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Study Evaluating Etanercept on Skin and Joint Disease in Psoriatic Arthritis

This study has been completed.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00245960
First received: October 26, 2005
Last updated: March 31, 2009
Last verified: March 2009
History of Changes
Results First Received: March 31, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Condition: Psoriatic Arthritis
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 worldwide from December 2005 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.

Reporting Groups
  Description
Etanercept Period 1 received etanercept 50mg bi-weekly for 12 weeks. Period 2 received etanercept 50mg weekly for 12 weeks.
Etanercept and Placebo Period 1 received etanercept 50mg and placebo weekly for 12 weeks. Period 2 received etanercept 50mg weekly for 12 weeks.

Participant Flow:   Overall Study
    Etanercept     Etanercept and Placebo  
STARTED     379     373  
COMPLETED     350     345  
NOT COMPLETED     29     28  
Adverse Event                 14                 10  
Lost to Follow-up                 2                 2  
Protocol Violation                 4                 3  
Withdrawal by Subject                 5                 7  
Lack of Efficacy                 4                 6  



  Baseline Characteristics
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Reporting Groups
  Description
Etanercept Period 1 received etanercept 50mg bi-weekly for 12 weeks. Period 2 received etanercept 50mg weekly for 12 weeks.
Etanercept and Placebo Period 1 received etanercept 50mg and placebo weekly for 12 weeks. Period 2 received etanercept 50mg weekly for 12 weeks.
Total Total of all reporting groups

Baseline Measures
    Etanercept     Etanercept and Placebo     Total  
Number of Participants  
[units: participants]
 		  379     373     752  
Age  
[units: years]
Mean ± Standard Deviation 		  46.11  ± 11.39     46.93  ± 11.41     46.52  ± 11.40  
Gender  
[units: participants]
 		     
Female     136     143     279  
Male     243     230     473  



  Outcome Measures
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1.  Primary:   Efficacy of Two Different Treatment Regimens of Etanercept in Treating Skin Manifestations of Psoriasis Subjects With Psoriatic Arthritis.   [ Time Frame: 12 weeks ]
  Show Outcome Measure 1

2.  Secondary:   Efficacy of Two Different Treatment Regimens of Etanercept in Treating Joint Disease.   [ Time Frame: 24 weeks ]
  Show Outcome Measure 2


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


No publications provided by Wyeth is now a wholly owned subsidiary of Pfizer

Publications automatically indexed to this study:


Responsible Party: Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
ClinicalTrials.gov Identifier: NCT00245960     History of Changes
Other Study ID Numbers: 0881A5-401
Study First Received: October 26, 2005
Results First Received: March 31, 2009
Last Updated: March 31, 2009
Health Authority: European Union: European Medicines Agency