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Completed

NCT Number: NCT00658606

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

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

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Key information

Conditions

Plaque Psoriasis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Calgary, Alberta, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Alefacept

Drug

IM

Other names: Amevive, ASP0485

Narrow Band UVB Phototherapy

Procedure

UVB Phototherapy

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Astellas Pharma Inc

Industry

Collaborators

  • Astellas Pharma Canada, Inc.

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Apr 15, 2008
Registry last updated
Jan 8, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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