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Study to Evaluate the Safety and Efficacy of Alefacept (Amevive) in Subjects With Moderate to Severe Atopic Dermatitis

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ClinicalTrials.gov Identifier: NCT00832585
Recruitment Status : Completed
First Posted : January 30, 2009
Results First Posted : January 28, 2011
Last Update Posted : March 10, 2011
Sponsor:
Collaborator:
Astellas Pharma US, Inc.
Information provided by:
Rush University Medical Center

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Atopic Dermatitis
Intervention Drug: Alefacept
Enrollment 5
Recruitment Details Subjects were recruited from physician referrals and advertisements placed within the Rush University Medical Center campus. Recruitment was opened between Jan 08 through Sept 09
Pre-assignment Details  
Arm/Group Title Alefacept
Hide Arm/Group Description Amevive® has been shown to be a safe and effective agent in the treatment of psoriasis but may prove useful in treating atopic dermatitis. Unlike other “biologics” for the treatment of skin diseases, the use of alefacept is not associated with increased infection, congestive heart failure, demyelinating disorders or lupus- like syndromes. The dose for Alefacept is 15mg, the dosage form is intramuscular injection (IM), and the frequency of administration is once a week for 12 weeks.
Period Title: Overall Study
Started 5 [1]
Completed 3 [2]
Not Completed 2
Reason Not Completed
Withdrawal by Subject             1
Lost to Follow-up             1
[1]
Eight subjects were screened but only 5 started the study and received study drug.
[2]
Only three subjects completed all of the visits for the study as per protocol.
Arm/Group Title Alefacept
Hide Arm/Group Description Amevive® has been shown to be a safe and effective agent in the treatment of psoriasis but may prove useful in treating atopic dermatitis. Unlike other “biologics” for the treatment of skin diseases, the use of alefacept is not associated with increased infection, congestive heart failure, demyelinating disorders or lupus- like syndromes. The dose for Alefacept is 15mg, the dosage form is intramuscular injection (IM), and the frequency of administration is once a week for 12 weeks.
Overall Number of Baseline Participants 5
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants
<=18 years
0
   0.0%
Between 18 and 65 years
5
 100.0%
>=65 years
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 5 participants
32.84  (6.34)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants
Female
3
  60.0%
Male
2
  40.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 5 participants
5
1.Primary Outcome
Title Change in Eczema Area Severity Index (EASI) Score From Baseline (Week 1) to Week 16.
Hide Description The Eczema Area Severity Index (EASI) measures erythema (E), infiltration (I), excoriation (Ex) and lichenification (L) using 0=none, 1=mild, 2=moderate, 3=severe. Head/neck, upper limbs, trunk, lower limbs are rated from 1 to 6 (0=no eruption, 1=1-9%, 2=10-29%, 3=30-49%, 4=50-69%, 5=70-89%, 6=90-100%). The proportional factor for the head/neck =.01, upper limbs=.02, trunk=.03 and lower limbs=.04. The algorithm for calculating the EASI is the sum of E+I+Ex+L multiplied by the area, multiplied by the proportional factor. The total score is the sum of the four body-region scores, max=72, min=0.
Time Frame Week 1 to week 16
Hide Outcome Measure Data
Hide Analysis Population Description
8 (4 female and 4 male) atopic patients, ranging in age from 24 to 54 yrs of age, were screened for the study. 5 patients were enrolled for 12 wks of treatment, but only 3 completed the study.
Arm/Group Title Alefacept
Hide Arm/Group Description:
Amevive® has been shown to be a safe and effective agent in the treatment of psoriasis but may prove useful in treating atopic dermatitis. Unlike other “biologics” for the treatment of skin diseases, the use of alefacept is not associated with increased infection, congestive heart failure, demyelinating disorders or lupus- like syndromes. The dose for Alefacept is 15mg, the dosage form is intramuscular injection (IM), and the frequency of administration is once a week for 12 weeks.
Overall Number of Participants Analyzed 3
Median (Full Range)
Unit of Measure: Scores on a scale.
26.4
(13.2 to 29.8)
2.Secondary Outcome
Title Change in Physician Global Assessment (PGA) Score From Baseline (Week 1) to Week 16.
Hide Description The Physician Global Assessment (PGA) evaluates the overall severity of Atopic Dermatitis (AD) at a given time using a four point scale (0=clear, 0.5=clear to mild, 1=mild, 1.5=mild to moderate, 2=moderate, 2.5=moderate to severe, and 3=severe).
Time Frame Week 1 to week 16
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Alefacept
Hide Arm/Group Description:
Amevive® has been shown to be a safe and effective agent in the treatment of psoriasis but may prove useful in treating atopic dermatitis. Unlike other “biologics” for the treatment of skin diseases, the use of alefacept is not associated with increased infection, congestive heart failure, demyelinating disorders or lupus- like syndromes. The dose for Alefacept is 15mg, the dosage form is intramuscular injection (IM), and the frequency of administration is once a week for 12 weeks.
Overall Number of Participants Analyzed 3
Median (Full Range)
Unit of Measure: Scores on a scale
1
(1 to 1.5)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Alefacept
Hide Arm/Group Description Amevive® has been shown to be a safe and effective agent in the treatment of psoriasis but may prove useful in treating atopic dermatitis. Unlike other “biologics” for the treatment of skin diseases, the use of alefacept is not associated with increased infection, congestive heart failure, demyelinating disorders or lupus- like syndromes. The dose for Alefacept is 15mg, the dosage form is intramuscular injection (IM), and the frequency of administration is once a week for 12 weeks.
All-Cause Mortality
Alefacept
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Alefacept
Affected / at Risk (%) # Events
Total   1/5 (20.00%)    
Musculoskeletal and connective tissue disorders   
Joint Infection   1/5 (20.00%)  1
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Alefacept
Affected / at Risk (%) # Events
Total   0/5 (0.00%)    
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
Name/Title: Dr. Michael D. Tharp
Organization: Rush University Medical Center - Department of Dermatology
Phone: 312-563-4001
EMail: derm@rush.edu
Responsible Party: Michael D. Tharp, Rush University Medical Center
ClinicalTrials.gov Identifier: NCT00832585     History of Changes
Other Study ID Numbers: AC 07-001
First Submitted: January 28, 2009
First Posted: January 30, 2009
Results First Submitted: July 9, 2010
Results First Posted: January 28, 2011
Last Update Posted: March 10, 2011