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Trial record 41 of 298 for:    "Ankylosing spondylitis"

Study Evaluating Etanercept for the Treatment of Active, Severe, and Advanced Axial Ankylosing Spondylitis

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: NCT00420238
Recruitment Status : Completed
First Posted : January 11, 2007
Results First Posted : June 15, 2010
Last Update Posted : June 29, 2010
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Ankylosing Spondylitis
Interventions Drug: Etanercept (Enbrel)
Other: Placebo
Enrollment 82
Recruitment Details Subjects with advanced ankylosing spondylitis (AS) by Modified New York criteria, advanced and severe disease with intervertebral bridges, and an axial defined by a score of ≥30 for overall level of AS neck, back, or hip pain on the BASDAI were eligible to participate in the study and were randomized at 19 study sites.
Pre-assignment Details Subjects completed a screening period of up to 6 weeks duration prior to entering the treatment period; 95 subjects were screened, and 82 subjects were randomized.
Arm/Group Title Etanercept/Etanercept Placebo/Etanercept
Hide Arm/Group Description Etanercept 50 mg subcutaneously (SC) once weekly Placebo subcutaneously (SC), once weekly; Etanercept 50 mg SC, once weekly
Period Title: 12 Week Double-Blind Treatment Period 1
Started 39 43
Completed 38 39
Not Completed 1 4
Reason Not Completed
Adverse Event             1             0
Lack of Efficacy             0             2
Lost to Follow-up             0             1
Withdrawal of Consent             0             1
Period Title: 12 Week Open-Label Treatment Period 2
Started 38 39
Completed 36 38
Not Completed 2 1
Reason Not Completed
Lost to Follow-up             1             0
Withdrawal of Consent             1             1
Arm/Group Title Etanercept Placebo Total
Hide Arm/Group Description 50 mg subcutaneously (SC), once weekly Subcutaneously (SC), once weekly Total of all reporting groups
Overall Number of Baseline Participants 39 43 82
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 39 participants 43 participants 82 participants
46.2  (10.8) 48.2  (47.3) 47.3  (10.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 39 participants 43 participants 82 participants
Female
2
   5.1%
4
   9.3%
6
   7.3%
Male
37
  94.9%
39
  90.7%
76
  92.7%
1.Primary Outcome
Title Normalized Net Incremental Area Under the Curve (AUC) for the Bath Ankylosing Spondylitis Disease Activities Index (BASDAI) Between Randomization and Week 12
Hide Description BASDAI subject asessment of discomfort, pain and fatigue measured using a 100 millimeter Visual Analog Scale; range: 0=none to 100=very severe. Normalized net incremental area under the curve (AUC) = area between baseline and the BASDAI curve as a function of time (randomization to Week 12); computed using the linear trapezoidal method. All areas above baseline and under the curve are positive and all areas below baseline and above the curve are negative. Net incremental AUC = sum of these areas; this result was then divided by the study duration of the patients; negative value = improvement.
Time Frame Baseline, Week 2, Week 4, Week 8, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Intent-To-Treat (mITT) population: includes all randomized subjects who received at least 1 dose of blinded study drug. Last observation carried forward (LOCF).
Arm/Group Title Etanercept Placebo
Hide Arm/Group Description:
50 mg subcutaneously (SC), once weekly
Subcutaneously (SC), once weekly
Overall Number of Participants Analyzed 39 43
Least Squares Mean (95% Confidence Interval)
Unit of Measure: millimeters
-19.79
(-25.03 to -14.54)
-10.96
(-15.95 to -5.97)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
Comments Comparison of least squares means. Primary analysis: analysis of covariance (ANCOVA) with treatment as a factor and BASDAI baseline as a covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.019
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -8.83
Confidence Interval (2-Sided) 95%
-16.5 to -1.51
Estimation Comments Least squares mean difference = mean difference final value.
2.Secondary Outcome
Title Percent of Subjects Achieving Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 Response
Hide Description BASDAI subject assessment of discomfort, pain and fatigue was measured using a 100 millimeter Visual Analog Scale (VAS); range: 0=none to 100=very severe. BASDAI 50 response defined as at least a 50 percent (%) improvement (decrease) from baseline to observation (last observation carried forward) in the BASDAI. Baseline score minus score at observation divided by Baseline score * 100 = >=50%.
Time Frame Baseline, Week 2, Week 4, Week 8, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
mITT; LOCF.
Arm/Group Title Etanercept Placebo
Hide Arm/Group Description:
50 mg subcutaneously (SC), once weekly
Subcutaneously (SC), once weekly
Overall Number of Participants Analyzed 39 43
Measure Type: Number
Unit of Measure: percent of participants
Week 2 23.08 9.30
Week 4 28.21 16.28
Week 8 41.03 23.26
Week 12 46.15 23.26
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
Comments Week 2: Generalized estimating equations (GEE) model, using a logit link, a binomial distribution and an auto-regressive correlation structure, with treatment groups, visits and their interactions as fixed factors.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.098
Comments [Not Specified]
Method GEE model
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.92
Confidence Interval (2-Sided) 95%
0.82 to 10.42
Estimation Comments An odds-ratio greater than 1 indicates the odds of response is greater in the etanercept group than in the placebo group.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
Comments Week 4: Generalized estimating equations (GEE) model, using a logit link, a binomial distribution and an auto-regressive correlation structure, with treatment groups, visits and their interactions as fixed factors.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.197
Comments [Not Specified]
Method GEE model
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.02
Confidence Interval (2-Sided) 95%
0.69 to 5.88
Estimation Comments An odds-ratio greater than 1 indicates the odds of response is greater in the etanercept group than in the placebo group.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
Comments Week 8: Generalized estimating equations (GEE) model, using a logit link, a binomial distribution and an auto-regressive correlation structure, with treatment groups, visits and their interactions as fixed factors.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.087
Comments [Not Specified]
Method GEE model
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.30
Confidence Interval (2-Sided) 95%
0.89 to 5.95
Estimation Comments An odds-ratio greater than 1 indicates the odds of response is greater in the etanercept group than in the placebo group.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
Comments Week 12: Generalized estimating equations (GEE) model, using a logit link, a binomial distribution and an auto-regressive correlation structure, with treatment groups, visits and their interactions as fixed factors.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.031
Comments [Not Specified]
Method GEE model
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.83
Confidence Interval (2-Sided) 95%
1.10 to 7.29
Estimation Comments An odds-ratio greater than 1 indicates the odds of response is greater in the etanercept group than in the placebo group.
3.Secondary Outcome
Title Percent of Subjects Achieving Assessment Ankylosing Spondylitis (ASAS) 20 at Weeks 2, 4, 8, 12
Hide Description ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) patients; 4 domains: patient global assessment of disease activity, pain, function,and inflammation. ASAS 20 = 20% improvement (versus baseline) and an absolute change (net improvement) ≥ 10 millimeters (mm) on a 0-100 mm scale (100=high disease activity) for ≥ 3 domains, and no worsening (absence of deterioration by >=20% and by >= 10 mm) in remaining domain.
Time Frame Week 2, Week 4, Week 8, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
mITT; LOCF.
Arm/Group Title Etanercept Placebo
Hide Arm/Group Description:
50 mg subcutaneously (SC), once weekly
Subcutaneously (SC), once weekly
Overall Number of Participants Analyzed 39 43
Measure Type: Number
Unit of Measure: percent of participants
Week 2 30.77 20.93
Week 4 41.03 30.23
Week 8 64.10 27.91
Week 12 66.67 32.56
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
Comments Week 2: Generalized estimating equations (GEE) model, using a logit link, a binomial distribution and an auto-regressive correlation structure, with treatment groups, visits, and their interaction as fixed factors.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.310
Comments [Not Specified]
Method GEE model
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.68
Confidence Interval (2-Sided) 95%
0.62 to 4.57
Estimation Comments An odds ratio greater than 1 indicates the odds of response is greater in the etanercept group than in the placebo group.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
Comments Week 4: Generalized estimating equations (GEE) model, using a logit link, a binomial distribution and an auto-regressive correlation structure, with treatment groups, visits, and their interaction as fixed factors.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.309
Comments [Not Specified]
Method GEE model
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.61
Confidence Interval (2-Sided) 95%
0.65 to 3.99
Estimation Comments An odds ratio greater than 1 indicates the odds of response is greater in the etanercept group than in the placebo group.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
Comments Week 8: Generalized estimating equations (GEE) model, using a logit link, a binomial distribution and an auto-regressive correlation structure, with treatment groups, visits, and their interaction as fixed factors.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments [Not Specified]
Method GEE model
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 4.61
Confidence Interval (2-Sided) 95%
1.81 to 11.74
Estimation Comments An odds ratio greater than 1 indicates the odds of response is greater in the etanercept group than in the placebo group.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
Comments Week 12: Generalized estimating equations (GEE) model, using a logit link, a binomial distribution and an auto-regressive correlation structure, with treatment groups, visits, and their interaction as fixed factors.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.003
Comments [Not Specified]
Method GEE model
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 4.14
Confidence Interval 95%
1.65 to 10.42
Estimation Comments An odds ratio greater than 1 indicates the odds of response is greater in the etanercept group than in the placebo group.
4.Secondary Outcome
Title Percent of Subjects Acheiving Assessment Ankylosing Spondylitis (ASAS) 20 at Weeks 14, 18, 24
Hide Description ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) patients; 4 domains: patient global assessment of disease activity, pain, function, and inflammation. ASAS 20 = 20% improvement (versus baseline) and an absolute change (net improvement) ≥ 10 units (millimeters) on a 0-100 scale (100=high disease activity) for ≥ 3 domains, and no worsening (absence of deterioration by >=20% and by >=10 mm) in remaining domain.
Time Frame Week 14, Week 18, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Open-label population: all subjects who received at least 1 dose of open test article (Etanercept). LOCF.
Arm/Group Title Etanercept/Etanercept Placebo/Etanercept
Hide Arm/Group Description:
Double-blind Period 1: Etanercept 50 mg subcutaneously (SC) once weekly; Open-label Period 2: etanercept 50 mg subcutaneously (SC), once weekly
Double-blind Period 1: placebo subcutaneously (SC), once weekly; Open-label Period 2: etanercept subcutaneously (SC), once weekly
Overall Number of Participants Analyzed 38 39
Measure Type: Number
Unit of Measure: percent of participants
Week 14 71.05 53.85
Week 18 71.05 64.10
Week 24 84.21 66.67
5.Secondary Outcome
Title Percent of Subjects Achieving Assessment Ankylosing Spondylitis (ASAS) 50 at Weeks 2, 4, 8, 12
Hide Description ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) patients; 4 domains: patient global assessment of disease activity, pain, function, inflammation. ASAS 50 = 50% improvement (versus baseline) and an absolute (net) change ≥ 20 units on a 0-100 scale (high disease activity) for ≥ 3 domains, and no worsening (absence of deterioration by >=20% and by >=10 mm) in remaining domain.
Time Frame Week 2, Week 4, Week 8, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
mITT; LOCF.
Arm/Group Title Etanercept Placebo
Hide Arm/Group Description:
50 mg subcutaneously (SC), once weekly
Subcutaneously (SC), once weekly
Overall Number of Participants Analyzed 39 43
Measure Type: Number
Unit of Measure: percent of participants
Week 2 17.95 9.30
Week 4 23.08 16.28
Week 8 35.90 16.28
Week 12 38.46 13.95
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
Comments Week 2: Generalized estimating equations (GEE) model, using a logit link, a binomial distribution and an auto-regressive correlation structure, with treatment groups, visits, and their interaction as fixed factors.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.259
Comments [Not Specified]
Method GEE model
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.13
Confidence Interval (2-Sided) 95%
0.57 to 7.94
Estimation Comments An odds ratio greater than 1 indicates the odds of response is greater in etanercept group than in placebo group.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
Comments Week 4: Generalized estimating equations (GEE) model, using a logit link, a binomial distribution and an auto-regressive correlation structure, with treatment groups, visits, and their interaction as fixed factors.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.440
Comments [Not Specified]
Method GEE model
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.54
Confidence Interval 95%
0.51 to 4.64
Estimation Comments An odds ratio greater than 1 indicates the odds of response is greater in etanercept group than in placebo group.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
Comments Week 8: Generalized estimating equations (GEE) model, using a logit link, a binomial distribution and an auto-regressive correlation structure, with treatment groups, visits, and their interaction as fixed factors.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.046
Comments [Not Specified]
Method GEE model
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.88
Confidence Interval 95%
1.02 to 8.16
Estimation Comments An odds ratio greater than 1 indicates the odds of response is greater in etanercept group than in placebo group.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
Comments Week 12: Generalized estimating equations (GEE) model, using a logit link, a binomial distribution and an auto-regressive correlation structure, with treatment groups, visits, and their interaction as fixed factors.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.014
Comments [Not Specified]
Method GEE model
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 3.85
Confidence Interval 95%
1.31 to 11.32
Estimation Comments An odds ratio greater than 1 indicates the odds of response is greater in etanercept group than in placebo group.
6.Secondary Outcome
Title Percent of Subjects Achieving Assessment Ankylosing Spondylitis (ASAS) 50 at Weeks 14, 18, 24
Hide Description ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) patients; 4 domains: patient global assessment of disease activity, pain, function, inflammation. ASAS 50 = 50% improvement (vs. baseline) and an absolute (net) change ≥ 20 units on a 0-100 scale (high disease activity) for ≥ 3 domains, and no worsening (absence of deterioration by >=20% and by >=10 mm) in remaining domain.
Time Frame Week 14, Week 18, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Open-label population; LOCF.
Arm/Group Title Etanercept/Etanercept Placebo/Etanercept
Hide Arm/Group Description:
Double-blind Period 1: Etanercept 50 mg subcutaneously (SC) once weekly; Open-label Period 2: Etanercept 50 mg subcutaneously (SC), once weekly
Double-blind Period 1: placebo subcutaneously (SC), once weekly; Open-label Period 2: etanercept subcutaneously (SC), once weekly
Overall Number of Participants Analyzed 38 39
Measure Type: Number
Unit of Measure: percent of particpants
Week 14 44.74 43.59
Week 18 50.00 48.72
Week 24 60.53 51.28
7.Secondary Outcome
Title Percent of Subjects Achieving Assessment Ankylosing Spondylitis (ASAS) 70 at Weeks 2, 4, 8, 12
Hide Description ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) patients; 4 domains: patient global assessment of disease activity, pain, function, inflammation. ASAS 70 = 70% improvement (vs. baseline) and an absolute change ≥ 20 units on a 0-100 scale (high disease activity) for ≥ 3 domains, and no worsening (absence of deterioration by >=20% and by >= 10 mm) in remaining domain.
Time Frame Week 2, Week 4, Week 8, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
mITT; LOCF.
Arm/Group Title Etanercept Placebo
Hide Arm/Group Description:
50 mg subcutaneously (SC), once weekly
Subcutaneously (SC), once weekly
Overall Number of Participants Analyzed 39 43
Measure Type: Number
Unit of Measure: percent of participants
Week 2 12.82 4.65
Week 4 17.95 4.65
Week 8 15.38 4.65
Week 12 25.64 9.30
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
Comments Week 2: Generalized estimating equations (GEE) model, using a logit link, a binomial distribution and an auto-regressive correlation structure, with treatment groups, visits, and their interaction as fixed factors.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.204
Comments [Not Specified]
Method GEE model
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 3.01
Confidence Interval (2-Sided) 95%
0.55 to 16.53
Estimation Comments An odds ratio greater than 1 indicates the odds of response is greater in etanercept group than in placebo group.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
Comments Week 4: Generalized estimating equations (GEE) model, using a logit link, a binomial distribution and an auto-regressive correlation structure, with treatment groups, visits, and their interaction as fixed factors.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.073
Comments [Not Specified]
Method GEE model
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 4.48
Confidence Interval 95%
0.87 to 23.07
Estimation Comments An odds ratio greater than 1 indicates the odds of response is greater in etanercept group than in placebo group.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
Comments Week 8: Generalized estimating equations (GEE) model, using a logit link, a binomial distribution and an auto-regressive correlation structure, with treatment groups, visits, and their interaction as fixed factors.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.121
Comments [Not Specified]
Method GEE model
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 3.73
Confidence Interval 95%
0.71 to 19.69
Estimation Comments An odds ratio greater than 1 indicates the odds of response is greater in etanercept group than in placebo group.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
Comments Week 12: Generalized estimating equations (GEE) model, using a logit link, a binomial distribution and an auto-regressive correlation structure, with treatment groups, visits, and their interaction as fixed factors.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.058
Comments [Not Specified]
Method GEE model
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 3.36
Confidence Interval 95%
0.96 to 11.80
Estimation Comments An odds ratio greater than 1 indicates the odds of response is greater in etanercept group than in placebo group.
8.Secondary Outcome
Title Percent of Subjects Achieiving Assessment Ankylosing Spondylitis (ASAS) 70 at Weeks 14, 18, 24
Hide Description ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) patients; 4 domains: patient global assessment of disease activity, pain, function, inflammation. ASAS 70 = 70% improvement (vs. baseline) and an absolute change ≥ 20 units on a 0-100 scale (high disease activity) for ≥ 3 domains, and no worsening (absence of deterioration by >=20% and by >= 10 mm) in remaining domain.
Time Frame Week 14, Week 18, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Open-label population; LOCF.
Arm/Group Title Etanercept/Etanercept Placebo/Etanercept
Hide Arm/Group Description:
Double-blind Period 1: Etanercept 50 mg subcutaneously (SC) once weekly; Open-label Period 2: Etanercept 50 mg subcutaneously (SC), once weekly
Double-blind Period 1: placebo subcutaneously (SC), once weekly; Open-label Period 2: etanercept subcutaneously (SC), once weekly
Overall Number of Participants Analyzed 38 39
Measure Type: Number
Unit of Measure: percent of participants
Week 14 31.58 33.33
Week 18 31.58 30.77
Week 24 36.84 35.90
9.Secondary Outcome
Title Percent of Subjects Achieving Partial Remission at Weeks 2, 4, 8, 12
Hide Description Partial remission defined as a score of <20 millimeters (mm) on a scale of 0 to 100 mm in each of 4 domains: Visual Analog Scale (VAS) patient global assessment, VAS pain score (Total Back Pain), Bath Ankylosing Spondylitis Functional Index (BASFI) score, and Bath Ankylosing Spondylitis Disease Activities Index (BASDAI)-mean of two morning stiffness-related VAS scores. A negative score indicates an improvement in disease activity and a positive score indicates worsening.
Time Frame Week 2, Week 4, Week 8, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
mITT; LOCF.
Arm/Group Title Etanercept Placebo
Hide Arm/Group Description:
50 mg subcutaneously (SC), once weekly
Subcutaneously (SC), once weekly
Overall Number of Participants Analyzed 39 43
Measure Type: Number
Unit of Measure: percent of participants
Week 2 7.69 2.33
Week 4 10.26 2.33
Week 8 17.95 4.65
Week 12 17.95 4.65
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
Comments Week 2: Generalized estimating equations (GEE) model, using a logit link, a binomial distribution and an auto-regressive correlation structure, with treatment groups, visits, and their interaction as fixed factors.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.287
Comments [Not Specified]
Method GEE model
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 3.50
Confidence Interval (2-Sided) 95%
0.35 to 35.14
Estimation Comments An odds ratio greater than 1 indicates the odds of response is greater in etanercept group than in placebo group.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
Comments Week 4: Generalized estimating equations (GEE) model, using a logit link, a binomial distribution and an auto-regressive correlation structure, with treatment groups, visits, and their interaction as fixed factors.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.169
Comments [Not Specified]
Method GEE model
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 4.80
Confidence Interval 95%
0.51 to 44.94
Estimation Comments An odds ratio greater than 1 indicates the odds of response is greater in etanercept group than in placebo group.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
Comments Week 8: Generalized estimating equations (GEE) model, using a logit link, a binomial distribution and an auto-regressive correlation structure, with treatment groups, visits, and their interaction as fixed factors.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.073
Comments [Not Specified]
Method GEE model
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 4.48
Confidence Interval 95%
0.87 to 23.07
Estimation Comments An odds ratio greater than 1 indicates the odds of response is greater in etanercept group than in placebo group.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
Comments Week 12: Generalized estimating equations (GEE) model, using a logit link, a binomial distribution and an auto-regressive correlation structure, with treatment groups, visits, and their interaction as fixed factors.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.073
Comments [Not Specified]
Method GEE model
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 4.48
Confidence Interval 95%
0.87 to 23.07
Estimation Comments An odds ratio greater than 1 indicates the odds of response is greater in etanercept group than in placebo group.
10.Secondary Outcome
Title Percent of Subjects Achieving Partial Remission at Weeks 14, 18, 24
Hide Description Partial remission defined as a score of <20 millimeters (mm) on a scale of 0 to 100 mm in each of 4 domains: Visual Analog Scale (VAS) patient global assessment, VAS pain score (Total Back Pain), Bath Ankylosing Spondylitis Functional Index (BASFI) score, and Bath Ankylosing Spondylitis Disease Activities Index (BASDAI)-mean of two morning stiffness-related VAS scores. A negative score indicates an improvement in disease activity and a positive score indicates worsening.
Time Frame Week 14, Week 18, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Open-label population; LOCF.
Arm/Group Title Etanercept/Etanercept Placebo/Etanercept
Hide Arm/Group Description:
Double-blind Period 1: Etanercept 50 mg subcutaneously (SC) once weekly; Open-label Period 2: Etanercept 50 mg subcutaneously (SC), once weekly
Double-blind Period 1: placebo subcutaneously (SC), once weekly; Open-label Period 2: etanercept subcutaneously (SC), once weekly
Overall Number of Participants Analyzed 38 39
Measure Type: Number
Unit of Measure: percent of participants
Week 14 28.95 23.08
Week 18 31.58 25.64
Week 24 28.95 23.08
11.Secondary Outcome
Title Normalized Net Incremental Area Under the Curve (AUC) for Patient Global Assessment (PGA) Between Baseline and Week 12
Hide Description PGA was measured using a 100 millimeter Visual Analog Scale (VAS) ranging from 0 = very good to 100 = very bad. Normalized net incremental area under the curve (AUC)=area between baseline and the Patient Global Asessment curve as a function of time (randomization to Week 12); computed using the linear trapezoidal method. All areas above baseline and under the curve are positive and all area below baseline and above the curve are negative. Net incremental AUC = sum of these areas; this result was then divided by the study duration of the patients; negative value = improvement.
Time Frame Baseline, Week 2, Week 4, Week 8, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
mITT; LOCF. N = number of subjects with evaluable data.
Arm/Group Title Etanercept Placebo
Hide Arm/Group Description:
50 mg subcutaneously (SC), once weekly
Subcutaneously (SC), once weekly
Overall Number of Participants Analyzed 39 41
Least Squares Mean (95% Confidence Interval)
Unit of Measure: millimeters
-20.35
(-26.23 to -14.47)
-10.39
(-16.13 to -4.66)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
Comments Analysis of covariance (ANCOVA) with treatment as a factor and baseline value as a covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.018
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -9.95
Confidence Interval (2-Sided) 95%
-18.19 to -1.72
Estimation Comments Least squares mean difference = mean difference final value.
12.Secondary Outcome
Title Change From Baseline in Patient Global Assessment Visual Analog Scale (VAS) at Weeks 2, 4, 8, 12
Hide Description Patient global assessment of all the ways ankylosing spondylitis affected them in the last 48 hours using a 100 millimeter (mm) Visual Analog Scale (VAS); range 0=very good to 100=very bad.
Time Frame Baseline, Week 2, Week 4, Week 8, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
mITT; LOCF.
Arm/Group Title Etanercept Placebo
Hide Arm/Group Description:
50 mg subcutaneously (SC), once weekly
Subcutaneously (SC), once weekly
Overall Number of Participants Analyzed 39 43
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on scale
Week 2
-16.90
(-23.96 to -9.85)
-8.36
(-15.24 to -1.49)
Week 4
-19.06
(-26.11 to -12.01)
-11.04
(-17.92 to -4.16)
Week 8
-25.29
(-32.35 to -18.24)
-10.56
(-17.44 to -3.68)
Week 12
-25.79
(-32.84 to -18.74)
-16.52
(-23.40 to -9.64)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
Comments Week 2: Comparison of leasts squares means. Mixed-model analysis of covariance (ANCOVA) using an auto-regressive correlation structure with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate, and patients as a random factor.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.089
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -8.54
Confidence Interval (2-Sided) 95%
-18.40 to 1.33
Estimation Comments Least squares mean difference = mean difference final value.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
Comments Week 4: Comparison of leasts squares means. Mixed-model analysis of covariance (ANCOVA) using an auto-regressive correlation structure with treatment groups, visits and their interactions as fixed factors, baseline value as a covariate, and patients as a random factor.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.110
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -8.02
Confidence Interval 95%
-17.89 to 1.85
Estimation Comments Least squares mean difference = mean difference final value.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
Comments Week 8: Comparison of leasts squares means. Mixed-model analysis of covariance (ANCOVA) using an auto-regressive correlation structure with treatment groups, visits and their interactions as fixed factors, baseline value as a covariate, and patients as a random factor.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.004
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -14.73
Confidence Interval 95%
-24.60 to -4.86
Estimation Comments Least squares mean difference = mean difference final value.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
Comments Week 12: Comparison of leasts squares means. Mixed-model analysis of covariance (ANCOVA) using an auto-regressive correlation structure with treatment groups, visits and their interactions as fixed factors, baseline value as a covariate, and patients as a random factor.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.065
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -9.27
Confidence Interval 95%
-19.14 to 0.59
Estimation Comments Least squares mean difference = mean difference final value.
13.Secondary Outcome
Title Change From Baseline in Patient Global Assessment at Weeks 14, 18, 24
Hide Description Patient global assessment of all the ways ankylosing spondylitis affected them in the last 48 hours using a 100 millimeter (mm) Visual Analog Scale (VAS); range 0=very good to 100=very bad.
Time Frame Week 14, Week 18, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Open-label population; LOCF.
Arm/Group Title Etanercept/Etanercept Placebo/Etanercept
Hide Arm/Group Description:
Double-blind Period 1: Etanercept 50 mg subcutaneously (SC) once weekly; Open-label Period 2: Etanercept 50 mg subcutaneously (SC), once weekly
Double-blind Period 1: Placebo subcutaneously (SC), once weekly; Open-label Period 2: Etanercept subcutaneously (SC), once weekly
Overall Number of Participants Analyzed 38 39
Mean (95% Confidence Interval)
Unit of Measure: units on scale
Week 14
-31.26
(-40.35 to -22.18)
-31.20
(-40.57 to -21.83)
Week 18
-35.50
(-44.18 to -26.82)
-31.92
(-41.44 to -22.40)
Week 24
-40.70
(-49.18 to -32.23)
-34.19
(-42.86 to -25.53)
14.Secondary Outcome
Title Normalized Net Incremental Area Under the Curve (AUC) for Physician Global Assessment (PGA) Between Baseline and Week 12
Hide Description PGA was measured using a 100 millimeter Visual Analog Scale (VAS) ranging from 0 = very good to 100 = very bad. Normalized net incremental area under the curve (AUC) = area between baseline and the Physician Global Assessment curve as a function of time (randomization to Week 12); computed using the linear trapezoidal method. All areas above baseline and under the curve are positive and all area below baseline and above the curve are negative. Net incremental AUC = sum of these areas; this result was then divided by the study duration of the patients; negative value = improvement.
Time Frame Baseline, Week 2, Week 4, Week 8, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
mITT; LOCF. N= number of subjects with evaluable data.
Arm/Group Title Etanercept Placebo
Hide Arm/Group Description:
50 mg subcutaneously (SC), once weekly
Subcutaneously (SC), once weekly
Overall Number of Participants Analyzed 39 42
Least Squares Mean (95% Confidence Interval)
Unit of Measure: millimeters
-24.14
(-28.97 to -19.32)
-13.15
(-17.80 to -8.50)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
Comments Analysis of covariance (ANCOVA) with treatment as a factor and baseline value as a covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -10.99
Confidence Interval (2-Sided) 95%
-17.70 to -4.28
Estimation Comments Least squares mean difference = mean difference final value.
15.Secondary Outcome
Title Change From Baseline in Physician Global Assessment Visual Analog Scale at Weeks 2, 4, 8, 12
Hide Description Physician global assessment of all the ways ankylosing spondylitis has affected patient during the last 48 hours. 100 millimeter (mm) Visual Analog Scale (VAS); range: 0=very good to 100=very bad.
Time Frame Baseline, Week 2, Week 4, Week 8, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
mITT; LOCF. N = number of subjects with evaluable data.
Arm/Group Title Etanercept Placebo
Hide Arm/Group Description:
50 mg subcutaneously (SC), once weekly
Subcutaneously (SC), once weekly
Overall Number of Participants Analyzed 39 42
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on scale
Week 2
-15.77
(-21.87 to -9.67)
-7.43
(-13.31 to -1.55)
Week 4
-26.25
(-32.35 to -20.15)
-15.23
(-21.11 to -9.35)
Week 8
-28.80
(-34.90 to -22.70)
-16.05
(-21.93 to -10.17)
Week 12
-32.62
(-38.72 to -26.52)
-17.32
(-23.20 to -11.44)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
Comments Week 2: Comparison of leasts squares means. Mixed-model analysis of covariance (ANCOVA) using an auto-regressive correlation structure with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate, and patients as a random factor.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.054
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -8.33
Confidence Interval (2-Sided) 95%
-16.81 to 0.15
Estimation Comments Least squares mean difference = mean difference final value.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
Comments Week 4: Comparison of leasts squares means. Mixed-model analysis of covariance (ANCOVA) using an auto-regressive correlation structure with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate, and patients as a random factor.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.011
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -11.02
Confidence Interval 95%
-19.50 to -2.54
Estimation Comments Least squares mean difference = mean difference final value.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
Comments Week 8: Comparison of leasts squares means. Mixed-model analysis of covariance (ANCOVA) using an auto-regressive correlation structure with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate, and patients as a random factor.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.003
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -12.75
Confidence Interval 95%
-21.23 to -4.27
Estimation Comments Least squares mean difference = mean difference final value.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
Comments Week 8: Comparison of leasts squares means. Mixed-model analysis of covariance (ANCOVA) using an auto-regressive correlation structure with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate, and patients as a random factor.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -15.29
Confidence Interval 95%
-23.7 to -6.82
Estimation Comments Least squares mean difference = mean difference final value.
16.Secondary Outcome
Title Change From Baseline in Physician Global Assessment at Weeks 14, 18, 24
Hide Description Physician global assessment of all the ways ankylosing spondylitis has affected patient during the last 48 hours. 100 millimeter (mm) Visual Analog Scale (VAS); range: 0=very good to 100=very bad.
Time Frame Week 14, Week 18, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Open-label population; LOCF.
Arm/Group Title Etanercept/Etanercept Placebo/Etanercept
Hide Arm/Group Description:
Double-blind Period 1: Etanercept 50 mg subcutaneously (SC) once weekly; Open-label Period 2: Etanercept 50 mg subcutaneously (SC), once weekly
Double-blind Period 1: Placebo subcutaneously (SC), once weekly; Open-label Period 2: Etanercept subcutaneously (SC), once weekly
Overall Number of Participants Analyzed 38 39
Mean (95% Confidence Interval)
Unit of Measure: units on scale
Week 14
-37.66
(-46.14 to -29.19)
-35.57
(-42.41 to -28.73)
Week 18
-43.22
(-49.79 to -36.65)
-37.05
(-44.14 to -29.96)
Week 24
-42.68
(-50.25 to -35.10)
-40.41
(-47.64 to -33.17)
17.Secondary Outcome
Title Normalized Net Incremental Area Under the Curve (AUC) for Nocturnal Back Pain Between Baseline and Week 12
Hide Description Nocturnal back pain was measured using a 100 millimeter Visual Analog Scale (VAS); range: 0 = none to 100 = extreme. Normalized net incremental area under the curve (AUC) = area between baseline and the Nocturnal Back Pain curve as a function of time (randomization to Week 12); computed using the linear trapezoidal method. All areas above baseline and under the curve are positive and all area below baseline and above the curve are negative. Net incremental AUC = sum of these areas; this result was then divided by the study duration of the patients; negative value = improvement.
Time Frame Baseline, Week 2, Week 4, Week 8, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
mITT; LOCF. N=number of subjects with evaluable data.
Arm/Group Title Etanercept Placebo
Hide Arm/Group Description:
50 mg subcutaneously (SC), once weekly
Subcutaneously (SC), once weekly
Overall Number of Participants Analyzed 39 41
Least Squares Mean (95% Confidence Interval)
Unit of Measure: millimeters
-23.23
(-29.65 to -16.81)
-13.64
(-19.89 to -7.38)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
Comments Analysis of covariance (ANCOVA) with treatment as a factor and baseline value as a covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.039
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -9.59
Confidence Interval (2-Sided) 95%
-18.69 to -0.49
Estimation Comments Least squares mean difference = mean difference final value.
18.Secondary Outcome
Title Change From Baseline in Nocturnal Back Pain at Weeks 2, 4, 8, 12
Hide Description Subject assessment of nocturnal back pain due to ankylosing spondylitis during the last 48 hours using a 100 millimeter (mm) Visual Analog Scale (VAS); range: 0=none to 100=extreme.
Time Frame Baseline, Week 2, Week 4, Week 8, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
mITT; LOCF.
Arm/Group Title Etanercept Placebo
Hide Arm/Group Description:
50 mg subcutaneously (SC), once weekly
Subcutaneously (SC), once weekly
Overall Number of Participants Analyzed 39 43
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on scale
Week 2
-19.41
(-27.09 to -11.72)
-13.12
(-20.61 to -5.63)
Week 4
-20.90
(-28.58 to -13.21)
-15.72
(-23.21 to -8.23)
Week 8
-29.27
(-36.95 to -21.58)
-15.54
(-23.03 to -8.05)
Week 12
-32.07
(-39.75 to -24.38)
-12.38
(-19.87 to -4.89)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
Comments Week 2: Comparison of leasts squares means. Mixed-model analysis of covariance (ANCOVA) using an auto-regressive correlation structure with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate, and patients as a random factor.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.254
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -6.28
Confidence Interval (2-Sided) 95%
-17.13 to 4.57
Estimation Comments Least squares mean difference = mean difference final value.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
Comments Week 4: Comparison of leasts squares means. Mixed-model analysis of covariance (ANCOVA) using an auto-regressive correlation structure with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate, and patients as a random factor.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.348
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -5.17
Confidence Interval 95%
-16.02 to 5.68
Estimation Comments Least squares mean difference = mean difference final value.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
Comments Week 8: Comparison of leasts squares means. Mixed-model analysis of covariance (ANCOVA) using an auto-regressive correlation structure with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate, and patients as a random factor.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.014
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -13.72
Confidence Interval 95%
-24.57 to -2.88
Estimation Comments Least squares mean difference = mean difference final value.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
Comments Week 12: Comparison of leasts squares means. Mixed-model analysis of covariance (ANCOVA) using an auto-regressive correlation structure with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate, and patients as a random factor.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -19.69
Confidence Interval 95%
-30.54 to -8.84
Estimation Comments Least squares mean difference = mean difference final value.
19.Secondary Outcome
Title Change From Baseline in Nocturnal Back Pain at Weeks 14, 18, 24
Hide Description Subject assessment of nocturnal back pain due to ankylosing spondylitis during the last 48 hours using a 100 millimeter (mm) Visual Analog Scale (VAS); range: 0=none to 100=extreme.
Time Frame Week 14, Week 18, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Open-label population; LOCF.
Arm/Group Title Etanercept/Etanercept Placebo/Etanercept
Hide Arm/Group Description:
Double-blind Period 1: Etanercept 50 mg subcutaneously (SC) once weekly; Open-label Period 2: Etanercept 50 mg subcutaneously (SC), once weekly
Double-blind Period 1: Placebo subcutaneously (SC), once weekly; Open-label Period 2: Etanercept subcutaneously (SC), once weekly
Overall Number of Participants Analyzed 38 39
Mean (95% Confidence Interval)
Unit of Measure: units on scale
Week 14
-36.92
(-46.48 to -27.36)
-27.76
(-37.34 to -18.18)
Week 18
-41.73
(-50.58 to -32.87)
-27.89
(-37.91 to -17.86)
Week 24
-45.26
(-54.25 to -36.28)
-28.44
(-38.45 to -18.43)
20.Secondary Outcome
Title Normalized Net Incremental Area Under the Curve (AUC) for Total Back Pain Between Baseline and Week 12
Hide Description Total back pain was measured using a 100 millimeter Visual Analog Scale (VAS); range: 0 = none to 100 = extreme. Normalized net incremental area under the curve (AUC) = area between baseline and the Total Back Pain curve as a function of time (randomization to Week 12); computed using the linear trapezoidal method. All areas above baseline and under the curve are positive and all area below baseline and above the curve are negative. Net incremental AUC = sum of these areas; this result was then divided by the study duration of the patients; negative value = improvement.
Time Frame Baseline, Week 2, Week 4, Week 8, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
mITT; LOCF. N=number of subjects with evaluable data.
Arm/Group Title Etanercept Placebo
Hide Arm/Group Description:
50 mg subcutaneously (SC), once weekly
Subcutaneously (SC), once weekly
Overall Number of Participants Analyzed 39 41
Least Squares Mean (95% Confidence Interval)
Unit of Measure: millimeters
-21.73
(-28.26 to -15.20)
-13.24
(-19.61 to -6.88)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
Comments Analysis of covariance (ANCOVA) with treatment as a factor and baseline value as a covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.071
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -8.49
Confidence Interval (2-Sided) 95%
-17.73 to 0.75
Estimation Comments Least squares mean difference = mean difference final value.
21.Secondary Outcome
Title Change From Baseline in Total Back Pain at Weeks 2, 4, 8, 12
Hide Description Subject assessment of total back pain due to ankylosing spondylitis during the last 48 hours using a 100 millimeter (mm) Visual Analog Scale (VAS); range: 0=none to 100=extreme.
Time Frame Baseline, Week 2, Week 4, Week 8, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
mITT; LOCF.
Arm/Group Title Etanercept Placebo
Hide Arm/Group Description:
50 mg subcutaneously (SC), once weekly
Subcutaneously (SC), once weekly
Overall Number of Participants Analyzed 39 43
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on scale
Week 2
-15.37
(-22.99 to -7.76)
-11.80
(-19.22 to -4.38)
Week 4
-18.93
(-26.54 to -11.32)
-14.36
(-21.78 to -6.94)
Week 8
-28.24
(-35.85 to -20.62)
-15.78
(-23.20 to -8.36)
Week 12
-29.18
(-36.79 to -21.57)
-14.93
(-22.35 to -7.51)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
Comments Week 2: Comparison of leasts squares means. Mixed-model analysis of covariance (ANCOVA) using an auto-regressive correlation structure with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate, and patients as a random factor.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.511
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -3.57
Confidence Interval (2-Sided) 95%
-14.31 to 7.17
Estimation Comments Least squares mean difference = mean difference final value.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
Comments Week 4: Comparison of leasts squares means. Mixed-model analysis of covariance (ANCOVA) using an auto-regressive correlation structure with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate, and patients as a random factor.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.401
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -4.57
Confidence Interval 95%
-15.31 to 6.17
Estimation Comments Least squares mean difference = mean difference final value.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
Comments Week 8: Comparison of leasts squares means. Mixed-model analysis of covariance (ANCOVA) using an auto-regressive correlation structure with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate, and patients as a random factor.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.023
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -12.45
Confidence Interval 95%
-23.19 to -1.71
Estimation Comments Least squares mean difference = mean difference final value.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
Comments Week 12: Comparison of leasts squares means. Mixed-model analysis of covariance (ANCOVA) using an auto-regressive correlation structure with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate, and patients as a random factor.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.010
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -14.25
Confidence Interval 95%
-24.99 to -3.51
Estimation Comments Least squares mean difference = mean difference final value.
22.Secondary Outcome
Title Change From Baseline in Total Back Pain at Weeks 14, 18, 24
Hide Description Subject assessment of total back pain due to ankylosing spondylitis during the last 48 hours using a 100 millimeter Visual Analog Scale (VAS); range: 0=none to 100=extreme.
Time Frame Week 14, Week 18, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Open-label population; LOCF.
Arm/Group Title Etanercept/Etanercept Placebo/Etanercept
Hide Arm/Group Description:
Double-blind Period 1: Etanercept 50 mg subcutaneously (SC) once weekly; Open-label Period 2: Etanercept 50 mg subcutaneously (SC), once weekly
Double-blind Period 1: Placebo subcutaneously (SC), once weekly; Open-label Period 2: Etanercept subcutaneously (SC), once weekly
Overall Number of Participants Analyzed 38 39
Mean (95% Confidence Interval)
Unit of Measure: units on scale
Week 14
-35.21
(-43.72 to -26.71)
-30.29
(-40.43 to -20.16)
Week 18
-40.02
(-48.40 to -31.64)
-31.19
(-42.27 to -20.12)
Week 24
-44.50
(-52.74 to -36.25)
-32.27
(-42.71 to -21.83)
23.Secondary Outcome
Title Normalized Net Incremental Area Under the Curve (AUC) for the Bath Ankylosing Spondylitis Functional Index (BASFI) Between Baseline and Week 12
Hide Description BASFI was measured using a 100 millimeter Visual Analog Scale (VAS) ranging from 0 = easy to 100 = impossible. Normalized net incremental area under the curve (AUC) = area between baseline and the BASFI curve as a function of time (randomization to Week 12); computed using the linear trapezoidal method. All areas above baseline and under the curve are positive and all area below baseline and above the curve are negative. Net incremental AUC = sum of these areas; this result was then divided by the study duration of the patients; negative value = improvement.
Time Frame Baseline, Week 2, Week 4, Week 8, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
mITT; LOCF. N=number of subjects with evaluable data.
Arm/Group Title Etanercept Placebo
Hide Arm/Group Description:
50 mg subcutaneously (SC), once weekly
Subcutaneously (SC), once weekly
Overall Number of Participants Analyzed 39 42
Least Squares Mean (95% Confidence Interval)
Unit of Measure: millimeters
-14.59
(-19.44 to -9.74)
-9.34
(-14.02 to -4.67)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
Comments Analysis of covariance (ANCOVA) with treatment as a factor and baseline as a covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.127
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -5.25
Confidence Interval (2-Sided) 95%
-12.03 to 1.53
Estimation Comments Least squares mean difference = mean difference final value.
24.Secondary Outcome
Title Change From Baseline in the Bath Ankylosing Spondylitis Functional Index (BASFI) at Weeks 2, 4, 8, 12
Hide Description BASFI is a validated self assessment tool that determines the degree of functional limitation in ankylosing spondylitis (AS) patients using a 100 millimeter (mm) Visual Analog Scale (VAS) measuring level of ability with activities in the last 48 hours; range: 0=easy to 100=impossible. Higher score = greater limitation.
Time Frame Baseline, Week 2, Week 4, Week 8, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
mITT; LOCF. N = number of subjects with evaluable data.
Arm/Group Title Etanercept Placebo
Hide Arm/Group Description:
50 mg subcutaneously (SC), once weekly
Subcutaneously (SC), once weekly
Overall Number of Participants Analyzed 39 42
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on scale
Week 2
-8.23
(-13.82 to -2.63)
-7.80
(-13.19 to -2.41)
Week 4
-12.44
(-18.03 to -6.85)
-10.04
(-15.43 to -4.65)
Week 8
-19.75
(-25.35 to -14.16)
-11.54
(-16.93 to -6.15)
Week 12
-21.63
(-27.22 to -16.03)
-10.09
(-15.47 to -4.70)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
Comments Week 2: Comparison of leasts squares means. Mixed-model analysis of covariance (ANCOVA) using an auto-regressive correlation structure with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate, and patients as a random factor.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.914
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.43
Confidence Interval (2-Sided) 95%
-8.23 to 7.38
Estimation Comments Least squares mean difference = mean difference final value.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
Comments Week 4: Comparison of leasts squares means. Mixed-model analysis of covariance (ANCOVA) using an auto-regressive correlation structure with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate, and patients as a random factor.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.544
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -2.40
Confidence Interval 95%
-10.21 to 5.41
Estimation Comments Least squares mean difference = mean difference final value.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
Comments Week 8: Comparison of leasts squares means. Mixed-model analysis of covariance (ANCOVA) using an auto-regressive correlation structure with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate, and patients as a random factor.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.039
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -8.21
Confidence Interval 95%
-16.02 to -0.40
Estimation Comments Least squares mean difference = mean difference final value.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
Comments Week 12: Comparison of leasts squares means. Mixed-model analysis of covariance (ANCOVA) using an auto-regressive correlation structure with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate, and patients as a random factor.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.004
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -11.54
Confidence Interval 95%
-19.35 to -3.73
Estimation Comments Least squares mean difference = mean difference final value.
25.Secondary Outcome
Title Bath Ankylosing Functional Index (BASFI): Independent Components at Weeks 2, 4, 8, 12
Hide Description Subject rating of last 48 hours, 100 millimeter Visual Analog Scale; range 0=easy to 100=impossible: 1)Putting on socks/tights without (w/o) help; 2)Bending forward from waist to pickup pen from floor w/o aid; 3)Reaching to high shelf w/o aid; 4)Getting out of armless dining room chair w/o using hands/other help; 5)Getting up off floor w/o help from lying on back; 6)Standing unsupported 10 minutes w/o discomfort; 7)Climbing 12-15 steps w/o handrail or walking aid; 8)Looking over shoulder w/o turning body; 9) Doing physically demanding activities; 10) Doing full days activities (home or work).
Time Frame Baseline, Week 2, Week 4, Week 8, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
mITT; in the case of missing data, no replacement or imputation method was performed. Abbreviations: C = component (number), Act = Activities.
Arm/Group Title Etanercept Placebo
Hide Arm/Group Description:
50 mg subcutaneously (SC), once weekly
Subcutaneously (SC), once weekly
Overall Number of Participants Analyzed 39 43
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
Baseline C1: Putting on Socks or Tights
51.1
(42.8 to 59.4)
43.8
(35.7 to 52.0)
Week 2 C1: Putting on Socks or Tights
47.6
(37.9 to 57.3)
36.5
(27.4 to 45.5)
Week 4 C1: Putting on Socks or Tights
41.1
(31.4 to 50.8)
32.7
(24.0 to 41.4)
Week 8 C1: Putting on Socks or Tights
32.3
(24.0 to 40.7)
30.6
(22.0 to 39.1)
Week 12 C1: Putting on Socks or Tights
33.2
(23.4 to 43.0)
36.0
(24.6 to 45.6)
Baseline C2: Bending from Waist
63.4
(54.2 to 72.7)
61.5
(52.6 to 70.5)
Week 2 C2: Bending from Waist
54.1
(43.0 to 65.3)
55.7
(45.5 to 65.9)
Week 4 C2: Bending from Waist
51.1
(39.1 to 63.0)
54.0
(44.1 to 63.9)
Week 8 C2: Bending from Waist
43.3
(32.3 to 54.3)
54.2
(43.5 to 64.9)
Week 12 C2: Bending from Waist
41.1
(29.8 to 52.4)
56.2
(45.6 to 66.7)
Baseline C3: Reaching to High Shelf
61.5
(52.5 to 70.6)
54.3
(46.3 to 62.3)
Week 2 C3: Reaching to High Shelf
52.1
(41.9 to 62.2)
50.3
(40.8 to 59.7)
Week 4 C3: Reaching to High Shelf
50.2
(39.7 to 60.7)
43.8
(35.2 to 52.4)
Week 8 C3: Reaching to High Shelf
37.4
(27.7 to 47.1)
44.1
(36.4 to 51.8)
Week 12 C3: Reaching to High Shelf
37.3
(26.8 to 47.9)
44.5
(36.2 to 52.8)
Baseline C4: Getting Out Armless Chair
55.8
(46.1 to 65.5)
47.5
(38.8 to 56.2)
Week 2 C4: Getting Out Armless Chair
47.2
(36.7 to 57.6)
38.1
(29.0 to 47.2)
Week 4 C4: Getting Out Armless Chair
42.1
(31.0 to 53.3)
36.1
(27.7 to 44.6)
Week 8 C4: Getting Out Armless Chair
33.6
(24.3 to 42.9)
35.1
(25.9 to 44.3)
Week 12 C4: Getting Out Armless Chair
31.7
(21.7 to 41.7)
36.5
(26.8 to 46.3)
Baseline C5: Getting Up Off Floor
71.8
(64.1 to 79.5)
60.8
(52.7 to 68.9)
Week 2 C5: Getting Up Off Floor
57.0
(46.7 to 67.3)
49.4
(40.1 to 58.8)
Week 4 C5: Getting Up Off Floor
55.0
(44.5 to 65.6)
48.5
(39.4 to 57.5)
Week 8 C5: Getting Up Off Floor
43.7
(32.9 to 54.4)
44.2
(34.7 to 53.7)
Week 12 C5: Getting Up Off Floor
44.5
(33.7 to 55.2)
46.1
(36.7 to 55.5)
Baseline C6: Standing Unsupported
58.9
(49.9 to 67.9)
49.0
(39.7 to 58.3)
Week 2 C6: Standing Unsupported
50.8
(40.4 to 61.2)
44.9
(35.5 to 54.3)
Week 4 C6: Standing Unsupported
46.4
(35.8 to 57.0)
42.0
(33.6 to 50.3)
Week 8 C6: Standing Unsupported
40.8
(30.9 to 50.7)
40.9
(31.6 to 50.1)
Week 12 C6: Standing Unsupported
39.0
(28.3 to 49.7)
42.2
(32.5 to 51.9)
Baseline C7: Climbing 12-15 Steps
55.0
(45.3 to 64.8)
47.5
(37.9 to 57.1)
Week 2 C7: Climbing 12-15 Steps
47.4
(36.7 to 58.1)
38.4
(29.3 to 47.4)
Week 4 C7: Climbing 12-15 Steps
42.3
(31.8 to 52.8)
37.4
(28.4 to 46.4)
Week 8 C7: Climbing 12-15 Steps
37.4
(27.5 to 47.3)
35.6
(25.8 to 45.3)
Week 12 C7: Climbing 12-15 Steps
35.0
(24.7 to 45.2)
32.9
(23.6 to 42.3)
Baseline C8: Looking Over Shoulder
81.0
(74.0 to 87.9)
81.9
(75.7 to 88.0)
Week 2 C8: Looking Over Shoulder
72.9
(64.3 to 81.5)
68.4
(59.5 to 77.2)
Week 4 C8: Looking Over Shoulder
63.7
(53.5 to 74.0)
71.6
(62.8 to 80.4)
Week 8 C8: Looking Over Shoulder
56.9
(45.9 to 67.9)
71.1
(61.6 to 80.7)
Week 12: C8: Looking Over Shoulder
54.1
(43.0 to 65.2)
68.1
(58.8 to 77.4)
Baseline C9: Physically Demanding Act
67.6
(60.7 to 74.5)
65.4
(59.2 to 71.6)
Week 2 C9: Physically Demanding Act
60.7
(51.7 to 69.6)
58.4
(51.4 to 65.4)
Week 4 C9: Physically Demanding Act
53.0
(43.4 to 62.6)
53.6
(46.4 to 60.8)
Week 8 C9: Physically Demanding Act
48.4
(38.4 to 58.3)
47.8
(40.5 to 55.1)
Week 12 C9: Physically Demanding Act
43.2
(33.4 to 52.9)
54.9
(47.7 to 62.1)
Baseline C10: Full Days Act
66.9
(59.4 to 74.5)
57.1
(49.4 to 64.8)
Week 2 C10: Full Days Act
57.2
(48.7 to 65.7)
49.3
(42.1 to 56.5)
Week 4 C10: Full Days Act
52.4
(43.3 to 61.4)
51.6
(43.7 to 59.5)
Week 8 C10: Full Days Act
47.6
(37.3 to 57.8)
44.4
(37.5 to 51.3)
Week 12 C10: Full Days Act
43.1
(32.2 to 53.9)
49.0
(40.9 to 57.2)
26.Secondary Outcome
Title Bath Ankylosing Functional Index (BASFI) Independent Components at Weeks 14, 18, 24
Hide Description Subject rating of last 48 hours, 100 mm Visual Analog Scale; range 0=easy to 100=impossible: 1) Putting on socks/tights without (w/o) help; 2) Bending forward from waist to pickup pen from floor w/o aid; 3) Reaching to high shelf w/o aid; 4) Getting out of armless dining room chair w/o using hands/other help; 5) Getting up off floor w/o help from lying on back; 6) Standing unsupported 10 minutes w/o discomfort; 7) Climbing 12-15 steps w/o handrail or walking aid; 8) Looking over shoulder w/o turning body; 9) Doing physically demanding activities; 10) Doing full days activities (home or work).
Time Frame Week 14, Week 18, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Open-label population; in the case of missing data, no replacement or imputation method was performed. Abbreviations: C=component (number), Act=Activities.
Arm/Group Title Etanercept/Etanercept Placebo/Etanercept
Hide Arm/Group Description:
Double-blind Period 1: Etanercept 50 mg subcutaneously (SC) once weekly; Open-label Period 2: Etanercept 50 mg subcutaneously (SC), once weekly
Double-blind Period 1: Placebo subcutaneously (SC), once weekly; Open-label Period 2: Etanercept subcutaneously (SC), once weekly
Overall Number of Participants Analyzed 38 39
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
Week 14 C1: Putting on Socks or Tights
32.7
(22.6 to 42.8)
25.7
(16.6 to 34.8)
Week 18 C1: Putting on Socks or Tights
31.3
(21.3 to 41.2)
26.6
(17.1 to 36.1)
Week 24 C1: Putting on Socks or Tights
26.7
(16.8 to 36.5)
24.5
(15.4 to 33.6)
Week 14 C2: Bending from Waist
42.1
(29.6 to 54.6)
47.1
(35.9 to 58.4)
Week 18 C2: Bending from Waist
36.9
(25.0 to 48.8)
45.3
(32.9 to 57.7)
Week 24 C2: Bending from Waist
36.1
(23.9 to 48.3)
44.6
(33.0 to 56.3)
Week 14 C3: Reaching to High Shelf
37.0
(26.0 to 48.0)
31.7
(22.8 to 40.6)
Week 18 C3: Reaching to High Shelf
32.1
(21.7 to 42.6)
34.2
(25.0 to 43.5)
Week 24 C3: Reaching to High Shelf
27.4
(18.1 to 36.7)
32.1
(23.8 to 40.4)
Week 14 C4: Getting Out Armless Chair
32.0
(20.9 to 43.2)
27.9
(18.3 to 37.6)
Week 18 C4: Getting Out Armless Chair
27.3
(17.2 to 37.4)
26.5
(16.9 to 36.1)
Week 24 C4: Getting Out Armless Chair
23.4
(14.6 to 32.3)
26.2
(17.1 to 35.3)
Week 14 C5: Getting Up Off Floor
43.6
(31.1 to 56.1)
36.3
(26.6 to 46.1)
Week 18 C5: Getting Up Off Floor
40.0
(28.1 to 51.8)
36.5
(26.6 to 46.3)
Week 24 C5: Getting Up Off Floor
38.2
(27.0 to 49.4)
34.4
(24.1 to 44.7)
Week 14 C6: Standing Unsupported
38.8
(27.2 to 50.3)
29.7
(20.8 to 38.6)
Week 18 C6: Standing Unsupported
32.6
(22.1 to 43.2)
33.3
(22.9 to 43.7)
Week 24 C6: Standing Unsupported
30.5
(20.7 to 40.3)
33.8
(24.1 to 43.6)
Week 14 C7: Climbing 12-15 Steps
34.0
(22.4 to 45.6)
26.7
(17.7 to 35.7)
Week 18 C7: Climbing 12-15 Steps
30.7
(20.0 to 41.3)
27.4
(17.2 to 37.6)
Week 24 C7: Climbing 12-15 Steps
28.8
(18.7 to 38.9)
27.1
(17.0 to 37.2)
Week 14 C8: Looking Over Shoulder
52.4
(40.2 to 64.5)
58.6
(47.5 to 69.8)
Week 18 C8: Looking Over Shoulder
50.7
(38.6 to 62.7)
57.7
(46.9 to 68.5)
Week 24 C8: Looking Over Shoulder
46.4
(34.2 to 58.6)
55.3
(44.8 to 65.9)
Week 14 C9: Physically Demanding Act
41.8
(30.7 to 53.0)
37.3
(29.9 to 44.7)
Week 18 C9: Physically Demanding Act
38.6
(28.5 to 48.8)
43.5
(34.9 to 52.1)
Week 24 C9: Physically Demanding Act
33.7
(23.7 to 43.6)
38.5
(29.9 to 47.1)
Week 14 C10: Full Days Act
40.4
(29.2 to 51.6)
36.1
(27.7 to 44.4)
Week 18 C10: Full Days Act
37.9
(26.7 to 49.0)
40.0
(30.9 to 49.0)
Week 24 C10: Full Days Act
32.1
(22.6 to 41.6)
37.5
(28.4 to 46.5)
27.Secondary Outcome
Title Change From Baseline in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Weeks 2, 4, 8, 12
Hide Description BASDAI is a validated self assessment tool used to determine disease activity in patients with ankylosing spondylitis in the last 48 hours. Utilizing a Visual Analog Scale (VAS) of 0–10 (0=none and 10=very severe) patient’s answered 6 questions measuring discomfort, pain and fatigue. The BASDAI final mean score was calculated taking all 6 VAS assessments.
Time Frame Baseline, Week 2, Week 4, Week 8, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
mITT; LOCF.
Arm/Group Title Etanercept Placebo
Hide Arm/Group Description:
50 mg subcutaneously (SC), once weekly
Subcutaneously (SC), once weekly
Overall Number of Participants Analyzed 39 43
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
Week 2
-14.25
(-20.51 to -7.99)
-7.39
(-13.34 to -1.43)
Week 4
-18.41
(-24.67 to -12.15)
-11.97
(-17.92 to -6.01)
Week 8
-26.06
(-32.31 to -19.80)
-13.51
(-19.46 to -7.55)
Week 12
-26.38
(-32.64 to -20.12)
-14.43
(-20.39 to -8.47)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
Comments Week 2: Comparison of leasts squares means. Mixed-model analysis of covariance (ANCOVA) using an auto-regressive correlation structure with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate, and patients as a random factor.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.122
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -6.86
Confidence Interval (2-Sided) 95%
-15.57 to 1.85
Estimation Comments Least squares mean difference = mean difference final value.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
Comments Week 4: Comparison of leasts squares means. Mixed-model analysis of covariance (ANCOVA) using an auto-regressive correlation structure with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate, and patients as a random factor.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.145
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -6.45
Confidence Interval 95%
-15.16 to 2.26
Estimation Comments Least squares mean difference = mean difference final value.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
Comments Week 8: Comparison of leasts squares means. Mixed-model analysis of covariance (ANCOVA) using an auto-regressive correlation structure with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate, and patients as a random factor.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.005
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -12.55
Confidence Interval 95%
-21.26 to -3.84
Estimation Comments Least squares mean difference = mean difference final value.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
Comments Week 12: Comparison of leasts squares means. Mixed-model analysis of covariance (ANCOVA) using an auto-regressive correlation structure with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate, and patients as a random factor.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.008
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -11.95
Confidence Interval 95%
-20.66 to -3.24
Estimation Comments Least squares mean difference = mean difference final value.
28.Secondary Outcome
Title Change From Baseline in the Bath Ankylosing Spondylitis (AS) Disease Activity Index (BASDAI) at Weeks 14, 18, 24
Hide Description BASDAI is a validated self assessment tool used to determine disease activity in patients with ankylosing spondylitis (AS) in the last 48 hours. Utilizing a Visual Analog Scale (VAS) of 0–10 (0=none and 10=very severe) patient’s answered 6 questions measuring discomfort, pain and fatigue. The BASDAI final mean score was calculated taking all 6 VAS assessments.
Time Frame Week 14, Week 18, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Open-label population; LOCF.
Arm/Group Title Etanercept/Etanercept Placebo/Etanercept
Hide Arm/Group Description:
Double-blind Period 1: Etanercept 50 mg subcutaneously (SC) once weekly; Open-label Period 2: Etanercept 50 mg subcutaneously (SC), once weekly
Double-blind Period 1: Placebo subcutaneously (SC), once weekly; Open-label Period 2: Etanercept subcutaneously (SC), once weekly
Overall Number of Participants Analyzed 38 39
Mean (95% Confidence Interval)
Unit of Measure: units on scale
Week 14
-29.26
(-37.34 to -21.17)
-27.41
(-34.52 to -20.30)
Week 18
-34.20
(-41.89 to -26.52)
-28.21
(-35.94 to -20.47)
Week 24
-37.62
(-44.97 to -30.27)
-28.62
(-36.49 to -20.76)
29.Secondary Outcome
Title Bath Ankylosing Spondylitis (AS) Disease Activity Index (BASDAI) Independent Components at Weeks 2, 4, 8, 12
Hide Description BASDAI subject rated components over last 48 hours using 100 mm Visual Analog Scale; components 1-5: range 0=none to 100=very severe; component 6: range:0=0 hours to 100=2 hours or more. 1) Overall level of fatigue/tiredness experienced; 2) Overall level of AS neck,back or hip pain experienced; 3) Overall level of pain/swelling in joints other than neck, back or hips; 4) Overall level of discomfort from any areas tender to touch or pressure; 5) Overall level of morning stiffness from time of awakening; 6) Duration of morning stiffness from time of awakening, and morning stiffness subscale.
Time Frame Week 2, Week 4, Week 8, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
mITT; in case of mising data, no replacement or imputation method was performed. Abbreviations: C=component, AS=Ankylosing Spondylitis.
Arm/Group Title Etanercept Placebo
Hide Arm/Group Description:
50 mg subcutaneously (SC), once weekly
Subcutaneously (SC), once weekly
Overall Number of Participants Analyzed 39 43
Mean (95% Confidence Interval)
Unit of Measure: units on scale
Baseline C1: Fatigue/Tiredness
68.2
(62.5 to 73.8)
61.9
(57.1 to 66.8)
Week 2 C1: Fatigue/Tiredness
56.6
(48.7 to 64.5)
55.8
(49.1 to 62.5)
Week 4 C1: Fatigue/Tiredness
51.4
(43.1 to 59.6)
54.2
(47.0 to 61.4)
Week 8 C1: Fatigue/Tiredness
44.4
(36.2 to 52.7)
50.9
(43.3 to 58.5)
Week 12 C1: Fatigue/Tiredness
43.9
(33.9 to 53.9)
48.5
(40.1 to 56.9)
Baseline C2: AS Neck, Back or Hip Pain
73.0
(68.7 to 77.3)
68.1
(63.4 to 72.9)
Week 2 C2: AS Neck, Back or Hip Pain
53.9
(45.7 to 62.1)
57.6
(50.2 to 65.0)
Week 4 C2: AS Neck, Back or Hip Pain
51.5
(43.0 to 60.0)
55.0
(47.2 to 62.9)
Week 8 C2: AS Neck, Back or Hip Pain
41.4
(32.8 to 50.1)
52.1
(45.0 to 59.2)
Week 12 C2: AS Neck, Back or Hip Pain
41.0
(31.8 to 50.2)
52.0
(44.5 to 59.5)
Baseline C3: Pain/Swelling in Other Joints
49.3
(41.1 to 57.5)
45.3
(36.1 to 54.4)
Week 2 C3: Pain/Swelling in Other Joints
39.2
(29.5 to 48.9)
41.7
(31.7 to 51.7)
Week 4 C3: Pain/Swelling in Other Joints
37.3
(27.8 to 46.8)
38.2
(30.0 to 46.5)
Week 8 C3: Pain/Swelling in Other Joints
30.1
(20.8 to 39.5)
40.4
(32.0 to 48.8)
Week 12 C3: Pain/Swelling in Other Joints
31.8
(21.7 to 41.8)
37.9
(29.6 to 46.2)
Baseline C4: Discomfort Areas Tender to Touch
62.3
(55.5 to 69.2)
57.2
(49.9 to 64.4)
Week 2 C4: Discomfort Areas Tender to Touch
42.1
(32.5 to 51.6)
51.9
(43.3 to 60.4)
Week 4 C4: Discomfort Areas Tender to Touch
38.3
(29.0 to 47.5)
41.5
(33.2 to 49.9)
Week 8 C4: Discomfort Areas Tender to Touch
31.2
(22.6 to 39.9)
40.7
(32.5 to 48.8)
Week 12 C4: Discomfort Areas Tender to Touch
28.8
(19.9 to 37.7)
38.0
(30.5 to 45.4)
Baseline C5: Morning Stiffness
70.8
(64.8 to 76.8)
66.3
(61.6 to 70.9)
Week 2 C5: Morning Stiffness
51.3
(42.9 to 59.8)
55.6
(48.7 to 62.4)
Week 4 C5: Morning Stiffness
46.5
(37.2 to 55.7)
50.7
(43.6 to 57.8)
Week 8 C5: Morning Stiffness
38.1
(29.1 to 47.2)
44.7
(37.4 to 52.0)
Week 12 C5: Morning Stiffness
37.8
(27.6 to 48.1)
44.8
(37.7 to 52.0)
Baseline C6: Duration Morning Stiffness
62.1
(53.9 to 70.3)
52.4
(44.5 to 60.3)
Week 2 C6: Duration Morning Stiffness
46.8
(36.6 to 57.0)
44.0
(35.7 to 52.3)
Week 4 C6: Duration Morning Stiffness
42.2
(31.9 to 52.6)
43.0
(35.2 to 50.9)
Week 8 C6: Duration Morning Stiffness
34.6
(24.2 to 44.9)
43.7
(36.1 to 51.4)
Week 12 C6: Duration Morning Stiffness
34.9
(24.0 to 45.8)
44.7
(36.1 to 53.3)
Baseline: Subscore Morning Stiffness (n=39, 43)
66.45
(60.42 to 72.48)
59.34
(54.19 to 64.48)
Week 2: Subscore Morning Stiffness
49.72
(41.16 to 58.29)
49.78
(42.88 to 56.68)
Week 4: Subscore Morning Stiffness
44.34
(35.58 to 53.11)
46.87
(39.83 to 53.91)
Week 8: Subscore Morning Stiffness
36.34
(27.19 to 45.48)
44.22
(37.20 to 51.24)
Week 12: Subscore Morning Stiffness
36.39
(26.41 to 46.37)
44.77
(37.41 to 52.13)
30.Secondary Outcome
Title Bath Ankylosing Spondylitis (AS) Disease Activity Index (BASDAI) Independent Components at Weeks 14, 18, 24
Hide Description BASDAI subject rated components over last 48 hours using a 100 millimeter Visual Analog Scale; components 1-5: range 0=none to 100=very severe; component 6: range:0=0 hours to 100=2 hours or more. 1) Overall level of fatigue/tiredness experienced; 2) Overall level of AS neck,back or hip pain experienced; 3)Overall level of pain/swelling in joints other than neck,back or hips; 4) Overall level of discomfort from any areas tender to touch or pressure; 5) Overall level of morning stiffness from time of awakening; 6) Duration of morning stiffness from time of awakening.
Time Frame Week 14, Week 18, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Open-label population; in case of missing data, no replacement or imputation method was performed. Abbreviations: C=component, AS=Ankylosing Spondylitis.
Arm/Group Title Etanercept/Etanercept Placebo/Etanercept
Hide Arm/Group Description:
Double-blind Period 1: Etanercept 50 mg subcutaneously (SC) once weekly; Open-label Period 2: Etanercept 50 mg subcutaneously (SC), once weekly
Double-blind Period 1: placebo subcutaneously (SC), once weekly; Open-label Period 2: etanercept subcutaneously (SC), once weekly
Overall Number of Participants Analyzed 38 39
Mean (95% Confidence Interval)
Unit of Measure: units on scale
Week 14 C1: Fatigue/Tiredness
41.7
(31.4 to 52.0)
38.3
(29.5 to 47.0)
Week 18 C1: Fatigue/Tiredness
33.1
(24.0 to 42.2)
38.9
(28.9 to 48.9)
Week 24 C1: Fatigue/Tiredness
28.0
(20.1 to 35.9)
35.3
(25.5 to 45.1)
Week 14 C2: AS Neck, Back or Hip Pain
39.9
(29.6 to 50.1)
35.0
(26.8 to 43.3)
Week 18 C2: AS Neck, Back or Hip Pain
35.1
(26.2 to 44.0)
35.0
(25.7 to 44.3)
Week 24 C2: AS Neck, Back or Hip Pain
28.2
(19.5 to 36.8)
30.0
(21.3 to 38.7)
Week 14 C3: Pain/Swelling in Other Joints
27.0
(17.3 to 36.8)
28.4
(20.5 to 36.3)
Week 18 C3: Pain/Swelling in Other Joints
23.8
(14.5 to 33.1)
26.4
(17.4 to 35.4)
Week 24 C3: Pain/Swelling in Other Joints
21.0
(12.5 to 29.4)
24.9
(16.5 to 33.3)
Week 14 C4: Discomfort Areas Tender to Touch
30.0
(19.9 to 40.0)
29.1
(21.2 to 36.9)
Week 18 C4: Discomfort Areas Tender to Touch
24.1
(15.4 to 32.8)
28.7
(19.6 to 37.9)
Week 24 C4: Discomfort Areas Tender to Touch
19.3
(11.9 to 26.8)
25.6
(17.5 to 33.8)
Week 14 C5: Morning Stiffness
35.8
(25.6 to 46.1)
28.5
(20.3 to 36.7)
Week 18 C5: Morning Stiffness
31.4
(21.5 to 41.4)
28.6
(20.2 to 37.0)
Week 24 C5: Morning Stiffness
26.4
(17.5 to 35.4)
24.7
(17.8 to 31.7)
Week 14 C6: Duration Morning Stiffness
31.3
(20.9 to 41.6)
27.7
(19.4 to 36.0)
Week 18 C6: Duration Morning Stiffness
31.3
(20.9 to 41.7)
25.7
(17.6 to 33.9)
Week 24 C6: Duration Morning Stiffness
24.9
(15.4 to 34.4)
24.4
(17.2 to 31.6)
Week 14: Subscore Morning Stiffness
33.5
(24.03 to 43.06)
28.09
(20.14 to 36.04)
Week 18: Subscore Morning Stiffness
31.38
(21.66 to 41.10)
27.17
(19.02 to 35.32)
Week 24: Subscore Morning Stiffness
25.40
(16.69 to 34.12)
24.55
(17.77 to 31.34)
31.Secondary Outcome
Title Normalized Net Incremental Area Under the Curve (AUC) for Bath Ankylosing Spondylitis-Global Score (BAS-G) Visual Analog Scale Between Baseline and Week 12
Hide Description BAS-G was measured using a 100 millimeter Visual Analog Scale (VAS) ranging from 0=none to 100=very important. Normalized net incremental area under the curve (AUC) = area between baseline and the BAS-G curve as a function of time (randomization to Week 12); computed using the linear trapezoidal method. All areas above baseline and under the curve are positive and all area below baseline and above the curve are negative. Net incremental AUC = sum of these areas; this result was then divided by the study duration of the patients; negative value = improvement.
Time Frame Baseline, Week 2, Week 4, Week 8, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
mITT; LOCF. N=number of subjects with evaluable data.
Arm/Group Title Etanercept Placebo
Hide Arm/Group Description:
50 mg subcutaneously (SC), once weekly
Subcutaneously (SC), once weekly
Overall Number of Participants Analyzed 38 42
Least Squares Mean (95% Confidence Interval)
Unit of Measure: millimeters
-21.36
(-27.07 to -15.66)
-15.43
(-20.85 to -10.00)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
Comments Analysis of covariance (ANCOVA) with treatment as a factor and baseline value as a covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.139
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -5.94
Confidence Interval (2-Sided) 95%
-13.84 to 1.96
Estimation Comments Least squares mean difference = mean difference final value.
32.Secondary Outcome
Title Change From Baseline in the Bath Ankylosing Spondylitis-Global Score (BAS-G) at Weeks 2, 4, 8, 12
Hide Description Subject assessment of the effect of their disease on well-being over last 48 hours using a 100 millimeter (mm) Visual Analog Scale (VAS); range: 0=none to 100=very important.
Time Frame Baseline, Week 2, Week 4, Week 8, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
mITT; LOCF. N=number of subjects with evaluable data.
Arm/Group Title Etanercept Placebo
Hide Arm/Group Description:
50 mg subcutaneously (SC), once weekly
Subcutaneously (SC), once weekly
Overall Number of Participants Analyzed 38 42
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on scale
Week 2
-13.74
(-20.81 to -6.68)
-14.64
(-21.36 to -7.92)
Week 4
-20.09
(-27.16 to -13.02)
-14.99
(-21.71 to -8.27)
Week 8
-28.17
(-35.24 to -21.11)
-18.27
(-24.99 to -11.55)
Week 12
-29.78
(-36.84 to -22.71)
-16.12
(-22.84 to -9.40)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
Comments Week 2: Comparison of leasts squares means. Mixed-model analysis of covariance (ANCOVA) using an auto-regressive correlation structure with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate, and patients as a random factor.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.857
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.89
Confidence Interval (2-Sided) 95%
-8.88 to 10.67
Estimation Comments Least squares mean difference = mean difference final value.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
Comments Week 4: Comparison of leasts squares means. Mixed-model analysis of covariance (ANCOVA) using an auto-regressive correlation structure with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate, and patients as a random factor.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.304
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -5.10
Confidence Interval 95%
-14.88 to 4.67
Estimation Comments Least squares mean difference = mean difference final value.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
Comments Week 8: Comparison of leasts squares means. Mixed-model analysis of covariance (ANCOVA) using an auto-regressive correlation structure with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate, and patients as a random factor.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.047
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -9.90
Confidence Interval 95%
-19.68 to -0.13
Estimation Comments Least squares mean difference = mean difference final value.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
Comments Week 12: Comparison of leasts squares means. Mixed-model analysis of covariance (ANCOVA) using an auto-regressive correlation structure with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate, and patients as a random factor.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.007
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -13.65
Confidence Interval 95%
-23.43 to -3.88
Estimation Comments Least squares mean difference = mean difference final value.
33.Secondary Outcome
Title Change From Baseline in the Bath Ankylosing Spondylitis-Global Score (BAS-G) at Weeks 14, 18, 24
Hide Description Subject assessment of the effect of their disease on well-being over last 48 hours using a 100 millimeter Visual Analog Scale (VAS); range: 0=none to 100=very important.
Time Frame Week 14, Week 18, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Open-label population; LOCF.
Arm/Group Title Etanercept/Etanercept Placebo/Etanercept
Hide Arm/Group Description:
Double-blind Period 1: Etanercept 50 mg subcutaneously (SC) once weekly; Open-label Period 2: Etanercept 50 mg subcutaneously (SC), once weekly
Double-blind Period 1: Placebo subcutaneously (SC), once weekly; Open-label Period 2: Etanercept subcutaneously (SC), once weekly
Overall Number of Participants Analyzed 38 39
Mean (95% Confidence Interval)
Unit of Measure: units on scale
Week 14
-34.29
(-43.58 to -25.00)
-34.93
(-44.51 to -25.34)
Week 18
-36.93
(-45.27 to -28.60)
-35.98
(-44.69 to -27.26)
Week 24
-42.35
(-50.58 to -34.13)
-35.89
(-44.30 to -27.48)
34.Secondary Outcome
Title Bath Ankylosing Spondylitis Global Score (BAS-G) Independent Component: Effect of Disease on Well-being at Weeks 2, 4, 8, 12
Hide Description Subject evaluation of the effect of their disease on well-being over the last week using a using a 100 millimeter Visual Anaog Scale; range: 0=none to 100=very important.
Time Frame Baseline, Week 2, Week 4, Week 8, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
mITT; LOCF.
Arm/Group Title Etanercept Placebo
Hide Arm/Group Description:
50 mg subcutaneously (SC), once weekly
Subcutaneously (SC), once weekly
Overall Number of Participants Analyzed 39 43
Mean (95% Confidence Interval)
Unit of Measure: units on scale
Baseline
72.1
(66.9 to 77.4)
68.3
(62.6 to 73.9)
Week 2
57.8
(49.9 to 65.6)
54.4
(47.4 to 61.4)
Week 4
51.4
(43.5 to 59.4)
54.0
(46.8 to 61.3)
Week 8
43.3
(34.9 to 51.6)
50.8
(44.9 to 56.7)
Week 12
42.1
(33.0 to 51.1)
52.9
(46.3 to 59.5)
35.Secondary Outcome
Title Change From Baseline to Week 12 in Forced Vital Capacity (FVC), Vital Capacity (VC), and Forced Expiratory Volume in One Second (FEV1)
Hide Description [Not Specified]
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
mITT. In the case of missing data, no replacement or imputation method was performed.
Arm/Group Title Etanercept Placebo
Hide Arm/Group Description:
50 mg subcutaneously (SC), once weekly
Subcutaneously (SC), once weekly
Overall Number of Participants Analyzed 39 43
Least Squares Mean (95% Confidence Interval)
Unit of Measure: liters
Vital Capacity
0.14
(0.05 to 0.23)
-0.05
(-0.14 to 0.04)
Forced Vital Capacity (FVC)
0.16
(0.07 to 0.25)
-0.02
(-0.11 to 0.07)
Forced Expiratory Volume in 1 Second
0.05
(-0.02 to 0.12)
-0.02
(-0.09 to 0.05)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
Comments Vital Capacity: Analysis of covariance (ANCOVA) with treatment as a factor and baseline value as a covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.003
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.19
Confidence Interval (2-Sided) 95%
0.06 to 0.31
Estimation Comments Least squares mean difference = mean difference final value.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
Comments Forced Vital Capacity: Analysis of covariance (ANCOVA) with treatment as a factor and baseline value as a covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.006
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.18
Confidence Interval (2-Sided) 95%
0.05 to 0.31
Estimation Comments Least squares mean difference = mean difference final value.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
Comments Forced Expitatory Volume in 1 second: Analysis of covariance (ANCOVA) with treatment as a factor and baseline value as a covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.205
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.06
Confidence Interval (2-Sided) 95%
-0.04 to 0.17
Estimation Comments Least squares mean difference = mean difference final value.
36.Secondary Outcome
Title Change From Baseline to Week 12 in Ratio Forced Expitatory Volume in One Second (FEV1)/Forced Vital Capacity (FVC) (%)
Hide Description [Not Specified]
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
mITT; N=number of subjects with evaluable data. In the case of missing data, no replacement or imputation method was performed.
Arm/Group Title Etanercept Placebo
Hide Arm/Group Description:
50 mg subcutaneously (SC), once weekly
Subcutaneously (SC), once weekly
Overall Number of Participants Analyzed 37 38
Least Squares Mean (95% Confidence Interval)
Unit of Measure: percent
-2.49
(-4.15 to -0.84)
0.10
(-1.53 to 1.73)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
Comments Analysis oaf covariance (ANCOVA) with treatment as a factor and baseline value as a covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.030
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -2.59
Confidence Interval (2-Sided) 95%
-4.93 to -0.26
Estimation Comments Least squares mean difference = mean difference final value.
37.Secondary Outcome
Title Normalized Net Incremental Area Under the Curve (AUC) for the Bath Ankylosing Spondylitis Metrology Index (BASMI) Between Baseline and Week 12
Hide Description BASMI was composed of 5 measures; each measure scored 0-2 (0=normal mobility, 2=severe reduction); final score range: 0 to 10. Normalized net incremental area under the curve (AUC) = area between baseline and the BASMI curve as a function of time (randomization to Week 12); computed using the linear trapezoidal method. All areas above baseline and under the curve are positive and all area below baseline and above the curve are negative. Net incremental AUC = sum of these areas; this result was then divided by the study duration of the patients; negative value = improvement.
Time Frame Baseline, Week 2, Week 4, Week 8, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
mITT; LOCF.
Arm/Group Title Etanercept Placebo
Hide Arm/Group Description:
50 mg subcutaneously (SC), once weekly
Subcutaneously (SC), once weekly
Overall Number of Participants Analyzed 39 43
Least Squares Mean (95% Confidence Interval)
Unit of Measure: millimeters
-0.41
(-0.57 to -0.26)
-0.18
(-0.33 to -0.03)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
Comments Analysis of covariance (ANCOVA) with treatment as a factor and baseline value as covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.035
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.23
Confidence Interval (2-Sided) 95%
-0.45 to -0.02
Estimation Comments Least squares mean difference = mean difference final value.
38.Secondary Outcome
Title Change From Baseline in Spinal Mobility Measured With the Bath Ankylosing Spondylitis Metrology Index (BASMI) at Weeks 2, 4, 8, 12
Hide Description BASMI is an objective measure of spinal mobility. The BASMI score is composed of 5 measures: cervical rotation, intermalleolar distance, modified Schober test, lateral flexion and tragus to wall distance. Each measure was scored 0-2 (0=normal mobility, 2=severe reduction) to give a final score ranging 0 to 10. Higher score = greater reduction in spinal mobility.
Time Frame Week 2, Week 4, Week 8, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
mITT; LOCF.
Arm/Group Title Etanercept Placebo
Hide Arm/Group Description:
50 mg subcutaneously (SC), once weekly
Subcutaneously (SC), once weekly
Overall Number of Participants Analyzed 39 43
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on scale
Week 2
-0.27
(-0.47 to -0.06)
-0.17
(-0.37 to 0.02)
Week 4
-0.37
(-0.58 to -0.17)
-0.23
(-0.43 to -0.04)
Week 8
-0.57
(-0.77 to -0.36)
-0.18
(-0.38 to 0.01)
Week 12
-0.57
(-0.77 to -0.36)
-0.20
(-0.40 to -0.01)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
Comments Week 2: Mixed model analysis of covariance (ANCOVA), using an auto-regressive correlation structure, with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate and patients as a random factor.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.515
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.09
Confidence Interval (2-Sided) 95%
-0.38 to 0.19
Estimation Comments Least squares mean difference = mean difference final value.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
Comments Week 4: Mixed model analysis of covariance (ANCOVA), using an auto-regressive correlation structure, with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate and patients as a random factor.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.316
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.14
Confidence Interval 95%
-0.43 to 0.14
Estimation Comments Least squares mean difference = mean difference final value.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
Comments Week 8: Mixed model analysis of covariance (ANCOVA), using an auto-regressive correlation structure, with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate and patients as a random factor.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.008
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.39
Confidence Interval 95%
-0.67 to -0.10
Estimation Comments Least squares mean difference = mean difference final value.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
Comments Week 12: Mixed model analysis of covariance (ANCOVA), using an auto-regressive correlation structure, with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate and patients as a random factor.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.011
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.37
Confidence Interval 95%
-0.65 to -0.08
Estimation Comments Least squares mean difference = mean difference final value.
39.Secondary Outcome
Title Change From Baseline in Spinal Mobility Measured With the Bath Ankylosing Spondylitis Metrology Index (BASMI) at Weeks 14, 18, 24
Hide Description BASMI is an objective measure of spinal mobility. The BASMI score is composed of 5 measures: cervical rotation, intermalleolar distance, modified Schober’s test, lateral flexion and tragus to wall distance. Each measure was scored 0-2 (0=normal mobility, 2=severe reduction) to give a final score ranging 0 to 10. Higher score = greater reduction in spinal mobility.
Time Frame Week 14, Week 18, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Open-label population; LOCF.
Arm/Group Title Etanercept/Etanercept Placebo/Etanercept
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Double-blind Period 1: Etanercept 50 mg subcutaneously (SC) once weekly; Open-label Period 2: Etanercept 50 mg subcutaneously (SC), once weekly
Double-blind Period 1: Placebo subcutaneously (SC), once weekly; Open-label Period 2: Etanercept subcutaneously (SC), once weekly
Overall Number of Participants Analyzed 38 39
Mean (95% Confidence Interval)
Unit of Measure: units on scale
Week 14
-0.73
(-0.98 to -0.49)
-0.49
(-0.68 to -0.30)
Week 18
-0.65
(-0.94 to -0.36)
-0.49
(-0.69 to -0.29)
Week 24
-0.80
(-1.05 to -0.55)
-0.50
(-0.72 to -0.29)
40.Secondary Outcome
Title Bath Ankylosing Spondylitis Metrology Index (BASMI) Independent Component: Cervical Rotation at Weeks 2, 4, 8, 12
Hide Description Cervical rotation: measurement of degrees to which the subjects could turn their heads as far as possible to the right and then to the left. Mean of ordinal scores from 0: >= 85 degrees to 10: <= 8.5 degrees.
Time Frame Baseline, Week 2, Week 4, Week 8, Week 12
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Hide Analysis Population Description
mITT; LOCF. In the case of missing data, no replacement or imputation method was performed.
Arm/Group Title Etanercept Placebo
Hide Arm/Group Description:
50 mg subcutaneously (SC), once weekly
Subcutaneously (SC), once weekly
Overall Number of Participants Analyzed 39 43
Mean (95% Confidence Interval)
Unit of Measure: units on scale
Baseline
39.85
(33.77 to 45.92)
37.14
(30.37 to 43.91)
Week 2
43.05
(35.73 to 50.38)
38.34
(32.08 to 44.60)
Week 4
42.55
(35.64 to 49.47)
39.67
(33.21 to 46.14)
Week 8
44.34
(37.57 to 51.11)
39.79
(32.44 to 47.14)
Week 12
46.39
(39.55 to 53.24)
42.67
(35.58 to 49.75)
41.Secondary Outcome
Title Bath Ankylosing Spondylitis Metrology Index (BASMI): Spinal Mobility Measured With Cervical Rotation at Weeks 14, 18, 24
Hide Description Cervical rotation: measurement in degree to which the subjects could turn their heads as far as possible to the right and then to the left. Mean of ordinal scores from 0: >= 85 degrees to 10: <= 8.5 degrees.
Time Frame Week 14, Week 18, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Open-label population; in the case of missing data, no replacement or imputation method was performed.
Arm/Group Title Etanercept/Etanercept Placebo/Etanercept
Hide Arm/Group Description:
Double-blind Period 1: Etanercept 50 mg subcutaneously (SC) once weekly; Open-label Period 2: Etanercept 50 mg subcutaneously (SC), once weekly
Double-blind Period 1: Placebo subcutaneously (SC), once weekly; Open-label Period 2: Etanercept subcutaneously (SC), once weekly
Overall Number of Participants Analyzed 38 39
Mean (95% Confidence Interval)
Unit of Measure: units on scale
Week 14
47.75
(40.85 to 54.65)
44.78
(37.32 to 52.24)
Week 18
44.62
(37.20 to 52.03)
43.92
(36.57 to 51.27)
Week 24
48.74
(41.78 to 55.71)
43.82
(36.26 to 51.37)
42.Secondary Outcome
Title Bath Ankylosing Spondylitis Metrology Index (BASMI) Independent Component: Spinal Mobility Measured With Tragus-to-wall Distance at Baseline and Weeks 2, 4, 8, 12
Hide Description Measurement in centimeters (cm) of distance between the tragus and wall from right and left side while subject is standing with back against the wall; knees straight; scapulae, buttocks, and heels against the wall; with head in neutral position. Measurement of two attempts on right and left sides. Mean of ordinal scores from 0: <= 10 cm to 10: >= 37 cm.
Time Frame Baseline, Week 2, Week 4, Week 8, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
mITT. In the case of missing data, no replacement or imputation method was performed.
Arm/Group Title Etanercept Placebo
Hide Arm/Group Description:
50 mg subcutaneously (SC), once weekly
Subcutaneously (SC), once weekly
Overall Number of Participants Analyzed 39 43
Mean (95% Confidence Interval)
Unit of Measure: centimeters
Baseline
20.18
(17.90 to 22.45)
19.76
(17.64 to 21.87)
Week 2
19.69
(17.36 to 22.03)
18.81
(16.40 to 21.22)
Week 4
19.19
(16.82 to 21.56)
18.82
(16.54 to 21.09)
Week 8
18.70
(16.39 to 21.01)
20.03
(16.91 to 23.14)
Week 12
18.54
(16.25 to 20.83)
18.45
(16.06 to 20.83)
43.Secondary Outcome
Title Bath Ankylosing Spondylitis Metrology Index (BASMI): Spinal Mobility Measured With Tragus-to-wall Measurement at Weeks 14, 18, 24
Hide Description Measurement in centimeters (cm) of distance between the tragus and wall from right and left side while subject is standing with back against the wall; knees straight; scapulae, buttocks, and heels against the wall; with head in neutral position. Measurement of two tries on right and left sides. Mean of ordinal scores from 0: <= 10 cm to 10: >= 37 cm.
Time Frame Week 14, Week 18, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Open-label population; in the case of missing data, no replacement or imputation method was performed.
Arm/Group Title Etanercept/Etanercept Placebo/Etanercept
Hide Arm/Group Description:
Double-blind Period 1: Etanercept 50 mg subcutaneously (SC) once weekly; Open-label Period 2: Etanercept 50 mg subcutaneously (SC), once weekly
Double-blind Period 1: Placebo subcutaneously (SC), once weekly; Open-label Period 2: Etanercept subcutaneously (SC), once weekly
Overall Number of Participants Analyzed 38 39
Mean (95% Confidence Interval)
Unit of Measure: centimeters
Week 14
19.12
(16.86 to 21.38)
18.38
(16.05 to 20.70)
Week 18
19.86
(17.74 to 21.98)
18.55
(16.17 to 20.94)
Week 24
18.99
(16.85 to 21.13)
18.60
(16.28 to 20.92)
44.Secondary Outcome
Title Bath Ankylosing Spondylitis Metrology Index (BASMI) Independent Component: Spinal Mobility Measured With Lateral Flexion at Baseline and Weeks 2, 4, 8, and 12
Hide Description Measurement in centimters (cm) of distance between subject's middle fingertip and the floor after bending sideways, without bending knees or lifting heels, while attemting to keep shoulders in same place (flexion position). Measurement of two attempts on each side (right and left). Mean of ordinal scores from 0: >=20 cm to 10: <=1.2 cm.
Time Frame Baseline, Week 2, Week 4, Week 8, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
mITT. In the case of missing data, no replacement or imputation method was performed.
Arm/Group Title Etanercept Placebo
Hide Arm/Group Description:
50 mg subcutaneously (SC), once weekly
Subcutaneously (SC), once weekly
Overall Number of Participants Analyzed 39 43
Mean (95% Confidence Interval)
Unit of Measure: centimeters
Baseline
13.79
(7.34 to 20.25)
9.80
(5.30 to 14.30)
Week 2
13.58
(7.57 to 19.59)
10.62
(5.94 to 15.31)
Week 4
13.01
(7.46 to 18.55)
10.60
(5.75 to 15.45)
Week 8
12.19
(6.74 to 17.63)
10.21
(5.52 to 14.89)
Week 12
12.41
(6.94 to 17.87)
8.56
(4.41 to 12.71)
45.Secondary Outcome
Title Bath Ankylosing Spondylitis Metrology Index (BASMI): Spinal Mobility Measured With Lateral Flexion at Weeks 14, 18, 24