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Alefacept in Subjects With Chronic Plaque Psoriasis Who Failed to Respond to Anti-TNF Therapy

This study has been terminated.
(Subjects declined enrollment; sponsor/PI elected to close study.)
Sponsor:
Collaborator:
Astellas Pharma US, Inc.
Information provided by (Responsible Party):
John Murray, Duke University Medical Center
ClinicalTrials.gov Identifier:
NCT00953329
First received: July 22, 2009
Last updated: February 20, 2013
Last verified: February 2013
History of Changes
Results First Received: October 18, 2012  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Chronic Plaque Psoriasis
Intervention: Drug: alefacept

  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
Recruitment ended in Dec 2008. Clinical Trial was located in Medical Center Clinic.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No adverse events occurred

Reporting Groups
  Description
Alefacept Treated No text entered.

Participant Flow:   Overall Study
    Alefacept Treated  
STARTED     1  
COMPLETED     0  
NOT COMPLETED     1  
Lack of Efficacy                 1  



  Baseline Characteristics
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Reporting Groups
  Description
Group 1 No text entered.

Baseline Measures
    Group 1  
Number of Participants  
[units: participants]
 		  1  
Age  
[units: participants]
 		 
<=18 years     0  
Between 18 and 65 years     1  
>=65 years     0  
Age  
[units: years]
Mean ± Standard Deviation 		  35  
Gender  
[units: participants]
 		 
Female     1  
Male     0  
Region of Enrollment  
[units: participants]
 		 
United States     1  



  Outcome Measures

1.  Primary:   Treatment Alefacept   [ Time Frame: 12 weeks (study terminated) ]
  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
Early termination due to one patient enrolled . The patient stopped the study because she was not improved and desired alternative treatment.  


Results Point of Contact:  
Name/Title: Shirley Blalock
Organization: DukeUMC
phone: 919-668-0999
e-mail: shirley.blalock@duke.edu


No publications provided


Responsible Party: John Murray, Duke University Medical Center
ClinicalTrials.gov Identifier: NCT00953329     History of Changes
Other Study ID Numbers: Pro00002474, Funding Agency # ER-07-001, IND # 100770
Study First Received: July 22, 2009
Results First Received: October 18, 2012
Last Updated: February 20, 2013
Health Authority: United States: Food and Drug Administration