A Study of Adalimumab in Japanese Subjects With Moderately to Severely Active Ulcerative Colitis

This study has been completed.
Sponsor:
Collaborator:
Eisai Co., Ltd.
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT00853099
First received: February 27, 2009
Last updated: September 3, 2014
Last verified: September 2014
Results First Received: October 26, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Ulcerative Colitis
Interventions: Biological: adalimumab
Drug: placebo

  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
Double-blind Placebo Participants received placebo subcutaneous injections every 2 weeks for 52 weeks. From Week 8, participants with an inadequate response could switch to rescue therapy, where they initially received adalimumab 160 mg, 80 mg 2 weeks later, and then 40 mg every other week.
Double-blind Adalimumab 80 mg/40 mg Participants received adalimumab 80 mg on Day 1, 40 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week.
Double-blind Adalimumab 160 mg/80 mg Participants received adalimumab 160 mg on Day 1, 80 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week.
All Adalimumab All participants who received at least one dose of adalimumab during the study (adalimumab treatment groups in the double-blind phase, and participants randomized to placebo who received adalimumab in the rescue phase or open-label phase).

Participant Flow for 2 periods

Period 1:   Double-blind Period
    Double-blind Placebo     Double-blind Adalimumab 80 mg/40 mg     Double-blind Adalimumab 160 mg/80 mg     All Adalimumab  
STARTED     96     87     91     0  
Treated     96     87     90 [1]   0  
Completed Week 8     92     85     86     0  
COMPLETED     73 [2]   58 [2]   60 [2]   0  
NOT COMPLETED     23     29     31     0  
Adverse Event                 7                 9                 13                 0  
Withdrawal by Subject                 2                 3                 0                 0  
Lack of Efficacy                 14                 17                 16                 0  
Not Specified                 0                 0                 1                 0  
Mistreated with rescue study drug                 0                 0                 1                 0  
[1] 1 participant, incorrectly treated with open-label (rescue) study drug at Week 0, was excluded.
[2] Participants who completed Week 52.

Period 2:   Double-blind + Open-label Periods
    Double-blind Placebo     Double-blind Adalimumab 80 mg/40 mg     Double-blind Adalimumab 160 mg/80 mg     All Adalimumab  
STARTED     0     0     0     266 [1]
COMPLETED     0     0     0     119  
NOT COMPLETED     0     0     0     147  
Lack of Efficacy                 0                 0                 0                 74  
Adverse Event                 0                 0                 0                 47  
Withdrawal by Subject                 0                 0                 0                 20  
Not Specified                 0                 0                 0                 6  
[1] 7 participants randomized to placebo did not receive any adalimumab; 1 participant was excluded.



  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.
1 participant in the adalimumab 160 mg/80 mg arm was incorrectly treated with open-label (rescue) study drug at Week 0, and was not included in Baseline Characteristics.

Reporting Groups
  Description
Placebo Participants received placebo subcutaneous injections every 2 weeks for 52 weeks. From Week 8, participants with an inadequate response could switch to rescue therapy, where they initially received adalimumab 160 mg, 80 mg 2 weeks later, and then 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.
Adalimumab 80 mg/40 mg Participants received adalimumab 80 mg on Day 1, 40 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.
Adalimumab 160 mg/80 mg Participants received adalimumab 160 mg on Day 1, 80 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.
Total Total of all reporting groups

Baseline Measures
    Placebo     Adalimumab 80 mg/40 mg     Adalimumab 160 mg/80 mg     Total  
Number of Participants  
[units: participants]
  96     87     90     273  
Age [1]
[units: years]
Mean ± Standard Deviation
  41.3  ± 13.56     44.4  ± 15.04     42.5  ± 14.56     42.7  ± 14.38  
Gender  
[units: participants]
       
Female     26     37     29     92  
Male     70     50     61     181  
Region of Enrollment  
[units: participants]
       
Japan     96     87     90     273  
Mayo score [2]
[units: scores on a scale]
Mean ± Standard Deviation
  8.5  ± 1.56     8.5  ± 1.42     8.6  ± 1.44     8.5  ± 1.47  
[1] Demographic data are provided for the Full Analysis Set (participants who received at least one dose of study drug in the double-blind portion of the study).
[2]

A composite score of ulcerative colitis disease activity calculated as the sum of 4 subscores:

  • Stool frequency, based on the participant's diary, scored from 0 (normal number of stools) to 3 (≥5 stools than normal);
  • Rectal bleeding, based on the participant's diary, scored from 0 (no blood) to 3 (blood only passed);
  • Endoscopy, scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding, ulceration);
  • Physician's Global Assessment, scored from 0 (normal) to 3 (severe disease). The total Mayo score ranges from 0 to 12; higher scores indicate more severe disease.



  Outcome Measures
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1.  Primary:   Percentage of Participants With Clinical Remission at 8 Weeks   [ Time Frame: Week 8 ]

2.  Primary:   Percentage of Participants With Clinical Remission at 52 Weeks   [ Time Frame: Week 52 ]

3.  Secondary:   Percentage of Participants With Clinical Remission at 8, 32, and 52 Weeks   [ Time Frame: Weeks 8, 32, and 52 ]

4.  Secondary:   Percentage of Participants With a Clinical Response   [ Time Frame: Baseline and Weeks 8, 32, and 52 ]

5.  Secondary:   Percentage of Participants With Mucosal Healing   [ Time Frame: Weeks 8, 32, and 52 ]

6.  Secondary:   Percentage of Participants With Rectal Bleeding Subscore Indicative of Mild Disease (≤ 1)   [ Time Frame: Weeks 8, 32, and 52 ]

7.  Secondary:   Percentage of Participants With Physician's Global Assessment Subscore Indicative of Mild Disease (≤ 1)   [ Time Frame: Weeks 8, 32, and 52 ]

8.  Secondary:   Percentage of Participants With Stool Frequency Subscore Indicative of Mild Disease (≤ 1)   [ Time Frame: Weeks 8, 32, and 52 ]

9.  Secondary:   Percentage of Inflammatory Bowel Disease Questionnaire (IBDQ) Responders   [ Time Frame: Baseline and Weeks 8, 32, and 52 ]

10.  Secondary:   Number of Participants With Adverse Events up to Week 8   [ Time Frame: 8 weeks ]

11.  Secondary:   Number of Participants With Adverse Events up to Week 52   [ Time Frame: 52 weeks ]

12.  Secondary:   Number of Participants With Adverse Events During the Adalimumab Treatment Period   [ Time Frame: 221 weeks ]


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


No publications provided


Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT00853099     History of Changes
Other Study ID Numbers: M10-447
Study First Received: February 27, 2009
Results First Received: October 26, 2012
Last Updated: September 3, 2014
Health Authority: Japan: Ministry of Health, Labor and Welfare