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Utilization of Narrow Band Ultraviolet B (UVB) Light Therapy and Etanercept for the Treatment of Psoriasis

Primary Purpose

Psoriasis

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
NB-UVB
Etanerept
Etanercept
Sponsored by
Amgen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psoriasis focused on measuring psoriasis, dermatology, plaque psoriasis, skin, etanercept, ENBREL, NB-UVB, narrow-band UVB, phototherapy, combination therapy, 50 mg prefilled syringes

Eligibility Criteria

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

Inclusion Criteria: - Chronic plaque psoriasis eligible for systemic therapy and NB-UVB in the opinion of the investigator - Psoriasis Activity and Severity Index (PASI) greater than or equal to 15 and at least 25% of individual plaques must be considered severe - Patients must have body surface area (BSA) involvement of greater than or equal to 5% - Before any study-specific procedure, subject must sign and date the appropriate written informed consent - Negative urine pregnancy test within 7 days before the first dose of study drug in all women (except those surgically sterile or at least 5 years postmenopausal) - Sexually active subjects of childbearing potential must agree to use medically acceptable form of contraception during screening and throughout the study Exclusion Criteria: - Prior phototherapy - Current or prior treatment with any tumor necrosis factor (TNF) antagonist, including etanercept, infliximab and adalimumab - Erythrodermic, pustular or guttate psoriasis - Evidence of skin conditions (e.g., eczema) other than psoriasis that would interfere with study-related evaluations of psoriasis - Evidence of active infections such as fevers, chills, sweats, or history of untreated Lyme disease and active severe infections within 4 weeks before screening visit or between the screening and baseline visits - History of immune compromised health [e.g., human immunodeficiency virus (HIV) positive status] - History of any cutaneous malignancy at any time, including squamous or basal cell carcinomas or melanoma - History of non-cutaneous cancer within 5 years - Actinic keratosis or atypical moles - History of alcohol or drug abuse within 12 months of screening visit - Current enrollment in another clinical study and treatment with another experimental drug or approved therapy for experimental use within 30 days prior to etanercept administration - Severe comorbidities as outlined in ENBREL(r) Package Insert: diabetes mellitus requiring insulin, congestive heart failure of any severity, myocardial infarction (within less than or equal to 52 weeks before screening), unstable angina pectoris, oxygen-dependent severe pulmonary disease, tuberculosis or tuberculosis exposure, chronic hepatitis B or hepatitis C, systemic lupus erythematosus, history of multiple sclerosis or other demyelinating disease, transverse myelitis, optic neuritis or epilepsy, uncontrolled hypertension (defined as systolic blood pressure greater than 180 mm Hg or diastolic blood pressure greater than 110 mm Hg) - Contraindications according to the ENBREL(r) Package Insert - Evidence of open cutaneous ulcers - Evidence of photosensitivity disorder (e.g., polymorphous light eruption) - Nursing mothers, female subjects planning on becoming pregnant or male subjects planning a pregnancy with their spouse/partner while in the study - Subjects that cannot commit to all the assessments required by the protocol - Known photosensitivity or known sensitivity to any of the excipients or products to be administered during dosing - Any disorder that compromises the ability of the subject to give written informed consent and/or to comply with study procedures

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Single-arm

    Arm Description

    Outcomes

    Primary Outcome Measures

    Proportion of subjects achieving Psoriasis Area Severity Area (PASI) 75 at Week 12

    Secondary Outcome Measures

    Time to PASI 75 responses
    Proportion of subjects achieving PASI 90 at Week 12
    Improvement in PASI at Week 12
    Improvement in body surface area (BSA) involved with psoriasis at Week 12
    Improvement in physician global assesssment of psoriasis, including an assessment of the proportion of subjects achieving clear or almost clear status at Week 12
    Improvement in patient global assesssment of psoriasis at Week 12
    Improvement in Dermatology Life Quality Index (DLQI) at Week 12
    Subject incidence of serious adverse events (SAEs) and events of medical interests (EMI) at Week 12

    Full Information

    First Posted
    May 16, 2005
    Last Updated
    May 22, 2013
    Sponsor
    Amgen
    Collaborators
    Wyeth is now a wholly owned subsidiary of Pfizer
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00110981
    Brief Title
    Utilization of Narrow Band Ultraviolet B (UVB) Light Therapy and Etanercept for the Treatment of Psoriasis
    Official Title
    A Multicenter, Open-Label, Pilot Trial to Evaluate the Effectiveness and Safety of ENBREL(r) in Combination With Narrowband UVB Phototherapy for the Treatment of Psoriasis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2013
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2005 (undefined)
    Primary Completion Date
    February 2006 (Actual)
    Study Completion Date
    March 2006 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Amgen
    Collaborators
    Wyeth is now a wholly owned subsidiary of Pfizer

    4. Oversight

    5. Study Description

    Brief Summary
    The purpose of this study is to evaluate the safety and effectiveness of combination therapy with etanercept and narrow-band (NB) UVB phototherapy for the treatment of psoriasis in a pilot study. This is a Phase 4 clinical study being conducted under an Amgen Investigational New Drug Application (IND).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Psoriasis
    Keywords
    psoriasis, dermatology, plaque psoriasis, skin, etanercept, ENBREL, NB-UVB, narrow-band UVB, phototherapy, combination therapy, 50 mg prefilled syringes

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    86 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Single-arm
    Arm Type
    Experimental
    Intervention Type
    Device
    Intervention Name(s)
    NB-UVB
    Other Intervention Name(s)
    Phototherapy
    Intervention Description
    Three times a week (TIW) for 12 weeks
    Intervention Type
    Drug
    Intervention Name(s)
    Etanerept
    Other Intervention Name(s)
    Enbrel
    Intervention Description
    50 mg subcutaneously twice weekly (SC BIW) for 12 weeks
    Intervention Type
    Drug
    Intervention Name(s)
    Etanercept
    Other Intervention Name(s)
    Enbrel
    Intervention Description
    50 mg subcutaneously twice weekly (SC BIW) for 12 weeks
    Primary Outcome Measure Information:
    Title
    Proportion of subjects achieving Psoriasis Area Severity Area (PASI) 75 at Week 12
    Time Frame
    3 months
    Secondary Outcome Measure Information:
    Title
    Time to PASI 75 responses
    Time Frame
    Variable
    Title
    Proportion of subjects achieving PASI 90 at Week 12
    Time Frame
    3 months
    Title
    Improvement in PASI at Week 12
    Time Frame
    3 months
    Title
    Improvement in body surface area (BSA) involved with psoriasis at Week 12
    Time Frame
    3 months
    Title
    Improvement in physician global assesssment of psoriasis, including an assessment of the proportion of subjects achieving clear or almost clear status at Week 12
    Time Frame
    3 months
    Title
    Improvement in patient global assesssment of psoriasis at Week 12
    Time Frame
    3 months
    Title
    Improvement in Dermatology Life Quality Index (DLQI) at Week 12
    Time Frame
    3 months
    Title
    Subject incidence of serious adverse events (SAEs) and events of medical interests (EMI) at Week 12
    Time Frame
    3 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: - Chronic plaque psoriasis eligible for systemic therapy and NB-UVB in the opinion of the investigator - Psoriasis Activity and Severity Index (PASI) greater than or equal to 15 and at least 25% of individual plaques must be considered severe - Patients must have body surface area (BSA) involvement of greater than or equal to 5% - Before any study-specific procedure, subject must sign and date the appropriate written informed consent - Negative urine pregnancy test within 7 days before the first dose of study drug in all women (except those surgically sterile or at least 5 years postmenopausal) - Sexually active subjects of childbearing potential must agree to use medically acceptable form of contraception during screening and throughout the study Exclusion Criteria: - Prior phototherapy - Current or prior treatment with any tumor necrosis factor (TNF) antagonist, including etanercept, infliximab and adalimumab - Erythrodermic, pustular or guttate psoriasis - Evidence of skin conditions (e.g., eczema) other than psoriasis that would interfere with study-related evaluations of psoriasis - Evidence of active infections such as fevers, chills, sweats, or history of untreated Lyme disease and active severe infections within 4 weeks before screening visit or between the screening and baseline visits - History of immune compromised health [e.g., human immunodeficiency virus (HIV) positive status] - History of any cutaneous malignancy at any time, including squamous or basal cell carcinomas or melanoma - History of non-cutaneous cancer within 5 years - Actinic keratosis or atypical moles - History of alcohol or drug abuse within 12 months of screening visit - Current enrollment in another clinical study and treatment with another experimental drug or approved therapy for experimental use within 30 days prior to etanercept administration - Severe comorbidities as outlined in ENBREL(r) Package Insert: diabetes mellitus requiring insulin, congestive heart failure of any severity, myocardial infarction (within less than or equal to 52 weeks before screening), unstable angina pectoris, oxygen-dependent severe pulmonary disease, tuberculosis or tuberculosis exposure, chronic hepatitis B or hepatitis C, systemic lupus erythematosus, history of multiple sclerosis or other demyelinating disease, transverse myelitis, optic neuritis or epilepsy, uncontrolled hypertension (defined as systolic blood pressure greater than 180 mm Hg or diastolic blood pressure greater than 110 mm Hg) - Contraindications according to the ENBREL(r) Package Insert - Evidence of open cutaneous ulcers - Evidence of photosensitivity disorder (e.g., polymorphous light eruption) - Nursing mothers, female subjects planning on becoming pregnant or male subjects planning a pregnancy with their spouse/partner while in the study - Subjects that cannot commit to all the assessments required by the protocol - Known photosensitivity or known sensitivity to any of the excipients or products to be administered during dosing - Any disorder that compromises the ability of the subject to give written informed consent and/or to comply with study procedures
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    MD
    Organizational Affiliation
    Amgen
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    18380206
    Citation
    Kircik L, Bagel J, Korman N, Menter A, Elmets CA, Koo J, Yang YC, Chiou CF, Dann F, Stevens SR; Unite Study Group. Utilization of narrow-band ultraviolet light B therapy and etanercept for the treatment of psoriasis (UNITE): efficacy, safety, and patient-reported outcomes. J Drugs Dermatol. 2008 Mar;7(3):245-53.
    Results Reference
    result
    Links:
    URL
    http://www.amgentrials.com
    Description
    AmgenTrials clinical trials website
    URL
    http://download.veritasmedicine.com/REGFILES/amgen/Amgen_results_disclaimer.pdf
    Description
    Notice regarding posted summaries of trial results
    URL
    http://download.veritasmedicine.com/REGFILES/amgen/08D_FDAMA_113_Posting_Summary_916_ENBREL_20040171.pdf
    Description
    To access clinical trial results information click on this link
    URL
    http://www.enbrel.com/
    Description
    FDA-approved Drug Labeling

    Learn more about this trial

    Utilization of Narrow Band Ultraviolet B (UVB) Light Therapy and Etanercept for the Treatment of Psoriasis

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