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Assess the Efficacy and Safety of Alefacept With Narrow Band Ultraviolet B Phototherapy (nbUVB) vs. Alefacept Alone in Chronic Plaque Psoriasis Subjects

Primary Purpose

Plaque Psoriasis

Status
Completed
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
alefacept
Narrow Band UVB Phototherapy
Sponsored by
Astellas Pharma Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Plaque Psoriasis focused on measuring plaque psoriasis, alefacept, Amevive, narrow band ultraviolet B, phototherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Subject has given written informed consent
  • Subject has a diagnosis of moderate to severe chronic plaque psoriasis involving >=10% with a Psoriasis Area and Severity Index (PASI) score >=10 at Baseline
  • Subject has CD4+ T lymphocyte (CD4) count at or above the lower limit of normal
  • Male and female subjects must use an adequate means of contraception from screening to end of study.

Exclusion Criteria:

  • Subject who received alefacept in the past
  • Subject who has shown no improvement following an adequate course of nbUVB in the past
  • Subject who has been treated in the past with either therapy or cyclosporine
  • Subject with any active cancer, including skin cancer at Baseline
  • Subject with erythrodermic, pustular or predominantly guttate psoriasis

  • Subject who has used treatment for psoriasis prior to Baseline as follows:

    • Topical treatment within 14 days
    • Oral treatment within 28 days
    • Broad band UVB (bbUVB) or nbUVB treatment within 56 days
    • Biological treatment within 84 days
  • Serious local infection or serious systemic infection within the 3 months prior to the first dose of study drug
  • Subject with a history of drug or alcohol abuse within the past 2 years
  • Subject that is known to be infected with the AIDS virus
  • Subject with any other skin disease or other disease that might interfere with psoriasis status assessments
  • Female subject who is nursing, pregnant or planning to become pregnant while in this study
  • Subject who is currently enrolled in any other investigational drug or device study

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Alefacept alone

Alefacept + nbUVB

Arm Description

15 mg alefacept intramuscularly (IM) once weekly for 12 weeks

15 mg alefacept intramuscularly once weekly and narrow band Ultraviolet B (nbUVB) phototherapy 3 times per week for 12 weeks

Outcomes

Primary Outcome Measures

Percentage of Subjects Who Achieve Psoriasis Area and Severity Index (PASI) 75 at Week 16
The PASI score is a tool that allows investigators to assign an objective number to the degree of severity of a person's psoriasis, and considers: redness, scaling and thickness. Values for PASI score range from 0 (least) to 72 (worst). PASI 75 was defined as an improvement of at least 75% in PASI as compared to Baseline. The Last Observation Carry Forward (LOCF) method was used to impute missing data.

Secondary Outcome Measures

Percentage of Subjects Reaching PASI 75 Over the Entire Course of the Study
The PASI score is a tool that allows investigators to assign an objective number to the degree of severity of a person's psoriasis, and considers: redness, scaling and thickness. Values for PASI score range from 0 (least) to 72 (worst). PASI 75 was defined as an improvement of at least 75% in PASI as compared to Baseline. The Last Observation Carry Forward (LOCF) method was used to impute missing data.
Change in Body Surface Area (BSA) Covered With Psoriasis at Week 16
A negative change from Baseline represents improvement. Change is calculated as Week 16- Baseline. The Last Observation Carry Forward (LOCF) method was used to impute missing data.
Change in Body Surface Area (BSA) Covered With Psoriasis Over the Entire Course of the Study
A negative change from Baseline represents improvement. Change is calculated as Week 36- Baseline. The Last Observation Carry Forward (LOCF) method was used to impute missing data.
Percentage of Subjects Who Achieved Physical Global Assessment (PGA) of Clear or Almost Clear at Week 16
The PGA scale is a tool used to evaluate the degree of overall lesion severity. The scale ranges from 0 (clear) to 5 (very severe). Clear is defined as a score of 0; Almost Clear is defined as a score of 1. Subjects who achieved PGA of clear or almost clear at any visit during the study were assigned to the YES category for their respective groups. The Last Observation Carry Forward (LOCF) method was used to impute missing data.
Percentage of Subjects Who Achieved Physical Global Assessment (PGA) of Clear or Almost Clear Over the Entire Course of the Study
The PGA scale is a tool used to evaluate the degree of overall lesion severity. The scale ranges from 0 (clear) to 5 (very severe). Clear is defined as a score of 0; Almost Clear is defined as a score of 1. Subjects who achieved PGA of clear or almost clear at any visit during the study were assigned to the YES category for their respective groups. The Last Observation Carry Forward (LOCF) method was used to impute missing data.
Percentage of Subjects Who Achieve PASI 90 at Week 16
The PASI score is a tool that allows investigators to assign an objective number to the degree of severity of a person's psoriasis, and considers: redness, scaling and thickness. Values for PASI score range from 0 (least) to 72 (worst). PASI 90 was defined as an improvement of at least 90% in PASI as compared to Baseline. The Last Observation Carry Forward (LOCF) method was used to impute missing data.
Time to Relapse
The analysis only included subjects who achieved a 75% improvement in PASI and then relapsed. Relapse is defined by a loss of 50% of improvement in PASI.
Time for 50% Decrease in PASI
The PASI score is a tool that allows investigators to assign an objective number to the degree of severity of a person's psoriasis, and considers: redness, scaling and thickness. Values for PASI score range from 0 (least) to 72 (worst). Only subjects who experienced 50% decrease in PASI were included in the analysis.
Time for a 75% Decrease in PASI
The PASI score is a tool that allows investigators to assign an objective number to the degree of severity of a person's psoriasis, and considers: redness, scaling and thickness. Values for PASI score range from 0 (least) to 72 (worst). Only subjects who experienced 75% decrease in PASI were included in the analysis.
Change in Dermatology Life Quality Index (DLQI)
The DLQI questionnaire is intended to measure how much a subject's skin problem affects the subject's life. Subjects provide answers considering the past week. The scale of the DQLI ranges from 0 (best) to 30 (worst). A negative change from Baseline represents improvement. Change is calculated as Week 36- Baseline. The Last Observation Carry Forward (LOCF) method was used to impute missing data.

Full Information

First Posted
April 10, 2008
Last Updated
January 3, 2013
Sponsor
Astellas Pharma Inc
Collaborators
Astellas Pharma Canada, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00658606
Brief Title
Assess the Efficacy and Safety of Alefacept With Narrow Band Ultraviolet B Phototherapy (nbUVB) vs. Alefacept Alone in Chronic Plaque Psoriasis Subjects
Official Title
Efficacy and Safety of Alefacept in Combination With Narrow-band UVB (nbUVB) Compared to Alefacept Alone in Subjects With Moderate to Severe Chronic Plaque Psoriasis
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Astellas Pharma Inc
Collaborators
Astellas Pharma Canada, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Assess the efficacy and safety of alefacept with nbUVB compared to alefacept alone in chronic plaque psoriasis subjects. Combination therapy may improve the clinical response to psoriatic subjects as both modalities have an effect on T cells

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Plaque Psoriasis
Keywords
plaque psoriasis, alefacept, Amevive, narrow band ultraviolet B, phototherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
98 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Alefacept alone
Arm Type
Active Comparator
Arm Description
15 mg alefacept intramuscularly (IM) once weekly for 12 weeks
Arm Title
Alefacept + nbUVB
Arm Type
Experimental
Arm Description
15 mg alefacept intramuscularly once weekly and narrow band Ultraviolet B (nbUVB) phototherapy 3 times per week for 12 weeks
Intervention Type
Drug
Intervention Name(s)
alefacept
Other Intervention Name(s)
Amevive, ASP0485
Intervention Description
IM
Intervention Type
Procedure
Intervention Name(s)
Narrow Band UVB Phototherapy
Intervention Description
UVB Phototherapy
Primary Outcome Measure Information:
Title
Percentage of Subjects Who Achieve Psoriasis Area and Severity Index (PASI) 75 at Week 16
Description
The PASI score is a tool that allows investigators to assign an objective number to the degree of severity of a person's psoriasis, and considers: redness, scaling and thickness. Values for PASI score range from 0 (least) to 72 (worst). PASI 75 was defined as an improvement of at least 75% in PASI as compared to Baseline. The Last Observation Carry Forward (LOCF) method was used to impute missing data.
Time Frame
Week 16
Secondary Outcome Measure Information:
Title
Percentage of Subjects Reaching PASI 75 Over the Entire Course of the Study
Description
The PASI score is a tool that allows investigators to assign an objective number to the degree of severity of a person's psoriasis, and considers: redness, scaling and thickness. Values for PASI score range from 0 (least) to 72 (worst). PASI 75 was defined as an improvement of at least 75% in PASI as compared to Baseline. The Last Observation Carry Forward (LOCF) method was used to impute missing data.
Time Frame
Week 36
Title
Change in Body Surface Area (BSA) Covered With Psoriasis at Week 16
Description
A negative change from Baseline represents improvement. Change is calculated as Week 16- Baseline. The Last Observation Carry Forward (LOCF) method was used to impute missing data.
Time Frame
Baseline and Week 16
Title
Change in Body Surface Area (BSA) Covered With Psoriasis Over the Entire Course of the Study
Description
A negative change from Baseline represents improvement. Change is calculated as Week 36- Baseline. The Last Observation Carry Forward (LOCF) method was used to impute missing data.
Time Frame
Baseline and Week 36
Title
Percentage of Subjects Who Achieved Physical Global Assessment (PGA) of Clear or Almost Clear at Week 16
Description
The PGA scale is a tool used to evaluate the degree of overall lesion severity. The scale ranges from 0 (clear) to 5 (very severe). Clear is defined as a score of 0; Almost Clear is defined as a score of 1. Subjects who achieved PGA of clear or almost clear at any visit during the study were assigned to the YES category for their respective groups. The Last Observation Carry Forward (LOCF) method was used to impute missing data.
Time Frame
Week 16
Title
Percentage of Subjects Who Achieved Physical Global Assessment (PGA) of Clear or Almost Clear Over the Entire Course of the Study
Description
The PGA scale is a tool used to evaluate the degree of overall lesion severity. The scale ranges from 0 (clear) to 5 (very severe). Clear is defined as a score of 0; Almost Clear is defined as a score of 1. Subjects who achieved PGA of clear or almost clear at any visit during the study were assigned to the YES category for their respective groups. The Last Observation Carry Forward (LOCF) method was used to impute missing data.
Time Frame
Week 36
Title
Percentage of Subjects Who Achieve PASI 90 at Week 16
Description
The PASI score is a tool that allows investigators to assign an objective number to the degree of severity of a person's psoriasis, and considers: redness, scaling and thickness. Values for PASI score range from 0 (least) to 72 (worst). PASI 90 was defined as an improvement of at least 90% in PASI as compared to Baseline. The Last Observation Carry Forward (LOCF) method was used to impute missing data.
Time Frame
Week 16
Title
Time to Relapse
Description
The analysis only included subjects who achieved a 75% improvement in PASI and then relapsed. Relapse is defined by a loss of 50% of improvement in PASI.
Time Frame
Week 36
Title
Time for 50% Decrease in PASI
Description
The PASI score is a tool that allows investigators to assign an objective number to the degree of severity of a person's psoriasis, and considers: redness, scaling and thickness. Values for PASI score range from 0 (least) to 72 (worst). Only subjects who experienced 50% decrease in PASI were included in the analysis.
Time Frame
Week 36
Title
Time for a 75% Decrease in PASI
Description
The PASI score is a tool that allows investigators to assign an objective number to the degree of severity of a person's psoriasis, and considers: redness, scaling and thickness. Values for PASI score range from 0 (least) to 72 (worst). Only subjects who experienced 75% decrease in PASI were included in the analysis.
Time Frame
Week 36
Title
Change in Dermatology Life Quality Index (DLQI)
Description
The DLQI questionnaire is intended to measure how much a subject's skin problem affects the subject's life. Subjects provide answers considering the past week. The scale of the DQLI ranges from 0 (best) to 30 (worst). A negative change from Baseline represents improvement. Change is calculated as Week 36- Baseline. The Last Observation Carry Forward (LOCF) method was used to impute missing data.
Time Frame
Baseline and Week 36

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subject has given written informed consent Subject has a diagnosis of moderate to severe chronic plaque psoriasis involving >=10% with a Psoriasis Area and Severity Index (PASI) score >=10 at Baseline Subject has CD4+ T lymphocyte (CD4) count at or above the lower limit of normal Male and female subjects must use an adequate means of contraception from screening to end of study. Exclusion Criteria: Subject who received alefacept in the past Subject who has shown no improvement following an adequate course of nbUVB in the past Subject who has been treated in the past with either therapy or cyclosporine Subject with any active cancer, including skin cancer at Baseline Subject with erythrodermic, pustular or predominantly guttate psoriasis Subject who has used treatment for psoriasis prior to Baseline as follows: Topical treatment within 14 days Oral treatment within 28 days Broad band UVB (bbUVB) or nbUVB treatment within 56 days Biological treatment within 84 days Serious local infection or serious systemic infection within the 3 months prior to the first dose of study drug Subject with a history of drug or alcohol abuse within the past 2 years Subject that is known to be infected with the AIDS virus Subject with any other skin disease or other disease that might interfere with psoriasis status assessments Female subject who is nursing, pregnant or planning to become pregnant while in this study Subject who is currently enrolled in any other investigational drug or device study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Use Central Contact
Organizational Affiliation
Astellas Pharma Canada, Inc.
Official's Role
Study Director
Facility Information:
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2S 3B3
Country
Canada
City
Surrey
State/Province
British Columbia
ZIP/Postal Code
V3R 6A7
Country
Canada
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 4E8
Country
Canada
City
St. John's
State/Province
Newfoundland and Labrador
ZIP/Postal Code
A1C 2H5
Country
Canada
City
London
State/Province
Ontario
ZIP/Postal Code
N5X 2P1
Country
Canada
City
Markham
State/Province
Ontario
ZIP/Postal Code
L3P 1A8
Country
Canada
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5S 1B6
Country
Canada
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2K 4L5
Country
Canada
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3H 1V4
Country
Canada
City
Sainte-Foy
State/Province
Quebec
ZIP/Postal Code
G1V 4X7
Country
Canada
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7N 0W8
Country
Canada
City
Quebec
ZIP/Postal Code
G1J 1X7
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
22859237
Citation
Lui H, Gulliver W, Tan J, Hong CH, Hull P, Shear NH, Paradiso-Hardy F, Bissonette R. A randomized controlled study of combination therapy with alefacept and narrow band UVB phototherapy (UVB) for moderate to severe psoriasis: efficacy, onset, and duration of response. J Drugs Dermatol. 2012 Aug;11(8):929-37.
Results Reference
background
Links:
URL
http://www.astellas.us/docs/amevive.pdf
Description
Link to Prescribing Information

Learn more about this trial

Assess the Efficacy and Safety of Alefacept With Narrow Band Ultraviolet B Phototherapy (nbUVB) vs. Alefacept Alone in Chronic Plaque Psoriasis Subjects

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