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CompletedNCT00800982Updated May 7, 2013Results posted

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

An interventional study of Narrow band (310-312 nm) ultraviolet light B phototherapy and etanercept in Psoriasis, sponsored by University of California, San Francisco. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-05-07.

Sponsored by University of California, San Francisco · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

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.

02

Conditions studied

  • Psoriasis

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Keywords

  • Obese patients (BMI>30)
  • Patients with moderate to severe psoriasis
03

In context

Psoriasis

1,899 studies on the registry are indexed under Psoriasis; 233 are open to participants now.

This study's enrollment of 30 is below the median of 70 across 1,447 interventional studies indexed under Psoriasis.

Browse Psoriasis studies →

Lead sponsor

University of California, San Francisco is the lead sponsor of 2,132 studies on the registry; 375 are open to participants now.

Of its 262 completed or terminated interventional studies of FDA-regulated products, 196 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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 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

Exclusion criteria

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 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
  • 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).
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
30 participants (actual)

Study arms

  • Active comparator
    1 (Etanercept only)

    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

  • Experimental
    2 (Etanercept + nb-UVB)

    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

  • ProcedureNarrow band (310-312 nm) ultraviolet light B phototherapy

    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

  • Drugetanercept

    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

06

What researchers measure

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.

    Time frame: Weeks 12-24

07

Results

Posted May 7, 2013
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.

Participant flow

Dates of recruitment were July 2010 through June 2011. Recruitment was performed at the dermatologic medical clinic.

Participant flow — Overall Study
Milestone1 (Etanercept Only)2 (Etanercept + Nb-UVB)
Started1515
Completed1312
Not completed23
Withdrew: Lost to follow-up12
Withdrew: Withdrawal by subject01
Withdrew: Patient moved out of state10

Outcome measures

PrimaryPsoriasis 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.

Time frame:
Weeks 12-24
Reported as:
Number · participants
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.
participants1 (Etanercept Only)2 (Etanercept + Nb-UVB)
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.66

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
1 (Etanercept Only)—0/15 (0%)0/15 (0%)
2 (Etanercept + Nb-UVB)—0/15 (0%)0/15 (0%)

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)1 (Etanercept Only)2 (Etanercept + Nb-UVB)Total
<=18 years000
Between 18 and 65 years151530
>=65 years000
Age Continuous
Age Continuous(years)1 (Etanercept Only)2 (Etanercept + Nb-UVB)Total
Mean44.7 ± 1.843.8 ± 2.144.2 ± 1.9
Sex: Female, Male
Sex: Female, Male(Participants)1 (Etanercept Only)2 (Etanercept + Nb-UVB)Total
Female325
Male121325
Region of Enrollment
Region of Enrollment(participants)1 (Etanercept Only)2 (Etanercept + Nb-UVB)Total
United States151530
08

Study locations

1 site
  • UCSF Psoriasis and Skin Treatment Center
    San Francisco, California 94118, United States
09

References and documents

Publications

  • 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. PubMed 22702846 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 7, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00800982
Lead sponsor
University of California, San Francisco
Responsible party
Sponsor
First posted
Dec 3, 2008
Start date
Oct 2008
Primary completion
Jan 2012
Completion
Mar 2012
Results posted
May 7, 2013
Last update
May 7, 2013

Study contacts

John Koo, MD
principal investigator · UCSF Psoriasis and Skin Treatment Center, Department of Dermatology, University of California, San Francisco

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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