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Use of Etanercept in the Treatment of Moderate to Severe Lichen Planus

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ClinicalTrials.gov Identifier: NCT00285779
Recruitment Status : Terminated (Slow recruitment)
First Posted : February 2, 2006
Results First Posted : March 3, 2015
Last Update Posted : March 21, 2018
Sponsor:
Collaborators:
Wright State University
Tufts Medical Center
University of Louisville
Wake Forest University Health Sciences
University of Michigan
Emory University
University Hospitals Cleveland Medical Center
Icahn School of Medicine at Mount Sinai
Oregon Health and Science University
The Cleveland Clinic
Fivenson, David, M.D.
Information provided by (Responsible Party):
David Fiorentino, Stanford University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Lichen Planus
Interventions Drug: Etanercept
Drug: Placebo
Enrollment 27

Recruitment Details This is a randomized, multi-center interventional trial in which patients were recruited at 11 sites in the United States (10 academic and one private practice). Enrollment was between June, 2006 and December, 2008. The first subject was enrolled in August, 2006 and the last patient was enrolled in November, 2008.
Pre-assignment Details  
Arm/Group Title Placebo Injection Etanercept
Hide Arm/Group Description Placebo: Normal saline twice weekly for 12 weeks Etanercept: etanercept 50 mg twice weekly for 12 weeks
Period Title: Placebo-controlled Period (wk 1-12)
Started 14 13
Completed 11 12
Not Completed 3 1
Period Title: Open Label Period (wk 12-24)
Started 11 12
Completed 9 10
Not Completed 2 2
Period Title: Follow-up Period (wk 24-32)
Started 9 10
Completed 8 10
Not Completed 1 0
Arm/Group Title Placebo Injection Etanercept Total
Hide Arm/Group Description Placebo: Normal saline twice weekly for 12 weeks Etanercept: etanercept 50 mg twice weekly for 12 weeks Total of all reporting groups
Overall Number of Baseline Participants 14 13 27
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 14 participants 13 participants 27 participants
50.4  (16.9) 57.4  (16.0) 53.7  (16.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 13 participants 27 participants
Female
8
  57.1%
8
  61.5%
16
  59.3%
Male
6
  42.9%
5
  38.5%
11
  40.7%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 13 participants 27 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
3
  21.4%
3
  23.1%
6
  22.2%
White
11
  78.6%
10
  76.9%
21
  77.8%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title The Percentage of Patients Achieving a Response in Mucosal Disease (or Cutaneous Disease if no Mucosal Disease) at 12 Weeks
Hide Description Physician global assessment of disease scores: 0=clear; 1=minimal disease; 2=mild disease; 3=moderate disease; 4=severe disease. Subjects had a level >=3 at baseline. To be considered a responder, the subject must achieve a level of 0 or 1, or, at least a 2 point improvement in the scale.
Time Frame 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intention to treat analysis (all participants received at least one dose of study drug). Missing data imputed using Last Observation Carried Forward (LOCF).
Arm/Group Title Placebo Injection Etanercept
Hide Arm/Group Description:
Placebo: Normal saline twice weekly for 12 weeks
Etanercept: etanercept 50 mg twice weekly for 12 weeks
Overall Number of Participants Analyzed 14 13
Measure Type: Number
Unit of Measure: percentage of participants
28.6 0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Injection, Etanercept
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0978
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
2.Secondary Outcome
Title Count of Patients Achieving a Response in Cutaneous or Mucosal Disease at 24 Weeks
Hide Description Physician global assessment of disease scores: 0=clear; 1=minimal disease; 2=mild disease; 3=moderate disease; 4=severe disease. Subjects had a level >=3 at baseline. To be considered a responder, the subject must achieve a level of 0 or 1, or, at least a 2 point improvement in the scale.
Time Frame Baseline; Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Injection Etanercept
Hide Arm/Group Description:
Placebo: Normal saline twice weekly for 12 weeks
Etanercept: etanercept 50 mg twice weekly for 12 weeks
Overall Number of Participants Analyzed 14 13
Measure Type: Count of Participants
Unit of Measure: Participants
5
  35.7%
4
  30.8%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Injection, Etanercept
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.9999
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
3.Secondary Outcome
Title The Physician Assessment of Surface Area of Disease (PSAD) for Oral Disease at 12 and 24 Weeks
Hide Description The percentage of surface area involved with disease is reported as assessed by the physician using a Likert scale. Assessment scores range from 0-5, with lower scores corresponding lower percentage of surface area with disease. 0=clear, 1=<2%, 2=2-9%, 3=10-29%, 4=30-50%, 5=>50%.
Time Frame Baseline; Week 12; Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants with missing data were excluded from the analysis.
Arm/Group Title Placebo Injection Etanercept
Hide Arm/Group Description:
Placebo: Normal saline twice weekly for 12 weeks
Etanercept: etanercept 50 mg twice weekly for 12 weeks
Overall Number of Participants Analyzed 14 13
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline Number Analyzed 13 participants 13 participants
1.2  (1.31) 1.6  (1.73)
Week 12 Number Analyzed 11 participants 12 participants
0.8  (1.03) 1.5  (1.44)
Week 24 Number Analyzed 9 participants 10 participants
1.1  (1.10) 1.5  (1.20)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Injection
Comments Week 12 versus baseline
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.031
Comments [Not Specified]
Method Wilcoxon Paired
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Etanercept
Comments Week 12 versus baseline
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.34
Comments [Not Specified]
Method Wilcoxon Paired
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo Injection
Comments Week 24 versus baseline
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.13
Comments [Not Specified]
Method Wilcoxon Paired
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Etanercept
Comments Week 24 versus baseline
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.22
Comments [Not Specified]
Method Wilcoxon Paired
Comments [Not Specified]
4.Secondary Outcome
Title The Physician Assessment of Surface Area of Disease (PSAD) for Genital Disease at 12 and 24 Weeks
Hide Description The percentage of surface area involved with disease is reported as assessed by the physician using a Likert scale. Assessment scores range from 0-5, with lower scores corresponding lower percentage of surface area with disease. 0=clear, 1=<2%, 2=2-9%, 3=10-29%, 4=30-50%, 5=>50%.
Time Frame Baseline; Week 12; Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants with missing data were excluded from the analysis.
Arm/Group Title Placebo Injection Etanercept
Hide Arm/Group Description:
Placebo: Normal saline twice weekly for 12 weeks
Etanercept: etanercept 50 mg twice weekly for 12 weeks
Overall Number of Participants Analyzed 14 13
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline Number Analyzed 13 participants 13 participants
0.3  (0.82) 0.4  (1.33)
Week 12 Number Analyzed 12 participants 12 participants
0.5  (0.96) 0.4  (1.38)
Week 24 Number Analyzed 9 participants 10 participants
0.7  (1.05) 0.5  (1.50)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Injection
Comments Week 12 versus baseline
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.9999
Comments [Not Specified]
Method Wilcoxon Paired
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo Injection
Comments Week 24 versus baseline
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.9999
Comments [Not Specified]
Method Wilcoxon Paired
Comments [Not Specified]
5.Secondary Outcome
Title The Physician Assessment of Surface Area of Disease (PSAD) for Skin Disease at 12 and 24 Weeks
Hide Description The percentage of surface area involved with disease is reported as assessed by the physician using a Likert scale. Assessment scores range from 0-5, with lower scores corresponding lower percentage of surface area with disease. 0=clear, 1=<2%, 2=2-9%, 3=10-29%, 4=30-50%, 5=>50%.
Time Frame Baseline; Week 12; Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants with missing data were excluded from the analysis.
Arm/Group Title Placebo Injection Etanercept
Hide Arm/Group Description:
Placebo: Normal saline twice weekly for 12 weeks
Etanercept: etanercept 50 mg twice weekly for 12 weeks
Overall Number of Participants Analyzed 14 13
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline Number Analyzed 13 participants 13 participants
2.8  (1.56) 1.8  (1.61)
Week 12 Number Analyzed 12 participants 12 participants
2.2  (1.77) 1.7  (1.43)
Week 24 Number Analyzed 9 participants 10 participants
1.0  (0.94) 1.6  (1.36)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Injection
Comments Week 12 versus baseline
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.25
Comments [Not Specified]
Method Wilcoxon Paired
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Etanercept
Comments Week 12 versus baseline
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.9999
Comments [Not Specified]
Method Wilcoxon Paired
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo Injection
Comments Week 24 versus baseline
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.063
Comments [Not Specified]
Method Wilcoxon Paired
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Etanercept
Comments Week 24 versus baseline
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.9999
Comments [Not Specified]
Method Wilcoxon Paired
Comments [Not Specified]
6.Secondary Outcome
Title Cutaneous Target Lesion Scores - Erythema, at 12 and 24 Weeks
Hide Description This is an investigator-based assessment of a single preselected target skin lesion. Assessment scores range from 0-3 on a Likert scale, with higher scores meaning worse erythema. 0=clear, 1=mild/pink, 2=moderately red, 3=severely red/violaceous.
Time Frame Week 12; Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants with missing data were excluded from the analysis
Arm/Group Title Placebo Injection Etanercept
Hide Arm/Group Description:
Placebo: Normal saline twice weekly for 12 weeks
Etanercept: etanercept 50 mg twice weekly for 12 weeks
Overall Number of Participants Analyzed 14 13
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline Number Analyzed 12 participants 9 participants
2.5  (0.76) 2.3  (0.67)
Week 12 Number Analyzed 11 participants 8 participants
1.6  (1.30) 1.8  (0.83)
Week 24 Number Analyzed 8 participants 8 participants
0.9  (1.05) 1.8  (0.97)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Injection
Comments Week 12 versus baseline
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.063
Comments [Not Specified]
Method Wilcoxon Paired
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Etanercept
Comments Week 12 versus baseline
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.25
Comments [Not Specified]
Method Wilcoxon Paired
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo Injection
Comments Week 24 versus baseline
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.031
Comments [Not Specified]
Method Wilcoxon Paired
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Etanercept
Comments Week 24 versus baseline
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.32
Comments [Not Specified]
Method Wilcoxon Paired
Comments [Not Specified]
7.Secondary Outcome
Title Cutaneous Target Lesion Scores - Elevation, at 12 and 24 Weeks
Hide Description This is an investigator-based assessment of a single preselected target skin lesion. Assessment scores range from 0-3 on a Likert scale, with higher scores meaning worse elevation. 0=flat, 1=barely palpable (<0.5 mm), 2=moderate (0.5 mm-1 mm), 3=severe (>1 mm).
Time Frame Week 12; Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants with missing data were excluded from the analysis
Arm/Group Title Placebo Injection Etanercept
Hide Arm/Group Description:
Placebo: Normal saline twice weekly for 12 weeks
Etanercept: etanercept 50 mg twice weekly for 12 weeks
Overall Number of Participants Analyzed 14 13
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline Number Analyzed 12 participants 9 participants
2.1  (0.64) 2.1  (0.87)
Week 12 Number Analyzed 11 participants 8 participants
1.5  (1.16) 1.6  (0.70)
Week 24 Number Analyzed 8 participants 8 participants
1.0  (1.22) 0.8  (0.83)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Injection
Comments Week 12 versus baseline
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.094
Comments [Not Specified]
Method Wilcoxon Paired
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Etanercept
Comments Week 12 versus baseline
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.25
Comments [Not Specified]
Method Wilcoxon Paired
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo Injection
Comments Week 24 versus baseline
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.13
Comments [Not Specified]
Method Wilcoxon Paired
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Etanercept
Comments Week 24 versus baseline
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.13
Comments [Not Specified]
Method Wilcoxon Paired
Comments [Not Specified]
8.Secondary Outcome
Title Cutaneous Target Lesion Scores - Scale, at 12 and 24 Weeks
Hide Description This is an investigator-based assessment of a single preselected target skin lesion. Assessment scores range from 0-3 on a Likert scale, with higher scores meaning worse scaling. 0=none, 1=fine/dusty scale, 2=moderate scale, 3=thick/tenacious scale.
Time Frame Week 12; Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants with missing data were excluded from the analysis
Arm/Group Title Placebo Injection Etanercept
Hide Arm/Group Description:
Placebo: Normal saline twice weekly for 12 weeks
Etanercept: etanercept 50 mg twice weekly for 12 weeks
Overall Number of Participants Analyzed 14 13
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline Number Analyzed 12 participants 9 participants
0.9  (0.76) 1.2  (0.79)
Week 12 Number Analyzed 11 participants 8 participants
0.8  (0.72) 0.8  (0.66)
Week 24 Number Analyzed 8 participants 8 participants
0.4  (0.99) 0.8  (0.83)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Injection
Comments Week 12 versus baseline
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.63
Comments [Not Specified]
Method Wilcoxon Paired
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Etanercept
Comments Week 12 versus baseline
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.38
Comments [Not Specified]
Method Wilcoxon Paired
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo Injection
Comments Week 24 versus baseline
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.38
Comments [Not Specified]
Method Wilcoxon Paired
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Etanercept
Comments Week 24 versus baseline
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.50
Comments [Not Specified]
Method Wilcoxon Paired
Comments [Not Specified]
9.Secondary Outcome
Title Cutaneous Target Lesion Scores - Total, at 12 and 24 Weeks
Hide Description This score sums all of the 3 elements of the target lesion score (erythema, elevation, scale) described in Outcome Measures 6-8. Assessment scores range from 0-9 on a Likert scale, with higher numbers meaning more severe disease in the target skin lesion.
Time Frame Week 12; Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants with missing data were excluded from the analysis
Arm/Group Title Placebo Injection Etanercept
Hide Arm/Group Description:
Placebo: Normal saline twice weekly for 12 weeks
Etanercept: etanercept 50 mg twice weekly for 12 weeks
Overall Number of Participants Analyzed 14 13
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline Number Analyzed 12 participants 9 participants
4.7  (2.55) 3.9  (3.02)
Week 12 Number Analyzed 11 participants 8 participants
3.1  (3.10) 2.5  (2.50)
Week 24 Number Analyzed 8 participants 8 participants
1.3  (2.52) 2.4  (2.59)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Injection
Comments Week 12 versus baseline
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.031
Comments [Not Specified]
Method Wilcoxon Paired
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Etanercept
Comments Week 12 versus baseline
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.094
Comments [Not Specified]
Method Wilcoxon Paired
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo Injection
Comments Week 24 versus baseline
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.039
Comments [Not Specified]
Method Wilcoxon Paired
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Etanercept
Comments Week 24 versus baseline
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.19
Comments [Not Specified]
Method Wilcoxon Paired
Comments [Not Specified]
10.Secondary Outcome
Title Patient Assessment of Pain on a Visual Analogue Scale (VAS) at 12 and 24 Weeks
Hide Description Participants were asked to indicate their pain level by marking it on a 10 cm linear VAS scale. The number of centimeters from the left end of the line to the mark was measured in cm. Total range was 0-10. Lower scores correspond to less pain, higher scores correspond to more pain.
Time Frame Baseline; Week 12; Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants with missing data were excluded from the analysis.
Arm/Group Title Placebo Injection Etanercept
Hide Arm/Group Description:
Placebo: Normal saline twice weekly for 12 weeks
Etanercept: etanercept 50 mg twice weekly for 12 weeks
Overall Number of Participants Analyzed 14 13
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline Number Analyzed 13 participants 13 participants
3.8  (3.08) 3.4  (2.50)
Week 12 Number Analyzed 12 participants 13 participants
3.4  (3.08) 3.0  (2.85)
Week 24 Number Analyzed 9 participants 11 participants
2.4  (2.83) 2.8  (3.25)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Injection
Comments Week 12 versus baseline
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.26
Comments [Not Specified]
Method Paired t test
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Etanercept
Comments Week 12 versus baseline
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.55
Comments [Not Specified]
Method Paired t test
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo Injection
Comments Week 24 versus baseline
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.18
Comments [Not Specified]
Method Paired t test
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Etanercept
Comments Week 24 versus baseline
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.13
Comments [Not Specified]
Method Paired t test
Comments [Not Specified]
11.Secondary Outcome
Title Patient Assessment of Pruritus (Itching) on a Visual Analogue Scale (VAS) at 12 and 24 Weeks
Hide Description Participants were asked to indicate their itching level by marking it on a 10 cm linear VAS scale. The number of centimeters from the left end of the line to the mark was measured in cm. Total range was 0-10. Lower scores correspond to less itching, higher scores correspond to more itching.
Time Frame Baseline; Week 12; Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants with missing data were excluded from the analysis.
Arm/Group Title Placebo Injection Etanercept
Hide Arm/Group Description:
Placebo: Normal saline twice weekly for 12 weeks
Etanercept: etanercept 50 mg twice weekly for 12 weeks
Overall Number of Participants Analyzed 14 13
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline Number Analyzed 13 participants 13 participants
3.8  (2.84) 3.2  (2.55)
Week 12 Number Analyzed 12 participants 13 participants
3.3  (3.38) 3.4  (3.14)
Week 24 Number Analyzed 9 participants 11 participants
1.5  (1.64) 3.0  (2.71)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Injection
Comments Week 12 versus baseline
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.51
Comments [Not Specified]
Method Paired t test
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Etanercept
Comments Week 24 versus baseline
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.47
Comments [Not Specified]
Method Paired t test
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo Injection
Comments Week 24 versus baseline
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.087
Comments [Not Specified]
Method Paired t test
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Etanercept
Comments Week 24 versus baseline
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.86
Comments [Not Specified]
Method Paired t test
Comments [Not Specified]
12.Secondary Outcome
Title Patient Assessment of Overall Disease Severity (Patient Global Assessment) at 12 and 24 Weeks
Hide Description Participants were asked to indicate their rate their overall assessment of disease severity compared to where it was at their baseline visit. The scale ranges from 0-5, with lower scores correspond to more disease improvement. 0=clear/no disease, 1=much improved (>75% improved), 2=improved (25-75%), 3=minimally improved (<25%), 4=no change, 5=worsened disease.
Time Frame Baseline; Week 12; Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants with missing data were excluded from the analysis.
Arm/Group Title Placebo Injection Etanercept
Hide Arm/Group Description:
Placebo: Normal saline twice weekly for 12 weeks
Etanercept: etanercept 50 mg twice weekly for 12 weeks
Overall Number of Participants Analyzed 14 13
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline Number Analyzed 9 participants 10 participants
3.9  (0.87) 4.1  (0.54)
Week 12 Number Analyzed 8 participants 10 participants
2.3  (1.56) 3.1  (1.23)
Week 24 Number Analyzed 7 participants 10 participants
2.9  (1.46) 2.6  (1.43)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Injection
Comments Week 12 versus baseline
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.033
Comments [Not Specified]
Method Paired t test
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Etanercept
Comments Week 12 versus baseline
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.069
Comments [Not Specified]
Method Paired t test
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo Injection
Comments Week 24 versus baseline
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.015
Comments [Not Specified]
Method Paired t test
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Etanercept
Comments Week 24 versus baseline
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.026
Comments [Not Specified]
Method Paired t test
Comments [Not Specified]
13.Secondary Outcome
Title The Count of Subjects Experiencing Serious Adverse Events (SAEs) by Week 12 and Week 24
Hide Description A serious adverse event was defined as any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect.
Time Frame Baseline; Week 12; Week 24
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Injection Etanercept
Hide Arm/Group Description:
Placebo: Normal saline twice weekly for 12 weeks
Etanercept: etanercept 50 mg twice weekly for 12 weeks
Overall Number of Participants Analyzed 14 13
Measure Type: Count of Participants
Unit of Measure: Participants
SAE by week 12
0
   0.0%
0
   0.0%
SAE by week 24
0
   0.0%
1
   7.7%
14.Secondary Outcome
Title The Count of Placebo Patients Who do Not Have a Complete Response (Defined as a Physician Global Assessment of "Clear") at 12 Weeks
Hide Description A complete response is defined as a score of 0 (representing “no disease”) on the Physician Global Assessment. Physician global assessment of disease scores: 0=clear; 1=minimal disease; 2=mild disease; 3=moderate disease; 4=severe disease. This endpoint is the number of patients on placebo that had any score other than 0 on this measure.
Time Frame 12 weeks
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Hide Analysis Population Description
Only participants in the Placebo injection group were evaluated for this outcome measure.
Arm/Group Title Placebo Injection
Hide Arm/Group Description:
Placebo: Normal saline twice weekly for 12 weeks
Overall Number of Participants Analyzed 14
Measure Type: Count of Participants
Unit of Measure: Participants
13
  92.9%
15.Secondary Outcome
Title The Percentage of Placebo and Study-drug Patients Able to Discontinue Use of Topical Corticosteroids Through Week 24
Hide Description [Not Specified]
Time Frame 24 weeks
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Hide Analysis Population Description
Data were not collected for this outcome measure
Arm/Group Title Placebo Injection Etanercept
Hide Arm/Group Description:
Placebo: Normal saline twice weekly for 12 weeks
Etanercept: etanercept 50 mg twice weekly for 12 weeks
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame This includes the entire 32 week timeframe of the trial. Thus, the placebo patients that cross over to etanercept from 12-24 weeks are also considered in the etanercept group during the 12-24 week timeframe. Also includes followup from 24-32 weeks.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Injection Etanercept
Hide Arm/Group Description Placebo: Normal saline twice weekly for 12 weeks Etanercept: etanercept 50 mg twice weekly for 12 weeks
All-Cause Mortality
Placebo Injection Etanercept
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Injection Etanercept
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/14 (0.00%)      1/24 (4.17%)    
Respiratory, thoracic and mediastinal disorders     
Pneumonia  [1]  0/14 (0.00%)  0 1/24 (4.17%)  1
Indicates events were collected by systematic assessment
[1]
Patient hospitalized for 3 days with chest congestion and fever and later found to have pneumonia.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Placebo Injection Etanercept
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/14 (28.57%)      14/24 (58.33%)    
Gastrointestinal disorders     
Oral pain with eating   1/14 (7.14%)  1 0/24 (0.00%)  0
sore throat   0/14 (0.00%)  0 2/24 (8.33%)  2
Stomach cramps   0/14 (0.00%)  0 1/24 (4.17%)  1
Nausea   0/14 (0.00%)  0 1/24 (4.17%)  2
Dysphagia   0/14 (0.00%)  0 1/24 (4.17%)  1
constipation   0/14 (0.00%)  0 2/24 (8.33%)  2
gastric reflux   0/14 (0.00%)  0 1/24 (4.17%)  1
abdominal pain   0/14 (0.00%)  0 1/24 (4.17%)  1
General disorders     
fever   0/14 (0.00%)  0 1/24 (4.17%)  1
Immune system disorders     
Allergies   0/14 (0.00%)  0 3/24 (12.50%)  3
Infections and infestations     
Vaginal yeast infection   1/14 (7.14%)  1 2/24 (8.33%)  2
Urinary tract infection   0/14 (0.00%)  0 1/24 (4.17%)  1
Bacterial vaginosis   0/14 (0.00%)  0 1/24 (4.17%)  1
Upper respiratory tract infection   2/14 (14.29%)  2 2/24 (8.33%)  2
otitis media   0/14 (0.00%)  0 1/24 (4.17%)  1
oral candidiasis   1/14 (7.14%)  1 0/24 (0.00%)  0
Influenza   0/14 (0.00%)  0 1/24 (4.17%)  1
Pneumonia   1/14 (7.14%)  1 0/24 (0.00%)  0
Bronchitis   0/14 (0.00%)  0 1/24 (4.17%)  1
Injury, poisoning and procedural complications     
Food poisoning   1/14 (7.14%)  1 0/24 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Gout flare   1/14 (7.14%)  1 0/24 (0.00%)  0
worsening diffuse joint pains   0/14 (0.00%)  0 2/24 (8.33%)  3
Knee arthritis   0/14 (0.00%)  0 1/24 (4.17%)  1
Ankle and finger swelling   0/14 (0.00%)  0 1/24 (4.17%)  1
increased back pain   0/14 (0.00%)  0 1/24 (4.17%)  1
Nervous system disorders     
Lightheadedness   0/14 (0.00%)  0 1/24 (4.17%)  1
Headache   0/14 (0.00%)  0 2/24 (8.33%)  2
Vertigo   0/14 (0.00%)  0 1/24 (4.17%)  1
Renal and urinary disorders     
Bladder spasms   0/14 (0.00%)  0 1/24 (4.17%)  1
Elevated creatinine   0/14 (0.00%)  0 1/24 (4.17%)  1
Respiratory, thoracic and mediastinal disorders     
cough   0/14 (0.00%)  0 1/24 (4.17%)  1
Chest congestion   0/14 (0.00%)  0 2/24 (8.33%)  2
Shortness of breath   0/14 (0.00%)  0 1/24 (4.17%)  1
Skin and subcutaneous tissue disorders     
Erythema at injection site   1/14 (7.14%)  1 1/24 (4.17%)  1
Bruising at injection site   1/14 (7.14%)  1 3/24 (12.50%)  3
pruritis, generalized   0/14 (0.00%)  0 1/24 (4.17%)  1
Surgical and medical procedures     
Cataract surgery   0/14 (0.00%)  0 2/24 (8.33%)  2
Knee surgery   0/14 (0.00%)  0 1/24 (4.17%)  1
Vascular disorders     
facial flushing   0/14 (0.00%)  0 1/24 (4.17%)  1
Indicates events were collected by systematic assessment
Trial was terminated early due to low recruitment rates.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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: David Fiorentino
Organization: Stanford University Department of Dermatology
Phone: 650-723-6316
Responsible Party: David Fiorentino, Stanford University
ClinicalTrials.gov Identifier: NCT00285779     History of Changes
Obsolete Identifiers: NCT00568581, NCT00691106
Other Study ID Numbers: 20041132
First Submitted: January 31, 2006
First Posted: February 2, 2006
Results First Submitted: January 28, 2015
Results First Posted: March 3, 2015
Last Update Posted: March 21, 2018