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

Sponsor:	Astellas Pharma Inc
Collaborator:	Astellas Pharma Canada, Inc.
Information provided by:	Astellas Pharma Inc
ClinicalTrials.gov Identifier:	NCT00658606

Purpose

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

Condition	Intervention	Phase
Chronic Small Plaque Psoriasis	Drug: alefacept Procedure: Narrow Band UVB Phototherapy	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
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

Resource links provided by NLM:

Genetics Home Reference related topics: psoriatic arthritis

MedlinePlus related topics: Psoriasis

Drug Information available for: Alefacept

U.S. FDA Resources

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:

Percentage of Subjects Who Achieve Psoriasis Area and Severity Index (PASI) 75 at Week 16 [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
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 [ Time Frame: Week 36 ] [ Designated as safety issue: No ]
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 [ Time Frame: Baseline and Week 16 ] [ Designated as safety issue: No ]
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 [ Time Frame: Baseline and Week 36 ] [ Designated as safety issue: No ]
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 [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
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 [ Time Frame: Week 36 ] [ Designated as safety issue: No ]
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 [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
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 [ Time Frame: Week 36 ] [ Designated as safety issue: No ]
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 [ Time Frame: Week 36 ] [ Designated as safety issue: No ]
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 [ Time Frame: Week 36 ] [ Designated as safety issue: No ]
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) [ Time Frame: Baseline and Week 36 ] [ Designated as safety issue: No ]
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.

Enrollment:	98
Study Start Date:	October 2007
Study Completion Date:	December 2009
Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Alefacept alone 15 mg alefacept intramuscularly (IM) once weekly for 12 weeks	Drug: alefacept IM Other Names: Amevive ASP0485
Experimental: Alefacept + nbUVB 15 mg alefacept intramuscularly once weekly and narrow band Ultraviolet B (nbUVB) phototherapy 3 times per week for 12 weeks	Procedure: Narrow Band UVB Phototherapy UVB Phototherapy

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00658606

Locations

Canada, Alberta

Calgary, Alberta, Canada, T2S 3B3
Canada, British Columbia

Surrey, British Columbia, Canada, V3R 6A7

Vancouver, British Columbia, Canada, V5Z 4E8
Canada, Newfoundland and Labrador

St. John's, Newfoundland and Labrador, Canada, A1C 2H5
Canada, Ontario

London, Ontario, Canada, N5X 2P1

Markham, Ontario, Canada, L3P 1A8

Toronto, Ontario, Canada, M5S 1B6
Canada, Quebec

Montreal, Quebec, Canada, H2K 4L5

Montreal, Quebec, Canada, H3H 1V4

Sainte-Foy, Quebec, Canada, G1V 4X7
Canada, Saskatchewan

Saskatoon, Saskatchewan, Canada, S7N 0W8
Canada

Quebec, Canada, G1J 1X7

Sponsors and Collaborators

Astellas Pharma Inc

Astellas Pharma Canada, Inc.

Investigators

Study Director:

Use Central Contact

Astellas Pharma Canada, Inc.

More Information

Additional Information:

Link to Prescribing Information This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Sr Manager Clinical Trials Registry, Astellas Pharma Global Development
ClinicalTrials.gov Identifier:	NCT00658606 History of Changes
Other Study ID Numbers:	AME-001
Study First Received:	April 10, 2008
Results First Received:	February 17, 2011
Last Updated:	March 28, 2011
Health Authority:	Canada: Health Canada

Keywords provided by Astellas Pharma Inc:

plaque psoriasis
alefacept
Amevive
narrow band ultraviolet B
phototherapy

Additional relevant MeSH terms:

Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Alefacept

Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 12, 2012