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Open Label Study of Alefacept Injections to Patients With Moderate to Severe Psoriasis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
John Koo, University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00678470
First received: May 13, 2008
Last updated: February 19, 2013
Last verified: February 2013
History of Changes
Results First Received: November 20, 2012  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Moderate to Severe Psoriasis
Intervention: Drug: Intralesional 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
Patients were recruited from our medical clinic as well as through flyers posted at other University of California at San Francisco sites.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Patients were required to have a 2 week washout from topicals and one month washout from any systemic agents.

Reporting Groups
  Description
Intralesional Alefacept

Investigational intervention without random assignment

Intralesional Alefacept : Patients enrolled in this study will receive intralesional alefacept injections once a week for 3 weeks in three different lesions. Each lesion will only be injected once with one alefacept concentration. The week it is administered will depend on the concentration. Three different concentrations of the alefacept preparation will be administered.

Participant Flow:   Overall Study
    Intralesional Alefacept  
STARTED     18  
COMPLETED     15  
NOT COMPLETED     3  



  Baseline Characteristics
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Reporting Groups
  Description
Intralesional Alefacept

Investigational intervention without random assignment

Intralesional Alefacept : Patients enrolled in this study will receive intralesional alefacept injections once a week for 3 weeks in three different lesions. Each lesion will only be injected once with one alefacept concentration. The week it is administered will depend on the concentration. Three different concentrations of the alefacept preparation will be administered.

Baseline Measures
    Intralesional Alefacept  
Number of Participants  
[units: participants]
 		  18  
Age  
[units: participants]
 		 
<=18 years     0  
Between 18 and 65 years     18  
>=65 years     0  
Gender  
[units: participants]
 		 
Female     8  
Male     10  
Region of Enrollment  
[units: participants]
 		 
United States     18  



  Outcome Measures

1.  Primary:   Number of Patients Who Were Both Intralesional and Intramuscular Responders.   [ Time Frame: 12 weeks after intramuscular injection of alefacept. ]
  Show Outcome Measure 1

2.  Primary:   To Evaluate the Effectiveness of Intralesional Alefacept Administration as Defined by the Psoriasis Severity Assessment Score Followed by the Evaluation of the Effectiveness of Intramuscular Alefacept Administration.   [ Time Frame: 6 months ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


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: John Koo MD
Organization: University of California at San Francisco
phone: 4154764701
e-mail: john.koo@ucsfmedctr.org


Publications of Results:


Responsible Party: John Koo, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00678470     History of Changes
Other Study ID Numbers: KOO-AMEVIVE-2008, CHR-H5939-31199-01
Study First Received: May 13, 2008
Results First Received: November 20, 2012
Last Updated: February 19, 2013
Health Authority: United States: Food and Drug Administration