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Effects of Etanercept on Nail Psoriasis and Plaque 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: NCT00581100
Recruitment Status : Completed
First Posted : December 27, 2007
Results First Posted : August 30, 2010
Last Update Posted : February 25, 2013
Sponsor:
Information provided by (Responsible Party):
Wyeth is now a wholly owned subsidiary of Pfizer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Nail Psoriasis
Plaque Psoriasis
Intervention Drug: etanercept
Enrollment 136
Recruitment Details  
Pre-assignment Details Eighty-five participants were screened for the study; 13 participants were screening failures, and 72 participants were randomized to treatment.
Arm/Group Title Etanercept: Twice, Then Once Weekly Etanercept: Once Weekly
Hide Arm/Group Description Etanercept 50 mg subcutaneous (SC) injection twice weekly for 12 weeks reduced to Etanercept 50 mg once weekly to week 24 Etanercept 50 mg SC once weekly for the complete 24 week treatment period
Period Title: Overall Study
Started 38 34
Modified Intent-To-Treat Population 36 [1] 33 [1]
Completed 31 29
Not Completed 7 5
Reason Not Completed
Death             1             0
Adverse Event             2             1
Withdrawal by Subject             1             4
Other             3             0
[1]
At least one dose of study medication, and had baseline and post-baseline data.
Arm/Group Title Etanercept: Twice, Then Once Weekly Etanercept: Once Weekly Total
Hide Arm/Group Description Etanercept 50 mg subcutaneous (SC) injection twice weekly for 12 weeks reduced to Etanercept 50 mg once weekly to week 24 Etanercept 50 mg SC once weekly for the complete 24 week treatment period Total of all reporting groups
Overall Number of Baseline Participants 36 33 69
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 36 participants 33 participants 69 participants
46.28  (13.51) 45.36  (9.19) 45.84  (11.57)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 36 participants 33 participants 69 participants
Female
10
  27.8%
9
  27.3%
19
  27.5%
Male
26
  72.2%
24
  72.7%
50
  72.5%
1.Primary Outcome
Title Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Score for Target Fingernail
Hide Description Target fingernail (highest matrix + bed scores at baseline) divided with imaginary lines into quadrants and graded for nail matrix and nail bed psoriasis. Sum of scores = total score for that nail (0-8). Nail Matrix Psoriasis = pitting, leukonychia, red spots in lunula, and/or nail plate crumbling. Nail Bed Psoriasis = onycholysis, splinter hemorrhages, oil drop (salmon patch) discoloration, and/or nail bed hyperkeratosis. Range for both scores: 0 (none), 1 (present in 1/4 nail), 2 (present in 2/4 nail), 3 (present in 3/4 nail), 4 (present in 4/4 nail). Higher scores = more severe psoriasis.
Time Frame Baseline, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Intent-to-Treat (mITT) population: all randomized participants who received at least one dose of study medication, and provided baseline and post-baseline data. N = number of participants with evaluable data.
Arm/Group Title Etanercept: Twice, Then Once Weekly Etanercept: Once Weekly
Hide Arm/Group Description:
Etanercept 50 mg subcutaneous (SC) injection twice weekly for 12 weeks reduced to Etanercept 50 mg once weekly to week 24
Etanercept 50 mg SC once weekly for the complete 24 week treatment period
Overall Number of Participants Analyzed 35 32
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
-4.32
(-4.91 to -3.73)
-4.36
(-4.98 to -3.74)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Etanercept: Twice, Then Once Weekly
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments Adjusted change calculated from mixed-model. Model for change = [Group visit Group*visit baseline baseline*visit].
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Etanercept: Once Weekly
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Adjusted change calculated from mixed-model. Model for change = [Group visit Group*visit baseline baseline*visit].
Method Mixed Models Analysis
Comments [Not Specified]
2.Secondary Outcome
Title Change From Baseline in Overall Nail Psoriasis Severity Index (NAPSI) Score
Hide Description NAPSI (matrix + bed score) performed on dorsal views of 8 fingers, excluding thumb; range: 0 to 8. Overall NAPSI score = sum of all fingernail scores; range: 0 to 64. Nails were divided into quadrants and graded for nail matrix and bed psoriasis. Nail Matrix Psoriasis = pitting, leukonychia, red spots in lunula, and/or nail plate crumbling. Nail Bed Psoriasis = onycholysis, splinter hemorrhages, oil drop (salmon patch) discoloration, and/or nail bed hyperkeratosis. Range for both scores: 0 (none), 1 (present 1/4 nail), 2 (present 2/4 nail), 3 (present 3/4 nail), and 4 (present 4/4 nail).
Time Frame Baseline, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
mITT, N = number of participants with evaluable data.
Arm/Group Title Etanercept: Twice, Then Once Weekly Etanercept: Once Weekly
Hide Arm/Group Description:
Etanercept 50 mg subcutaneous (SC) injection twice weekly for 12 weeks reduced to Etanercept 50 mg once weekly to week 24
Etanercept 50 mg SC once weekly for the complete 24 week treatment period
Overall Number of Participants Analyzed 35 32
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
-22.64
(-26.44 to -18.85)
-22.63
(-26.61 to -18.66)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Etanercept: Twice, Then Once Weekly
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments Adjusted change calculated from mixed-model. Model for change = [Group visit Group*visit baseline baseline*visit].
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Etanercept: Once Weekly
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Adjusted change calculated from mixed-model. Model for change = [Group visit Group*visit baseline baseline*visit].
Method Mixed Models Analysis
Comments [Not Specified]
3.Secondary Outcome
Title Percent of Participants Who Achieved a 50% Improvement in the Nail Psoriasis Severity Index (NAPSI) Score for Target Fingernail at Week 12 and Week 24
Hide Description Target fingernail (highest matrix + bed scores at baseline) divided with imaginary lines into quadrants and graded for nail matrix and nail bed psoriasis. Sum of scores = total score for that nail (0-8). Nail Matrix Psoriasis = pitting, leukonychia, red spots in lunula, and/or nail plate crumbling. Nail Bed Psoriasis = onycholysis, splinter hemorrhages, oil drop (salmon patch) discoloration, and/or nail bed hyperkeratosis. Range for both scores 0-8: 0 (none), 1 (present in 1/4 nail), 2 (present in 2/4 nail), 3 (present in 3/4 nail),4 (present in 4/4 nail). Higher score = more severe psoriasis.
Time Frame Week 12, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
mITT, N = number of participants with evaluable data.
Arm/Group Title Etanercept: Twice, Then Once Weekly Etanercept: Once Weekly
Hide Arm/Group Description:
Etanercept 50 mg subcutaneous (SC) injection twice weekly for 12 weeks reduced to Etanercept 50 mg once weekly to week 24
Etanercept 50 mg SC once weekly for the complete 24 week treatment period
Overall Number of Participants Analyzed 36 33
Measure Type: Number
Unit of Measure: percent of participants
Week 12 60.61 51.61
Week 24 82.86 81.25
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Etanercept: Twice, Then Once Weekly
Comments Week 12
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE), with treatment and visits as fixed factors. Model for proportion = [Group visit Group*visit].
Method GEE model
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Etanercept: Once Weekly
Comments Week 12
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE), with treatment and visits as fixed factors. Model for proportion = [Group visit Group*visit].
Method GEE model
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Etanercept: Twice, Then Once Weekly
Comments Week 24
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE), with treatment and visits as fixed factors. Model for proportion = [Group visit Group*visit].
Method GEE model
Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Etanercept: Once Weekly
Comments Week 24
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE), with treatment and visits as fixed factors. Model for proportion = [Group visit Group*visit].
Method GEE model
Comments [Not Specified]
4.Secondary Outcome
Title Percent of Participants Who Achieved a 75% Improvement in the Nail Psoriasis Severity Index (NAPSI) Score for Target Fingernail at Week 12 and Week 24
Hide Description Target fingernail (highest matrix + bed scores at baseline) divided with imaginary lines into quadrants and graded for nail matrix and nail bed psoriasis. Sum of scores = total score for that nail (0-8). Nail Matrix Psoriasis = pitting, leukonychia, red spots in lunula, and/or nail plate crumbling. Nail Bed Psoriasis = onycholysis, splinter hemorrhages, oil drop (salmon patch) discoloration, and/or nail bed hyperkeratosis. Range for both scores: 0 (none), 1 (present in 1/4 nail), 2 (present in 2/4 nail), 3 (present in 3/4 nail), 4 (present in 4/4 nail). Higher scores = more severe psoriasis.
Time Frame Week 12, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
mITT, N = number of participants with evaluable data.
Arm/Group Title Etanercept: Twice, Then Once Weekly Etanercept: Once Weekly
Hide Arm/Group Description:
Etanercept 50 mg subcutaneous (SC) injection twice weekly for 12 weeks reduced to Etanercept 50 mg once weekly to week 24
Etanercept 50 mg SC once weekly for the complete 24 week treatment period
Overall Number of Participants Analyzed 36 33
Measure Type: Number
Unit of Measure: percent of participants
Week 12 18.18 19.35
Week 24 57.14 68.75
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Etanercept: Twice, Then Once Weekly
Comments Week 12
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.007
Comments P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE) with treatment and visits as fixed factors. Model for proportion=[Group visit Group*visit].
Method GEE model
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Etanercept: Once Weekly
Comments Week 12
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.006
Comments P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE) with treatment and visits as fixed factors. Model for proportion=[Group visit Group*visit].
Method GEE model
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Etanercept: Twice, Then Once Weekly
Comments Week 24
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE) with treatment and visits as fixed factors. Model for proportion=[Group visit Group*visit].
Method GEE model
Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Etanercept: Once Weekly
Comments Week 24
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE) with treatment and visits as fixed factors. Model for proportion=[Group visit Group*visit].
Method GEE model
Comments [Not Specified]
5.Secondary Outcome
Title Percent of Participants Who Achieved a 50% Improvement in the Nail Psoriasis Severity Index (NAPSI) for Overall NAPSI Score at Week 12 and Week 24
Hide Description NAPSI (matrix + bed score) performed on dorsal views of 8 fingers, excluding thumb; range: 0 to 8. Overall NAPSI score = sum of all fingernail scores; range: 0 to 64. Nails were divided into quadrants and graded for nail matrix and bed psoriasis. Nail Matrix Psoriasis = pitting, leukonychia, red spots in lunula, and/or nail plate crumbling. Nail Bed Psoriasis = onycholysis, splinter hemorrhages, oil drop (salmon patch) discoloration, and/or nail bed hyperkeratosis. Range for both scores: 0 (none), 1 (present 1/4 nail), 2 (present 2/4 nail), 3 (present 3/4 nail), and 4 (present 4/4 nail).
Time Frame Week 12, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
mITT, N = number of participants with evaluable data.
Arm/Group Title Etanercept: Twice, Then Once Weekly Etanercept: Once Weekly
Hide Arm/Group Description:
Etanercept 50 mg subcutaneous (SC) injection twice weekly for 12 weeks reduced to Etanercept 50 mg once weekly to week 24
Etanercept 50 mg SC once weekly for the complete 24 week treatment period
Overall Number of Participants Analyzed 36 33
Measure Type: Number
Unit of Measure: percent of participants
Week 12 54.55 48.39
Week 24 68.57 81.25
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Etanercept: Twice, Then Once Weekly
Comments Week 12
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE), with treatment and visits as fixed factors. Model for proportion =[Group visit Group*visit].
Method GEE model
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Etanercept: Once Weekly
Comments Week 12
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE), with treatment and visits as fixed factors. Model for proportion =[Group visit Group*visit].
Method GEE model
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Etanercept: Twice, Then Once Weekly
Comments Week 24
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE), with treatment and visits as fixed factors. Model for proportion =[Group visit Group*visit].
Method GEE model
Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Etanercept: Once Weekly
Comments Week 24
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE), with treatment and visits as fixed factors. Model for proportion =[Group visit Group*visit].
Method GEE model
Comments [Not Specified]
6.Secondary Outcome
Title Percent of Participants Who Achieved a 75% Improvement in the Nail Psoriasis Severity Index (NAPSI) for Overall NAPSI Score at Week 12 and Week 24
Hide Description NAPSI (matrix + bed score) performed on dorsal views of 8 fingers, excluding thumb; range: 0 to 8. Overall NAPSI score = sum of all fingernail scores; range: 0 to 64. Nails were divided into quadrants and graded for nail matrix and bed psoriasis. Nail Matrix Psoriasis = pitting, leukonychia, red spots in lunula, and/or nail plate crumbling. Nail Bed Psoriasis = onycholysis, splinter hemorrhages, oil drop (salmon patch) discoloration, and/or nail bed hyperkeratosis. Range for both scores: 0 (none), 1 (present 1/4 nail), 2 (present 2/4 nail), 3 (present 3/4 nail), and 4 (present 4/4 nail).
Time Frame Week 12, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
mITT, N = number of participants with evaluable data.
Arm/Group Title Etanercept: Twice, Then Once Weekly Etanercept: Once Weekly
Hide Arm/Group Description:
Etanercept 50 mg subcutaneous (SC) injection twice weekly for 12 weeks reduced to Etanercept 50 mg once weekly to week 24
Etanercept 50 mg SC once weekly for the complete 24 week treatment period
Overall Number of Participants Analyzed 36 33
Measure Type: Number
Unit of Measure: units on a scale
Week 12 9.09 19.35
Week 24 62.86 62.50
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Etanercept: Twice, Then Once Weekly
Comments Week 12
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.069
Comments P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE) with treatment and visits as fixed factors. Model for proportion=[Group visit Group*visit].
Method GEE model
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Etanercept: Once Weekly
Comments Week 12
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.006
Comments P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE) with treatment and visits as fixed factors. Model for proportion=[Group visit Group*visit].
Method GEE model
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Etanercept: Twice, Then Once Weekly
Comments Week 24
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE) with treatment and visits as fixed factors. Model for proportion=[Group visit Group*visit].
Method GEE model
Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Etanercept: Once Weekly
Comments Week 24
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE) with treatment and visits as fixed factors. Model for proportion=[Group visit Group*visit].
Method GEE model
Comments [Not Specified]
7.Secondary Outcome
Title Change From Baseline in the Psoriasis Area and Severity Index (PASI) 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 was scored by itself and scores were combined for final PASI. For each section percent (%) area of skin involved was estimated: 0 (0%) to 6 (90 - 100%), and severity was estimated by clinical signs: erythema, induration, and desquamation; scale: 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each section * area score * weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4).
Time Frame Baseline, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
mITT, N = number of participants with evaluable data.
Arm/Group Title Etanercept: Twice, Then Once Weekly Etanercept: Once Weekly
Hide Arm/Group Description:
Etanercept 50 mg subcutaneous (SC) injection twice weekly for 12 weeks reduced to Etanercept 50 mg once weekly to week 24
Etanercept 50 mg SC once weekly for the complete 24 week treatment period
Overall Number of Participants Analyzed 35 32
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
-14.81
(-16.56 to -13.05)
-14.11
(-15.95 to -12.28)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Etanercept: Twice, Then Once Weekly
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Adjusted change calculated from mixed model. Model for change=[Group visit group*visit baseline baseline*visit].
Method Mixed Models Analysis
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Etanercept: Once Weekly
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Adjusted change calculated from mixed model. Model for change=[Group visit group*visit baseline baseline*visit].
Method Mixed Models Analysis
Comments [Not Specified]
8.Secondary Outcome
Title Percent of Participants Achieving a 50% Improvement in the Psoriasis Area and Severity Index (PASI) Score at Week 12 and 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 was scored by itself and scores were combined for final PASI. For each section percent (%) area of skin involved was estimated: 0 (0%) to 6 (90 - 100%), and severity was estimated by clinical signs: erythema, induration, and desquamation; scale: 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each section * area score * weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4).
Time Frame Week 12 , Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
mITT, N = number of participants with evaluable data.
Arm/Group Title Etanercept: Twice, Then Once Weekly Etanercept: Once Weekly
Hide Arm/Group Description:
Etanercept 50 mg subcutaneous (SC) injection twice weekly for 12 weeks reduced to Etanercept 50 mg once weekly to week 24
Etanercept 50 mg SC once weekly for the complete 24 week treatment period
Overall Number of Participants Analyzed 36 33
Measure Type: Number
Unit of Measure: percent of participants
Week 12 90.91 87.10
Week 24 85.71 84.38
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Etanercept: Twice, Then Once Weekly
Comments Week 12
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE) with treatment and visits as fixed factors. Model for proportion=[Group visit Group*visit].
Method GEE model
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Etanercept: Once Weekly
Comments Week 12
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE) with treatment and visits as fixed factors. Model for proportion=[Group visit Group*visit].
Method GEE model
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Etanercept: Twice, Then Once Weekly
Comments Week 24
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE) with treatment and visits as fixed factors. Model for proportion=[Group visit Group*visit].
Method GEE model
Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Etanercept: Once Weekly
Comments Week 24
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE) with treatment and visits as fixed factors. Model for proportion=[Group visit Group*visit].
Method GEE model
Comments [Not Specified]
9.Secondary Outcome
Title Percent of Participants Achieving a 75% Improvement in the Psoriasis Area and Severity Index (PASI) Score at Week 12 and 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 was scored by itself and scores were combined for final PASI. For each section percent (%) area of skin involved was estimated: 0 (0%) to 6 (90 - 100%), and severity was estimated by clinical signs: erythema, induration, and desquamation; scale: 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each section * area score * weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4).
Time Frame Week 12 , Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
mITT, N = number of participants with evaluable data.
Arm/Group Title Etanercept: Twice, Then Once Weekly Etanercept: Once Weekly
Hide Arm/Group Description:
Etanercept 50 mg subcutaneous (SC) injection twice weekly for 12 weeks reduced to Etanercept 50 mg once weekly to week 24
Etanercept 50 mg SC once weekly for the complete 24 week treatment period
Overall Number of Participants Analyzed 36 33
Measure Type: Number
Unit of Measure: percent of participants
Week 12 51.52 58.06
Week 24 77.14 62.50
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Etanercept: Twice, Then Once Weekly
Comments Week 12
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE) with treatment and visits as fixed factors. Model for proportion=[Group visit Group*visit].
Method GEE model
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Etanercept: Once Weekly
Comments Week 12
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE) with treatment and visits as fixed factors. Model for proportion=[Group visit Group*visit].
Method GEE model
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Etanercept: Twice, Then Once Weekly
Comments Week 24
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE) with treatment and visits as fixed factors. Model for proportion=[Group visit Group*visit].
Method GEE model
Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Etanercept: Once Weekly
Comments Week 24
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE) with treatment and visits as fixed factors. Model for proportion=[Group visit Group*visit].
Method GEE model
Comments [Not Specified]
10.Secondary Outcome
Title Change From Baseline in Physician Global Assessment (PGA) of Psoriasis
Hide Description Physician Global Assessment (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.
Time Frame Baseline, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
mITT, N = number of participants with evaluable data.
Arm/Group Title Etanercept: Twice, Then Once Weekly Etanercept: Once Weekly
Hide Arm/Group Description:
Etanercept 50 mg subcutaneous (SC) injection twice weekly for 12 weeks reduced to Etanercept 50 mg once weekly to week 24
Etanercept 50 mg SC once weekly for the complete 24 week treatment period
Overall Number of Participants Analyzed 35 32
Mean (95% Confidence Interval)
Unit of Measure: unts on a scale
-1.65
(-2.05 to -1.26)
-1.84
(-2.25 to -1.43)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Etanercept: Twice, Then Once Weekly
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Adjusted change calculated from mixed model. Model for change-[Group visit Group*visit baseline baseline*visit].
Method Mixed Models Analysis
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Etanercept: Once Weekly
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Adjusted change calculated from mixed model. Model for change-[Group visit Group*visit baseline baseline*visit].
Method Mixed Models Analysis
Comments [Not Specified]
11.Secondary Outcome
Title Percent of Participants Achieving a Status on the Physician Global Assessment (PGA) of Psoriasis of Clear or Almost Clear
Hide Description Physician Global Assessment (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, Week 24 or Early Termination
Hide Outcome Measure Data
Hide Analysis Population Description
mITT, N = number of participants with evaluable data.
Arm/Group Title Etanercept: Twice, Then Once Weekly Etanercept: Once Weekly
Hide Arm/Group Description:
Etanercept 50 mg subcutaneous (SC) injection twice weekly for 12 weeks reduced to Etanercept 50 mg once weekly to week 24
Etanercept 50 mg SC once weekly for the complete 24 week treatment period
Overall Number of Participants Analyzed 35 32
Measure Type: Number
Unit of Measure: percent of participants
68.57 75.00
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Etanercept: Twice, Then Once Weekly
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE) with treatment and visits as fixed factors. Model for proportion=[Group visit Group*visit].
Method GEE model
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Etanercept: Once Weekly
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE) with treatment and visits as fixed factors. Model for proportion=[Group visit Group*visit].
Method GEE model
Comments [Not Specified]
12.Secondary Outcome
Title Percent of Participants Achieving a Status on the Physician Global Assessment (PGA) of Psoriasis of Mild or Better
Hide Description Physician Global Assessment (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 mild or better = PGA score of ≤ 2 (mild plaque elevation, mild scaling, and light red coloration).
Time Frame Baseline, Week 24 or Early Termination
Hide Outcome Measure Data
Hide Analysis Population Description
mITT, N = number of participants with evaluable data.
Arm/Group Title Etanercept: Twice, Then Once Weekly Etanercept: Once Weekly
Hide Arm/Group Description:
Etanercept 50 mg subcutaneous (SC) injection twice weekly for 12 weeks reduced to Etanercept 50 mg once weekly to week 24
Etanercept 50 mg SC once weekly for the complete 24 week treatment period
Overall Number of Participants Analyzed 35 32
Measure Type: Number
Unit of Measure: percent of participants
82.86 87.50
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Etanercept: Twice, Then Once Weekly
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE) with treatment and visits as fixed factors. Model for proportion=[Group visit Group*visit].
Method GEE model
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Etanercept: Once Weekly
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE) with treatment and visits as fixed factors. Model for proportion=[Group visit Group*visit].
Method GEE model
Comments [Not Specified]
13.Secondary Outcome
Title Change From Baseline in the Dermatology Life Quality Index (DLQI)
Hide Description Self-administered questionnaire to measure health-related quality of life (QoL)of adult patients suffering from skin disease; 10 questions concerning patients' perception of impact of their disease over last week encompassing aspects such as symptoms, feelings, daily activities, leisure, work, school, personal relationships and side effects of treatment. Questions scored on a 4-point Likert scale: 0 (not at all/not relevant), 1 (a little), 2 (a lot), and 3 (very much). Scores of individual items (0-3) were added to yield a total score (0-30); higher score = greater impairment of patient's QoL.
Time Frame Baseline, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
mITT, N = number of participants with evaluable data.
Arm/Group Title Etanercept: Twice, Then Once Weekly Etanercept: Once Weekly
Hide Arm/Group Description:
Etanercept 50 mg subcutaneous (SC) injection twice weekly for 12 weeks reduced to Etanercept 50 mg once weekly to week 24
Etanercept 50 mg SC once weekly for the complete 24 week treatment period
Overall Number of Participants Analyzed 35 31
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
-8.60
(-9.98 to -7.21)
-8.74
(-10.21 to -7.26)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Etanercept: Twice, Then Once Weekly
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Adjusted change calculated from mixed-model. Model for change=[Group visit Group*visit baseline baseline*visit].
Method Mixed Models Analysis
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Etanercept: Once Weekly
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Adjusted change calculated from mixed-model. Model for change=[Group visit Group*visit baseline baseline*visit].
Method Mixed Models Analysis
Comments [Not Specified]
14.Secondary Outcome
Title Change From Baseline in Physician Assessment of Nail Psoriasis Activity Visual Analog Scale (VAS)
Hide Description Physician global assessment of disease activity using a visual analog scale; range: 0 (no nail disease) to 100 (worst possible nail disease).
Time Frame Baseline, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
mITT, N = number of participants with evaluable data.
Arm/Group Title Etanercept: Twice, Then Once Weekly Etanercept: Once Weekly
Hide Arm/Group Description:
Etanercept 50 mg subcutaneous (SC) injection twice weekly for 12 weeks reduced to Etanercept 50 mg once weekly to week 24
Etanercept 50 mg SC once weekly for the complete 24 week treatment period
Overall Number of Participants Analyzed 34 32
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
-44.66
(-52.11 to -37.21)
-41.03
(-48.70 to -33.35)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Etanercept: Twice, Then Once Weekly
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Adjusted change calculated from mixed model. Model for change=[Group visit Group*visit baseline baseline*visit].
Method Mixed Models Analysis
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Etanercept: Once Weekly
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Adjusted change calculated from mixed model. Model for change=[Group visit Group*visit baseline baseline*visit].
Method Mixed Models Analysis
Comments [Not Specified]
15.Secondary Outcome
Title Change From Baseline in Patient Assessment of Nail Psoriasis Activity Visual Analog Scale (VAS)
Hide Description Patient global assessment of disease activity using a visual analog scale; range: 0 (no nail disease) to 100 (worst possible nail disease).
Time Frame Baseline, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
mITT, N = number of participants with evaluable data.
Arm/Group Title Etanercept: Twice, Then Once Weekly Etanercept: Once Weekly
Hide Arm/Group Description:
Etanercept 50 mg subcutaneous (SC) injection twice weekly for 12 weeks reduced to Etanercept 50 mg once weekly to week 24
Etanercept 50 mg SC once weekly for the complete 24 week treatment period
Overall Number of Participants Analyzed 35 32
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
-48.89
(-56.86 to -40.91)
-41.69
(-50.02 to -33.35)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Etanercept: Twice, Then Once Weekly
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Adjusted change calculated from mixed model. Model for change=[Group visit Group*visit baseline baseline*visit].
Method Mixed Models Analysis
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Etanercept: Once Weekly
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments <Table 8-14> Change from baseline in Physician and Patient Assessment of Nail Psoriasis Activity Visual Analog Scale (VAS)
Method Mixed Models Analysis
Comments [Not Specified]
16.Secondary Outcome
Title Change From Baseline in Physician Fingernail Grading Assessment Total Score
Hide Description Physician assessment of disease activity for each fingernail; range: 0 (no disease), 1 (mild disease, 2 (moderate disease), or 3 (severe disease). Total score range = 0-30.
Time Frame Baseline, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
mITT, N = number of participants with evaluable data.
Arm/Group Title Etanercept: Twice, Then Once Weekly Etanercept: Once Weekly
Hide Arm/Group Description:
Etanercept 50 mg subcutaneous (SC) injection twice weekly for 12 weeks reduced to Etanercept 50 mg once weekly to week 24
Etanercept 50 mg SC once weekly for the complete 24 week treatment period
Overall Number of Participants Analyzed 35 32
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
-11.47
(-13.54 to -9.41)
-12.21
(-14.37 to -10.05)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Etanercept: Twice, Then Once Weekly
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Adjusted change calculated from mixed-model. Model for change=[Group visit Group*visit baseline baseline*visit].
Method Mixed Models Analysis
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Etanercept: Once Weekly
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Adjusted change calculated from mixed-model. Model for change=[Group visit Group*visit baseline baseline*visit].
Method Mixed Models Analysis
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description Safety population: all subjects who took at least one dose of study medication.
 
Arm/Group Title Etanercept: Twice, Then Once Weekly Etanercept: Once Weekly
Hide Arm/Group Description Etanercept 50 mg subcutaneous (SC) injection twice weekly for 12 weeks reduced to Etanercept 50 mg once weekly to week 24 Etanercept 50 mg SC once weekly for the complete 24 week treatment period
All-Cause Mortality
Etanercept: Twice, Then Once Weekly Etanercept: Once Weekly
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Etanercept: Twice, Then Once Weekly Etanercept: Once Weekly
Affected / at Risk (%) Affected / at Risk (%)
Total   2/38 (5.26%)   0/34 (0.00%) 
Cardiac disorders     
Myocardial infarction  1  1/38 (2.63%)  0/34 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Lung cancer stage unspecified  1  1/38 (2.63%)  0/34 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12.1
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Etanercept: Twice, Then Once Weekly Etanercept: Once Weekly
Affected / at Risk (%) Affected / at Risk (%)
Total   22/38 (57.89%)   12/34 (35.29%) 
Blood and lymphatic system disorders     
Leukocytosis not otherwise specified (NOS)  1  1/38 (2.63%)  0/34 (0.00%) 
Neutrophilia  1  1/38 (2.63%)  0/34 (0.00%) 
Eye disorders     
Conjunctivitis NEC  1  0/38 (0.00%)  1/34 (2.94%) 
Gastrointestinal disorders     
Hyperacidity  1  1/38 (2.63%)  0/34 (0.00%) 
Abdominal pain NOS  1  1/38 (2.63%)  0/34 (0.00%) 
Vomiting NOS  1  1/38 (2.63%)  0/34 (0.00%) 
Constipation  1  1/38 (2.63%)  0/34 (0.00%) 
Diarrhea NOS  1  1/38 (2.63%)  0/34 (0.00%) 
Loose stools  1  0/38 (0.00%)  1/34 (2.94%) 
Sore throat NOS  1  1/38 (2.63%)  0/34 (0.00%) 
General disorders     
Injection site dermatitis  1  1/38 (2.63%)  1/34 (2.94%) 
Injection site pain  1  1/38 (2.63%)  1/34 (2.94%) 
Pyrexia  1  2/38 (5.26%)  1/34 (2.94%) 
Application site rash  1  0/38 (0.00%)  1/34 (2.94%) 
Influenza like illness  1  0/38 (0.00%)  1/34 (2.94%) 
Injection site burning  1  1/38 (2.63%)  0/34 (0.00%) 
Injection site urticaria  1  1/38 (2.63%)  0/34 (0.00%) 
Hepatobiliary disorders     
Liver fatty  1  1/38 (2.63%)  0/34 (0.00%) 
Infections and infestations     
Nasopharyngitis  1  4/38 (10.53%)  4/34 (11.76%) 
Tooth abscess  1  1/38 (2.63%)  0/34 (0.00%) 
Folliculitis  1  0/38 (0.00%)  1/34 (2.94%) 
Respiratory tract infection NOS  1  1/38 (2.63%)  0/34 (0.00%) 
Pharyngitis NOS  1  0/38 (0.00%)  1/34 (2.94%) 
Influenza  1  1/38 (2.63%)  1/34 (2.94%) 
Localized infection  1  1/38 (2.63%)  0/34 (0.00%) 
Investigations     
Transaminase NOS increased  1  1/38 (2.63%)  0/34 (0.00%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  1/38 (2.63%)  1/34 (2.94%) 
Localized osteoarthritis  1  0/38 (0.00%)  1/34 (2.94%) 
Pain in limb  1  1/38 (2.63%)  0/34 (0.00%) 
Nervous system disorders     
Headache NOS  1  4/38 (10.53%)  3/34 (8.82%) 
Burning sensation NOS  1  0/38 (0.00%)  1/34 (2.94%) 
Paraesthesia NEC  1  1/38 (2.63%)  0/34 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Chronic obstructive airways disease exacerbated  1  0/38 (0.00%)  1/34 (2.94%) 
Skin and subcutaneous tissue disorders     
Dermatitis allergic  1  2/38 (5.26%)  0/34 (0.00%) 
Panniculitis  1  1/38 (2.63%)  0/34 (0.00%) 
Alopecia areata  1  0/38 (0.00%)  1/34 (2.94%) 
Pruritus NOS  1  1/38 (2.63%)  0/34 (0.00%) 
Psoriasis aggravated  1  0/38 (0.00%)  1/34 (2.94%) 
Skin disorder NOS  1  1/38 (2.63%)  0/34 (0.00%) 
Rash papular  1  0/38 (0.00%)  1/34 (2.94%) 
Vascular disorders     
Hematoma NOS  1  1/38 (2.63%)  0/34 (0.00%) 
Hypertension NOS  1  1/38 (2.63%)  0/34 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The PIs agreed to allow the sponsor 60 days to review and require changes to presentations or publications but only to protect confidential information and intellectual property, and for the sponsor to file a patent application, as applicable. The PIs also agreed for data to be presented first as a joint, multi-center publication.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: U. S. Contact Center
Organization: Wyeth
EMail: clintrialresults@wyeth.com
Layout table for additonal information
Responsible Party: Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier: NCT00581100    
Other Study ID Numbers: 0881A6-409
First Submitted: December 21, 2007
First Posted: December 27, 2007
Results First Submitted: August 3, 2010
Results First Posted: August 30, 2010
Last Update Posted: February 25, 2013