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Evaluation of Etanercept in Patients With Plaque Psoriasis After Stopping Ciclosporin Therapy

Primary Purpose

Psoriasis

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Etanercept
Placebo
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psoriasis focused on measuring Psoriasis

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Between age 18 and 70 years
  • Active and stable plaque psoriasis with a BSA≥10 or PASI≥10.

Exclusion Criteria:

  • Evidence of skin conditions other than psoriasis
  • Psoralen plus psoralen + ultraviolet A (PUVA), ciclosporin, acitretin, alefacept, anakinra, or any other systemic anti-psoriasis therapy or disease-modifying antirheumatic drugs (DMARD) with 28 days of screening
  • ultraviolet B (UVB) therapy, topical steroids, topical Vitamin A or D analog preparations, or anthralin
  • Prior exposure to any TNF-inhibitor. Prior exposure to efalizumab
  • Corticosteroid dose of prednisone >10 mg/day
  • Serious infection
  • Receipt of any live vaccine
  • Abnormal hematology or chemistry
  • Body mass index (BMI) > 38
  • Pregnancy or Breastfeeding
  • Significant concurrent medical conditions

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    etanercept

    placebo

    Arm Description

    Participants were administered a 50 mg dose of etanercept subcutaneously once a week after an initial course of ciclosporin.

    Participants were administered placebo subcutaneously once a week after an initial course of ciclosporin.

    Outcomes

    Primary Outcome Measures

    Change From Randomization in PASI Score to Week 24 (Week 18 of Etanercept Monotherapy/Placebo)
    PASI score: range: 0 (none) to 72 (maximum). Body was divided into head, upper extremities, trunk and lower extremities; each area score was combined for final PASI. For each section, percent area of skin involved was estimated: 0 (0%) to 6 (90 - 100%), and severity was estimated by clinical signs: (erythema, induration, and desquamation); scale: 0 (none) to 4 (maximum). Final PASI= sum of severity parameters for each section times area score times weight of section (head: 0.1, upper extremities: 0.2, trunk: 0.3, lower extremities: 0.4). Change = PASI at Week 24 - PASI at baseline.

    Secondary Outcome Measures

    PASI Area Under the Curve (AUC) Between Randomization and Week 24
    PASI AUC = Area under the curve from randomization (Week 6) to Week 24.
    Change From Randomization in PGA Score to Week 24
    PGA score is based on dermatologist's assessment of disease averaged over all lesions. Overall lesions were graded for individual scores of induration, erythema, and scaling; range: 0 (no evidence) to 5 (severe). The sum of the 3 scores was divided by 3 to obtain a final PGA score. Higher scores indicate greater severity of disease. Change = PGA at Week 24 - PGA at baseline.
    Relapse (Loss of 50% Improvement in PASI) During the 24 Weeks After Randomization
    Relapse was defined as the loss of 50% improvement in PASI.
    Probability of Being Relapse Free During the 24 Weeks After Randomization
    Relapse was defined as loss of 50% improvement in PASI. The time to relapse was estimated using a Kaplan-Meier analysis.
    Percent (%) Change of PASI Score From Randomization to Week 24
    Percent improvement in PASI score was calculated from Week 6 to Week 24.
    Change From Randomization in DLQI to Week 24
    DLQI is the dermatology-specific quality of life measure used for psoriatic population. The 10-item questionnaire has a score range of 0 to 30 with higher scores indicating poor quality of life. An estimate of the minimal clinically important difference of the DLQI total score is a 5 point improvement. Total score range: 0 (best) to 30 (worst).
    DLQI at Each Visit From Baseline
    DLQI is the dermatology-specific quality of life measure used for psoriatic population. The 10 item questionnaire has a score range of 0 to 30 with higher scores indicating poor quality of life. An estimate of the minimal clinically important difference of the DLQI total score is a 5 point improvement. Total score range: 0 (best) to 30 (worst).
    Percentage of Rebound Effects
    Rebound effects was defined as worsening of psoriasis to 125% of the baseline PASI or appearance of psoriasis variants such as erythrodermic or pustular psoriasis within 12 weeks of discontinuation of therapy.

    Full Information

    First Posted
    December 21, 2007
    Last Updated
    March 28, 2012
    Sponsor
    Pfizer
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00581555
    Brief Title
    Evaluation of Etanercept in Patients With Plaque Psoriasis After Stopping Ciclosporin Therapy
    Official Title
    A Randomized Pilot Study Evaluating the Efficacy and Safety of Etanercept in Patients With Moderate to Severe Plaque Psoriasis After Cessation of Ciclosporin Therapy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2012
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2007 (undefined)
    Primary Completion Date
    November 2009 (Actual)
    Study Completion Date
    November 2009 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Pfizer

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this study is to evaluate the use of etanercept as a replacement therapy for ciclosporin in patients with plaque psoriasis.
    Detailed Description
    The purpose of this study is to evaluate the efficacy and safety of etanercept as a replacement therapy for ciclosporin in patients with moderate to severe plaque psoriasis who have achieved an adequate response with ciclosporin.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Psoriasis
    Keywords
    Psoriasis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    120 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    etanercept
    Arm Type
    Experimental
    Arm Description
    Participants were administered a 50 mg dose of etanercept subcutaneously once a week after an initial course of ciclosporin.
    Arm Title
    placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Participants were administered placebo subcutaneously once a week after an initial course of ciclosporin.
    Intervention Type
    Drug
    Intervention Name(s)
    Etanercept
    Other Intervention Name(s)
    Enbrel
    Intervention Description
    Etanercept 50 mg QW initiated during taper of ciclosporin
    Intervention Type
    Other
    Intervention Name(s)
    Placebo
    Intervention Description
    Randomized to placebo during taper of ciclosporin
    Primary Outcome Measure Information:
    Title
    Change From Randomization in PASI Score to Week 24 (Week 18 of Etanercept Monotherapy/Placebo)
    Description
    PASI score: range: 0 (none) to 72 (maximum). Body was divided into head, upper extremities, trunk and lower extremities; each area score was combined for final PASI. For each section, percent area of skin involved was estimated: 0 (0%) to 6 (90 - 100%), and severity was estimated by clinical signs: (erythema, induration, and desquamation); scale: 0 (none) to 4 (maximum). Final PASI= sum of severity parameters for each section times area score times weight of section (head: 0.1, upper extremities: 0.2, trunk: 0.3, lower extremities: 0.4). Change = PASI at Week 24 - PASI at baseline.
    Time Frame
    Randomization to Week 24.
    Secondary Outcome Measure Information:
    Title
    PASI Area Under the Curve (AUC) Between Randomization and Week 24
    Description
    PASI AUC = Area under the curve from randomization (Week 6) to Week 24.
    Time Frame
    Randomization to Week 24.
    Title
    Change From Randomization in PGA Score to Week 24
    Description
    PGA score is based on dermatologist's assessment of disease averaged over all lesions. Overall lesions were graded for individual scores of induration, erythema, and scaling; range: 0 (no evidence) to 5 (severe). The sum of the 3 scores was divided by 3 to obtain a final PGA score. Higher scores indicate greater severity of disease. Change = PGA at Week 24 - PGA at baseline.
    Time Frame
    Randomization to Week 24.
    Title
    Relapse (Loss of 50% Improvement in PASI) During the 24 Weeks After Randomization
    Description
    Relapse was defined as the loss of 50% improvement in PASI.
    Time Frame
    Randomization to Week 24.
    Title
    Probability of Being Relapse Free During the 24 Weeks After Randomization
    Description
    Relapse was defined as loss of 50% improvement in PASI. The time to relapse was estimated using a Kaplan-Meier analysis.
    Time Frame
    Randomization to Week 24.
    Title
    Percent (%) Change of PASI Score From Randomization to Week 24
    Description
    Percent improvement in PASI score was calculated from Week 6 to Week 24.
    Time Frame
    Randomization to Week 24.
    Title
    Change From Randomization in DLQI to Week 24
    Description
    DLQI is the dermatology-specific quality of life measure used for psoriatic population. The 10-item questionnaire has a score range of 0 to 30 with higher scores indicating poor quality of life. An estimate of the minimal clinically important difference of the DLQI total score is a 5 point improvement. Total score range: 0 (best) to 30 (worst).
    Time Frame
    Randomization to Week 24.
    Title
    DLQI at Each Visit From Baseline
    Description
    DLQI is the dermatology-specific quality of life measure used for psoriatic population. The 10 item questionnaire has a score range of 0 to 30 with higher scores indicating poor quality of life. An estimate of the minimal clinically important difference of the DLQI total score is a 5 point improvement. Total score range: 0 (best) to 30 (worst).
    Time Frame
    Baseline to Week 24.
    Title
    Percentage of Rebound Effects
    Description
    Rebound effects was defined as worsening of psoriasis to 125% of the baseline PASI or appearance of psoriasis variants such as erythrodermic or pustular psoriasis within 12 weeks of discontinuation of therapy.
    Time Frame
    Baseline to Week 24.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Between age 18 and 70 years Active and stable plaque psoriasis with a BSA≥10 or PASI≥10. Exclusion Criteria: Evidence of skin conditions other than psoriasis Psoralen plus psoralen + ultraviolet A (PUVA), ciclosporin, acitretin, alefacept, anakinra, or any other systemic anti-psoriasis therapy or disease-modifying antirheumatic drugs (DMARD) with 28 days of screening ultraviolet B (UVB) therapy, topical steroids, topical Vitamin A or D analog preparations, or anthralin Prior exposure to any TNF-inhibitor. Prior exposure to efalizumab Corticosteroid dose of prednisone >10 mg/day Serious infection Receipt of any live vaccine Abnormal hematology or chemistry Body mass index (BMI) > 38 Pregnancy or Breastfeeding Significant concurrent medical conditions
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Medical Monitor
    Organizational Affiliation
    Wyeth is now a wholly owned subsidiary of Pfizer
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    24682319
    Citation
    Micali G, Wilsmann-Theis D, Mallbris L, Gallo G, Marino V, Brault Y, Germain JM. Etanercept reduces symptoms and severity of psoriasis after cessation of cyclosporine therapy: results of the SCORE study. Acta Derm Venereol. 2015 Jan;95(1):57-61. doi: 10.2340/00015555-1845.
    Results Reference
    derived

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    Evaluation of Etanercept in Patients With Plaque Psoriasis After Stopping Ciclosporin Therapy

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