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Study of Tumor Necrosis Factor Receptor Fusion Protein Etanercept (Enbrel) in Psoriasis of the Hands and/or Feet

This study has been completed.
Sponsor:
Collaborator:
Amgen
Information provided by (Responsible Party):
Jennifer Soung, MD, University of California, Irvine
ClinicalTrials.gov Identifier:
NCT00585650
First received: December 26, 2007
Last updated: October 5, 2011
Last verified: October 2011
History of Changes
Results First Received: May 12, 2011  
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: Psoriasis
Interventions: Biological: Entercept
Other: Placebo injections

  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 with palmoplantar psoriasis were randomized to use etanercept 50mg twice weekly or placebo injection for 12 weeks. All subjects receiving placebo were then crossed over to etanercept 50mg twice weekly for another 12 weeks. An additional follow-up visit was performed on week 28.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The number of subjects who achieve 50% improvement in the Palmoplantar psoriasis severity index at 12 weeks. The number of subjects who achieve a Physician Global Assessment (PGA) score of 0 or 1 (clear or almost clear) at 12 weeks. Quality of life assessments (SF-36 and DLQI) at 12 weeks. Adverse event rates in the etanercept and placebo groups.

Reporting Groups
  Description
Subjects Receiving Etanercept 50 mg Twice Week for 12 Weeks Subjects randomized to use etanercept 50mg twice weekly for 12 weeks. An additional follow-up visit was performed on week 28.
Subjects Receiving Placebo for the First 12 Weeks Subjects randomized placebo injection for first 12 weeks. All subjects receiving placebo were then crossed over to etanercept 50mg twice weekly for another 12 weeks. An additional follow-up visit was performed on week 28.

Participant Flow:   Overall Study
    Subjects Receiving Etanercept 50 mg Twice Week for 12 Weeks     Subjects Receiving Placebo for the First 12 Weeks  
STARTED     8     12  
COMPLETED     8     12  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Reporting Groups
  Description
Subjects Receiving Etanercept 50 mg Twice Week for 12 Weeks Subjects randomized to use etanercept 50mg twice weekly for 12 weeks. An additional follow-up visit was performed on week 28.
Subjects Receiving Placebo for the First 12 Weeks Subjects randomized placebo injection for first 12 weeks. All subjects receiving placebo were then crossed over to etanercept 50mg twice weekly for another 12 weeks. An additional follow-up visit was performed on week 28.
Total Total of all reporting groups

Baseline Measures
    Subjects Receiving Etanercept 50 mg Twice Week for 12 Weeks     Subjects Receiving Placebo for the First 12 Weeks     Total  
Number of Participants  
[units: participants]
 		  8     12     20  
Age  
[units: participants]
 		     
<=18 years     0     0     0  
Between 18 and 65 years     8     12     20  
>=65 years     0     0     0  
Gender  
[units: participants]
 		     
Female     5     9     14  
Male     3     3     6  
Region of Enrollment  
[units: participants]
 		     
United States     8     12     20  



  Outcome Measures

1.  Primary:   The Number of Subjects Who Achieve a 50% Reduction in the Palmoplantar Psoriasis Severity Index at 12 Weeks   [ Time Frame: Week 12 ]
  Show Outcome Measure 1


  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 NOT 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.


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: Steven Feldman, MD, PhD
Organization: Wake Forest Baptist Health, Department of Dermatology
phone: 336-716-3775
e-mail: sfeldman@wakehealth.edu


No publications provided


Responsible Party: Jennifer Soung, MD, University of California, Irvine
ClinicalTrials.gov Identifier: NCT00585650     History of Changes
Other Study ID Numbers: 2006-5092, Amgen Protocol 20060514
Study First Received: December 26, 2007
Results First Received: May 12, 2011
Last Updated: October 5, 2011
Health Authority: United States: Food and Drug Administration