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

May 22, 2013 updated by: Amgen

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

86

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Single-arm
Device: NB-UVB
Three times a week (TIW) for 12 weeks
Other Names:
  • Phototherapy
Drug: Etanerept
50 mg subcutaneously twice weekly (SC BIW) for 12 weeks
Other Names:
  • Enbrel
Drug: Etanercept
50 mg subcutaneously twice weekly (SC BIW) for 12 weeks
Other Names:
  • Enbrel

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of subjects achieving Psoriasis Area Severity Area (PASI) 75 at Week 12
Time Frame: 3 months
3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Time to PASI 75 responses
Time Frame: Variable
Variable
Proportion of subjects achieving PASI 90 at Week 12
Time Frame: 3 months
3 months
Improvement in PASI at Week 12
Time Frame: 3 months
3 months
Improvement in body surface area (BSA) involved with psoriasis at Week 12
Time Frame: 3 months
3 months
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
3 months
Improvement in patient global assesssment of psoriasis at Week 12
Time Frame: 3 months
3 months
Improvement in Dermatology Life Quality Index (DLQI) at Week 12
Time Frame: 3 months
3 months
Subject incidence of serious adverse events (SAEs) and events of medical interests (EMI) at Week 12
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Amgen

Collaborators

Wyeth is now a wholly owned subsidiary of Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2005

Primary Completion (Actual)

February 1, 2006

Study Completion (Actual)

March 1, 2006

Study Registration Dates

First Submitted

May 16, 2005

First Submitted That Met QC Criteria

May 16, 2005

First Posted (Estimate)

May 17, 2005

Study Record Updates

Last Update Posted (Estimate)

May 24, 2013

Last Update Submitted That Met QC Criteria

May 22, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20040171

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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