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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00800982
First received: May 13, 2008
Last updated: March 26, 2013
Last verified: March 2013
Results First Received: February 19, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Psoriasis
Interventions: Procedure: Narrow band (310-312 nm) ultraviolet light B phototherapy
Drug: etanercept

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Dates of recruitment were July 2010 through June 2011. Recruitment was performed at the dermatologic medical clinic.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The following treatments for psoriasis required wash-out before group assignment: any type of ultraviolet B phototherapy or topical therapy for 14 days; psoralen and ultraviolet A or any oral or systemic psoriasis treatment for 28 days; alefacept or ustekinumab for 12 weeks, Tumor Necrosis Factor-a inhibitor or monoclonal antibody for 4 weeks.

Reporting Groups
  Description
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 Ultraviolet B will be given. Sham Ultraviolet B will not be used because the subjects are not blinded because they often know they are receiving sham Ultraviolet B due to differences in light intensity and heat.
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. Narrow Band Ultraviolet B therapy will be adjusted according to the clinical judgment of the University of California San Francisco Psoriasis Treatment Center phototherapy staff.


Participant Flow:   Overall Study
    1 (Etanercept Only)     2 (Etanercept + Nb-UVB)  
STARTED     15     15  
COMPLETED     13     12  
NOT COMPLETED     2     3  
Lost to Follow-up                 1                 2  
Withdrawal by Subject                 0                 1  
Patient moved out of state                 1                 0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.
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 NB-UVB 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 UCSF Psoriasis Treatment Center phototherapy staff.

Total Total of all reporting groups

Baseline Measures
    1 (Etanercept Only)     2 (Etanercept + Nb-UVB)     Total  
Number of Participants  
[units: participants]
  15     15     30  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     15     15     30  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  44.7  ± 1.8     43.8  ± 2.1     44.2  ± 1.9  
Gender  
[units: participants]
     
Female     3     2     5  
Male     12     13     25  
Region of Enrollment  
[units: participants]
     
United States     15     15     30  



  Outcome Measures

1.  Primary:   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 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr Ethan Levin
Organization: University of California San Francisco
phone: 4154764019
e-mail: levine@derm.ucsf.edu


Publications of Results:

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00800982     History of Changes
Other Study ID Numbers: KOO - ENBREL-2008, H5939-31693-01
Study First Received: May 13, 2008
Results First Received: February 19, 2013
Last Updated: March 26, 2013
Health Authority: United States: Food and Drug Administration