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Acitretin and Etanercept in Psoriasis

Primary Purpose

Psoriasis

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
acitretin
Sponsored by
University of Medicine and Dentistry of New Jersey
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psoriasis focused on measuring psoriasis, etanercept, acitretin

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Adults (aged 18 to 80 years old) with moderate to severe psoriasis (defined as having a physician global assessment score of 3 [moderate] or higher) who are on etanercept 50 mg SQ once weekly and have not achieved PASI 75 after 12 weeks or more of treatment with etanercept All patients on etanercept have been tested for TB before initiation of etanercept Exclusion Criteria: Patients < 18 years old or > 80 years old Patients who are not on etanercept 50 mg SQ once weekly Women of childbearing potential (Note: women of non-childbearing potential, meaning surgically sterile [bilateral oophorectomy, hysterectomy, and/or bilateral tubal ligation] or post-menopausal for at least 2 years, are eligible) Inability to understand consent or comply with study requirements Uncontrolled hypertriglyceridemia Patients with severely impaired hepatic function Patients without health insurance or who are not willing to pay out-of-pocket for etanercept and laboratory tests Systemic psoriasis therapies or PUVA within the past 2 weeks UVB or topical psoriasis therapies (other than emollients/moisturizers and OTC shampoos) within the past 1 week Patients with epilepsy or multiple sclerosis

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    etanercept with acitretin

    Arm Description

    open-label

    Outcomes

    Primary Outcome Measures

    Percent of Patients Achieving PASI 75 at 6 Months After the Addition of Acitretin Therapy
    Percentage of participants achieving at least a 75% decrease (improvement) from Baseline in the Psoriasis Area and Severity Index (PASI) at 6 months. PASI Score incorporates measures of erythema, desquamation, infiltration, and affected body surface area. Involvement and severity of psoriasis was scored using a scale of 0 to 72, where 0 = no psoriasis and 72 = severe disease.

    Secondary Outcome Measures

    Percent of Patients Achieving PASI 50 at 6 Months After the Addition of Acitretin Therapy
    Percentage of participants achieving at least a 50% decrease (improvement) from Baseline in the Psoriasis Area and Severity Index (PASI) at 6 months. PASI Score incorporates measures of erythema, desquamation, infiltration, and affected body surface area. Involvement and severity of psoriasis was scored using a scale of 0 to 72, where 0 = no psoriasis and 72 = severe disease.
    Percent of Patients Achieving a PGA of Clear or Almost Clear at 6 Months After the Addition of Acitretin Therapy
    Percentage of participants achieving a clear (0) or almost clear (1) status on the Physician Global Assessment (PGA) at 6 months. This index evaluates the physician's global assessment of the participant's psoriasis based on severity of induration, scaling, and erythema. The assessment was scored on a scale of 0 to 5, where 0 = clear, with no evidence of plaque elevation, erythema, or scale, and 5 = severe induration, erythema, and scaling.

    Full Information

    First Posted
    September 7, 2005
    Last Updated
    February 13, 2015
    Sponsor
    University of Medicine and Dentistry of New Jersey
    Collaborators
    Connetics Corp.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00156247
    Brief Title
    Acitretin and Etanercept in Psoriasis
    Official Title
    Pilot, Single-Arm Study of the Effect of Adding Acitretin to Etanercept Therapy in Patients With Moderate to Severe Psoriasis Who Fail to Respond to Etanercept Monotherapy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2005 (undefined)
    Primary Completion Date
    March 2009 (Actual)
    Study Completion Date
    March 2009 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Medicine and Dentistry of New Jersey
    Collaborators
    Connetics Corp.

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    To determine whether acitretin plus etanercept is more effective than etanercept alone in clearing psoriasis plaques in adults.
    Detailed Description
    This study will include patients with moderate to severe psoriasis who have been taking etanercept 50 mg/week for at least 3 months (12 weeks) and have not achieved PASI 75. They will be given acitretin 25 mg/day. The combined treatment will occur over 6 months. Subjects' progress will be assessed monthly, based on the improvement of their PASI and PGA scores.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    10 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    etanercept with acitretin
    Arm Type
    Experimental
    Arm Description
    open-label
    Intervention Type
    Drug
    Intervention Name(s)
    acitretin
    Other Intervention Name(s)
    Soriatane
    Intervention Description
    Patients who have been taking etanercept 50 mg/week for at least 3 months (12 weeks) will take acitretin 25 mg pill once daily for 6 months.
    Primary Outcome Measure Information:
    Title
    Percent of Patients Achieving PASI 75 at 6 Months After the Addition of Acitretin Therapy
    Description
    Percentage of participants achieving at least a 75% decrease (improvement) from Baseline in the Psoriasis Area and Severity Index (PASI) at 6 months. PASI Score incorporates measures of erythema, desquamation, infiltration, and affected body surface area. Involvement and severity of psoriasis was scored using a scale of 0 to 72, where 0 = no psoriasis and 72 = severe disease.
    Time Frame
    6 months
    Secondary Outcome Measure Information:
    Title
    Percent of Patients Achieving PASI 50 at 6 Months After the Addition of Acitretin Therapy
    Description
    Percentage of participants achieving at least a 50% decrease (improvement) from Baseline in the Psoriasis Area and Severity Index (PASI) at 6 months. PASI Score incorporates measures of erythema, desquamation, infiltration, and affected body surface area. Involvement and severity of psoriasis was scored using a scale of 0 to 72, where 0 = no psoriasis and 72 = severe disease.
    Time Frame
    6 months
    Title
    Percent of Patients Achieving a PGA of Clear or Almost Clear at 6 Months After the Addition of Acitretin Therapy
    Description
    Percentage of participants achieving a clear (0) or almost clear (1) status on the Physician Global Assessment (PGA) at 6 months. This index evaluates the physician's global assessment of the participant's psoriasis based on severity of induration, scaling, and erythema. The assessment was scored on a scale of 0 to 5, where 0 = clear, with no evidence of plaque elevation, erythema, or scale, and 5 = severe induration, erythema, and scaling.
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Adults (aged 18 to 80 years old) with moderate to severe psoriasis (defined as having a physician global assessment score of 3 [moderate] or higher) who are on etanercept 50 mg SQ once weekly and have not achieved PASI 75 after 12 weeks or more of treatment with etanercept All patients on etanercept have been tested for TB before initiation of etanercept Exclusion Criteria: Patients < 18 years old or > 80 years old Patients who are not on etanercept 50 mg SQ once weekly Women of childbearing potential (Note: women of non-childbearing potential, meaning surgically sterile [bilateral oophorectomy, hysterectomy, and/or bilateral tubal ligation] or post-menopausal for at least 2 years, are eligible) Inability to understand consent or comply with study requirements Uncontrolled hypertriglyceridemia Patients with severely impaired hepatic function Patients without health insurance or who are not willing to pay out-of-pocket for etanercept and laboratory tests Systemic psoriasis therapies or PUVA within the past 2 weeks UVB or topical psoriasis therapies (other than emollients/moisturizers and OTC shampoos) within the past 1 week Patients with epilepsy or multiple sclerosis
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Melissa A. Magliocco, MD
    Organizational Affiliation
    Rutgers, The State University of New Jersey
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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    Acitretin and Etanercept in Psoriasis

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