rated as non-responders in evaluation on Week 4.

Period 2:   Period B - Week 4 - Week 8
    Adalimumab 160 mg/80 mg     Adalimumab 80 mg/40 mg     Placebo     Adalimumab 40mg /40 mg  
STARTED     16 [1]   0 [2]   0 [3]   21 [4]
COMPLETED     14     0     0     20  
NOT COMPLETED     2     0     0     1  
Adverse Event                 2                 0                 0                 1  
[1] Non-responders continued after 4 weeks, previous 16 placebo subjects allocated to 160/80 mg group.
[2] Non-responders continued after 4 weeks, previous 80/40 mg subjects allocated to 40/40 mg group.
[3] Non-responders continued after 4 weeks, previous placebo subjects allocated to 160/80 mg group.
[4] Non-responders continued after 4 weeks, previous 160/80 and 80/40 subjects allocated to 40/40 group.



  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.
No text entered.

Reporting Groups
  Description
Adalimumab 160 mg/80 mg Adalimumab 160 mg at Week 0, 80 mg at Week 2
Adalimumab 80 mg/40 mg Adalimumab 80 mg at Week 0, 40 mg at Week 2
Placebo Placebo at Week 0, placebo Week 2
Total Total of all reporting groups

Baseline Measures
    Adalimumab 160 mg/80 mg     Adalimumab 80 mg/40 mg     Placebo     Total  
Number of Participants  
[units: participants]
  33     34     23     90  
Age  
[units: years]
Mean ± Standard Deviation
  32.0  ± 9.60     30.6  ± 9.26     30.4  ± 6.93     31.1  ± 8.80  
Gender [1]
[units: participants]
       
Female     13     18     7     38  
Male     20     16     16     52  
Region of Enrollment  
[units: participants]
       
Japan     33     34     23     90  
[1] Gender, Male/Female who received first dose of study drug



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   The Number of Subjects With a Clinical Remission (Crohn's Disease Activity Index [CDAI] < 150) at Week 4   [ Time Frame: 4 Weeks ]

2.  Secondary:   Clinical Remission (CDAI < 150) at Week 2   [ Time Frame: Week 2 ]

3.  Secondary:   Clinical Response (CR-70 and CR-100) in Period A   [ Time Frame: Weeks 2 and Week 4 ]

4.  Secondary:   Clinical Response (CR-70 and CR-100) in Period B   [ Time Frame: Week 6 and Week 8 ]

5.  Secondary:   Clinical Remission (CDAI <150) at Week 6 and Week 8   [ Time Frame: Week 6 and Week 8 ]


  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
Small population, therefore no statistical tests were performed


  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: Abbott
phone: 800-633-9110


No publications provided by Abbott

Publications automatically indexed to this study:

Responsible Party: Eiichi Makino, Abbott
ClinicalTrials.gov Identifier: NCT00445939     History of Changes
Other Study ID Numbers: M04-729
Study First Received: March 7, 2007
Results First Received: December 23, 2008
Last Updated: June 20, 2011
Health Authority: Japan: Ministry of Health, Labor and Welfare