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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00110981
Recruitment Status : Completed
First Posted : May 17, 2005
Last Update Posted : May 24, 2013
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by (Responsible Party):

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).

Condition or disease Intervention/treatment Phase
Psoriasis Device: NB-UVB Drug: Etanerept Drug: Etanercept Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 86 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : March 2005
Actual Primary Completion Date : February 2006
Actual Study Completion Date : March 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis
Drug Information available for: Etanercept

Arm Intervention/treatment
Experimental: Single-arm 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

Primary Outcome Measures :
  1. Proportion of subjects achieving Psoriasis Area Severity Area (PASI) 75 at Week 12 [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. Time to PASI 75 responses [ Time Frame: Variable ]
  2. Proportion of subjects achieving PASI 90 at Week 12 [ Time Frame: 3 months ]
  3. Improvement in PASI at Week 12 [ Time Frame: 3 months ]
  4. Improvement in body surface area (BSA) involved with psoriasis at Week 12 [ Time Frame: 3 months ]
  5. 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 ]
  6. Improvement in patient global assesssment of psoriasis at Week 12 [ Time Frame: 3 months ]
  7. Improvement in Dermatology Life Quality Index (DLQI) at Week 12 [ Time Frame: 3 months ]
  8. Subject incidence of serious adverse events (SAEs) and events of medical interests (EMI) at Week 12 [ Time Frame: 3 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00110981

Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
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Study Director: MD Amgen
Additional Information:
Publications of Results:
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Responsible Party: Amgen Identifier: NCT00110981    
Other Study ID Numbers: 20040171
First Posted: May 17, 2005    Key Record Dates
Last Update Posted: May 24, 2013
Last Verified: May 2013
Keywords provided by Amgen:
plaque psoriasis
NB-UVB, narrow-band UVB, phototherapy
combination therapy, 50 mg prefilled syringes
Additional relevant MeSH terms:
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Skin Diseases, Papulosquamous
Skin Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Gastrointestinal Agents
Immunosuppressive Agents
Immunologic Factors