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Long-Term One Year Use of Alefacept (Amevive®) in Moderate to Severe Chronic Plaque Type Psoriasis

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ClinicalTrials.gov Identifier: NCT00655564
Recruitment Status : Completed
First Posted : April 10, 2008
Results First Posted : August 3, 2012
Last Update Posted : September 11, 2018
Sponsor:
Information provided by (Responsible Party):
Wake Forest University Health Sciences ( Wake Forest University )

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Psoriasis
Intervention Drug: Alefacept
Enrollment 15
Recruitment Details Fifteen subjects with moderate to severe chronic plaque type psoriasis were recruited from the Wake Forest University Health Sciences Dermatology Clinic
Pre-assignment Details  
Arm/Group Title Alefacept
Hide Arm/Group Description All subjects will receive 15 mg of alefacept IM per week (unless CD4<250 cells/µL, then dose will be withheld), for 16 weeks of treatment. After that they will be receive alefacept (15mg IM) once every 4 weeks for 8 months
Period Title: Overall Study
Started 15
Completed 12
Not Completed 3
Reason Not Completed
Adverse Event             1
Lost to Follow-up             1
Desired Alternate Therapy             1
Arm/Group Title Alefacept
Hide Arm/Group Description All subjects will receive 15 mg of alefacept IM per week (unless CD4<250 cells/µL, then dose will be withheld), for 16 weeks of treatment. After that they will be receive alefacept (15mg IM) once every 4 weeks for 8 months
Overall Number of Baseline Participants 15
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants
<=18 years
0
   0.0%
Between 18 and 65 years
15
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants
Female
3
  20.0%
Male
12
  80.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 15 participants
15
1.Primary Outcome
Title Efficacy
Hide Description Efficacy of continuous use of alefacept as defined as the number of participants with a 75% reduction in Psoriasis Area and Severity Index (PASI) score from Baseline to week 52
Time Frame 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Alefacept
Hide Arm/Group Description:
Alefacept's FDA indication is for the treatment of adult subjects with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy. The approved dosing regimen is 15mg once weekly as an intramuscular injection or 7.5mg given once weekly as an intravenous bolus. The recommended regimen is a course of 12 weeks.
Overall Number of Participants Analyzed 15
Measure Type: Number
Unit of Measure: #Participants
1
2.Secondary Outcome
Title Safety of Alefacept Using CD4 Counts
Hide Description Number of participants experiencing CD4 cell counts below 250/uL
Time Frame 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Alefacept
Hide Arm/Group Description:
All subjects received alefacept injections per FDA dosing guidelines for the duration of the 52 weeks study
Overall Number of Participants Analyzed 15
Measure Type: Number
Unit of Measure: Participants
2
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Alefacept
Hide Arm/Group Description All subjects will receive 15 mg of alefacept IM per week (unless CD4<250 cells/µL, then dose will be withheld), for 16 weeks of treatment. After that they will be receive alefacept (15mg IM) once every 4 weeks for 8 months
All-Cause Mortality
Alefacept
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Alefacept
Affected / at Risk (%) # Events
Total   2/15 (13.33%)    
Immune system disorders   
Low CD4 cell count * [1]  1/15 (6.67%)  1
Skin and subcutaneous tissue disorders   
Severe allergic contact dermatitis *  1/15 (6.67%)  1
*
Indicates events were collected by non-systematic assessment
[1]
CD4 cell count <250 cells/uL
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Alefacept
Affected / at Risk (%) # Events
Total   8/15 (53.33%)    
Eye disorders   
Eye irritation *  1/15 (6.67%)  1
Musculoskeletal and connective tissue disorders   
Back pain *  2/15 (13.33%)  2
Generalized muscle aches *  1/15 (6.67%)  1
Reproductive system and breast disorders   
Breast tenderness *  1/15 (6.67%)  1
Respiratory, thoracic and mediastinal disorders   
Upper respiratory infection *  4/15 (26.67%)  4
Skin and subcutaneous tissue disorders   
Generalized itching *  1/15 (6.67%)  1
*
Indicates events were collected by non-systematic assessment
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Steven Feldman, MD, PhD
Organization: Wake Forest University Health Sciences
Phone: 336-716-3775
EMail: sfeldman@wakehealth.edu
Layout table for additonal information
Responsible Party: Wake Forest University Health Sciences ( Wake Forest University )
ClinicalTrials.gov Identifier: NCT00655564     History of Changes
Other Study ID Numbers: IRB00004816
32547 Contract number
First Submitted: April 4, 2008
First Posted: April 10, 2008
Results First Submitted: June 27, 2012
Results First Posted: August 3, 2012
Last Update Posted: September 11, 2018