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

• ClinicalTrials.gov Identifier: NCT00800982
• Recruitment Status: Completed
• First Posted: December 3, 2008
• Results First Posted: May 7, 2013
• Last Update Posted: May 7, 2013
• Sponsor: University of California, San Francisco
• Information provided by (Responsible Party): University of California, San Francisco

Tracking Information

• First Submitted Date: May 13, 2008
• First Posted Date: December 3, 2008
• Results First Submitted Date: February 19, 2013
• Results First Posted Date: May 7, 2013
• Last Update Posted Date: May 7, 2013
• Study Start Date: October 2008
• Actual Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 26, 2013)

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. [ Time Frame: Weeks 12-24 ]

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.

• Original Primary Outcome Measures (submitted: December 2, 2008): To evaluate, after 12 weeks on the etanercept induction dose (50 mg twice a week), the effectiveness of NB-UVB phototherapy in enhancing the efficacy of etanercept's maintenance dose (50 mg once a week) in the treatment of obese patients. [ Time Frame: Weeks 12-24 ]
• Change History: Complete list of historical versions of study NCT00800982 on ClinicalTrials.gov Archive Site
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures (submitted: December 2, 2008): Prevention of "step down" deterioration following the initiation of the maintenance dose [ Time Frame: Weeks 12-24 ]
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Open Label Study Etanercept's Maintenance Dose in Obese Patients With Moderate to Severe Plaque Type Psoriasis
• Official Title: 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
• 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.
• 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.
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Psoriasis

Intervention

• Procedure: Narrow 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
  Other Names:

  • nb-UVB
  • nbUVB
  • narrowband UVB
• Drug: etanercept
  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.
  Other Name: Enbrel

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.
  Intervention: 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.

  Interventions:

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

• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: December 2, 2008): 30
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: March 2012
• Actual Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)

Eligibility Criteria

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:

• 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).

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00800982
• Other Study ID Numbers: KOO - ENBREL-2008; H5939-31693-01 ( Other Identifier: UCSF Committee for Human Research )
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: University of California, San Francisco
• Study Sponsor: University of California, San Francisco
• Collaborators: Not Provided

Investigators

• Principal Investigator: John Koo, MD; UCSF Psoriasis and Skin Treatment Center, Department of Dermatology, University of California, San Francisco

• PRS Account: University of California, San Francisco
• Verification Date: March 2013