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Adalimumab in Adult Japanese Subjects With Rheumatoid Arthritis

This study has been completed.
Sponsor:
Collaborators:
Abbott Japan Co.,Ltd
Eisai Co., Ltd.
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT00235872
First received: October 7, 2005
Last updated: April 7, 2011
Last verified: April 2011
History of Changes
Results First Received: December 9, 2009  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Rheumatoid Arthritis
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
Adalimumab 40 mg Eow Adalimumab 40 mg subcutaneously (sc) administered every other week (eow) until approval of adalimumab in Japan

Participant Flow:   Overall Study
    Adalimumab 40 mg Eow  
STARTED     309  
COMPLETED     162  
NOT COMPLETED     147  
Adverse Event                 34  
Death                 1  
Lost to Follow-up                 1  
Withdrawal by Subject                 50  
Administrative reason                 61  



  Baseline Characteristics
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Reporting Groups
  Description
Adalimumab 40 mg Eow Adalimumab 40 mg subcutaneously (sc) administered every other week (eow) until approval of adalimumab in Japan

Baseline Measures
    Adalimumab 40 mg Eow  
Number of Participants  
[units: participants]
 		  309  
Age, Customized  
[units: participants]
 		 
< 40 years     35  
Between 40 and 49 years     57  
Between 50 and 59 years     111  
>/= 60 years     106  
Gender  
[units: participants]
 		 
Female     249  
Male     60  
Region of Enrollment  
[units: participants]
 		 
Japan     309  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement Consisting of 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively)   [ Time Frame: Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value) ]
  Show Outcome Measure 1

2.  Secondary:   Mean Change From Baseline in Tender Joint Count (TJC, Max=68), a Component of the American College of Rheumatology (ACR) by Visit   [ Time Frame: Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value) ]
  Hide Outcome Measure 2

Measure Type Secondary
Measure Title Mean Change From Baseline in Tender Joint Count (TJC, Max=68), a Component of the American College of Rheumatology (ACR) by Visit
Measure Description Mean change from Baseline in TJC (max=68) at each visit, a component of ACR. For M02-575 completers, the Baseline for all efficacy analyses was defined as the Week 0 [before dosing] of the M02-575 study; for the M02-575 rescue arm, the Baseline was defined as the Week 0 [before dosing] of the M03-651 study.
Time Frame Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value)  
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.
Full Analysis Set - all subjects who received at least one treatment with the study drug were included in the maximum population for analysis. In this study, the safety set was defined to be identical to the full analysis set. Analysis was based on observed data.

Reporting Groups
  Description
Adalimumab 40 mg Eow Adalimumab 40 mg subcutaneously (sc) administered every other week (eow) until approval of adalimumab in Japan

Measured Values
    Adalimumab 40 mg Eow  
Number of Participants Analyzed  
[units: participants]
 		  309  
Mean Change From Baseline in Tender Joint Count (TJC, Max=68), a Component of the American College of Rheumatology (ACR) by Visit  
[units: TJC]
Mean ± Standard Deviation 		 
TJC Baseline (n=309)     22.3  ± 11.59  
TJC Week 0 (n=309)     -7.2  ± 10.10  
TJC Week 4 (n=307)     -10.0  ± 10.10  
TJC Week 8 (n=304)     -10.6  ± 10.37  
TJC Week 12 (n=298)     -11.0  ± 10.70  
TJC Week 16 (n=287)     -11.5  ± 10.88  
TJC Week 20 (n=271)     -12.3  ± 10.84  
TJC Week 24 (n=261)     -13.3  ± 10.72  
TJC Week 36 (n=245)     -14.3  ± 10.43  
TJC Week 48(n=232)     -14.9  ± 10.88  
TJC Week 60 (n=209)     -15.4  ± 10.75  
TJC Week 72 (n=162)     -15.9  ± 10.86  
TJC Week 84 (n=125)     -16.0  ± 10.27  
TJC Week 96 (n=102)     -16.0  ± 9.74  
TJC Week 108 (n=95)     -16.0  ± 9.49  
TJC Week 120 (n=91)     -15.9  ± 9.42  
TJC Week 132 (n=90)     -16.1  ± 10.00  
TJC Week 144 (n=87)     -16.4  ± 10.15  
TJC Week 156(n=82)     -16.2  ± 11.63  
TJC Week 168 (n=78)     -17.7  ± 10.43  
TJC Week 180 (n=59)     -17.7  ± 11.39  
TJC Week 192 (n=33)     -17.8  ± 11.75  
TJC Week 204 (n=9)     -22.4  ± 8.50  
TJC Week 216 (n=1)     -24.0  ± 0  
TJC Final Value (n=309)     -12.5  ± 12.36  

No statistical analysis provided for Mean Change From Baseline in Tender Joint Count (TJC, Max=68), a Component of the American College of Rheumatology (ACR) by Visit



3.  Secondary:   Mean Change From Baseline in Swollen Joint Count (SJC, Max=66), a Component of the American College of Rheumatology (ACR) by Visit   [ Time Frame: Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value) ]
  Show Outcome Measure 3

4.  Secondary:   Mean Change From Baseline in Physician Global Assessment of Disease Activity (PGA), a Component of the ACR Criteria by Visit   [ Time Frame: Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value). ]
  Show Outcome Measure 4

5.  Secondary:   Mean Change From Baseline in Subject's Global Assessment of Disease Activity Using a Visual Analog Scale, a Component of the ACR Criteria by Visit   [ Time Frame: Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value). ]
  Show Outcome Measure 5

6.  Secondary:   Mean Change From Baseline in Subject's Assessment of Pain Using a Visual Analog Scale, a Component of the ACR Criteria by Visit   [ Time Frame: Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value). ]
  Show Outcome Measure 6

7.  Secondary:   Mean Change From Baseline in the Disability Index of the Health Assessment Questionaire (DI-HAQ, a Component of the American College of Rheumatology (ACR) Criteria by Visit   [ Time Frame: Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value) ]
  Show Outcome Measure 7

8.  Secondary:   Mean Change From Baseline in C-reactive Protein (CRP), a Component of the American College of Rheumatology (ACR) Criteria by Visit   [ Time Frame: Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value) ]
  Show Outcome Measure 8

9.  Secondary:   Presence of Morning Stiffness   [ Time Frame: Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value) ]
  Show Outcome Measure 9

10.  Secondary:   Mean Change From Baseline in the Duration (Minutes) of Morning Stiffness by Visit   [ Time Frame: Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value) ]
  Show Outcome Measure 10

11.  Secondary:   Presence of Rheumatoid Factor (RF)   [ Time Frame: Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value) ]
  Show Outcome Measure 11

12.  Secondary:   Mean Change From Baseline in Rheumatoid Factor (IU/ML) by Visit   [ Time Frame: Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value) ]
  Show Outcome Measure 12


  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
No text entered.  


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


No publications provided


Responsible Party: Eiichi Makino, Abbott
ClinicalTrials.gov Identifier: NCT00235872     History of Changes
Other Study ID Numbers: M03-651
Study First Received: October 7, 2005
Results First Received: December 9, 2009
Last Updated: April 7, 2011
Health Authority: Japan: Ministry of Health, Labor and Welfare