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Safety and Efficacy Study of Adalimumab in Adult Chinese Rheumatoid Arthritis Subjects Treated With Methotrexate

This study has been completed.
Sponsor:
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT00538902
First received: October 1, 2007
Last updated: April 7, 2011
Last verified: April 2011
Results First Received: November 23, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Rheumatoid Arthritis
Interventions: Biological: Placebo
Biological: Adalimumab 80 mg
Biological: Adalimumab 40 mg

  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
Placebo Placebo administered subcutaneously (SC) every other week (eow) for 12 weeks, followed by adalimumab 40 mg SC eow for 12 weeks.
Adalimumab 40 mg Adalimumab 40 mg administered subcutaneously (SC) every other week (eow) for 24 weeks.
Adalimumab 80 mg Adalimumab 80 mg administered subcutaneously (SC) every other week (eow) for 12 weeks, followed by adalimumab 40 mg SC eow for 12 weeks.

Participant Flow for 2 periods

Period 1:   DB Wk 0 Through 12 (Primary D/C Reasons)
    Placebo   Adalimumab 40 mg   Adalimumab 80 mg
STARTED   60   121   121 
COMPLETED   59   119   116 
NOT COMPLETED   1   2   5 
Adverse Event                1                2                3 
Withdrawal by Subject                0                0                1 
Lost to Follow-up                0                0                1 
Various                0                0                0 

Period 2:   OL Wk 24 to End (Primary D/C Reasons)
    Placebo   Adalimumab 40 mg   Adalimumab 80 mg
STARTED   59   119   116 
COMPLETED   23   55   52 
NOT COMPLETED   36   64   64 
Adverse Event                2                10                11 
Withdrawal by Subject                15                19                25 
Lost to Follow-up                1                10                6 
Various                18                25                22 



  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
Placebo Placebo administered subcutaneously (SC) every other week (eow) for 12 weeks, followed by adalimumab 40 mg SC eow for 92 weeks.
Adalimumab 40 mg Adalimumab 40 mg administered subcutaneously (SC) every other week (eow) for 104 weeks.
Adalimumab 80 mg Adalimumab 80 mg administered subcutaneously (SC) every other week (eow) for 12 weeks, followed by adalimumab 40 mg SC eow for 92 weeks.
Total Total of all reporting groups

Baseline Measures
   Placebo   Adalimumab 40 mg   Adalimumab 80 mg   Total 
Overall Participants Analyzed 
[Units: Participants]
 60   121   121   302 
Age 
[Units: Participants]
       
<=18 years   0   0   0   0 
Between 18 and 65 years   58   115   111   284 
>=65 years   2   6   10   18 
Gender 
[Units: Participants]
       
Female   49   104   101   254 
Male   11   17   20   48 
Region of Enrollment 
[Units: Participants]
       
China   60   121   121   302 


  Outcome Measures
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1.  Primary:   Number of Participants With American College of Rheumatology (ACR)20 at Week 12 of the Double-Blind Period   [ Time Frame: Week 12 ]

2.  Secondary:   Number of Participants Achieving American College of Rheumatology (ACR)50/70 at Week 12 of the Double-Blind Period   [ Time Frame: Week 12 ]

3.  Secondary:   Number of Participants Achieving American College of Rheumatology (ACR)20 Response Through Week 92 of Open-Label Period   [ Time Frame: Week 0, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 92 ]

4.  Secondary:   Number of Participants Achieving American College of Rheumatology (ACR)50 Response Through Week 92 of Open-Label Period   [ Time Frame: Week 0, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 92 ]

5.  Secondary:   Number of Participants Achieving American College of Rheumatology (ACR)70 Response Through Week 92 of Open-Label Period   [ Time Frame: Week 0, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 92 ]

6.  Secondary:   Mean Change in Tender Joint Count (TJC) and Swollen Joint Count (SJC) at Week 12 of the Double-Blind Period   [ Time Frame: Baseline, Week 12 ]

7.  Secondary:   Mean Change in Tender Joint Count (TJC) Through Week 92 of the Open-Label Period   [ Time Frame: Baseline, Week 0, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 92 ]

8.  Secondary:   Mean Change in Swollen Joint Count (SJC) Through Week 92 of the Open-Label Period   [ Time Frame: Baseline, Week 0, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 92 ]

9.  Secondary:   Mean Change in Visual Analog Scale (VAS) Score at Week 12 of the Double-Blind Period   [ Time Frame: Baseline, Week 12 ]

10.  Secondary:   Mean Change in Physician's Global Assessment of Disease Activity (Visual Analog Scale [VAS]) Through Week 92 of the Open-Label Period   [ Time Frame: Baseline, Week 0, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 92 ]

11.  Secondary:   Mean Change in Patient's Assessment of Pain (Visual Analog Scale [VAS]) Through Week 92 of the Open-Label Period   [ Time Frame: Baseline, Week 0, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 92 ]

12.  Secondary:   Mean Change in Patient's Global Assessment of Disease Activity (Visual Analog Scale [VAS]) Through Week 92 of the Open-Label Period   [ Time Frame: Baseline, Week 0, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 92 ]

13.  Secondary:   Mean Change in the Disability Index of the Health Assessment Questionnaire (HAQ) Scores From Baseline to Week 12 of the Double-Blind Period   [ Time Frame: Baseline, Week 12 ]

14.  Secondary:   Mean Change in the Disability Index of the Health Assessment Questionnaire (HAQ) Through Week 92 of the Open-Label Period   [ Time Frame: Baseline, Week 0, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 92 ]

15.  Secondary:   Mean Change in the SF-36 Health Survey Index Physical Component Summary (PCS) and Mental Component Summary (MCS) at Week 12 of the Double-Blind Period   [ Time Frame: Baseline, Week 12 ]

16.  Secondary:   Mean Change in the SF-36 Health Survey Index Physical Component Summary (PCS) Through Week 92 of the Open-Label Period   [ Time Frame: Baseline, Week 0, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 92 ]

17.  Secondary:   Mean Change in the SF-36 Health Survey Index Mental Component Summary (MCS) Through Week 92 of the Open-Label Period   [ Time Frame: Baseline, Week 0, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 92 ]


  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



Responsible Party: Laura Redden MD, PhD, Project Director, Abbott
ClinicalTrials.gov Identifier: NCT00538902     History of Changes
Other Study ID Numbers: M04-705
Study First Received: October 1, 2007
Results First Received: November 23, 2009
Last Updated: April 7, 2011
Health Authority: China: Food and Drug Administration