A Single-Center, Open-Label, Pilot Study to Evaluate the Efficacy and Tolerability of Narrow Band UVB Phototherapy in Enhancing Etanercept's Maintenance Dose in Obese Patients With Moderate to Severe Plaque-Type Psoriasis
| City: |
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San Francisco |
| State: |
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California |
| Zip Code: |
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94118 |
| Conditions: |
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Psoriasis |
| Purpose: |
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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.
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| Study Summary: |
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In Phase I, all subjects will receive etanercept's induction dose, 50 mg twice a week, for a
total of 12 weeks. In Phase II, all subjects will receive etanercept's maintenance dose, 50
mg once a week, during Weeks 12-24. Those subjects randomized to the treatment arm will
receive NB-UVB phototherapy 3 times a week during Phase II. In order to ensure homogeneity
between the NB-UVB arm and non-NB-UVB arm, subjects will be randomized according to their
Body Mass Index (BMI). The Psoriasis Area Severity Index (PASI) score and Physician Global
Assessment (PGA) will be calculated at each visit to determine the effectiveness of the
etanercept and NB-UVB treatment during both phases of the study. The hypothesis is that the
combination of NB-UVB phototherapy three times a week and etanercept maintenance dose (50 mg
once a week) will enhance the efficacy of the maintenance dose alone in obese patients (BMI
>30) with moderate to severe psoriasis.
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| Criteria: |
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Inclusion Criteria:
- 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 NB-UVB in the opinion of
the investigator.
- Sign and date the appropriate written informed consent and HIPAA 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 PPD 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
Exclusion Criteria:
- 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 TNF-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
- Cannot commit to all the assessments required by the protocol
- Any disorder that compromises the ability of the subject to give written informed
consent and/or to comply with study procedures
- Considered by the investigator, for any reason, to be an unsuitable candidate for
study participation.
- Cannot or do not wish to comply with the protocol washout requirements (please see
section below entitled "Washout Period Prior to Week 0).
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| NCT ID: |
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NCT00800982 |
| Primary Contact: |
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Principal Investigator
John Koo, MD
UCSF Psoriasis and Skin Treatment Center, Department of Dermatology, University of California, San F
John Koo, MD
Phone: 415-476-4701
Email: john.koo@ucsfmedctr.org
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| Backup Contact: |
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Email: chiangc@derm.ucsf.edu
Charles Chiang, MD
Phone: 415-476-4701
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| Location Contact: |
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San Francisco, California 94118
United States
John Koo, MD
Phone: 415-476-4701
Email: john.koo@ucsfmedctr.org
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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June 19, 2013 |
| Modifications to this listing: |
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