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

This study has been completed.
Sponsor:
Collaborator:
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT00110981
First received: May 16, 2005
Last updated: May 22, 2013
Last verified: May 2013

May 16, 2005
May 22, 2013
March 2005
February 2006   (final data collection date for primary outcome measure)
Proportion of subjects achieving Psoriasis Area Severity Area (PASI) 75 at Week 12 [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00110981 on ClinicalTrials.gov Archive Site
  • Time to PASI 75 responses [ Time Frame: Variable ] [ Designated as safety issue: No ]
  • Proportion of subjects achieving PASI 90 at Week 12 [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Improvement in PASI at Week 12 [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Improvement in body surface area (BSA) involved with psoriasis at Week 12 [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Improvement in patient global assesssment of psoriasis at Week 12 [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Improvement in Dermatology Life Quality Index (DLQI) at Week 12 [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Subject incidence of serious adverse events (SAEs) and events of medical interests (EMI) at Week 12 [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
Not Provided
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Utilization of Narrow Band Ultraviolet B (UVB) Light Therapy and Etanercept for the Treatment of Psoriasis
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

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).

Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Psoriasis
  • 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
Experimental: Single-arm
Interventions:
  • Device: NB-UVB
  • Drug: Etanerept
  • Drug: Etanercept
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.
 
Completed
86
March 2006
February 2006   (final data collection date for primary outcome measure)

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

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00110981
20040171
Not Provided
Amgen
Amgen
Wyeth is now a wholly owned subsidiary of Pfizer
Study Director: MD Amgen
Amgen
May 2013

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