Open Label Study Etanercept's Maintenance Dose in Obese Patients With Moderate to Severe Plaque Type Psoriasis

NCT00800982 | Completed Results DMC

• 2 other identifiers: KOO - ENBREL-2008H5939-31693-01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single-center, open-label, pilot study. A total of 30 subjects (15 in each study arm) will be enrolled in this 6 month study to evaluate whether the addition of narrow band UVB (NB-UVB) phototherapy can enhance the efficacy of etanercept's maintenance dose, 50 mg once a week, in obese psoriasis patients.

Conditions

Psoriasis

Keywords

Obese patients (BMI>30); Patients with moderate to severe psoriasis

Outcome Measures

Primary Outcomes (1)

• Psoriasis Area Severity Index. This Scale Ranges From 0-72, 0 Being no Disease, and 72 Being Most Severe. The Number of Patients Who Achieved 75% Improvement of Their Psoriasis at the End of 24 Weeks Are Indicated in the Outcomes Data Below.

  Psoriasis area severity index was used to determine the number of patients in each treatment arm who had 75% improvement in their psoriasis. This scale uses the characteristics of the psoriasis, such as body surface area, redness, thickness, and scaling, to determine the severity score.

  Weeks 12-24

Study Arms (2)

1 (Etanercept only)

ACTIVE COMPARATOR

Subjects will only be treated with etanercept. This is given at the standard FDA approved dosage of 50 mg twice weekly x 3 months then 50 mg once weekly x 3 months. No UVB will be given. Sham UVB will not be used because the subjects are not blinded because they often know they are receiving sham UVB due to differences in light intensity and heat.

Drug: etanercept

2 (Etanercept + nb-UVB)

EXPERIMENTAL

Subjects will receive etanercept. This is given at the standard FDA approved dosage of 50 mg twice weekly x 3 months then 50 mg once weekly x 3 months. In addition, for months 3-6, subjects will receive Narrow Band Ultraviolet B phototherapy three times a week for 12 weeks in addition to the etanercept maintenance dose. The safety and efficacy of the combination therapy will be evaluated by the registered phototherapy nurses at each phototherapy visit and by the study investigator at monthly visits. NB-UVB therapy will be adjusted according to the clinical judgment of the University of California San Francisco Psoriasis Treatment Center phototherapy staff.

Procedure: Narrow band (310-312 nm) ultraviolet light B phototherapy; Drug: etanercept

Interventions

Narrow band (310-312 nm) ultraviolet light B phototherapy PROCEDURE

Narrow band (310-312 nm) ultraviolet light B phototherapy 3 times a week during Weeks 12-24. NB-UVB therapy will be adjusted according to the clinical judgment of the University of California San Francisco Psoriasis Treatment Center phototherapy staff

Also known as: nb-UVB, nbUVB, narrowband UVB

2 (Etanercept + nb-UVB)

etanercept DRUG

Etanercept is given at the standard FDA approved dosage of 50 mg twice weekly x 3 months then 50 mg once weekly x 3 months.

Also known as: Enbrel

1 (Etanercept only); 2 (Etanercept + nb-UVB)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Nonimmunocompromised males or females 18 years of age or older.
• Must be able to read, understand, and speak basic English.
• Body Surface Area (BSA) involvement of greater than 10%.
• Psoriasis Area and Severity Index greater than 10.
• Obese defined as having a Body Mass Index greater than 30.
• Eligible for systemic therapy, particularly etanercept, and Narrow Band Ultraviolet B in the opinion of the investigator.
• Sign and date the appropriate written informed consent and Health Insurance Portability and Accountability Act authorization
• Negative urine pregnancy test within 7 days before the first dose of etanercept in all women (except those surgically sterile or at least 5 years postmenopausal).
• No evidence of active or latent tuberculosis based on a negative Purified Protein Derivative skin test. Patients with documentation of adequately treated tuberculosis may be enrolled.
• Sexually active subjects of childbearing potential must agree to use medically acceptable form of contraception during screening and throughout the study.
• Willing and able to self-administer subcutaneous injections or to have a qualified person available to administer subcutaneous injections
• Agrees to comply with protocol requirements, attend all regularly study visits and is considered to be a good study subject
• Meets concomitant medication washout requirements

You may not qualify if:

• Erythrodermic, pustular, or guttate psoriasis
• Evidence of skin conditions other than psoriasis that would interfere with study-related evaluations of psoriasis.
• Known sensitivity to any component of the study medications.
• 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 Week 0 visits.
• Evidence of latent or active hepatitis B infection as indicated by positive HBsAg test during the screening visit.
• Personal or first degree family history of neurologic disease.
• Poorly controlled medical condition including, but not limited to, unstable cardiovascular disease, poorly controlled diabetes, recent stroke, history of recurrent infections, or any other condition for which, in the opinion of the investigator, participation in the study would place the subject at risk.
• History of any Tumor Necrosis Factor-α inhibitor use including etanercept, infliximab, and adalimumab within 4 weeks of starting study drug.
• History of non-cutaneous malignancy within the past 5 years.
• History of drug or alcohol abuse. Substance abuse must clearly be documented so those patients with a remote and minor history of drug/alcohol use will still have an opportunity to participate in the study.
• Female subjects who are not postmenopausal for at least 1 year, surgically sterile, or willing to practice effective contraception during the study. Nursing mothers, pregnant women and women planning to become pregnant while on study are to be excluded.
• Plans to receive any live vaccines during the study.
• Evidence of photosensitivity disorder (i.e. polymorphous light eruption).
• Known photosensitivity or known sensitivity to any of the excipients or products to be administered during dosing.
• Current enrollment in another clinical study and treatment with another experimental drug or approved therapy for experimental use within 30 days prior to Week 0

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

UCSF Psoriasis and Skin Treatment Center

San Francisco, California, 94118, United States

Location

Related Publications (1)

• Park KK, Wu JJ, Koo J. A randomized, 'head-to-head' pilot study comparing the effects of etanercept monotherapy vs. etanercept and narrowband ultraviolet B (NB-UVB) phototherapy in obese psoriasis patients. J Eur Acad Dermatol Venereol. 2013 Jul;27(7):899-906. doi: 10.1111/j.1468-3083.2012.04611.x. Epub 2012 Jun 15.

  PMID: 22702846 RESULT

MeSH Terms

Conditions

Psoriasis

Interventions

Etanercept

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Immunoglobulin Fc Fragments; Immunoglobulin Fragments; Peptide Fragments; Peptides; Amino Acids, Peptides, and Proteins; Immunoglobulin Constant Regions; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins; Receptors, Tumor Necrosis Factor; Receptors, Cytokine; Receptors, Immunologic; Receptors, Cell Surface; Membrane Proteins

Limitations and Caveats

Of the 30 subjects enrolled, 3 were lost to follow-up, one moved out of state, and one voluntarily withdrew due to worsening of psoriasis.

Results Point of Contact

• Title: Dr Ethan Levin
• Organization: University of California San Francisco

levine@derm.ucsf.edu

4154764019

Study Officials

• John Koo, MD

  UCSF Psoriasis and Skin Treatment Center, Department of Dermatology, University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2008
• First Posted: December 3, 2008
• Study Start: October 1, 2008
• Primary Completion: January 1, 2012
• Study Completion: March 1, 2012
• Last Updated: May 7, 2013
• Results First Posted: May 7, 2013

Record last verified: 2013-03

Locations

US (1)