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Trial record 10 of 31 for:    ACITRETIN

Study Evaluating the Efficacy and Safety of Etanercept and Acitretin in Korean Patient With Moderate to Severe Psoriasis

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: NCT00936065
Recruitment Status : Completed
First Posted : July 9, 2009
Results First Posted : April 9, 2012
Last Update Posted : April 9, 2012
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Moderate to Severe Psoriasis
Interventions Drug: Etanercept
Drug: Etanercept + Acitretin
Drug: Acitretin
Enrollment 60
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Etanercept Etanercept and Acitretin Acitretin
Hide Arm/Group Description Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks. Acitretin 10 mg subcutaneous injection BID for 24 weeks
Period Title: Overall Study
Started 21 20 19
Received Treatment 21 20 18
Study Assessments Performed 21 19 18
Completed 17 16 12
Not Completed 4 4 7
Reason Not Completed
Adverse Event             1             0             1
Lack of Efficacy             1             0             1
Lost to Follow-up             1             0             0
Protocol Violation             1             2             1
Withdrawal by Subject             0             2             4
Arm/Group Title Etanercept Etanercept and Acitretin Acitretin Total
Hide Arm/Group Description Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks. Acitretin 10 mg subcutaneous injection BID for 24 weeks Total of all reporting groups
Overall Number of Baseline Participants 21 19 18 58
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 21 participants 19 participants 18 participants 58 participants
38.57  (9.53) 35.5  (8.75) 42.39  (11.95) 38.78  (10.31)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants 19 participants 18 participants 58 participants
Female
5
  23.8%
2
  10.5%
3
  16.7%
10
  17.2%
Male
16
  76.2%
17
  89.5%
15
  83.3%
48
  82.8%
1.Primary Outcome
Title Percentage of Participants Achieving a 75 Percent (%) Improvement in Psoriasis Area and Severity Index (PASI 75) Score at Week 24
Hide Description Combined assessment of lesion severity and area affected into single score; range: 0 (no disease) to 72 (maximal disease). Body was divided into 4 sections (head, arms, trunk, legs); each area scored by itself and scores combined for final PASI. For each section, area of skin involved was estimated: 0 (0%) to 6 (90 - 100%), and severity estimated by clinical signs: erythema, induration, and desquamation; scale: 0 (none) to 4 (exceptionally striking). Final PASI = sum of severity parameters for each section * area score * weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4).
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Modified intent to treat (mITT) population: randomized participants who took at least 1 dose of test article and had both baseline and on-therapy PASI evaluations; Last Observation Carried Forward (LOCF)
Arm/Group Title Etanercept Etanercept and Acitretin Acitretin
Hide Arm/Group Description:
Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
Acitretin 10 mg subcutaneous injection BID for 24 weeks
Overall Number of Participants Analyzed 21 19 18
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
52.38
(29.78 to 74.29)
57.89
(33.50 to 79.75)
22.22
(6.41 to 47.64)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Etanercept, Etanercept and Acitretin, Acitretin
Comments Overall treatment difference
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0672
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
2.Secondary Outcome
Title Percentage of Participants Achieving a 50% Improvement in Psoriasis Area and Severity Index (PASI 50) Score
Hide Description Combined assessment of lesion severity and area affected into single score; range: 0 (no disease) to 72 (maximal disease). Body was divided into 4 sections (head, arms, trunk, legs); each area scored by itself and scores combined for final PASI. For each section, area of skin involved was estimated: 0 (0%) to 6 (90 - 100%), and severity estimated by clinical signs: erythema, induration, and desquamation; scale: 0 (none) to 4 (exceptionally striking). Final PASI = sum of severity parameters for each section * area score * weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4).
Time Frame Weeks 2, 4, 8, 12, 18, and 24
Hide Outcome Measure Data
Hide Analysis Population Description
mITT; LOCF
Arm/Group Title Etanercept Etanercept and Acitretin Acitretin
Hide Arm/Group Description:
Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
Acitretin 10 mg subcutaneous injection BID for 24 weeks
Overall Number of Participants Analyzed 21 19 18
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Week 2
4.76
(0.12 to 23.82)
0
(0 to 0)
0
(0 to 0)
Week 4
47.62
(25.71 to 70.22)
15.79
(3.38 to 39.58)
11.11
(1.38 to 34.71)
Week 8
71.43
(47.82 to 88.72)
57.89
(33.50 to 79.75)
27.78
(9.69 to 53.48)
Week 12
76.19
(52.83 to 91.78)
78.95
(54.43 to 93.95)
22.22
(6.41 to 47.64)
Week 18
76.19
(52.83 to 91.78)
84.21
(60.42 to 96.62)
38.89
(17.30 to 64.25)
Week 24
71.43
(47.82 to 88.72)
84.21
(60.42 to 96.62)
44.44
(21.53 to 69.24)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Etanercept, Etanercept and Acitretin, Acitretin
Comments Overall treatment difference Week 2
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0000
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Etanercept, Etanercept and Acitretin, Acitretin
Comments Overall treatment difference Week 4
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0229
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Etanercept, Etanercept and Acitretin, Acitretin
Comments Overall treatment difference Week 8
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0256
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Etanercept, Etanercept and Acitretin, Acitretin
Comments Overall treatment difference Week 12
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0004
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Etanercept, Etanercept and Acitretin, Acitretin
Comments Overall treatment difference Week 18
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0105
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Etanercept, Etanercept and Acitretin, Acitretin
Comments Overall treatment difference Week 24
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0366
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
3.Secondary Outcome
Title Percentage of Participants Achieving a Status on the Physician Global Assessment (PGA) of Psoriasis of Clear
Hide Description PGA of Psoriasis: score based on dermatologist's assessment of disease averaged over all lesions of head, scalp, and neck. Overall lesions were graded for 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. Assessment of clear = PGA score of 0 (no evidence).
Time Frame Baseline, Weeks 2, 4, 8, 12, 18 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
mITT; LOCF
Arm/Group Title Etanercept Etanercept and Acitretin Acitretin
Hide Arm/Group Description:
Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
Acitretin 10 mg subcutaneous injection BID for 24 weeks
Overall Number of Participants Analyzed 21 19 18
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
Baseline
0
(0 to 0)
0
(0 to 0)
0
(0 to 0)
Week 2
0
(0 to 0)
0
(0 to 0)
0
(0 to 0)
Week 4
0
(0 to 0)
0
(0 to 0)
0
(0 to 0)
Week 8
4.76
(0.12 to 23.82)
0
(0 to 0)
0
(0 to 0)
Week 12
9.52
(1.17 to 30.38)
0
(0 to 0)
0
(0 to 0)
Week 18
9.52
(1.17 to 30.38)
5.26
(0.13 to 26.03)
5.56
(0.14 to 27.29)
Week 24
9.52
(1.17 to 30.38)
10.53
(1.30 to 33.14)
5.56
(0.14 to 27.29)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Etanercept, Etanercept and Acitretin, Acitretin
Comments Overall treatment difference at Week 8
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0000
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Etanercept, Etanercept and Acitretin, Acitretin
Comments Overall treatment difference at Week 12
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3230
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Etanercept, Etanercept and Acitretin, Acitretin
Comments Overall treatment difference at Week 18
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0000
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Etanercept, Etanercept and Acitretin, Acitretin
Comments Overall treatment difference at Week 24
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0000
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
4.Secondary Outcome
Title Percentage of Participants Achieving a Status on the PGA of Psoriasis of Clear or Almost Clear
Hide Description PGA of Psoriasis: score based on dermatologist's assessment of disease averaged over all lesions of head, scalp, and neck. Overall lesions were graded for 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. Assessment of clear or almost clear = PGA score of 0 (no evidence), or 1 (minimal/faint).
Time Frame Baseline, Weeks 2, 4, 8, 12, 18 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
mITT; LOCF
Arm/Group Title Etanercept Etanercept and Acitretin Acitretin
Hide Arm/Group Description:
Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
Acitretin 10 mg subcutaneous injection BID for 24 weeks
Overall Number of Participants Analyzed 21 19 18
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Baseline
0
(0 to 0)
0
(0 to 0)
0
(0 to 0)
Week 2
0
(0 to 0)
0
(0 to 0)
5.56
(0.14 to 27.29)
Week 4
19.05
(5.45 to 41.91)
5.26
(0.13 to 26.03)
11.11
(1.38 to 34.71)
Week 8
28.57
(11.28 to 52.18)
21.05
(6.05 to 45.57)
5.56
(0.14 to 27.29)
Week 12
42.86
(21.82 to 65.98)
21.05
(6.05 to 45.57)
5.56
(0.14 to 27.29)
Week 18
33.33
(14.59 to 56.97)
31.58
(12.58 to 56.55)
16.67
(3.58 to 41.42)
Week 24
52.38
(29.78 to 74.29)
52.63
(28.86 to 75.55)
16.67
(3.58 to 41.42)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Etanercept, Etanercept and Acitretin, Acitretin
Comments Overall treatment difference at Week 2
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3103
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Etanercept, Etanercept and Acitretin, Acitretin
Comments Overall treatment difference at Week 4
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4763
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Etanercept, Etanercept and Acitretin, Acitretin
Comments Overall treatment difference at Week 8
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1961
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Etanercept, Etanercept and Acitretin, Acitretin
Comments Overall treatment difference at Week 12
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0272
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Etanercept, Etanercept and Acitretin, Acitretin
Comments Overall treatment difference at Week 18
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5038
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Etanercept, Etanercept and Acitretin, Acitretin
Comments Overall treatment difference at Week 24
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0374
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
5.Secondary Outcome
Title Percentage of Participants Achieving a Status on the PGA of Psoriasis of Clear or Almost Clear or Mild
Hide Description PGA of Psoriasis: score based on dermatologist's assessment of disease averaged over all lesions of head, scalp, and neck. Overall lesions were graded for 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. Assessment of clear or almost clear or mild = PGA score of 0 (no evidence), 1 (minimal/faint), 2 (mild).
Time Frame Baseline, Weeks 2, 4, 8, 12, 18 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
mITT; LOCF
Arm/Group Title Etanercept Etanercept and Acitretin Acitretin
Hide Arm/Group Description:
Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
Acitretin 10 mg subcutaneous injection BID for 24 weeks
Overall Number of Participants Analyzed 21 19 18
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Baseline
14.29
(3.05 to 36.34)
5.26
(0.13 to 26.03)
16.67
(3.58 to 41.42)
Week 2
33.33
(14.59 to 56.97)
26.32
(9.15 to 51.20)
11.11
(1.38 to 34.71)
Week 4
42.86
(21.82 to 65.98)
47.37
(24.45 to 74.14)
16.67
(3.58 to 41.42)
Week 8
61.90
(38.44 to 81.89)
42.11
(20.25 to 66.50)
27.78
(9.69 to 53.48)
Week 12
76.19
(52.83 to 91.78)
78.95
(54.43 to 93.95)
33.33
(13.34 to 59.01)
Week 18
80.95
(58.09 to 94.55)
84.21
(60.42 to 96.62)
38.89
(17.30 to 64.25)
Week 24
76.19
(52.83 to 91.78)
84.21
(60.42 to 96.62)
33.33
(13.34 to 59.01)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Etanercept, Etanercept and Acitretin, Acitretin
Comments Overall treatment difference at Baseline
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6061
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Etanercept, Etanercept and Acitretin, Acitretin
Comments Overall treatment difference at Week 2
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2971
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Etanercept, Etanercept and Acitretin, Acitretin
Comments Overall treatment difference at Week 4
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1119
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Etanercept, Etanercept and Acitretin, Acitretin
Comments Overall treatment difference at Week 8
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1081
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Etanercept, Etanercept and Acitretin, Acitretin
Comments Overall treatment difference at Week 12
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0063
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Etanercept, Etanercept and Acitretin, Acitretin
Comments Overall treatment difference at Week 18
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0055
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Etanercept, Etanercept and Acitretin, Acitretin
Comments Overall treatment difference at Week 24
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0031
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
6.Secondary Outcome
Title Time to Achieve a PASI 50 Score
Hide Description PASI 50 defined as a 50% or greater improvement in PASI score from Baseline
Time Frame Baseline up to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
mITT
Arm/Group Title Etanercept Etanercept and Acitretin Acitretin
Hide Arm/Group Description:
Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
Acitretin 10 mg subcutaneous injection BID for 24 weeks
Overall Number of Participants Analyzed 21 19 18
Median (95% Confidence Interval)
Unit of Measure: days
56
(28 to 56)
56
(54 to 84)
126 [1] 
(56 to NA)
[1]
Not Available (NA): The number of events to observe the upper limit of 95% Confidence Interval (CI) did not occur during the specified period.
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Etanercept, Etanercept and Acitretin, Acitretin
Comments Overall treatment difference
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0033
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
7.Secondary Outcome
Title Time to Achieve a PASI 75 Score
Hide Description PASI 75 defined as a 75% or greater improvement in PASI score from Baseline
Time Frame Baseline up to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
mITT
Arm/Group Title Etanercept Etanercept and Acitretin Acitretin
Hide Arm/Group Description:
Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
Acitretin 10 mg subcutaneous injection BID for 24 weeks
Overall Number of Participants Analyzed 21 19 18
Median (95% Confidence Interval)
Unit of Measure: days
126
(56 to 146)
146 [1] 
(124 to NA)
NA [2] 
(127 to NA)
[1]
The number of events to observe the upper limit of 95% CI did not occur during the specified period.
[2]
The number of events to observe the median time to PASI 75 did not occur during the specified period.
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Etanercept, Etanercept and Acitretin, Acitretin
Comments Overall treatment difference
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0448
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
8.Secondary Outcome
Title Time to Achieve a Status on the PGA of Psoriasis of Clear or Almost Clear or Mild
Hide Description PGA of Psoriasis: score based on dermatologist's assessment of disease averaged over all lesions of head, scalp, and neck. Overall lesions were graded for 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. Assessment of clear or almost clear or mild = PGA score of 0 (no evidence), 1 (minimal/faint), or 2 (mild).
Time Frame Baseline up to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
mITT
Arm/Group Title Etanercept Etanercept and Acitretin Acitretin
Hide Arm/Group Description:
Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
Acitretin 10 mg subcutaneous injection BID for 24 weeks
Overall Number of Participants Analyzed 21 19 18
Median (95% Confidence Interval)
Unit of Measure: days
57
(19 to 84)
57
(14 to 84)
169 [1] 
(56 to NA)
[1]
The number of events to observe the upper limit of 95% CI did not occur during the specified period.
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Etanercept, Etanercept and Acitretin, Acitretin
Comments Overall treatment difference
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0041
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
9.Secondary Outcome
Title Time to Achieve a Status on the PGA of Psoriasis of Clear or Almost Clear
Hide Description PGA of Psoriasis: score based on dermatologist's assessment of disease averaged over all lesions of head, scalp, and neck. Overall lesions were graded for 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. Assessment of clear or almost clear = PGA score of 0 (no evidence), or 1 (minimal/faint).
Time Frame Baseline up to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
mITT
Arm/Group Title Etanercept Etanercept and Acitretin Acitretin
Hide Arm/Group Description:
Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
Acitretin 10 mg subcutaneous injection BID for 24 weeks
Overall Number of Participants Analyzed 21 19 18
Median (95% Confidence Interval)
Unit of Measure: days
167
(55 to 172)
165 [1] 
(59 to NA)
NA [2] 
(87 to NA)
[1]
The number of events to observe the upper limit of 95% CI did not occur during the specified period.
[2]
The number of events to observe the median time to achieve PGA of Clear or Almost Clear did not occur during the specified period.
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Etanercept, Etanercept and Acitretin, Acitretin
Comments Overall treatment difference
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3536
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
10.Secondary Outcome
Title Change From Baseline in the PGA of Psoriasis
Hide Description PGA of Psoriasis: score based on dermatologist's assessment of disease averaged over all lesions of head, scalp, and neck. Overall lesions were graded for 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. Assessment of clear = PGA score of 0 (no evidence). Change = Week x, minus Baseline, where smaller scores indicate improvement.
Time Frame Baseline, Weeks 2, 4, 8, 12, 18, and 24
Hide Outcome Measure Data
Hide Analysis Population Description
mITT; LOCF
Arm/Group Title Etanercept Etanercept and Acitretin Acitretin
Hide Arm/Group Description:
Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
Acitretin 10 mg subcutaneous injection BID for 24 weeks
Overall Number of Participants Analyzed 21 19 18
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 3.40  (0.82) 3.38  (0.59) 3.50  (0.92)
Change at Week 2 -0.51  (0.71) -0.35  (0.58) 0.02  (0.56)
Change at Week 4 -1.00  (1.03) -0.84  (0.60) -0.26  (0.74)
Change at Week 8 -1.34  (1.07) -1.09  (0.86) -0.43  (0.91)
Change at Week 12 -1.62  (1.33) -1.42  (0.69) -0.48  (0.98)
Change at Week 18 -1.58  (1.33) -1.68  (1.00) -0.69  (1.35)
Change at Week 24 -1.67  (1.47) -1.86  (1.06) -0.71  (1.37)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Etanercept, Etanercept and Acitretin, Acitretin
Comments Overall treatment difference at Week 2
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0203
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Etanercept, Etanercept and Acitretin, Acitretin
Comments Overall treatment difference at Week 4
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0102
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Etanercept, Etanercept and Acitretin, Acitretin
Comments Overall treatment difference at Week 8
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0056
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Etanercept, Etanercept and Acitretin, Acitretin
Comments Overall treatment difference at Week 12
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0006
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Etanercept, Etanercept and Acitretin, Acitretin
Comments Overall treatment difference at Week 18
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0066
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Etanercept, Etanercept and Acitretin, Acitretin
Comments Overall treatment difference at Week 24
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0058
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
11.Secondary Outcome
Title Change From Baseline in the PASI Score
Hide Description Combined assessment of lesion severity, area affected into single score; range:0(no disease) to 72(maximal disease).Body divided into 4 sections (head, arms, trunk, legs); each area scored by itself and scores combined for final PASI. For each section, area of skin involved was estimated:0(0%) to 6(90–100%), severity estimated by clinical signs: erythema, induration, desquamation; scale: 0(none) to 4(maximum). Final PASI = sum of severity parameters for each section * area score * weight of section(head:0.1,arm:0.2,body: 0.3, leg:0.4). Change=Week X-Baseline, smaller scores show improvement.
Time Frame Baseline, Weeks 2, 4, 8, 12, 18 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
mITT; LOCF
Arm/Group Title Etanercept Etanercept and Acitretin Acitretin
Hide Arm/Group Description:
Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
Acitretin 10 mg subcutaneous injection BID for 24 weeks
Overall Number of Participants Analyzed 21 19 18
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 20.83  (14.02) 19.75  (9.85) 26.31  (13.63)
Change at Week 2 -5.38  (7.13) -3.27  (1.88) -3.17  (5.60)
Change at Week 4 -9.98  (10.64) -6.45  (3.19) -4.06  (5.68)
Change at Week 8 -11.11  (10.89) -9.96  (3.73) -6.84  (9.57)
Change at Week 12 -11.97  (11.63) -11.39  (4.72) -6.71  (6.81)
Change at Week 18 -12.13  (11.67) -13.54  (6.80) -8.77  (8.54)
Change at Week 24 -12.16  (12.15) -13.92  (5.75) -9.62  (10.10)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Etanercept, Etanercept and Acitretin, Acitretin
Comments Overall treatment difference at Week 2
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0329
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Etanercept, Etanercept and Acitretin, Acitretin
Comments Overall treatment difference at Week 4
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0003
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Etanercept, Etanercept and Acitretin, Acitretin
Comments Overall treatment difference at Week 8
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0598
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Etanercept, Etanercept and Acitretin, Acitretin
Comments Overall treatment difference at Week 12
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0241
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Etanercept, Etanercept and Acitretin, Acitretin
Comments Overall treatment difference at Week 18
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0543
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Etanercept, Etanercept and Acitretin, Acitretin
Comments Overall treatment difference at Week 24
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1205
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
12.Secondary Outcome
Title Change From Baseline in Percent Body Surface Area (BSA) Involvement of Psoriasis at Weeks 2, 4, 8, 12, 18 and 24
Hide Description Change from Baseline in the percentage of the surface area of the body affected by psoriasis. Change = Week x minus Baseline, where smaller scores indicate improvement.
Time Frame Baseline, Weeks 2, 4, 8, 12, 18 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
mITT; LOCF
Arm/Group Title Etanercept Etanercept and Acitretin Acitretin
Hide Arm/Group Description:
Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
Acitretin 10 mg subcutaneous injection BID for 24 weeks
Overall Number of Participants Analyzed 21 19 18
Mean (Standard Deviation)
Unit of Measure: percentage of BSA
Baseline 32.98  (20.21) 32.50  (24.15) 39.75  (22.96)
Change at Week 2 -2.64  (6.69) -1.55  (5.07) -0.36  (5.54)
Change at Week 4 -7.36  (10.89) -4.50  (6.48) -0.75  (7.66)
Change at Week 8 -12.67  (13.17) -7.97  (9.27) -5.14  (16.96)
Change at Week 12 -15.43  (14.90) -10.29  (9.19) -5.08  (11.89)
Change at Week 18 -16.57  (14.70) -14.76  (11.61) -9.25  (16.72)
Change at Week 24 -17.52  (14.91) -16.87  (10.79) -10.30  (18.86)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Etanercept, Etanercept and Acitretin, Acitretin
Comments Overall treatment difference at Week 2
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1385
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Etanercept, Etanercept and Acitretin, Acitretin
Comments Overall treatment difference at Week 4
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0019
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Etanercept, Etanercept and Acitretin, Acitretin
Comments Overall treatment difference at Week 8
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0442
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Etanercept, Etanercept and Acitretin, Acitretin
Comments Overall treatment difference at Week 12
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0034
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Etanercept, Etanercept and Acitretin, Acitretin
Comments Overall treatment difference at Week 18
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0454
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Etanercept, Etanercept and Acitretin, Acitretin
Comments Overall treatment difference at Week 24
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0539
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
13.Secondary Outcome
Title Change From Baseline in Subject Global Assessment (SGA) of Joint Pain at Weeks 2, 4, 8, 12 ,18 and 24
Hide Description Participants were asked to rate the severity of their joint pain on a 6-point scale, where 0=good and 5=severe. Change = Week X minus Baseline, where smaller scores indicate improvement.
Time Frame Baseline, Weeks 2, 4, 8, 12, 18 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
mITT; LOCF; Number of participants analyzed (N)= participants with evaluable data
Arm/Group Title Etanercept Etanercept and Acitretin Acitretin
Hide Arm/Group Description:
Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
Acitretin 10 mg subcutaneous injection BID for 24 weeks
Overall Number of Participants Analyzed 21 18 18
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 0.67  (1.43) 0.56  (1.15) 0.94  (1.73)
Change at Week 2 0.00  (0.71) 0.00  (0.49) -0.44  (1.10)
Change at Week 4 0.29  (1.19) -0.06  (0.42) -0.72  (1.81)
Change at Week 8 0.19  (0.81) -0.22  (0.88) -0.56  (1.72)
Change at Week 12 0.00  (0.63) -0.28  (0.96) -0.44  (2.36)
Change at Week 18 -0.05  (0.67) -0.28  (1.02) -0.44  (1.85)
Change at Week 24 0.29  (1.06) -0.39  (0.85) -0.61  (2.03)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Etanercept, Etanercept and Acitretin, Acitretin
Comments Overall treatment difference at Week 2
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1723
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Etanercept, Etanercept and Acitretin, Acitretin
Comments Overall treatment difference at Week 4
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0292
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Etanercept, Etanercept and Acitretin, Acitretin
Comments Overall treatment difference at Week 8
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0908
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Etanercept, Etanercept and Acitretin, Acitretin
Comments Overall treatment difference at Week 12
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5678
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Etanercept, Etanercept and Acitretin, Acitretin
Comments Overall treatment difference at Week 18
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4820
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Etanercept, Etanercept and Acitretin, Acitretin
Comments Overall treatment difference at Week 24
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0394
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
14.Secondary Outcome
Title Change From Baseline in SGA of Psoriasis at Weeks 2, 4, 8, 12 ,18 and 24
Hide Description Participants were asked to rate the severity of their psoriasis disease activity on a 6-point scale, where 0=good and 5=severe. Change = Week X minus Baseline, where smaller scores indicate improvement.
Time Frame Baseline, Weeks 2, 4, 8, 12 ,18 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
mITT; LOCF; Number of participants analyzed (N)= participants with evaluable data
Arm/Group Title Etanercept Etanercept and Acitretin Acitretin
Hide Arm/Group Description:
Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
Acitretin 10 mg subcutaneous injection BID for 24 weeks
Overall Number of Participants Analyzed 21 18 18
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 3.90  (1.09) 3.94  (1.06) 4.72  (0.67)
Change at Week 2 -0.90  (1.58) -0.33  (1.24) -0.72  (1.02)
Change at Week 4 -1.86  (1.28) -0.94  (1.26) -0.83  (1.04)
Change at Week 8 -2.29  (1.79) -1.89  (1.49) -1.67  (1.71)
Change at Week 12 -2.67  (1.56) -2.28  (1.53) -1.61  (1.72)
Change at Week 18 -2.57  (1.99) -2.11  (1.78) -1.83  (1.76)
Change at Week 24 -1.81  (2.20) -2.39  (1.54) -1.72  (1.93)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Etanercept, Etanercept and Acitretin, Acitretin
Comments Overall treatment difference at Week 2
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1079
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Etanercept, Etanercept and Acitretin, Acitretin
Comments Overall treatment difference at Week 4
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0004
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Etanercept, Etanercept and Acitretin, Acitretin
Comments Overall treatment difference at Week 8
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0146
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Etanercept, Etanercept and Acitretin, Acitretin
Comments Overall treatment difference at Week 12
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0019
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Etanercept, Etanercept and Acitretin, Acitretin
Comments Overall treatment difference at Week 18
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0062
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Etanercept, Etanercept and Acitretin, Acitretin
Comments Overall treatment difference at Week 24
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0197
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
15.Secondary Outcome
Title Change From Baseline in SGA of Itching at Each Visit
Hide Description Participants were asked to rate the severity of their psoriasis itching on a 6-point scale, where 0=good and 5=severe. Change = Week X minus Baseline, where smaller scores indicate improvement.
Time Frame Baseline, Weeks 2, 4, 8, 12 ,18 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
mITT; LOCF; Number of participants analyzed (N)= participants with evaluable data
Arm/Group Title Etanercept Etanercept and Acitretin Acitretin
Hide Arm/Group Description:
Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
Acitretin 10 mg subcutaneous injection BID for 24 weeks
Overall Number of Participants Analyzed 21 18 18
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 3.33  (1.35) 3.11  (1.81) 3.72  (1.45)
Change at Week 2 -0.67  (1.59) 0.28  (1.74) -0.39  (1.29)
Change at Week 4 -1.52  (1.33) -0.61  (1.65) -0.39  (2.03)
Change at Week 8 -1.86  (2.06) -1.06  (1.76) -1.28  (1.71)
Change at Week 12 -2.10  (2.07) -1.44  (2.09) -1.22  (1.73)
Change at Week 18 -1.81  (2.06) -1.83  (1.76) -1.17  (1.62)
Change at Week 24 -1.19  (2.23) -1.83  (2.04) -1.06  (1.89)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Etanercept, Etanercept and Acitretin, Acitretin
Comments Overall treatment difference at Week 2
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1229
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Etanercept, Etanercept and Acitretin, Acitretin
Comments Overall treatment difference at Week 4
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0136
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Etanercept, Etanercept and Acitretin, Acitretin
Comments Overall treatment difference at Week 8
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1578
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Etanercept, Etanercept and Acitretin, Acitretin
Comments Overall treatment difference at Week 12
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0565
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Etanercept, Etanercept and Acitretin, Acitretin
Comments Overall treatment difference at Week 18
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0685
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Etanercept, Etanercept and Acitretin, Acitretin
Comments Overall treatment difference at Week 24
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0493
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
16.Secondary Outcome
Title Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 1, at Weeks 2, 4, 8, 12, 18 and 24
Hide Description Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with the overall appearance of their skin. Responses were based on a 5-point scale: Very dissatisfied (0), Dissatisfied (1), Neither satisfied nor dissatisfied (2), Satisfied (3), Very satisfied (4), Never had this problem (5). Change = Week X minus Baseline, where larger scores indicate improvement.
Time Frame Baseline, Weeks 2, 4, 8, 12, 18 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
mITT; LOCF
Arm/Group Title Etanercept Etanercept and Acitretin Acitretin
Hide Arm/Group Description:
Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
Acitretin 10 mg subcutaneous injection BID for 24 weeks
Overall Number of Participants Analyzed 21 19 18
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Baseline 0.67  (0.80) 0.74  (0.99) 0.44  (0.78)
Change at Week 2 0.81  (1.25) 0.79  (1.40) 0.28  (1.41)
Change at Week 4 1.57  (1.16) 0.95  (1.31) 0.50  (1.38)
Change at Week 8 2.10  (1.58) 1.58  (1.71) 0.78  (1.40)
Change at Week 12 2.10  (1.58) 1.74  (1.76) 0.56  (1.38)
Change at Week 18 2.24  (1.87) 1.95  (1.54) 1.06  (1.66)
Change at Week 24 1.76  (1.67) 2.05  (1.18) 1.11  (1.84)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Etanercept, Etanercept and Acitretin, Acitretin
Comments Overall treatment difference at Week 2
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3112
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Etanercept, Etanercept and Acitretin, Acitretin
Comments Overall treatment difference at Week 4
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0196
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Etanercept, Etanercept and Acitretin, Acitretin
Comments Overall treatment difference at Week 8
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0109
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Etanercept, Etanercept and Acitretin, Acitretin
Comments Overall treatment difference at Week 12
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0035
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Etanercept, Etanercept and Acitretin, Acitretin
Comments Overall treatment difference at Week 18
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0603
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Etanercept, Etanercept and Acitretin, Acitretin
Comments Overall treatment difference at Week 24
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2184
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
17.Secondary Outcome
Title Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 2, at Weeks 2, 4, 8, 12, 18 and 24
Hide Description Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with the treatment's effect on the flaking of their skin. Responses were based on a 5-point scale: Very dissatisfied (0), Dissatisfied (1), Neither satisfied nor dissatisfied (2), Satisfied (3), Very satisfied (4), Never had this problem (5). Change = Week X minus Baseline, where larger scores indicate improvement.
Time Frame Baseline, Weeks 2, 4, 8, 12, 18 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
mITT; LOCF
Arm/Group Title Etanercept Etanercept and Acitretin Acitretin
Hide Arm/Group Description:
Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
Acitretin 10 mg subcutaneous injection BID for 24 weeks
Overall Number of Participants Analyzed 21 19 18
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Baseline 1.00  (1.30) 0.84  (1.21) 0.56  (0.78)
Change at Week 2 1.14  (1.53) 1.21  (1.51) 0.39  (1.50)
Change at Week 4 1.57  (1.36) 0.68  (1.42) 0.94  (1.66)
Change at Week 8 2.38  (1.83) 1.53  (1.95) 1.11  (1.78)
Change at Week 12 2.67  (1.88) 1.63  (1.46) 0.83  (1.76)
Change at Week 18 2.33  (2.01) 1.89  (1.41) 1.28  (1.84)
Change at Week 24 1.90  (2.17) 2.21  (1.18) 1.17  (1.86)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Etanercept, Etanercept and Acitretin, Acitretin
Comments Overall treatment difference at Week 2
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1774
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Etanercept, Etanercept and Acitretin, Acitretin
Comments Overall treatment difference at Week 4
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1195
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Etanercept, Etanercept and Acitretin, Acitretin
Comments Overall treatment difference at Week 8
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0606
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Etanercept, Etanercept and Acitretin, Acitretin
Comments Overall treatment difference at Week 12
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0030
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Etanercept, Etanercept and Acitretin, Acitretin
Comments Overall treatment difference at Week 18
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1567
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Etanercept, Etanercept and Acitretin, Acitretin
Comments Overall treatment difference at Week 24
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2094
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
18.Secondary Outcome
Title Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 3, at Weeks 2, 4, 8, 12, 18 and 24
Hide Description Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with the treatment's effect on the redness of their skin. Responses were based on a 5-point scale: Very dissatisfied (0), Dissatisfied (1), Neither satisfied nor dissatisfied (2), Satisfied (3), Very satisfied (4), Never had this problem (5). Change = Week X minus Baseline, where larger scores indicate improvement.
Time Frame Baseline, Weeks 2, 4, 8, 12, 18 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
mITT; LOCF
Arm/Group Title Etanercept Etanercept and Acitretin Acitretin
Hide Arm/Group Description:
Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
Acitretin 10 mg subcutaneous injection BID for 24 weeks
Overall Number of Participants Analyzed 21 19 18
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Baseline 0.90  (1.18) 0.63  (1.01) 0.72  (0.89)
Change at Week 2 0.86  (1.20) 1.32  (1.34) 0.17  (1.20)
Change at Week 4 0.95  (1.24) 1.16  (1.17) 0.44  (1.04)
Change at Week 8 2.05  (2.04) 1.58  (1.71) 0.83  (1.34)
Change at Week 12 2.19  (1.97) 1.68  (1.67) 0.61  (1.38)
Change at Week 18 2.05  (2.20) 2.16  (1.21) 1.22  (1.52)
Change at Week 24 2.00  (2.02) 2.21  (1.23) 1.00  (1.41)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Etanercept, Etanercept and Acitretin, Acitretin
Comments Overall treatment difference at Week 2
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0302
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Etanercept, Etanercept and Acitretin, Acitretin
Comments Overall treatment difference at Week 4
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0980
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Etanercept, Etanercept and Acitretin, Acitretin
Comments Overall treatment difference at Week 8
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0711
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Etanercept, Etanercept and Acitretin, Acitretin
Comments Overall treatment difference at Week 12
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0077
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Etanercept, Etanercept and Acitretin, Acitretin
Comments Overall treatment difference at Week 18
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1553
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Etanercept, Etanercept and Acitretin, Acitretin
Comments Overall treatment difference at Week 24
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0410
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
19.Secondary Outcome
Title Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 4, at Weeks 2, 4, 8, 12, 18 and 24
Hide Description Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with the treatment's effect on tightness in the skin. Responses were based on a 5-point scale: Very dissatisfied (0), Dissatisfied (1), Neither satisfied nor dissatisfied (2), Satisfied (3), Very satisfied (4), Never had this problem (5). Change = Week X minus Baseline, where larger scores indicate improvement.
Time Frame Baseline, Weeks 2, 4, 8, 12, 18 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
mITT; LOCF
Arm/Group Title Etanercept Etanercept and Acitretin Acitretin
Hide Arm/Group Description:
Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
Acitretin 10 mg subcutaneous injection BID for 24 weeks
Overall Number of Participants Analyzed 21 19 18
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Baseline 1.33  (1.28) 1.11  (1.05) 1.83  (1.76)
Change at Week 2 1.48  (1.50) 0.42  (1.61) -0.11  (1.57)
Change at Week 4 2.19  (1.72) 0.79  (1.13) 0.44  (1.79)
Change at Week 8 2.43  (2.34) 1.32  (1.29) 0.83  (1.76)
Change at Week 12 2.67  (2.18) 1.74  (1.48) 0.61  (2.20)
Change at Week 18 2.48  (2.16) 2.05  (1.18) 0.78  (1.77)
Change at Week 24 1.90  (2.47) 2.00  (1.05) 0.56  (1.62)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Etanercept, Etanercept and Acitretin, Acitretin
Comments Overall treatment difference at Week 2
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0060
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Etanercept, Etanercept and Acitretin, Acitretin
Comments Overall treatment difference at Week 4
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0058
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Etanercept, Etanercept and Acitretin, Acitretin
Comments Overall treatment difference at Week 8
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0127
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Etanercept, Etanercept and Acitretin, Acitretin
Comments Overall treatment difference at Week 12
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0068
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Etanercept, Etanercept and Acitretin, Acitretin
Comments Overall treatment difference at Week 18
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0096
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Etanercept, Etanercept and Acitretin, Acitretin
Comments Overall treatment difference at Week 24
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0132
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
20.Secondary Outcome
Title Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 5, at Weeks 2, 4, 8, 12, 18 and 24
Hide Description Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with the treatment's effect on bleeding of the skin. Responses were based on a 5-point scale: Very dissatisfied (0), Dissatisfied (1), Neither satisfied nor dissatisfied (2), Satisfied (3), Very satisfied (4), Never had this problem (5). Change = Week X minus Baseline, where larger scores indicate improvement.
Time Frame Baseline, Weeks 2, 4, 8, 12, 18 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
mITT; LOCF
Arm/Group Title Etanercept Etanercept and Acitretin Acitretin
Hide Arm/Group Description:
Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
Acitretin 10 mg subcutaneous injection BID for 24 weeks
Overall Number of Participants Analyzed 21 19 18
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Baseline 2.81  (1.86) 2.84  (1.64) 2.89  (2.14)
Change at Week 2 0.57  (1.60) 0.68  (1.53) 0.28  (1.74)
Change at Week 4 1.00  (1.95) 0.74  (1.45) 0.56  (2.09)
Change at Week 8 1.43  (1.99) 1.05  (1.22) 0.44  (1.82)
Change at Week 12 1.43  (2.23) 0.74  (1.28) 0.78  (2.41)
Change at Week 18 1.38  (2.25) 1.16  (1.92) 0.67  (2.09)
Change at Week 24 1.00  (2.32) 0.84  (1.64) 0.61  (2.20)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Etanercept, Etanercept and Acitretin, Acitretin
Comments Overall treatment difference at Week 2
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6904
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Etanercept, Etanercept and Acitretin, Acitretin
Comments Overall treatment difference at Week 4
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7021
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Etanercept, Etanercept and Acitretin, Acitretin
Comments Overall treatment difference at Week 8
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2199
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Etanercept, Etanercept and Acitretin, Acitretin
Comments Overall treatment difference at Week 12
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5071
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Etanercept, Etanercept and Acitretin, Acitretin
Comments Overall treatment difference at Week 18
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4765
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Etanercept, Etanercept and Acitretin, Acitretin
Comments Overall treatment difference at Week 24
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8662
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
21.Secondary Outcome
Title Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 6, at Weeks 2, 4, 8, 12, 18 and 24
Hide Description Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with the treatment's effect on burning sensation of the skin. Responses were based on a 5-point scale: Very dissatisfied (0), Dissatisfied (1), Neither satisfied nor dissatisfied (2), Satisfied (3), Very satisfied (4), Never had this problem (5). Change = Week X minus Baseline, where larger scores indicate improvement.
Time Frame Baseline, Weeks 2, 4, 8, 12, 18 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
mITT; LOCF
Arm/Group Title Etanercept Etanercept and Acitretin Acitretin
Hide Arm/Group Description:
Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
Acitretin 10 mg subcutaneous injection BID for 24 weeks
Overall Number of Participants Analyzed 21 19 18
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Baseline 2.81  (1.69) 2.37  (1.86) 2.28  (2.05)
Change at Week 2 0.57  (1.57) 0.37  (1.30) -0.44  (1.65)
Change at Week 4 0.76  (1.81) 0.89  (1.49) -0.06  (2.53)
Change at Week 8 0.86  (1.98) 1.37  (1.54) 0.78  (1.90)
Change at Week 12 1.14  (1.96) 1.16  (1.86) 0.56  (2.28)
Change at Week 18 1.24  (1.92) 1.58  (1.71) 0.61  (2.33)
Change at Week 24 0.67  (2.35) 1.05  (1.72) 0.44  (2.06)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Etanercept, Etanercept and Acitretin, Acitretin
Comments Overall treatment difference at Week 2
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1144
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Etanercept, Etanercept and Acitretin, Acitretin
Comments Overall treatment difference at Week 4
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4509
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Etanercept, Etanercept and Acitretin, Acitretin
Comments Overall treatment difference at Week 8
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4350
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Etanercept, Etanercept and Acitretin, Acitretin
Comments Overall treatment difference at Week 12
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6085
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Etanercept, Etanercept and Acitretin, Acitretin
Comments Overall treatment difference at Week 18
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2582
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Etanercept, Etanercept and Acitretin, Acitretin
Comments Overall treatment difference at Week 24
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5490
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
22.Secondary Outcome
Title Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 7, at Weeks 2, 4, 8, 12, 18 and 24
Hide Description Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with the treatment's effect on skin pain. Responses were based on a 5-point scale: Very dissatisfied (0), Dissatisfied (1), Neither satisfied nor dissatisfied (2), Satisfied (3), Very satisfied (4), Never had this problem (5). Change = Week X minus Baseline, where larger scores indicate improvement.
Time Frame Baseline, Weeks 2, 4, 8, 12, 18 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
mITT; LOCF
Arm/Group Title Etanercept Etanercept and Acitretin Acitretin
Hide Arm/Group Description:
Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
Acitretin 10 mg subcutaneous injection BID for 24 weeks
Overall Number of Participants Analyzed 21 19 18
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Baseline 2.95  (1.63) 2.21  (1.78) 2.72  (2.11)
Change at Week 2 0.48  (1.75) 0.89  (1.59) 0.28  (1.96)
Change at Week 4 0.90  (1.76) 1.00  (1.41) 0.50  (2.26)
Change at Week 8 1.24  (2.00) 1.32  (1.45) 0.89  (2.30)
Change at Week 12 1.29  (2.05) 1.32  (1.45) 0.78  (2.73)
Change at Week 18 1.10  (2.02) 1.63  (1.71) 1.00  (2.45)
Change at Week 24 0.62  (2.27) 1.37  (1.89) 0.67  (2.14)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Etanercept, Etanercept and Acitretin, Acitretin
Comments Overall treatment difference at Week 2
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3287
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Etanercept, Etanercept and Acitretin, Acitretin
Comments Overall treatment difference at Week 4
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4149
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Etanercept, Etanercept and Acitretin, Acitretin
Comments Overall treatment difference at Week 8
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3837
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Etanercept, Etanercept and Acitretin, Acitretin
Comments Overall treatment difference at Week 12
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6777
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Etanercept, Etanercept and Acitretin, Acitretin
Comments Overall treatment difference at Week 18
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4976
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Etanercept, Etanercept and Acitretin, Acitretin
Comments Overall treatment difference at Week 24
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4189
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
23.Secondary Outcome
Title Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 8, at Weeks 2, 4, 8, 12, 18 and 24
Hide Description Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with the treatment's effect on joint pain. Responses were based on a 5-point scale: Very dissatisfied (0), Dissatisfied (1), Neither satisfied nor dissatisfied (2), Satisfied (3), Very satisfied (4), Never had this problem (5). Change = Week X minus Baseline, where larger scores indicate improvement.
Time Frame Baseline, Weeks 2, 4, 8, 12, 18 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
mITT; LOCF
Arm/Group Title Etanercept Etanercept and Acitretin Acitretin
Hide Arm/Group Description:
Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
Acitretin 10 mg subcutaneous injection BID for 24 weeks
Overall Number of Participants Analyzed 21 19 18
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Baseline 4.43  (1.16) 3.79  (1.40) 4.17  (1.58)
Change at Week 2 -0.33  (1.11) -0.05  (1.18) 0.17  (0.99)
Change at Week 4 -0.52  (1.21) 0.05  (0.91) 0.22  (1.77)
Change at Week 8 -0.33  (1.20) 0.21  (1.03) 0.33  (1.53)
Change at Week 12 -0.29  (1.15) 0.21  (1.18) 0.00  (2.35)
Change at Week 18 -0.14  (0.85) 0.37  (1.38) -0.28  (1.60)
Change at Week 24 -0.57  (1.47) 0.05  (1.22) 0.17  (1.95)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Etanercept, Etanercept and Acitretin, Acitretin
Comments Overall treatment difference at Week 2
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4760
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Etanercept, Etanercept and Acitretin, Acitretin
Comments Overall treatment difference at Week 4
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4040
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Etanercept, Etanercept and Acitretin, Acitretin
Comments Overall treatment difference at Week 8
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4753
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Etanercept, Etanercept and Acitretin, Acitretin
Comments Overall treatment difference at Week 12
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5084
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Etanercept, Etanercept and Acitretin, Acitretin
Comments Overall treatment difference at Week 18
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2293
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Etanercept, Etanercept and Acitretin, Acitretin
Comments Overall treatment difference at Week 24
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3822
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
24.Secondary Outcome
Title Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 9, at Weeks 2, 4, 8, 12, 18 and 24
Hide Description Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with the treatment's effect on their comfort level with their personal appearance. Responses were based on a 5-point scale: Very dissatisfied (0), Dissatisfied (1), Neither satisfied nor dissatisfied (2), Satisfied (3), Very satisfied (4), Never had this problem (5). Change = Week X minus Baseline, where larger scores indicate improvement.
Time Frame Baseline, Weeks 2, 4, 8, 12, 18 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
mITT; LOCF
Arm/Group Title Etanercept Etanercept and Acitretin Acitretin
Hide Arm/Group Description:
Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
Acitretin 10 mg subcutaneous injection BID for 24 weeks
Overall Number of Participants Analyzed 21 19 18
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Baseline 1.14  (1.56) 0.79  (0.79) 0.83  (1.10)
Change at Week 2 0.43  (1.21) 0.63  (1.46) -0.11  (1.23)
Change at Week 4 0.90  (1.64) 1.05  (1.43) -0.11  (1.23)
Change at Week 8 1.48  (1.91) 1.58  (1.61) 0.44  (1.29)
Change at Week 12 1.52  (2.18) 1.89  (1.41) 0.17  (1.34)
Change at Week 18 1.90  (2.51) 1.68  (1.29) 0.72  (1.45)
Change at Week 24 1.57  (2.29) 2.21  (1.13) 0.78  (1.44)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Etanercept, Etanercept and Acitretin, Acitretin
Comments Overall treatment difference at Week 2
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2691
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Etanercept, Etanercept and Acitretin, Acitretin
Comments Overall treatment difference at Week 4
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0142
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Etanercept, Etanercept and Acitretin, Acitretin
Comments Overall treatment difference at Week 8
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0383
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Etanercept, Etanercept and Acitretin, Acitretin
Comments Overall treatment difference at Week 12
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0026
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Etanercept, Etanercept and Acitretin, Acitretin
Comments Overall treatment difference at Week 18
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0475
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Etanercept, Etanercept and Acitretin, Acitretin
Comments Overall treatment difference at Week 24
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0205
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
25.Secondary Outcome
Title Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 10, at Weeks 2, 4, 8, 12, 18 and 24
Hide Description Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with the treatment's effect on their anxiety. Responses were based on a 5-point scale: Very dissatisfied (0), Dissatisfied (1), Neither satisfied nor dissatisfied (2), Satisfied (3), Very satisfied (4), Never had this problem (5). Change = Week X minus Baseline, where larger scores indicate improvement.
Time Frame Baseline, Weeks 2, 4, 8, 12, 18 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
mITT; LOCF
Arm/Group Title Etanercept Etanercept and Acitretin Acitretin
Hide Arm/Group Description:
Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
Acitretin 10 mg subcutaneous injection BID for 24 weeks
Overall Number of Participants Analyzed 21 19 18
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Baseline 2.29  (1.87) 1.89  (1.73) 2.22  (1.80)
Change at Week 2 1.05  (1.66) 0.63  (1.89) -0.39  (1.54)
Change at Week 4 1.24  (1.55) 1.21  (1.84) -0.61  (1.61)
Change at Week 8 1.57  (1.91) 1.47  (1.95) 0.33  (2.06)
Change at Week 12 1.52  (2.14) 1.68  (1.73) 0.22  (2.60)
Change at Week 18 1.57  (2.01) 1.53  (1.87) 0.56  (2.15)
Change at Week 24 1.24  (1.95) 1.58  (1.68) 0.67  (2.25)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Etanercept, Etanercept and Acitretin, Acitretin
Comments Overall treatment difference at Week 2
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0512
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Etanercept, Etanercept and Acitretin, Acitretin
Comments Overall treatment difference at Week 4
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0024
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Etanercept, Etanercept and Acitretin, Acitretin
Comments Overall treatment difference at Week 8
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0946
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Etanercept, Etanercept and Acitretin, Acitretin
Comments Overall treatment difference at Week 12
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0935
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Etanercept, Etanercept and Acitretin, Acitretin
Comments Overall treatment difference at Week 18
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2073
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Etanercept, Etanercept and Acitretin, Acitretin
Comments Overall treatment difference at Week 24
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3415
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
26.Secondary Outcome
Title Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 11, at Weeks 2, 4, 8, 12, 18 and 24
Hide Description Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with the treatment's effect on their depression. Responses were based on a 5-point scale: Very dissatisfied (0), Dissatisfied (1), Neither satisfied nor dissatisfied (2), Satisfied (3), Very satisfied (4), Never had this problem (5). Change = Week X minus Baseline, where larger scores indicate improvement.
Time Frame Baseline, Weeks 2, 4, 8, 12, 18 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
mITT; LOCF
Arm/Group Title Etanercept Etanercept and Acitretin Acitretin
Hide Arm/Group Description:
Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
Acitretin 10 mg subcutaneous injection BID for 24 weeks
Overall Number of Participants Analyzed 21 19 18
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Baseline 2.43  (1.91) 1.95  (1.72) 2.33  (1.85)
Change at Week 2 0.95  (1.32) 1.11  (1.63) -0.11  (1.18)
Change at Week 4 1.33  (1.59) 1.26  (1.97) -0.22  (1.59)
Change at Week 8 1.38  (1.83) 1.47  (2.20) 0.28  (1.41)
Change at Week 12 1.71  (2.05) 1.58  (1.64) 0.17  (2.04)
Change at Week 18 1.57  (2.09) 1.47  (1.81) 0.61  (1.58)
Change at Week 24 1.19  (2.02) 1.68  (1.70) 0.67  (1.50)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Etanercept, Etanercept and Acitretin, Acitretin
Comments Overall treatment difference at Week 2
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0202
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Etanercept, Etanercept and Acitretin, Acitretin
Comments Overall treatment difference at Week 4
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0090
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Etanercept, Etanercept and Acitretin, Acitretin
Comments Overall treatment difference at Week 8
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0742
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Etanercept, Etanercept and Acitretin, Acitretin
Comments Overall treatment difference at Week 12
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0445
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Etanercept, Etanercept and Acitretin, Acitretin
Comments Overall treatment difference at Week 18
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2211
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Etanercept, Etanercept and Acitretin, Acitretin
Comments Overall treatment difference at Week 24
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1982
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
27.Secondary Outcome
Title Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 12, at Weeks 2, 4, 8, 12, 18 and 24
Hide Description Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with the treatment's effect on their fatigue. Responses were based on a 5-point scale: Very dissatisfied (0), Dissatisfied (1), Neither satisfied nor dissatisfied (2), Satisfied (3), Very satisfied (4), Never had this problem (5). Change = Week X minus Baseline, where larger scores indicate improvement.
Time Frame Baseline, Weeks 2, 4, 8, 12, 18 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
mITT; LOCF
Arm/Group Title Etanercept Etanercept and Acitretin Acitretin
Hide Arm/Group Description:
Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
Acitretin 10 mg subcutaneous injection BID for 24 weeks
Overall Number of Participants Analyzed 21 19 18
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Baseline 2.95  (1.75) 1.74  (1.52) 2.78  (1.73)