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

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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:
Information provided by (Responsible Party):
University of California, San Francisco

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Psoriasis
Interventions Procedure: Narrow band (310-312 nm) ultraviolet light B phototherapy
Drug: etanercept
Enrollment 30

Recruitment Details Dates of recruitment were July 2010 through June 2011. Recruitment was performed at the dermatologic medical clinic.
Pre-assignment Details 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.
Arm/Group Title 1 (Etanercept Only) 2 (Etanercept + Nb-UVB)
Hide Arm/Group Description 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.

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.

Period Title: Overall Study
Started 15 15
Completed 13 12
Not Completed 2 3
Reason Not Completed
Lost to Follow-up             1             2
Withdrawal by Subject             0             1
Patient moved out of state             1             0
Arm/Group Title 1 (Etanercept Only) 2 (Etanercept + Nb-UVB) Total
Hide Arm/Group Description 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.

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 of all reporting groups
Overall Number of Baseline Participants 15 15 30
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 15 participants 30 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
15
 100.0%
15
 100.0%
30
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 15 participants 15 participants 30 participants
44.7  (1.8) 43.8  (2.1) 44.2  (1.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 15 participants 30 participants
Female
3
  20.0%
2
  13.3%
5
  16.7%
Male
12
  80.0%
13
  86.7%
25
  83.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 15 participants 15 participants 30 participants
15 15 30
1.Primary Outcome
Title 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.
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All patients that completed the trial through week 24 were used for analysis.
Arm/Group Title 1 (Etanercept Only) 2 (Etanercept + Nb-UVB)
Hide Arm/Group Description:
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.

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.

Overall Number of Participants Analyzed 13 12
Measure Type: Number
Unit of Measure: participants
6 6
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 1 (Etanercept Only) 2 (Etanercept + Nb-UVB)
Hide Arm/Group Description 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.

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.

All-Cause Mortality
1 (Etanercept Only) 2 (Etanercept + Nb-UVB)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
1 (Etanercept Only) 2 (Etanercept + Nb-UVB)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/15 (0.00%)   0/15 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
1 (Etanercept Only) 2 (Etanercept + Nb-UVB)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/15 (0.00%)   0/15 (0.00%) 
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.
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
Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00800982     History of Changes
Other Study ID Numbers: KOO - ENBREL-2008
H5939-31693-01 ( Other Identifier: UCSF Committee for Human Research )
First Submitted: May 13, 2008
First Posted: December 3, 2008
Results First Submitted: February 19, 2013
Results First Posted: May 7, 2013
Last Update Posted: May 7, 2013