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Evaluation of Etanercept in Patients With Plaque Psoriasis After Stopping Ciclosporin Therapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00581555
Recruitment Status : Completed
First Posted : December 27, 2007
Results First Posted : April 23, 2012
Last Update Posted : April 23, 2012
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Psoriasis
Interventions Drug: Etanercept
Other: Placebo
Enrollment 120
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo Etanercept
Hide Arm/Group Description Participants were administered placebo subcutaneously once a week after an initial course of ciclosporin. Participants were administered a 50 mg dose of etanercept subcutaneously once a week after an initial course of ciclosporin.
Period Title: Overall Study
Started 62 58
Completed 19 38
Not Completed 43 20
Reason Not Completed
Adverse Event             4             3
Physician Decision             3             2
Withdrawal by Subject             18             9
Lost to Follow-up             2             2
Other reasons             16             4
Arm/Group Title Placebo Etanercept Total
Hide Arm/Group Description Participants were administered placebo subcutaneously once a week after an initial course of ciclosporin. Participants were administered a 50 mg dose of etanercept subcutaneously once a week after an initial course of ciclosporin. Total of all reporting groups
Overall Number of Baseline Participants 62 58 120
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 62 participants 58 participants 120 participants
41.50  (12.97) 41.78  (9.86) 41.63  (11.52)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 62 participants 58 participants 120 participants
Female
17
  27.4%
20
  34.5%
37
  30.8%
Male
45
  72.6%
38
  65.5%
83
  69.2%
PASI score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on scale
Number Analyzed 62 participants 58 participants 120 participants
19.35  (6.98) 20.19  (7.76) 19.74  (7.26)
[1]
Measure Description: Psoriasis Area and Severity Index (PASI) score: range: 0 (none) to 72 (maximum). Body was divided into head, upper extremities, trunk and lower extremities; each area score was combined for final PASI. For each section, percent area of skin involved was estimated: 0 (0%) to 6 (90 - 100%), and severity was estimated by clinical signs: (erythema, induration, and desquamation); scale: 0 (none) to 4 (maximum). Final PASI= sum of severity parameters for each section times area score times weight of section (head: 0.1, upper extremities: 0.2, trunk: 0.3, lower extremities: 0.4).
PGA   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on scale
Number Analyzed 62 participants 58 participants 120 participants
4.07  (0.73) 4.25  (0.85) 4.15  (0.78)
[1]
Measure Description: Physician Global Assessment (PGA) score is based on dermatologist's assessment of disease averaged over all lesions. Overall lesions were graded for individual scores of induration, erythema, and scaling; range: 0 (no evidence) to 5 (severe). The sum of the 3 scores was divided by 3 to obtain a final PGA score. Higher scores indicate greater severity of disease.
DLQI score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on scale
Number Analyzed 62 participants 58 participants 120 participants
11.26  (6.30) 11.20  (7.22) 11.23  (6.72)
[1]
Measure Description: Dermatology Life Quality Index (DLQI) is the dermatology-specific quality of life measure used for psoriatic population. The 10 item questionnaire has a score range of 0 to 30 with higher scores indicating poor quality of life. An estimate of the minimal clinically important difference of the DLQI total score is a 5 point improvement. Total score range: 0 (best) to 30 (worst).
1.Primary Outcome
Title Change From Randomization in PASI Score to Week 24 (Week 18 of Etanercept Monotherapy/Placebo)
Hide Description PASI score: range: 0 (none) to 72 (maximum). Body was divided into head, upper extremities, trunk and lower extremities; each area score was combined for final PASI. For each section, percent area of skin involved was estimated: 0 (0%) to 6 (90 - 100%), and severity was estimated by clinical signs: (erythema, induration, and desquamation); scale: 0 (none) to 4 (maximum). Final PASI= sum of severity parameters for each section times area score times weight of section (head: 0.1, upper extremities: 0.2, trunk: 0.3, lower extremities: 0.4). Change = PASI at Week 24 - PASI at baseline.
Time Frame Randomization to Week 24.
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-To-Treat (ITT) population: included all randomized participants. n equals number of participants with evaluable data for this outcome measure.
Arm/Group Title Placebo Etanercept
Hide Arm/Group Description:
Participants were administered placebo subcutaneously once a week after an initial course of ciclosporin.
Participants were administered a 50 mg dose of etanercept subcutaneously once a week after an initial course of ciclosporin.
Overall Number of Participants Analyzed 21 40
Mean (95% Confidence Interval)
Unit of Measure: scores on a scale
2.9
(1.0 to 4.8)
-1.8
(-3.5 to -0.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Etanercept
Comments Analysis from randomization to Week 24.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-values were not adjusted for multiplicity and the priori threshold for statistical significance was 0.05.
Method mixed model of ANCOVA
Comments Treatment groups and visits were fixed factors, participant was a random factor and baseline was a covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 4.7
Confidence Interval (2-Sided) 95%
2.1 to 7.3
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.3
Estimation Comments [Not Specified]
2.Secondary Outcome
Title PASI Area Under the Curve (AUC) Between Randomization and Week 24
Hide Description PASI AUC = Area under the curve from randomization (Week 6) to Week 24.
Time Frame Randomization to Week 24.
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population: included all randomized participants. n equals number of participants with evaluable data.
Arm/Group Title Placebo Etanercept
Hide Arm/Group Description:
Participants were administered placebo subcutaneously once a week after an initial course of ciclosporin.
Participants were administered a 50 mg dose of etanercept subcutaneously once a week after an initial course of ciclosporin.
Overall Number of Participants Analyzed 62 58
Mean (Standard Error)
Unit of Measure: scores on a scale * weeks
Week 8 (n= 59, 56) 20.7  (5.2) 20.7  (5.4)
Week 10 (n= 55, 55) 7.0  (5.3) 5.0  (5.4)
Week 12 (n= 52, 55) 6.7  (5.3) 4.4  (5.4)
Week 16 (n= 45, 49) 17.5  (5.4) 10.8  (5.4)
Week 20 (n= 29, 45) 33.6  (5.6) 17.5  (5.5)
Week 24 (n= 21,40) 54.8  (5.8) 24.3  (5.5)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Etanercept
Comments Analysis at randomization to Week 8.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.999
Comments P-values were not adjusted for multiplicity and the priori threshold for statistical significance was 0.05.
Method mixed model of ANCOVA
Comments Treatment groups and visits were fixed factors, participant was a random factor and baseline was covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.0
Confidence Interval (2-Sided) 95%
-14.7 to 14.7
Parameter Dispersion
Type: Standard Error of the mean
Value: 7.5
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Etanercept
Comments Analysis at randomization to Week 10.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.795
Comments P-values were not adjusted for multiplicity and the priori threshold for statistical significance was 0.05.
Method mixed model of ANCOVA
Comments Treatment groups and visits were fixed factors, participant was a random factor and baseline was covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 2.0
Confidence Interval (2-Sided) 95%
-12.8 to 16.7
Parameter Dispersion
Type: Standard Error of the mean
Value: 7.5
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Etanercept
Comments Analysis at randomization to Week 12.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.758
Comments P-values were not adjusted for multiplicity and the priori threshold for statistical significance was 0.05.
Method mixed model of ANCOVA
Comments Treatment groups and visits were fixed factors, participant was a random factor and baseline was covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 2.3
Confidence Interval (2-Sided) 95%
-12.5 to 17.1
Parameter Dispersion
Type: Standard Error of the mean
Value: 7.6
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, Etanercept
Comments Analysis at randomization to Week 16.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.381
Comments P-values were not adjusted for multiplicity and the priori threshold for statistical significance was 0.05.
Method mixed model of ANCOVA
Comments Treatment groups and visits were fixed factors, participant was a random factor and baseline was covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 6.7
Confidence Interval (2-Sided) 95%
-8.3 to 21.6
Parameter Dispersion
Type: Standard Error of the mean
Value: 7.6
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, Etanercept
Comments Analysis at randomization to Week 20.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.041
Comments P-values were not adjusted for multiplicity and the priori threshold for statistical significance was 0.05.
Method mixed model of ANCOVA
Comments Treatment groups and visits were fixed factors, participant was a random factor and baseline was a covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 16.1
Confidence Interval (2-Sided) 95%
0.8 to 31.4
Parameter Dispersion
Type: Standard Error of the mean
Value: 7.8
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo, Etanercept
Comments Analysis at randomization to Week 24.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-values were not adjusted for multiplicity and the priori threshold for statistical significance was 0.05.
Method mixed model of ANCOVA
Comments Treatment groups and visits were fixed factors, participant was a random factor and baseline was covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 30.5
Confidence Interval (2-Sided) 95%
14.8 to 46.3
Parameter Dispersion
Type: Standard Error of the mean
Value: 8.0
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Change From Randomization in PGA Score to Week 24
Hide Description PGA score is based on dermatologist's assessment of disease averaged over all lesions. Overall lesions were graded for individual scores of induration, erythema, and scaling; range: 0 (no evidence) to 5 (severe). The sum of the 3 scores was divided by 3 to obtain a final PGA score. Higher scores indicate greater severity of disease. Change = PGA at Week 24 - PGA at baseline.
Time Frame Randomization to Week 24.
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population: included all randomized participants. n equals number of participants with evaluable data for this outcome measure.
Arm/Group Title Placebo Etanercept
Hide Arm/Group Description:
Participants were administered placebo subcutaneously once a week after an initial course of ciclosporin.
Participants were administered a 50 mg dose of etanercept subcutaneously once a week after an initial course of ciclosporin.
Overall Number of Participants Analyzed 21 40
Mean (95% Confidence Interval)
Unit of Measure: scores on a scale
0.9
(0.4 to 1.3)
0.2
(-0.2 to 0.6)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Etanercept
Comments Analysis from randomization to Week 24.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.049
Comments P-values were not adjusted for multiplicity and the priori threshold for statistical significance was 0.05.
Method mixed model of ANCOVA
Comments Treatment groups and visits were fixed factors, participant was a random factor and baseline was a covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.6
Confidence Interval (2-Sided) 95%
0.0 to 1.2
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.3
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Relapse (Loss of 50% Improvement in PASI) During the 24 Weeks After Randomization
Hide Description Relapse was defined as the loss of 50% improvement in PASI.
Time Frame Randomization to Week 24.
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population: that included all randomized participants. n equals number of participants with evaluable data for this outcome measure.
Arm/Group Title Placebo Etanercept
Hide Arm/Group Description:
Participants were administered placebo subcutaneously once a week after an initial course of ciclosporin.
Participants were administered a 50 mg dose of etanercept subcutaneously once a week after an initial course of ciclosporin.
Overall Number of Participants Analyzed 62 58
Measure Type: Number
Unit of Measure: Percentage of participants
63.77 36.23
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Etanercept
Comments Analysis from randomization to Week 24.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments P-values were not adjusted for multiplicity and the priori threshold for statistical significance was 0.05.
Method Pearson chi-square
Comments Treatment groups and visits were fixed factors with a logit link, a binomial distribution and an auto-regressive correlation structure.
5.Secondary Outcome
Title Probability of Being Relapse Free During the 24 Weeks After Randomization
Hide Description Relapse was defined as loss of 50% improvement in PASI. The time to relapse was estimated using a Kaplan-Meier analysis.
Time Frame Randomization to Week 24.
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population: included all randomized participants. n equals number of participants with evaluable data for this outcome measure.
Arm/Group Title Placebo Etanercept
Hide Arm/Group Description:
Participants were administered placebo subcutaneously once a week after an initial course of ciclosporin.
Participants were administered a 50 mg dose of etanercept subcutaneously once a week after an initial course of ciclosporin.
Overall Number of Participants Analyzed 62 58
Measure Type: Number
Unit of Measure: probability of relapse free
Week 4 0.93 0.91
Week 8 0.84 0.84
Week 12 0.44 0.69
Week 16 0.34 0.60
Week 20 0.22 0.58
Week 24 0.17 0.58
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Etanercept
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0003
Comments [Not Specified]
Method Log Rank
Comments Time to first relapse was estimated using the Kaplan-Meier’s, and comparisons between groups was performed using log rank tests.
6.Secondary Outcome
Title Percent (%) Change of PASI Score From Randomization to Week 24
Hide Description Percent improvement in PASI score was calculated from Week 6 to Week 24.
Time Frame Randomization to Week 24.
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population: included all randomized participants. n equals number of participants with evaluable data for this outcome measure.
Arm/Group Title Placebo Etanercept
Hide Arm/Group Description:
Participants were administered placebo subcutaneously once a week after an initial course of ciclosporin.
Participants were administered a 50 mg dose of etanercept subcutaneously once a week after an initial course of ciclosporin.
Overall Number of Participants Analyzed 19 38
Mean (95% Confidence Interval)
Unit of Measure: percent change
121.9
(59.9 to 183.9)
-13.3
(-68.4 to 41.8)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Etanercept
Comments Analysis from randomization to Week 24.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments P-values were not adjusted for multiplicity and the priori threshold for statistical significance was 0.05.
Method mixed model of ANCOVA
Comments Treatment groups and visits were fixed factors, participant was a random factor and baseline was a covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 135.2
Confidence Interval (2-Sided) 95%
52.3 to 218.1
Parameter Dispersion
Type: Standard Error of the mean
Value: 42.3
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Change From Randomization in DLQI to Week 24
Hide Description DLQI is the dermatology-specific quality of life measure used for psoriatic population. The 10-item questionnaire has a score range of 0 to 30 with higher scores indicating poor quality of life. An estimate of the minimal clinically important difference of the DLQI total score is a 5 point improvement. Total score range: 0 (best) to 30 (worst).
Time Frame Randomization to Week 24.
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population: included all randomized participants. n equals number of participants with evaluable data for this outcome measure.
Arm/Group Title Placebo Etanercept
Hide Arm/Group Description:
Participants were administered placebo subcutaneously once a week after an initial course of ciclosporin.
Participants were administered a 50 mg dose of etanercept subcutaneously once a week after an initial course of ciclosporin.
Overall Number of Participants Analyzed 20 40
Mean (95% Confidence Interval)
Unit of Measure: scores on a scale
2.0
(-0.4 to 4.3)
-0.4
(-2.5 to 1.7)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Etanercept
Comments Analysis from randomization to Week 24.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.139
Comments P-values were not adjusted for multiplicity and the priori threshold for statistical significance was 0.05.
Method mixed model of ANCOVA
Comments Treatment groups and visits were fixed factors, participant was a random factor and baseline was a covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 2.4
Confidence Interval 95%
-0.8 to 5.5
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.6
Estimation Comments [Not Specified]
8.Secondary Outcome
Title DLQI at Each Visit From Baseline
Hide Description DLQI is the dermatology-specific quality of life measure used for psoriatic population. The 10 item questionnaire has a score range of 0 to 30 with higher scores indicating poor quality of life. An estimate of the minimal clinically important difference of the DLQI total score is a 5 point improvement. Total score range: 0 (best) to 30 (worst).
Time Frame Baseline to Week 24.
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population: included all randomized participants. n equals number of participants with evaluable data
Arm/Group Title Placebo Etanercept
Hide Arm/Group Description:
Participants were administered placebo subcutaneously once a week after an initial course of ciclosporin.
Participants were administered a 50 mg dose of etanercept subcutaneously once a week after an initial course of ciclosporin.
Overall Number of Participants Analyzed 62 58
Mean (Standard Error)
Unit of Measure: scores on a scale
Week 2 (n= 28, 30) 4.1  (0.9) 4.0  (0.9)
Week 4 (n= 25, 22) 3.0  (0.9) 4.0  (0.9)
Week 6 (n= 8, 3) 1.5  (1.2) 1.9  (1.9)
Week 8 (n= 58, 55) 1.6  (0.6) 1.6  (0.7)
Week 10 (n= 56, 54) 1.7  (0.6) 1.0  (0.7)
Week 12 (n= 52, 54) 2.0  (0.7) 1.0  (0.7)
Week 16 (n= 44, 48) 5.5  (0.7) 2.8  (0.7)
Week 20 (n= 29, 44) 6.2  (0.8) 3.3  (0.7)
Week 24 (n= 20, 40) 6.1  (10.9) 3.6  (0.7)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Etanercept
Comments Analysis from baseline to Week 2.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.956
Comments P-values were not adjusted for multiplicity and the priori threshold for statistical significance was 0.05.
Method mixed model of ANCOVA
Comments Treatment groups and visits were fixed factors, participant was a random factor and baseline was a covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.1
Confidence Interval (2-Sided) 95%
-2.3 to 2.5
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.2
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Etanercept
Comments Analysis from baseline to Week 4.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.41
Comments P-values were not adjusted for multiplicity and the priori threshold for statistical significance was 0.05.
Method mixed model of ANCOVA
Comments Treatment groups and visits were fixed factors, participant was a random factor and baseline was a covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.1
Confidence Interval (2-Sided) 95%
-3.6 to 1.5
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.3
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Etanercept
Comments Analysis from baseline to Week 6.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.844
Comments P-values were not adjusted for multiplicity and the priori threshold for statistical significance was 0.05.
Method mixed model of ANCOVA
Comments Treatment groups and visits were fixed factors, participant was a random factor and baseline was a covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.4
Confidence Interval (2-Sided) 95%
-4.8 to 3.9
Parameter Dispersion
Type: Standard Error of the mean
Value: 2.2
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, Etanercept
Comments Analysis from baseline to Week 8.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.968
Comments P-values were not adjusted for multiplicity and the priori threshold for statistical significance was 0.05.
Method mixed model of ANCOVA
Comments Treatment groups and visits were fixed factors, participant was a random factor and baseline was a covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.0
Confidence Interval (2-Sided) 95%
-1.8 to 1.8
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.9
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, Etanercept
Comments Analysis from baseline to Week 10.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.441
Comments P-values were not adjusted for multiplicity and the priori threshold for statistical significance was 0.05.
Method mixed model of ANCOVA
Comments Treatment groups and visits were fixed factors, participant was a random factor and baseline was a covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.7
Confidence Interval (2-Sided) 95%
-1.1 to 2.5
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.9
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo, Etanercept
Comments Analysis from baseline to Week 12.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3
Comments P-values were not adjusted for multiplicity and the priori threshold for statistical significance was 0.05.
Method mixed model of ANCOVA
Comments Treatment groups and visits were fixed factors, participant was a random factor and baseline was a covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.0
Confidence Interval (2-Sided) 95%
-0.9 to 2.8
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.9
Estimation Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Placebo, Etanercept
Comments Analysis from baseline to Week 16.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.008
Comments P-values were not adjusted for multiplicity and the priori threshold for statistical significance was 0.05.
Method mixed model of ANCOVA
Comments Treatment groups and visits were fixed factors, participant was a random factor and baseline was a covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 2.6
Confidence Interval (2-Sided) 95%
0.7 to 4.5
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.0
Estimation Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Placebo, Etanercept
Comments Analysis from baseline to Week 20.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.005
Comments P-values were not adjusted for multiplicity and the priori threshold for statistical significance was 0.05.
Method mixed model of ANCOVA
Comments Treatment groups and visits were fixed factors, participant was a random factor and baseline was a covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 3.0
Confidence Interval (2-Sided) 95%
0.9 to 5.0
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.0
Estimation Comments [Not Specified]
Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Placebo, Etanercept
Comments Analysis from baseline to Week 24.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.031
Comments P-values were not adjusted for multiplicity and the priori threshold for statistical significance was 0.05.
Method mixed model of ANCOVA
Comments Treatment groups and visits were fixed factors, participant was a random factor and baseline was a covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 2.4
Confidence Interval (2-Sided) 95%
0.2 to 4.6
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.1
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Percentage of Rebound Effects
Hide Description Rebound effects was defined as worsening of psoriasis to 125% of the baseline PASI or appearance of psoriasis variants such as erythrodermic or pustular psoriasis within 12 weeks of discontinuation of therapy.
Time Frame Baseline to Week 24.
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population: included all randomized participants.n equals number of participants with evaluable data for this outcome measure.
Arm/Group Title Placebo Etanercept
Hide Arm/Group Description:
Participants were administered placebo subcutaneously once a week after an initial course of ciclosporin.
Participants were administered a 50 mg dose of etanercept subcutaneously once a week after an initial course of ciclosporin.
Overall Number of Participants Analyzed 62 58
Measure Type: Number
Unit of Measure: percentage of participants
26.67 0.00
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Etanercept
Comments Analysis from baseline to Week 24.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1196
Comments P-values were not adjusted for multiplicity and the priori threshold for statistical significance was 0.05.
Method Pearson chi-square or Fisher exact test
Comments Treatment groups and visits were fixed factors with a logit link, a binomial distribution and an auto-regressive correlation structure.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Etanercept
Hide Arm/Group Description Participants were administered placebo subcutaneously once a week after an initial course of ciclosporin. Participants were administered a 50 mg dose of etanercept subcutaneously once a week after an initial course of ciclosporin.
All-Cause Mortality
Placebo Etanercept
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Placebo Etanercept
Affected / at Risk (%) Affected / at Risk (%)
Total   1/62 (1.61%)   2/58 (3.45%) 
Infections and infestations     
Tonsillitis * 1  0/62 (0.00%)  2/58 (3.45%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Bronchial carcinoma * 1  0/62 (0.00%)  1/58 (1.72%) 
Reproductive system and breast disorders     
Benign prostatic hyperplasia * 1  1/62 (1.61%)  0/58 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Placebo Etanercept
Affected / at Risk (%) Affected / at Risk (%)
Total   48/62 (77.42%)   43/58 (74.14%) 
Blood and lymphatic system disorders     
Iron deficiency anaemia * 1  0/62 (0.00%)  1/58 (1.72%) 
Leukopenia * 1  1/62 (1.61%)  0/58 (0.00%) 
Cardiac disorders     
Oedema peripheral * 1  1/62 (1.61%)  0/58 (0.00%) 
Congenital, familial and genetic disorders     
Inborn error of bilirubin metabolism * 1  0/62 (0.00%)  1/58 (1.72%) 
Odontogenic cyst * 1  0/62 (0.00%)  1/58 (1.72%) 
Ear and labyrinth disorders     
Ear pain * 1  1/62 (1.61%)  0/58 (0.00%) 
Eye disorders     
Conjunctivitis * 1  0/62 (0.00%)  1/58 (1.72%) 
Vision blurred * 1  1/62 (1.61%)  0/58 (0.00%) 
Vitreous detachment * 1  1/62 (1.61%)  0/58 (0.00%) 
Gastrointestinal disorders     
Abdominal discomfort * 1  0/62 (0.00%)  1/58 (1.72%) 
Abdominal distension * 1  1/62 (1.61%)  0/58 (0.00%) 
Abdominal pain * 1  8/62 (12.90%)  8/58 (13.79%) 
Anal pruritus * 1  1/62 (1.61%)  0/58 (0.00%) 
Diarrhoea * 1  4/62 (6.45%)  0/58 (0.00%) 
Diarrhoea infectious * 1  0/62 (0.00%)  1/58 (1.72%) 
Dysentery * 1  0/62 (0.00%)  1/58 (1.72%) 
Dyspepsia * 1  1/62 (1.61%)  1/58 (1.72%) 
Enteritis * 1  1/62 (1.61%)  0/58 (0.00%) 
Flatulence * 1  1/62 (1.61%)  0/58 (0.00%) 
Gastritis * 1  1/62 (1.61%)  1/58 (1.72%) 
Gastroenteritis * 1  1/62 (1.61%)  1/58 (1.72%) 
Gastrointestinal disorder * 1  0/62 (0.00%)  1/58 (1.72%) 
Gastrooesophageal reflux disease * 1  2/62 (3.23%)  0/58 (0.00%) 
Gingival disorder * 1  0/62 (0.00%)  1/58 (1.72%) 
Gingival hyperplasia * 1  1/62 (1.61%)  0/58 (0.00%) 
Gingival hypertrophy * 1  0/62 (0.00%)  1/58 (1.72%) 
Gingivitis * 1  2/62 (3.23%)  1/58 (1.72%) 
Haemorrhoids * 1  1/62 (1.61%)  0/58 (0.00%) 
Lip dry * 1  1/62 (1.61%)  0/58 (0.00%) 
Nausea * 1  13/62 (20.97%)  7/58 (12.07%) 
Paraesthesia oral * 1  0/62 (0.00%)  1/58 (1.72%) 
Throat irritation * 1  1/62 (1.61%)  0/58 (0.00%) 
Toothache * 1  0/62 (0.00%)  2/58 (3.45%) 
Vomiting * 1  1/62 (1.61%)  1/58 (1.72%) 
General disorders     
Asthenia * 1  0/62 (0.00%)  2/58 (3.45%) 
Chest pain * 1  0/62 (0.00%)  1/58 (1.72%) 
Fatigue * 1  4/62 (6.45%)  5/58 (8.62%) 
Feeling hot * 1  2/62 (3.23%)  1/58 (1.72%) 
Feeling of body temperature change * 1  2/62 (3.23%)  0/58 (0.00%) 
Hyperpyrexia * 1  1/62 (1.61%)  0/58 (0.00%) 
Injection site anaesthesia * 1  1/62 (1.61%)  0/58 (0.00%) 
Injection site pain * 1  0/62 (0.00%)  1/58 (1.72%) 
Injection site pruritus * 1  2/62 (3.23%)  0/58 (0.00%) 
Injection site reaction * 1  1/62 (1.61%)  2/58 (3.45%) 
Localised oedema * 1  0/62 (0.00%)  1/58 (1.72%) 
Malaise * 1  0/62 (0.00%)  1/58 (1.72%) 
Pyrexia * 1  1/62 (1.61%)  1/58 (1.72%) 
Infections and infestations     
Ascariasis * 1  1/62 (1.61%)  0/58 (0.00%) 
Asymptomatic bacteriuria * 1  0/62 (0.00%)  1/58 (1.72%) 
Escherichia urinary tract infection * 1  0/62 (0.00%)  1/58 (1.72%) 
Influenza * 1  2/62 (3.23%)  3/58 (5.17%) 
Nasopharyngitis * 1  13/62 (20.97%)  11/58 (18.97%) 
Oral herpes * 1  1/62 (1.61%)  0/58 (0.00%) 
Pharyngitis * 1  1/62 (1.61%)  1/58 (1.72%) 
Rhinitis * 1  0/62 (0.00%)  2/58 (3.45%) 
Superinfection * 1  1/62 (1.61%)  0/58 (0.00%) 
Tinea cruris * 1  1/62 (1.61%)  0/58 (0.00%) 
Tonsillitis * 1  0/62 (0.00%)  0/58 (0.00%) 
Tooth abscess * 1  0/62 (0.00%)  2/58 (3.45%) 
Urinary tract infection * 1  1/62 (1.61%)  0/58 (0.00%) 
Injury, poisoning and procedural complications     
Accidental overdose * 1  2/62 (3.23%)  0/58 (0.00%) 
Hand fracture * 1  0/62 (0.00%)  1/58 (1.72%) 
Investigations     
Alanine aminotransferase increased * 1  0/62 (0.00%)  1/58 (1.72%) 
Blood cholesterol abnormal * 1  1/62 (1.61%)  0/58 (0.00%) 
Blood cholesterol increased * 1  1/62 (1.61%)  0/58 (0.00%) 
Blood creatinine increased * 1  2/62 (3.23%)  4/58 (6.90%) 
Blood magnesium decreased * 1  0/62 (0.00%)  1/58 (1.72%) 
Blood pressure increased * 1  0/62 (0.00%)  1/58 (1.72%) 
Blood uric acid increased * 1  0/62 (0.00%)  1/58 (1.72%) 
Hepatic enzyme increased * 1  0/62 (0.00%)  3/58 (5.17%) 
Transaminases increased * 1  1/62 (1.61%)  0/58 (0.00%) 
Metabolism and nutrition disorders     
Diabetes mellitus * 1  1/62 (1.61%)  0/58 (0.00%) 
Hypercholesterolaemia * 1  1/62 (1.61%)  0/58 (0.00%) 
Hypertriglyceridaemia * 1  1/62 (1.61%)  0/58 (0.00%) 
Hyperuricaemia * 1  0/62 (0.00%)  1/58 (1.72%) 
Hypomagnesaemia * 1  0/62 (0.00%)  1/58 (1.72%) 
Musculoskeletal and connective tissue disorders     
Arthralgia * 1  3/62 (4.84%)  1/58 (1.72%) 
Arthropathy * 1  1/62 (1.61%)  0/58 (0.00%) 
Back pain * 1  0/62 (0.00%)  1/58 (1.72%) 
Intervertebral disc protrusion * 1  0/62 (0.00%)  1/58 (1.72%) 
Joint swelling * 1  0/62 (0.00%)  1/58 (1.72%) 
Limb discomfort * 1  0/62 (0.00%)  1/58 (1.72%) 
Muscle spasms * 1  3/62 (4.84%)  5/58 (8.62%) 
Musculoskeletal pain * 1  0/62 (0.00%)  1/58 (1.72%) 
Musculoskeletal stiffness * 1  1/62 (1.61%)  0/58 (0.00%) 
Myalgia * 1  1/62 (1.61%)  1/58 (1.72%) 
Neck pain * 1  1/62 (1.61%)  0/58 (0.00%) 
Pain in extremity * 1  2/62 (3.23%)  5/58 (8.62%) 
Sensation of heaviness * 1  1/62 (1.61%)  0/58 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Bronchial carcinoma * 1  0/62 (0.00%)  0/58 (0.00%) 
Nervous system disorders     
Burning sensation * 1  1/62 (1.61%)  1/58 (1.72%) 
Dizziness * 1  1/62 (1.61%)  5/58 (8.62%) 
Dysgeusia * 1  0/62 (0.00%)  1/58 (1.72%) 
Headache * 1  21/62 (33.87%)  17/58 (29.31%) 
Hyperaesthesia * 1  1/62 (1.61%)  0/58 (0.00%) 
Insomnia * 1  0/62 (0.00%)  1/58 (1.72%) 
Migraine * 1  2/62 (3.23%)  2/58 (3.45%) 
Paraesthesia * 1  10/62 (16.13%)  3/58 (5.17%) 
Presyncope * 1  1/62 (1.61%)  0/58 (0.00%) 
Sensory disturbance * 1  0/62 (0.00%)  1/58 (1.72%) 
Vertigo * 1  1/62 (1.61%)  0/58 (0.00%) 
Psychiatric disorders     
Anxiety * 1  0/62 (0.00%)  1/58 (1.72%) 
Depression * 1  1/62 (1.61%)  1/58 (1.72%) 
Somatoform disorder * 1  0/62 (0.00%)  1/58 (1.72%) 
Renal and urinary disorders     
Cystitis * 1  2/62 (3.23%)  0/58 (0.00%) 
Haematuria * 1  0/62 (0.00%)  1/58 (1.72%) 
Renovascular hypertension * 1  0/62 (0.00%)  1/58 (1.72%) 
Reproductive system and breast disorders     
Benign prostatic hyperplasia * 1  0/62 (0.00%)  0/58 (0.00%) 
Breast pain * 1  0/62 (0.00%)  1/58 (1.72%) 
Dysmenorrhoea * 1  0/62 (0.00%)  1/58 (1.72%) 
Menstruation irregular * 1  0/62 (0.00%)  1/58 (1.72%) 
Postmenopausal haemorrhage * 1  0/62 (0.00%)  1/58 (1.72%) 
Prostatitis * 1  1/62 (1.61%)  0/58 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Bronchitis * 1  3/62 (4.84%)  1/58 (1.72%) 
Cough * 1  0/62 (0.00%)  1/58 (1.72%) 
Oropharyngeal pain * 1  2/62 (3.23%)  1/58 (1.72%) 
Upper respiratory tract infection * 1  1/62 (1.61%)  2/58 (3.45%) 
Skin and subcutaneous tissue disorders     
Alopecia * 1  2/62 (3.23%)  0/58 (0.00%) 
Alopecia effluvium * 1  0/62 (0.00%)  2/58 (3.45%) 
Dermal cyst * 1  0/62 (0.00%)  1/58 (1.72%) 
Folliculitis * 1  1/62 (1.61%)  1/58 (1.72%) 
Hair disorder * 1  0/62 (0.00%)  1/58 (1.72%) 
Herpes simplex * 1  2/62 (3.23%)  0/58 (0.00%) 
Hypertrichosis * 1  2/62 (3.23%)  4/58 (6.90%) 
Ingrowing nail * 1  1/62 (1.61%)  0/58 (0.00%) 
Injection site dermatitis * 1  0/62 (0.00%)  1/58 (1.72%) 
Injection site rash * 1  0/62 (0.00%)  1/58 (1.72%) 
Pruritus * 1  1/62 (1.61%)  2/58 (3.45%) 
Psoriasis * 1  2/62 (3.23%)  3/58 (5.17%) 
Rash * 1  1/62 (1.61%)  0/58 (0.00%) 
Swelling face * 1  0/62 (0.00%)  1/58 (1.72%) 
Urticaria * 1  0/62 (0.00%)  1/58 (1.72%) 
Surgical and medical procedures     
Tooth extraction * 1  0/62 (0.00%)  1/58 (1.72%) 
Tooth repair * 1  1/62 (1.61%)  0/58 (0.00%) 
Vascular disorders     
Deep vein thrombosis * 1  1/62 (1.61%)  0/58 (0.00%) 
Essential hypertension * 1  2/62 (3.23%)  1/58 (1.72%) 
Hot flush * 1  3/62 (4.84%)  2/58 (3.45%) 
Hypertension * 1  9/62 (14.52%)  9/58 (15.52%) 
Hypotension * 1  1/62 (1.61%)  0/58 (0.00%) 
Lymphoedema * 1  0/62 (0.00%)  1/58 (1.72%) 
Migraine with aura * 1  1/62 (1.61%)  0/58 (0.00%) 
Secondary hypertension * 1  2/62 (3.23%)  1/58 (1.72%) 
Systolic hypertension * 1  1/62 (1.61%)  0/58 (0.00%) 
Venous injury * 1  1/62 (1.61%)  0/58 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA
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.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
EMail: ClinicalTrials.gov_Inquiries@pfizer.com
Layout table for additonal information
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00581555    
Other Study ID Numbers: 0881A6-410
First Submitted: December 21, 2007
First Posted: December 27, 2007
Results First Submitted: November 17, 2010
Results First Posted: April 23, 2012
Last Update Posted: April 23, 2012