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

NCT00110981

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Psoriasis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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

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Advanced Information
Descriptive Information
Brief Title  ICMJE Utilization of Narrow Band Ultraviolet B (UVB) Light Therapy and Etanercept for the Treatment of Psoriasis
Official Title  ICMJE 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
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Psoriasis
Intervention  ICMJE
  • Device: NB-UVB
    Three times a week (TIW) for 12 weeks
    Other Name: Phototherapy
  • Drug: Etanerept
    50 mg subcutaneously twice weekly (SC BIW) for 12 weeks
    Other Name: Enbrel
  • Drug: Etanercept
    50 mg subcutaneously twice weekly (SC BIW) for 12 weeks
    Other Name: Enbrel
Study Arms  ICMJE Experimental: Single-arm
Interventions:
  • Device: NB-UVB
  • Drug: Etanerept
  • Drug: Etanercept
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 18, 2008)
86
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE March 2006
Actual Primary Completion Date February 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries United States
 
Administrative Information
NCT Number  ICMJE NCT00110981
Other Study ID Numbers  ICMJE 20040171
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Amgen
Study Sponsor  ICMJE Amgen
Collaborators  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Investigators  ICMJE
Study Director:MDAmgen
PRS Account Amgen
Verification Date May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP