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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00658606
Recruitment Status : Completed
First Posted : April 15, 2008
Results First Posted : April 22, 2011
Last Update Posted : January 8, 2013
Sponsor:
Collaborator:
Astellas Pharma Canada, Inc.
Information provided by (Responsible Party):
Astellas Pharma Inc

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

Condition or disease Intervention/treatment Phase
Plaque Psoriasis Drug: alefacept Procedure: Narrow Band UVB Phototherapy Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 98 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : October 2007
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Percentage of Subjects Who Achieve Psoriasis Area and Severity Index (PASI) 75 at Week 16 [ Time Frame: 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 :
  1. Percentage of Subjects Reaching PASI 75 Over the Entire Course of the Study [ Time Frame: Week 36 ]

    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.


  2. Change in Body Surface Area (BSA) Covered With Psoriasis at Week 16 [ Time Frame: Baseline and 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.


  3. Change in Body Surface Area (BSA) Covered With Psoriasis Over the Entire Course of the Study [ Time Frame: Baseline and Week 36 ]

    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.


  4. Percentage of Subjects Who Achieved Physical Global Assessment (PGA) of Clear or Almost Clear at Week 16 [ Time Frame: 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.


  5. 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 ]

    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.


  6. Percentage of Subjects Who Achieve PASI 90 at Week 16 [ Time Frame: 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.


  7. Time to Relapse [ Time Frame: Week 36 ]

    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.


  8. Time for 50% Decrease in PASI [ Time Frame: Week 36 ]

    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.


  9. Time for a 75% Decrease in PASI [ Time Frame: Week 36 ]

    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.


  10. Change in Dermatology Life Quality Index (DLQI) [ Time Frame: Baseline and Week 36 ]

    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.




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00658606


Locations
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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
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Study Director: Use Central Contact Astellas Pharma Canada, Inc.

Additional Information:
Publications:
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Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT00658606    
Other Study ID Numbers: AME-001
First Posted: April 15, 2008    Key Record Dates
Results First Posted: April 22, 2011
Last Update Posted: January 8, 2013
Last Verified: January 2013
Keywords provided by Astellas Pharma Inc:
plaque psoriasis
alefacept
Amevive
narrow band ultraviolet B
phototherapy
Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Alefacept
Dermatologic Agents
Immunologic Factors
Physiological Effects of Drugs