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Open Label, Dose-Regimen Study Evaluating Etanercept 50 mg Once-Weekly In Japanese Subjects With RA

This study has been completed.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00418717
First received: January 2, 2007
Last updated: March 1, 2012
Last verified: March 2012
Results First Received: December 19, 2008  
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: Arthritis, Rheumatoid
Intervention: Drug: etanercept

  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
Subjects were recruited in Japan from January 2007 to September 2007.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Subjects were screened up to 4 weeks and received 25 mg etanercept (as test article) BW for 4 weeks during treatment period A. At the end of the period A, the same cohort of subjects entered period B and received etanercept 50 mg (as test article) QW for 8 weeks to assess the efficacy and safety of a QW regimen.

Reporting Groups
  Description
Etanercept (ETN)

Weeks 1-4 (Treatment period A): Etanercept 25 mg bi-weekly (BW)

Weeks 5-12 (Treatment period B): Etanercept 50mg once weekly (QW)


Participant Flow for 2 periods

Period 1:   Treatment Period A - Weeks 1-4
    Etanercept (ETN)  
STARTED     42  
COMPLETED     41  
NOT COMPLETED     1  
Protocol Violation                 1  

Period 2:   Treatment Period B - Weeks 5-12
    Etanercept (ETN)  
STARTED     41  
COMPLETED     39  
NOT COMPLETED     2  
Adverse Event                 2  



  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.
No text entered.

Reporting Groups
  Description
Etanercept (ETN)

Weeks 1-4 (Treatment period A): Etanercept 25 mg bi-weekly (BW)

Weeks 5-12 (Treatment period B): Etanercept 50mg once weekly (QW)


Baseline Measures
    Etanercept (ETN)  
Number of Participants  
[units: participants]
  42  
Age  
[units: years]
Mean ± Standard Deviation
  53.14  ± 13.21  
Gender  
[units: participants]
 
Female     35  
Male     7  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Disease Activity Score Using 28-joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4ESR) by Treatment Period.   [ Time Frame: weeks 4 and 12 ]

2.  Secondary:   Area Under the Concentration-Time Curve (AUC)   [ Time Frame: 7 days after week 4 and 7 days after week 12 ]


  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
No text entered.


  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: U. S. Contact Center
Organization: Wyeth
e-mail: clintrialresults@wyeth.com


No publications provided


Responsible Party: Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
ClinicalTrials.gov Identifier: NCT00418717     History of Changes
Other Study ID Numbers: 0881A1-321
Study First Received: January 2, 2007
Results First Received: December 19, 2008
Last Updated: March 1, 2012
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency