Ankylosing Spondylitis
Conditions
Keywords
Axial Ankylosing Spondylitis, Adult
Brief summary
Evaluation of the efficacy and safety of etanercept (Enbrel) in patients with active, severe and advanced ankylosing spondylitis.
Interventions
50 mg injection once weekly
OTHERPlacebo
placebo
Sponsors
Wyeth is now a wholly owned subsidiary of Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Active and severe ankylosing spondylitis * Ankylosing spondylitis refractory to standard anti-rheumatic treatment * Between 18 and 70 years of age
Exclusion criteria
* Prior exposure to any TNF-inhibitor, including etanercept * DMARDs (other than hydroxychloroquine, methotrexate and sulphasalazine) within 4 weeks of study drug initiation * Dose of NSAIDs changed within two weeks of study drug initiation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Normalized Net Incremental Area Under the Curve (AUC) for the Bath Ankylosing Spondylitis Disease Activities Index (BASDAI) Between Randomization and Week 12 | Baseline, Week 2, Week 4, Week 8, Week 12 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent of Subjects Achieving Assessment Ankylosing Spondylitis (ASAS) 20 at Weeks 2, 4, 8, 12 | Week 2, Week 4, Week 8, Week 12 | 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. |
| Percent of Subjects Acheiving Assessment Ankylosing Spondylitis (ASAS) 20 at Weeks 14, 18, 24 | Week 14, Week 18, Week 24 | 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. |
| Percent of Subjects Achieving Assessment Ankylosing Spondylitis (ASAS) 50 at Weeks 2, 4, 8, 12 | Week 2, Week 4, Week 8, Week 12 | 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. |
| Percent of Subjects Achieving Partial Remission at Weeks 2, 4, 8, 12 | Week 2, Week 4, Week 8, Week 12 | 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. |
| Percent of Subjects Achieving Assessment Ankylosing Spondylitis (ASAS) 50 at Weeks 14, 18, 24 | Week 14, Week 18, Week 24 | 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. |
| Percent of Subjects Achieving Assessment Ankylosing Spondylitis (ASAS) 70 at Weeks 2, 4, 8, 12 | Week 2, Week 4, Week 8, Week 12 | 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. |
| Percent of Subjects Achieiving Assessment Ankylosing Spondylitis (ASAS) 70 at Weeks 14, 18, 24 | Week 14, Week 18, Week 24 | 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. |
| Percent of Subjects Achieving Partial Remission at Weeks 14, 18, 24 | Week 14, Week 18, Week 24 | 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. |
| Normalized Net Incremental Area Under the Curve (AUC) for Patient Global Assessment (PGA) Between Baseline and Week 12 | Baseline, Week 2, Week 4, Week 8, Week 12 | 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. |
| Change From Baseline in Patient Global Assessment Visual Analog Scale (VAS) at Weeks 2, 4, 8, 12 | Baseline, Week 2, Week 4, Week 8, Week 12 | 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. |
| Change From Baseline in Patient Global Assessment at Weeks 14, 18, 24 | Week 14, Week 18, Week 24 | 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. |
| Normalized Net Incremental Area Under the Curve (AUC) for Physician Global Assessment (PGA) Between Baseline and Week 12 | Baseline, Week 2, Week 4, Week 8, Week 12 | 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. |
| Change From Baseline in Physician Global Assessment Visual Analog Scale at Weeks 2, 4, 8, 12 | Baseline, Week 2, Week 4, Week 8, Week 12 | 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. |
| Change From Baseline in Physician Global Assessment at Weeks 14, 18, 24 | Week 14, Week 18, Week 24 | 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. |
| Normalized Net Incremental Area Under the Curve (AUC) for Nocturnal Back Pain Between Baseline and Week 12 | Baseline, Week 2, Week 4, Week 8, Week 12 | 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. |
| Change From Baseline in Nocturnal Back Pain at Weeks 2, 4, 8, 12 | Baseline, Week 2, Week 4, Week 8, Week 12 | 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. |
| Change From Baseline in Nocturnal Back Pain at Weeks 14, 18, 24 | Week 14, Week 18, Week 24 | 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. |
| Normalized Net Incremental Area Under the Curve (AUC) for Total Back Pain Between Baseline and Week 12 | Baseline, Week 2, Week 4, Week 8, Week 12 | 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. |
| Change From Baseline in Total Back Pain at Weeks 2, 4, 8, 12 | Baseline, Week 2, Week 4, Week 8, Week 12 | 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. |
| Change From Baseline in Total Back Pain at Weeks 14, 18, 24 | Week 14, Week 18, Week 24 | 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. |
| Normalized Net Incremental Area Under the Curve (AUC) for the Bath Ankylosing Spondylitis Functional Index (BASFI) Between Baseline and Week 12 | Baseline, Week 2, Week 4, Week 8, Week 12 | 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. |
| Change From Baseline in the Bath Ankylosing Spondylitis Functional Index (BASFI) at Weeks 2, 4, 8, 12 | Baseline, Week 2, Week 4, Week 8, Week 12 | 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. |
| Bath Ankylosing Functional Index (BASFI): Independent Components at Weeks 2, 4, 8, 12 | Baseline, Week 2, Week 4, Week 8, Week 12 | 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). |
| Bath Ankylosing Functional Index (BASFI) Independent Components at Weeks 14, 18, 24 | Week 14, Week 18, Week 24 | 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). |
| Change From Baseline in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Weeks 2, 4, 8, 12 | Baseline, Week 2, Week 4, Week 8, Week 12 | 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. |
| Change From Baseline in the Bath Ankylosing Spondylitis (AS) Disease Activity Index (BASDAI) at Weeks 14, 18, 24 | Week 14, Week 18, Week 24 | 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. |
| Bath Ankylosing Spondylitis (AS) Disease Activity Index (BASDAI) Independent Components at Weeks 2, 4, 8, 12 | Week 2, Week 4, Week 8, Week 12 | 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. |
| Bath Ankylosing Spondylitis (AS) Disease Activity Index (BASDAI) Independent Components at Weeks 14, 18, 24 | Week 14, Week 18, Week 24 | 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. |
| Normalized Net Incremental Area Under the Curve (AUC) for Bath Ankylosing Spondylitis-Global Score (BAS-G) Visual Analog Scale Between Baseline and Week 12 | Baseline, Week 2, Week 4, Week 8, Week 12 | 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. |
| Change From Baseline in the Bath Ankylosing Spondylitis-Global Score (BAS-G) at Weeks 2, 4, 8, 12 | Baseline, Week 2, Week 4, Week 8, Week 12 | 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. |
| Change From Baseline in the Bath Ankylosing Spondylitis-Global Score (BAS-G) at Weeks 14, 18, 24 | Week 14, Week 18, Week 24 | 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. |
| Bath Ankylosing Spondylitis Global Score (BAS-G) Independent Component: Effect of Disease on Well-being at Weeks 2, 4, 8, 12 | Baseline, Week 2, Week 4, Week 8, Week 12 | 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. |
| Change From Baseline to Week 12 in Forced Vital Capacity (FVC), Vital Capacity (VC), and Forced Expiratory Volume in One Second (FEV1) | Baseline, Week 12 | — |
| Change From Baseline to Week 12 in Ratio Forced Expitatory Volume in One Second (FEV1)/Forced Vital Capacity (FVC) (%) | Baseline, Week 12 | — |
| Normalized Net Incremental Area Under the Curve (AUC) for the Bath Ankylosing Spondylitis Metrology Index (BASMI) Between Baseline and Week 12 | Baseline, Week 2, Week 4, Week 8, Week 12 | 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. |
| Change From Baseline in Spinal Mobility Measured With the Bath Ankylosing Spondylitis Metrology Index (BASMI) at Weeks 2, 4, 8, 12 | Week 2, Week 4, Week 8, Week 12 | 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. |
| Change From Baseline in Spinal Mobility Measured With the Bath Ankylosing Spondylitis Metrology Index (BASMI) at Weeks 14, 18, 24 | Week 14, Week 18, Week 24 | 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. |
| Bath Ankylosing Spondylitis Metrology Index (BASMI) Independent Component: Cervical Rotation at Weeks 2, 4, 8, 12 | Baseline, Week 2, Week 4, Week 8, Week 12 | 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. |
| Bath Ankylosing Spondylitis Metrology Index (BASMI): Spinal Mobility Measured With Cervical Rotation at Weeks 14, 18, 24 | Week 14, Week 18, Week 24 | 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. |
| Bath Ankylosing Spondylitis Metrology Index (BASMI) Independent Component: Spinal Mobility Measured With Tragus-to-wall Distance at Baseline and Weeks 2, 4, 8, 12 | Baseline, Week 2, Week 4, Week 8, Week 12 | 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. |
| Bath Ankylosing Spondylitis Metrology Index (BASMI): Spinal Mobility Measured With Tragus-to-wall Measurement at Weeks 14, 18, 24 | Week 14, Week 18, Week 24 | 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. |
| Bath Ankylosing Spondylitis Metrology Index (BASMI) Independent Component: Spinal Mobility Measured With Lateral Flexion at Baseline and Weeks 2, 4, 8, and 12 | Baseline, Week 2, Week 4, Week 8, Week 12 | 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. |
| Bath Ankylosing Spondylitis Metrology Index (BASMI): Spinal Mobility Measured With Lateral Flexion at Weeks 14, 18, 24 | Week 14, Week 18, Week 24 | Measurement in centimters (cm) of distance between subject's middle fingertip and the floor after bending sideways, without bending knees or lifting heels, while attempting 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. |
| Bath Ankylosing Spondylitis Metrology Index (BASMI) Independent Component: Spinal Mobility Measured With Modified Schober's Test at Baseline and Weeks 2, 4, 8, 12 | Baseline, Week 2, Week 4, Week 8, Week 12 | Measurement in centimeters of the distance between marks originally placed while the subject was standing erect 10 centimeters (cm) above and 5 cm below the midpoint of a line that joints the posterior superior iliac spines. Distance between marks was remeasured with subject maximally bend forward, knees fully extended, with spine in full flexion. Measurement of two attempts. Mean of ordinal scores from 1: 5.7 to 6.3 cm, to 10: \<=0.7 cm. |
| Bath Ankylosing Spondylitis Metrology Index (BASMI): Spinal Mobility Measured With Modified Schober's Test at Weeks 14, 18, 24 | Week 14, Week 18, Week 24 | Measurement in centimeters of the distance between marks originally placed while the subject was standing erect 10 centimeters (cm) above and 5 cm below the midpoint of a line that joints the posterior superior iliac spines. Distance between marks was remeasured with subject maximally bend forward, knees fully extended, with spine in full flexion. Measurement of two attempts. Mean of ordinal scores from 1: 5.7 to 6.3 cm, to 10: \<=0.7 cm. |
| Bath Ankylosing Spondylitis Metrology Index (BASMI) Independent Component: Spinal Mobility Measured With Intermalleolar Distance at Baseline and Weeks 2, 4, 8, 12 | Baseline, Week 2, Week 4, Week 8, Week 12 | Measurement in centimeters (cm) of the distance between the medial malleoli when subject is lying supine with knees and feet straight up with legs separated as far as possible. Measurement of two attempts. Mean of ordinal scores from 0: \>= 120 cm, to 9: 30 to 39.9 cm. |
| Bath Ankylosing Spondylitis Metrology Index (BASMI): Spinal Mobility Measured With Intermalleolar Distance at Weeks 14, 18, 24 | Week 14, Week 18, Week 24 | Measurement in centimeters (cm) of the distance between the medial malleoli when subject is lying supine with knees and feet straight up with legs separated as far as possible. Measurement of two attempts. Mean of ordinal scores from 0: \>= 120 cm, to 9: 30 to 39.9 cm. |
| Normalized Net Incremental Area Under the Curve (AUC) for the Chest Expansion Test Between Baseline and Week 12 | Baseline, Week 2, Week 4, Week 8, Week 12 | Normalized net incremental area under the curve (AUC) = area between baseline and the Chest Expansion Test 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. |
| Change From Baseline in the Chest Expansion Test at Weeks 2, 4, 8, 12 | Week 2, Week 4, Week 8, Week 12 | Measurement and remeasurement of standing maximal inspiration; chest circumference at nipple line or at 4th intercostal space in centimeters. |
| Change From Baseline in the Chest Expansion Test at Weeks 14, 18, 24 | Week 14, Week 18, Week 24 | Measurement and remeasurement of standing maximal inspiration; chest circumference at nipple line or at 4th intercostal space in centimeters (cm). |
| Change From Baseline in Level of Difficulty to Perform Physically Demanding Activities Due to Ankylosing Spondylitis at Weeks 2, 4, 8, 12 | Baseline, Week 2, Week 4, Week 8, Week 12 | Subject evaluation of level of difficulty to perform daily physical activities and/or kinesitherapy for ankylosing spondylitis (AS) because of AS using a 100 millimeter Visual Analog Scale (VAS) ranging from 0=easy to 100=impossible. Subgroup of subjects who responded that they were able to perform daily physical activities and/or kinesitherapy for their ankylosing spondylitis at each visit. |
| Change From Baseline in Self Assessment of Ability and or Easiness to Perform Physically Demanding Activities at Weeks 14, 18, 24 | Week 14, Week 18, Week 24 | Subject evaluation of level of difficulty to perform daily physical activities and/or kinesitherapy for ankylosing spondylitis (AS) due to AS using a 100 millimeter Visual Analog Scale (VAS) ranging from 0=easy to 100=impossible. Subgroup of subjects who responded that they were able to perform daily physical activities and/or kinesitherapy for their ankylosing spondylitis at each visit. |
| Normalized Net Incremental Area Under the Curve (AUC) for Erythtocyte Sedimentation Rate Between Baseline and Week 12 | Baseline, Week 2, Week 4, Week 8, Week 12 | Normalized net incremental area under the curve (AUC) = area between baseline and the Erythrocyte Sedimentation Rate 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. |
| Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Weeks 2, 4, 8, 12 | Week 2, Week 4, Week 8, Week 12 | ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. A higher rate is consistent with inflammation. |
| Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Weeks 14, 18, 24 | Week 14, Week 18, Week 24 | ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. A higher rate is consistent with inflammation. |
| Percent of Subjects Achieving Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 Response | Baseline, Week 2, Week 4, Week 8, Week 12 | 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%. |
| Change From Baseline in C-reactive Protein (CRP) at Weeks 2, 4, 8, 12 | Baseline, Week 2, Week 4, Week 8, Week 12 | CRP is a marker of inflammation. A higher level is consistent with inflammation. |
| Change From Baseline in C-reactive Protein (CRP) at Weeks 14, 18, 24 | Week 14, Week 18, Week 24 | Change from baseline in C-reactive Protein (CRP). |
| Percent of Subjects With Normal and Abnormal C-Reactive Protein at Weeks 14, 18, 24 | Week 14, Week 18, Week 24 | Percent of participants with normal (\<6 milligrams per liter) and abnormal (\>= 6 milligrams per liter) C-Reactive Protein. |
| Percent of Subjects With Patient Acceptable and Unacceptable Symptom State (PASS) at Weeks 2, 4, 8, 12 | Week 2, Week 4, Week 8, Week 12 | Percent of subjects reporting acceptable symptom state: acceptance to remain for the rest of their lives with the level of pain they had during the last 48 hours; and unacceptable symptom state: not able to remain for the rest of their lives with the level of pain they had during the last 48 hours. In the case of missing data, subjects who withdrew from the study because of inefficacy or toxicity were considered unacceptable. |
| Percent of Subjects With Patient Acceptable and Unacceptable Symptom State (PASS) at Weeks 14, 18, 24 | Week 14, Week 18, Week 24 | Percent of subjects reporting acceptable symptom state: acceptance to remain for the rest of their lives with the level of pain they had during the last 48 hours; and unacceptable symptom state: not able to remain for the rest of their lives with the level of pain they had during the last 48 hours. In the case of missing data, subjects who withdrew from the study because of inefficacy or toxicity were considered unacceptable. |
| Percent of Subjects With Minimum Clinically Important Improvement (MCII) in Pain Rating at Weeks 2, 4, 8, 12 | Week 2, Week 4, Week 8, Week 12 | Subjects were asked how their pain had been during the last 48 hours compared to baseline. Those subjects that reported improvement assessed how important this improvement was to them; range: very important, moderately important, slightly important, or not at all important. Binary response options: 1=improved very important, or improved moderately important; 2=slightly important, not at all important, no change, or worse-more pain. |
| Percent of Subjects With Minimum Clinially Important Improvement (MCII) at Weeks 14, 18, 24 | Week 14, Week 18, Week 24 | Subjects were asked how their pain had been during the last 48 hours compared to baseline. Those subjects that reported improvement assessed how important this improvement was to them; range: very important, moderately important, slightly important, or not at all important. Binary response options: 1=improved very important, or improved moderately important; 2=slightly important, not at all important, no change, or worse-more pain. |
| Normalized Net Incremental Area Under the Curve (AUC) for C-reactive Protein Between Baseline and Week 12 | Baseline, Week 2, Week 4, Week 8, Week 12 | Normalized net incremental area under the curve (AUC) = area between baseline and the C-reactive Protein 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. |
Countries
France, Germany, Hungary, Netherlands
Participant flow
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.
Participants by arm
| Arm | Count |
|---|---|
| Etanercept 50 mg subcutaneously (SC), once weekly | 39 |
| Placebo Subcutaneously (SC), once weekly | 43 |
| Total | 82 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| 12 Week Double-Blind Treatment Period 1 | Adverse Event | 1 | 0 |
| 12 Week Double-Blind Treatment Period 1 | Lack of Efficacy | 0 | 2 |
| 12 Week Double-Blind Treatment Period 1 | Lost to Follow-up | 0 | 1 |
| 12 Week Double-Blind Treatment Period 1 | Withdrawal of Consent | 0 | 1 |
| 12 Week Open-Label Treatment Period 2 | Lost to Follow-up | 1 | 0 |
| 12 Week Open-Label Treatment Period 2 | Withdrawal of Consent | 1 | 1 |
Baseline characteristics
| Characteristic | Etanercept | Placebo | Total |
|---|---|---|---|
| Age Continuous | 46.2 years STANDARD_DEVIATION 10.8 | 48.2 years STANDARD_DEVIATION 47.3 | 47.3 years STANDARD_DEVIATION 10.4 |
| Sex: Female, Male Female | 2 Participants | 4 Participants | 6 Participants |
| Sex: Female, Male Male | 37 Participants | 39 Participants | 76 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 24 / 39 | 28 / 43 | 16 / 38 | 22 / 39 |
| serious Total, serious adverse events | 2 / 39 | 1 / 43 | 0 / 38 | 1 / 39 |
Outcome results
Primary
Normalized Net Incremental Area Under the Curve (AUC) for the Bath Ankylosing Spondylitis Disease Activities Index (BASDAI) Between Randomization and Week 12
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
Population: 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 | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Etanercept | Normalized Net Incremental Area Under the Curve (AUC) for the Bath Ankylosing Spondylitis Disease Activities Index (BASDAI) Between Randomization and Week 12 | -19.79 millimeters | 95% Confidence Interval 16.83 |
| Placebo | Normalized Net Incremental Area Under the Curve (AUC) for the Bath Ankylosing Spondylitis Disease Activities Index (BASDAI) Between Randomization and Week 12 | -10.96 millimeters | 95% Confidence Interval 16.46 |
Comparison: Comparison of least squares means. Primary analysis: analysis of covariance (ANCOVA) with treatment as a factor and BASDAI baseline as a covariate.p-value: 0.01995% CI: [-16.5, -1.51]ANCOVA
Secondary
Bath Ankylosing Functional Index (BASFI) Independent Components at Weeks 14, 18, 24
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
Population: Open-label population; in the case of missing data, no replacement or imputation method was performed. Abbreviations: C=component (number), Act=Activities.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Etanercept | Bath Ankylosing Functional Index (BASFI) Independent Components at Weeks 14, 18, 24 | Week 18 C1: Putting on Socks or Tights | 31.3 units on a scale |
| Etanercept | Bath Ankylosing Functional Index (BASFI) Independent Components at Weeks 14, 18, 24 | Week 18 C8: Looking Over Shoulder | 50.7 units on a scale |
| Etanercept | Bath Ankylosing Functional Index (BASFI) Independent Components at Weeks 14, 18, 24 | Week 24 C5: Getting Up Off Floor | 38.2 units on a scale |
| Etanercept | Bath Ankylosing Functional Index (BASFI) Independent Components at Weeks 14, 18, 24 | Week 24 C8: Looking Over Shoulder | 46.4 units on a scale |
| Etanercept | Bath Ankylosing Functional Index (BASFI) Independent Components at Weeks 14, 18, 24 | Week 14 C4: Getting Out Armless Chair | 32.0 units on a scale |
| Etanercept | Bath Ankylosing Functional Index (BASFI) Independent Components at Weeks 14, 18, 24 | Week 18 C3: Reaching to High Shelf | 32.1 units on a scale |
| Etanercept | Bath Ankylosing Functional Index (BASFI) Independent Components at Weeks 14, 18, 24 | Week 14 C10: Full Days Act | 40.4 units on a scale |
| Etanercept | Bath Ankylosing Functional Index (BASFI) Independent Components at Weeks 14, 18, 24 | Week 18 C6: Standing Unsupported | 32.6 units on a scale |
| Etanercept | Bath Ankylosing Functional Index (BASFI) Independent Components at Weeks 14, 18, 24 | Week 14 C1: Putting on Socks or Tights | 32.7 units on a scale |
| Etanercept | Bath Ankylosing Functional Index (BASFI) Independent Components at Weeks 14, 18, 24 | Week 18 C4: Getting Out Armless Chair | 27.3 units on a scale |
| Etanercept | Bath Ankylosing Functional Index (BASFI) Independent Components at Weeks 14, 18, 24 | Week 24 C1: Putting on Socks or Tights | 26.7 units on a scale |
| Etanercept | Bath Ankylosing Functional Index (BASFI) Independent Components at Weeks 14, 18, 24 | Week 24 C6: Standing Unsupported | 30.5 units on a scale |
| Etanercept | Bath Ankylosing Functional Index (BASFI) Independent Components at Weeks 14, 18, 24 | Week 14 C2: Bending from Waist | 42.1 units on a scale |
| Etanercept | Bath Ankylosing Functional Index (BASFI) Independent Components at Weeks 14, 18, 24 | Week 14 C3: Reaching to High Shelf | 37.0 units on a scale |
| Etanercept | Bath Ankylosing Functional Index (BASFI) Independent Components at Weeks 14, 18, 24 | Week 18 C2: Bending from Waist | 36.9 units on a scale |
| Etanercept | Bath Ankylosing Functional Index (BASFI) Independent Components at Weeks 14, 18, 24 | Week 14 C7: Climbing 12-15 Steps | 34.0 units on a scale |
| Etanercept | Bath Ankylosing Functional Index (BASFI) Independent Components at Weeks 14, 18, 24 | Week 24 C2: Bending from Waist | 36.1 units on a scale |
| Etanercept | Bath Ankylosing Functional Index (BASFI) Independent Components at Weeks 14, 18, 24 | Week 24 C4: Getting Out Armless Chair | 23.4 units on a scale |
| Etanercept | Bath Ankylosing Functional Index (BASFI) Independent Components at Weeks 14, 18, 24 | Week 14 C9: Physically Demanding Act | 41.8 units on a scale |
| Etanercept | Bath Ankylosing Functional Index (BASFI) Independent Components at Weeks 14, 18, 24 | Week 18 C7: Climbing 12-15 Steps | 30.7 units on a scale |
| Etanercept | Bath Ankylosing Functional Index (BASFI) Independent Components at Weeks 14, 18, 24 | Week 18 C9: Physically Demanding Act | 38.6 units on a scale |
| Etanercept | Bath Ankylosing Functional Index (BASFI) Independent Components at Weeks 14, 18, 24 | Week 24 C3: Reaching to High Shelf | 27.4 units on a scale |
| Etanercept | Bath Ankylosing Functional Index (BASFI) Independent Components at Weeks 14, 18, 24 | Week 24 C9: Physically Demanding Act | 33.7 units on a scale |
| Etanercept | Bath Ankylosing Functional Index (BASFI) Independent Components at Weeks 14, 18, 24 | Week 24 C7: Climbing 12-15 Steps | 28.8 units on a scale |
| Etanercept | Bath Ankylosing Functional Index (BASFI) Independent Components at Weeks 14, 18, 24 | Week 18 C10: Full Days Act | 37.9 units on a scale |
| Etanercept | Bath Ankylosing Functional Index (BASFI) Independent Components at Weeks 14, 18, 24 | Week 14 C5: Getting Up Off Floor | 43.6 units on a scale |
| Etanercept | Bath Ankylosing Functional Index (BASFI) Independent Components at Weeks 14, 18, 24 | Week 24 C10: Full Days Act | 32.1 units on a scale |
| Etanercept | Bath Ankylosing Functional Index (BASFI) Independent Components at Weeks 14, 18, 24 | Week 18 C5: Getting Up Off Floor | 40.0 units on a scale |
| Etanercept | Bath Ankylosing Functional Index (BASFI) Independent Components at Weeks 14, 18, 24 | Week 14 C8: Looking Over Shoulder | 52.4 units on a scale |
| Etanercept | Bath Ankylosing Functional Index (BASFI) Independent Components at Weeks 14, 18, 24 | Week 14 C6: Standing Unsupported | 38.8 units on a scale |
| Placebo | Bath Ankylosing Functional Index (BASFI) Independent Components at Weeks 14, 18, 24 | Week 24 C10: Full Days Act | 37.5 units on a scale |
| Placebo | Bath Ankylosing Functional Index (BASFI) Independent Components at Weeks 14, 18, 24 | Week 14 C3: Reaching to High Shelf | 31.7 units on a scale |
| Placebo | Bath Ankylosing Functional Index (BASFI) Independent Components at Weeks 14, 18, 24 | Week 18 C3: Reaching to High Shelf | 34.2 units on a scale |
| Placebo | Bath Ankylosing Functional Index (BASFI) Independent Components at Weeks 14, 18, 24 | Week 24 C3: Reaching to High Shelf | 32.1 units on a scale |
| Placebo | Bath Ankylosing Functional Index (BASFI) Independent Components at Weeks 14, 18, 24 | Week 14 C4: Getting Out Armless Chair | 27.9 units on a scale |
| Placebo | Bath Ankylosing Functional Index (BASFI) Independent Components at Weeks 14, 18, 24 | Week 18 C4: Getting Out Armless Chair | 26.5 units on a scale |
| Placebo | Bath Ankylosing Functional Index (BASFI) Independent Components at Weeks 14, 18, 24 | Week 24 C4: Getting Out Armless Chair | 26.2 units on a scale |
| Placebo | Bath Ankylosing Functional Index (BASFI) Independent Components at Weeks 14, 18, 24 | Week 14 C5: Getting Up Off Floor | 36.3 units on a scale |
| Placebo | Bath Ankylosing Functional Index (BASFI) Independent Components at Weeks 14, 18, 24 | Week 24 C5: Getting Up Off Floor | 34.4 units on a scale |
| Placebo | Bath Ankylosing Functional Index (BASFI) Independent Components at Weeks 14, 18, 24 | Week 14 C6: Standing Unsupported | 29.7 units on a scale |
| Placebo | Bath Ankylosing Functional Index (BASFI) Independent Components at Weeks 14, 18, 24 | Week 18 C6: Standing Unsupported | 33.3 units on a scale |
| Placebo | Bath Ankylosing Functional Index (BASFI) Independent Components at Weeks 14, 18, 24 | Week 24 C6: Standing Unsupported | 33.8 units on a scale |
| Placebo | Bath Ankylosing Functional Index (BASFI) Independent Components at Weeks 14, 18, 24 | Week 14 C7: Climbing 12-15 Steps | 26.7 units on a scale |
| Placebo | Bath Ankylosing Functional Index (BASFI) Independent Components at Weeks 14, 18, 24 | Week 18 C7: Climbing 12-15 Steps | 27.4 units on a scale |
| Placebo | Bath Ankylosing Functional Index (BASFI) Independent Components at Weeks 14, 18, 24 | Week 24 C7: Climbing 12-15 Steps | 27.1 units on a scale |
| Placebo | Bath Ankylosing Functional Index (BASFI) Independent Components at Weeks 14, 18, 24 | Week 14 C8: Looking Over Shoulder | 58.6 units on a scale |
| Placebo | Bath Ankylosing Functional Index (BASFI) Independent Components at Weeks 14, 18, 24 | Week 18 C8: Looking Over Shoulder | 57.7 units on a scale |
| Placebo | Bath Ankylosing Functional Index (BASFI) Independent Components at Weeks 14, 18, 24 | Week 24 C8: Looking Over Shoulder | 55.3 units on a scale |
| Placebo | Bath Ankylosing Functional Index (BASFI) Independent Components at Weeks 14, 18, 24 | Week 24 C9: Physically Demanding Act | 38.5 units on a scale |
| Placebo | Bath Ankylosing Functional Index (BASFI) Independent Components at Weeks 14, 18, 24 | Week 14 C1: Putting on Socks or Tights | 25.7 units on a scale |
| Placebo | Bath Ankylosing Functional Index (BASFI) Independent Components at Weeks 14, 18, 24 | Week 18 C1: Putting on Socks or Tights | 26.6 units on a scale |
| Placebo | Bath Ankylosing Functional Index (BASFI) Independent Components at Weeks 14, 18, 24 | Week 24 C1: Putting on Socks or Tights | 24.5 units on a scale |
| Placebo | Bath Ankylosing Functional Index (BASFI) Independent Components at Weeks 14, 18, 24 | Week 14 C2: Bending from Waist | 47.1 units on a scale |
| Placebo | Bath Ankylosing Functional Index (BASFI) Independent Components at Weeks 14, 18, 24 | Week 18 C2: Bending from Waist | 45.3 units on a scale |
| Placebo | Bath Ankylosing Functional Index (BASFI) Independent Components at Weeks 14, 18, 24 | Week 24 C2: Bending from Waist | 44.6 units on a scale |
| Placebo | Bath Ankylosing Functional Index (BASFI) Independent Components at Weeks 14, 18, 24 | Week 14 C9: Physically Demanding Act | 37.3 units on a scale |
| Placebo | Bath Ankylosing Functional Index (BASFI) Independent Components at Weeks 14, 18, 24 | Week 18 C9: Physically Demanding Act | 43.5 units on a scale |
| Placebo | Bath Ankylosing Functional Index (BASFI) Independent Components at Weeks 14, 18, 24 | Week 14 C10: Full Days Act | 36.1 units on a scale |
| Placebo | Bath Ankylosing Functional Index (BASFI) Independent Components at Weeks 14, 18, 24 | Week 18 C10: Full Days Act | 40.0 units on a scale |
| Placebo | Bath Ankylosing Functional Index (BASFI) Independent Components at Weeks 14, 18, 24 | Week 18 C5: Getting Up Off Floor | 36.5 units on a scale |
Secondary
Bath Ankylosing Functional Index (BASFI): Independent Components at Weeks 2, 4, 8, 12
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
Population: mITT; in the case of missing data, no replacement or imputation method was performed. Abbreviations: C = component (number), Act = Activities.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Etanercept | Bath Ankylosing Functional Index (BASFI): Independent Components at Weeks 2, 4, 8, 12 | Week 12 C2: Bending from Waist | 41.1 units on a scale |
| Etanercept | Bath Ankylosing Functional Index (BASFI): Independent Components at Weeks 2, 4, 8, 12 | Week 12 C5: Getting Up Off Floor | 44.5 units on a scale |
| Etanercept | Bath Ankylosing Functional Index (BASFI): Independent Components at Weeks 2, 4, 8, 12 | Week 12 C3: Reaching to High Shelf | 37.3 units on a scale |
| Etanercept | Bath Ankylosing Functional Index (BASFI): Independent Components at Weeks 2, 4, 8, 12 | Week 8 C6: Standing Unsupported | 40.8 units on a scale |
| Etanercept | Bath Ankylosing Functional Index (BASFI): Independent Components at Weeks 2, 4, 8, 12 | Baseline C6: Standing Unsupported | 58.9 units on a scale |
| Etanercept | Bath Ankylosing Functional Index (BASFI): Independent Components at Weeks 2, 4, 8, 12 | Week 12 C6: Standing Unsupported | 39.0 units on a scale |
| Etanercept | Bath Ankylosing Functional Index (BASFI): Independent Components at Weeks 2, 4, 8, 12 | Week 2 C2: Bending from Waist | 54.1 units on a scale |
| Etanercept | Bath Ankylosing Functional Index (BASFI): Independent Components at Weeks 2, 4, 8, 12 | Baseline C7: Climbing 12-15 Steps | 55.0 units on a scale |
| Etanercept | Bath Ankylosing Functional Index (BASFI): Independent Components at Weeks 2, 4, 8, 12 | Week 2 C6: Standing Unsupported | 50.8 units on a scale |
| Etanercept | Bath Ankylosing Functional Index (BASFI): Independent Components at Weeks 2, 4, 8, 12 | Week 2 C7: Climbing 12-15 Steps | 47.4 units on a scale |
| Etanercept | Bath Ankylosing Functional Index (BASFI): Independent Components at Weeks 2, 4, 8, 12 | Baseline C4: Getting Out Armless Chair | 55.8 units on a scale |
| Etanercept | Bath Ankylosing Functional Index (BASFI): Independent Components at Weeks 2, 4, 8, 12 | Week 4 C7: Climbing 12-15 Steps | 42.3 units on a scale |
| Etanercept | Bath Ankylosing Functional Index (BASFI): Independent Components at Weeks 2, 4, 8, 12 | Baseline C2: Bending from Waist | 63.4 units on a scale |
| Etanercept | Bath Ankylosing Functional Index (BASFI): Independent Components at Weeks 2, 4, 8, 12 | Week 8 C7: Climbing 12-15 Steps | 37.4 units on a scale |
| Etanercept | Bath Ankylosing Functional Index (BASFI): Independent Components at Weeks 2, 4, 8, 12 | Week 4 C6: Standing Unsupported | 46.4 units on a scale |
| Etanercept | Bath Ankylosing Functional Index (BASFI): Independent Components at Weeks 2, 4, 8, 12 | Week 12 C7: Climbing 12-15 Steps | 35.0 units on a scale |
| Etanercept | Bath Ankylosing Functional Index (BASFI): Independent Components at Weeks 2, 4, 8, 12 | Week 8 C2: Bending from Waist | 43.3 units on a scale |
| Etanercept | Bath Ankylosing Functional Index (BASFI): Independent Components at Weeks 2, 4, 8, 12 | Baseline C8: Looking Over Shoulder | 81.0 units on a scale |
| Etanercept | Bath Ankylosing Functional Index (BASFI): Independent Components at Weeks 2, 4, 8, 12 | Week 4 C1: Putting on Socks or Tights | 41.1 units on a scale |
| Etanercept | Bath Ankylosing Functional Index (BASFI): Independent Components at Weeks 2, 4, 8, 12 | Week 2 C8: Looking Over Shoulder | 72.9 units on a scale |
| Etanercept | Bath Ankylosing Functional Index (BASFI): Independent Components at Weeks 2, 4, 8, 12 | Week 2 C4: Getting Out Armless Chair | 47.2 units on a scale |
| Etanercept | Bath Ankylosing Functional Index (BASFI): Independent Components at Weeks 2, 4, 8, 12 | Week 4 C8: Looking Over Shoulder | 63.7 units on a scale |
| Etanercept | Bath Ankylosing Functional Index (BASFI): Independent Components at Weeks 2, 4, 8, 12 | Week 8 C1: Putting on Socks or Tights | 32.3 units on a scale |
| Etanercept | Bath Ankylosing Functional Index (BASFI): Independent Components at Weeks 2, 4, 8, 12 | Baseline C1: Putting on Socks or Tights | 51.1 units on a scale |
| Etanercept | Bath Ankylosing Functional Index (BASFI): Independent Components at Weeks 2, 4, 8, 12 | Week 4 C3: Reaching to High Shelf | 50.2 units on a scale |
| Etanercept | Bath Ankylosing Functional Index (BASFI): Independent Components at Weeks 2, 4, 8, 12 | Week 2 C1: Putting on Socks or Tights | 47.6 units on a scale |
| Etanercept | Bath Ankylosing Functional Index (BASFI): Independent Components at Weeks 2, 4, 8, 12 | Week 12 C1: Putting on Socks or Tights | 33.2 units on a scale |
| Etanercept | Bath Ankylosing Functional Index (BASFI): Independent Components at Weeks 2, 4, 8, 12 | Week 8 C4: Getting Out Armless Chair | 33.6 units on a scale |
| Etanercept | Bath Ankylosing Functional Index (BASFI): Independent Components at Weeks 2, 4, 8, 12 | Week 2 C9: Physically Demanding Act | 60.7 units on a scale |
| Etanercept | Bath Ankylosing Functional Index (BASFI): Independent Components at Weeks 2, 4, 8, 12 | Week 4 C2: Bending from Waist | 51.1 units on a scale |
| Etanercept | Bath Ankylosing Functional Index (BASFI): Independent Components at Weeks 2, 4, 8, 12 | Week 4 C9: Physically Demanding Act | 53.0 units on a scale |
| Etanercept | Bath Ankylosing Functional Index (BASFI): Independent Components at Weeks 2, 4, 8, 12 | Baseline C3: Reaching to High Shelf | 61.5 units on a scale |
| Etanercept | Bath Ankylosing Functional Index (BASFI): Independent Components at Weeks 2, 4, 8, 12 | Week 8 C9: Physically Demanding Act | 48.4 units on a scale |
| Etanercept | Bath Ankylosing Functional Index (BASFI): Independent Components at Weeks 2, 4, 8, 12 | Week 2 C3: Reaching to High Shelf | 52.1 units on a scale |
| Etanercept | Bath Ankylosing Functional Index (BASFI): Independent Components at Weeks 2, 4, 8, 12 | Week 12 C9: Physically Demanding Act | 43.2 units on a scale |
| Etanercept | Bath Ankylosing Functional Index (BASFI): Independent Components at Weeks 2, 4, 8, 12 | Week 4 C4: Getting Out Armless Chair | 42.1 units on a scale |
| Etanercept | Bath Ankylosing Functional Index (BASFI): Independent Components at Weeks 2, 4, 8, 12 | Baseline C10: Full Days Act | 66.9 units on a scale |
| Etanercept | Bath Ankylosing Functional Index (BASFI): Independent Components at Weeks 2, 4, 8, 12 | Week 12 C4: Getting Out Armless Chair | 31.7 units on a scale |
| Etanercept | Bath Ankylosing Functional Index (BASFI): Independent Components at Weeks 2, 4, 8, 12 | Week 2 C10: Full Days Act | 57.2 units on a scale |
| Etanercept | Bath Ankylosing Functional Index (BASFI): Independent Components at Weeks 2, 4, 8, 12 | Week 2 C5: Getting Up Off Floor | 57.0 units on a scale |
| Etanercept | Bath Ankylosing Functional Index (BASFI): Independent Components at Weeks 2, 4, 8, 12 | Week 4 C10: Full Days Act | 52.4 units on a scale |
| Etanercept | Bath Ankylosing Functional Index (BASFI): Independent Components at Weeks 2, 4, 8, 12 | Week 8 C3: Reaching to High Shelf | 37.4 units on a scale |
| Etanercept | Bath Ankylosing Functional Index (BASFI): Independent Components at Weeks 2, 4, 8, 12 | Week 8 C10: Full Days Act | 47.6 units on a scale |
| Etanercept | Bath Ankylosing Functional Index (BASFI): Independent Components at Weeks 2, 4, 8, 12 | Week 4 C5: Getting Up Off Floor | 55.0 units on a scale |
| Etanercept | Bath Ankylosing Functional Index (BASFI): Independent Components at Weeks 2, 4, 8, 12 | Week 12 C10: Full Days Act | 43.1 units on a scale |
| Etanercept | Bath Ankylosing Functional Index (BASFI): Independent Components at Weeks 2, 4, 8, 12 | Week 8 C8: Looking Over Shoulder | 56.9 units on a scale |
| Etanercept | Bath Ankylosing Functional Index (BASFI): Independent Components at Weeks 2, 4, 8, 12 | Baseline C5: Getting Up Off Floor | 71.8 units on a scale |
| Etanercept | Bath Ankylosing Functional Index (BASFI): Independent Components at Weeks 2, 4, 8, 12 | Week 12: C8: Looking Over Shoulder | 54.1 units on a scale |
| Etanercept | Bath Ankylosing Functional Index (BASFI): Independent Components at Weeks 2, 4, 8, 12 | Week 8 C5: Getting Up Off Floor | 43.7 units on a scale |
| Etanercept | Bath Ankylosing Functional Index (BASFI): Independent Components at Weeks 2, 4, 8, 12 | Baseline C9: Physically Demanding Act | 67.6 units on a scale |
| Placebo | Bath Ankylosing Functional Index (BASFI): Independent Components at Weeks 2, 4, 8, 12 | Week 4 C7: Climbing 12-15 Steps | 37.4 units on a scale |
| Placebo | Bath Ankylosing Functional Index (BASFI): Independent Components at Weeks 2, 4, 8, 12 | Baseline C2: Bending from Waist | 61.5 units on a scale |
| Placebo | Bath Ankylosing Functional Index (BASFI): Independent Components at Weeks 2, 4, 8, 12 | Week 2 C2: Bending from Waist | 55.7 units on a scale |
| Placebo | Bath Ankylosing Functional Index (BASFI): Independent Components at Weeks 2, 4, 8, 12 | Week 4 C2: Bending from Waist | 54.0 units on a scale |
| Placebo | Bath Ankylosing Functional Index (BASFI): Independent Components at Weeks 2, 4, 8, 12 | Week 8 C2: Bending from Waist | 54.2 units on a scale |
| Placebo | Bath Ankylosing Functional Index (BASFI): Independent Components at Weeks 2, 4, 8, 12 | Baseline C3: Reaching to High Shelf | 54.3 units on a scale |
| Placebo | Bath Ankylosing Functional Index (BASFI): Independent Components at Weeks 2, 4, 8, 12 | Week 2 C3: Reaching to High Shelf | 50.3 units on a scale |
| Placebo | Bath Ankylosing Functional Index (BASFI): Independent Components at Weeks 2, 4, 8, 12 | Week 4 C3: Reaching to High Shelf | 43.8 units on a scale |
| Placebo | Bath Ankylosing Functional Index (BASFI): Independent Components at Weeks 2, 4, 8, 12 | Week 8 C3: Reaching to High Shelf | 44.1 units on a scale |
| Placebo | Bath Ankylosing Functional Index (BASFI): Independent Components at Weeks 2, 4, 8, 12 | Week 12 C3: Reaching to High Shelf | 44.5 units on a scale |
| Placebo | Bath Ankylosing Functional Index (BASFI): Independent Components at Weeks 2, 4, 8, 12 | Baseline C4: Getting Out Armless Chair | 47.5 units on a scale |
| Placebo | Bath Ankylosing Functional Index (BASFI): Independent Components at Weeks 2, 4, 8, 12 | Week 2 C4: Getting Out Armless Chair | 38.1 units on a scale |
| Placebo | Bath Ankylosing Functional Index (BASFI): Independent Components at Weeks 2, 4, 8, 12 | Week 8 C4: Getting Out Armless Chair | 35.1 units on a scale |
| Placebo | Bath Ankylosing Functional Index (BASFI): Independent Components at Weeks 2, 4, 8, 12 | Week 12 C4: Getting Out Armless Chair | 36.5 units on a scale |
| Placebo | Bath Ankylosing Functional Index (BASFI): Independent Components at Weeks 2, 4, 8, 12 | Baseline C5: Getting Up Off Floor | 60.8 units on a scale |
| Placebo | Bath Ankylosing Functional Index (BASFI): Independent Components at Weeks 2, 4, 8, 12 | Week 12 C5: Getting Up Off Floor | 46.1 units on a scale |
| Placebo | Bath Ankylosing Functional Index (BASFI): Independent Components at Weeks 2, 4, 8, 12 | Baseline C6: Standing Unsupported | 49.0 units on a scale |
| Placebo | Bath Ankylosing Functional Index (BASFI): Independent Components at Weeks 2, 4, 8, 12 | Week 2 C6: Standing Unsupported | 44.9 units on a scale |
| Placebo | Bath Ankylosing Functional Index (BASFI): Independent Components at Weeks 2, 4, 8, 12 | Week 12 C10: Full Days Act | 49.0 units on a scale |
| Placebo | Bath Ankylosing Functional Index (BASFI): Independent Components at Weeks 2, 4, 8, 12 | Week 4 C1: Putting on Socks or Tights | 32.7 units on a scale |
| Placebo | Bath Ankylosing Functional Index (BASFI): Independent Components at Weeks 2, 4, 8, 12 | Week 8 C1: Putting on Socks or Tights | 30.6 units on a scale |
| Placebo | Bath Ankylosing Functional Index (BASFI): Independent Components at Weeks 2, 4, 8, 12 | Week 12 C1: Putting on Socks or Tights | 36.0 units on a scale |
| Placebo | Bath Ankylosing Functional Index (BASFI): Independent Components at Weeks 2, 4, 8, 12 | Week 12 C2: Bending from Waist | 56.2 units on a scale |
| Placebo | Bath Ankylosing Functional Index (BASFI): Independent Components at Weeks 2, 4, 8, 12 | Week 4 C4: Getting Out Armless Chair | 36.1 units on a scale |
| Placebo | Bath Ankylosing Functional Index (BASFI): Independent Components at Weeks 2, 4, 8, 12 | Week 2 C5: Getting Up Off Floor | 49.4 units on a scale |
| Placebo | Bath Ankylosing Functional Index (BASFI): Independent Components at Weeks 2, 4, 8, 12 | Week 4 C5: Getting Up Off Floor | 48.5 units on a scale |
| Placebo | Bath Ankylosing Functional Index (BASFI): Independent Components at Weeks 2, 4, 8, 12 | Week 8 C5: Getting Up Off Floor | 44.2 units on a scale |
| Placebo | Bath Ankylosing Functional Index (BASFI): Independent Components at Weeks 2, 4, 8, 12 | Week 4 C6: Standing Unsupported | 42.0 units on a scale |
| Placebo | Bath Ankylosing Functional Index (BASFI): Independent Components at Weeks 2, 4, 8, 12 | Week 8 C6: Standing Unsupported | 40.9 units on a scale |
| Placebo | Bath Ankylosing Functional Index (BASFI): Independent Components at Weeks 2, 4, 8, 12 | Week 12 C6: Standing Unsupported | 42.2 units on a scale |
| Placebo | Bath Ankylosing Functional Index (BASFI): Independent Components at Weeks 2, 4, 8, 12 | Baseline C7: Climbing 12-15 Steps | 47.5 units on a scale |
| Placebo | Bath Ankylosing Functional Index (BASFI): Independent Components at Weeks 2, 4, 8, 12 | Week 2 C7: Climbing 12-15 Steps | 38.4 units on a scale |
| Placebo | Bath Ankylosing Functional Index (BASFI): Independent Components at Weeks 2, 4, 8, 12 | Week 8 C7: Climbing 12-15 Steps | 35.6 units on a scale |
| Placebo | Bath Ankylosing Functional Index (BASFI): Independent Components at Weeks 2, 4, 8, 12 | Week 12 C7: Climbing 12-15 Steps | 32.9 units on a scale |
| Placebo | Bath Ankylosing Functional Index (BASFI): Independent Components at Weeks 2, 4, 8, 12 | Baseline C8: Looking Over Shoulder | 81.9 units on a scale |
| Placebo | Bath Ankylosing Functional Index (BASFI): Independent Components at Weeks 2, 4, 8, 12 | Week 2 C8: Looking Over Shoulder | 68.4 units on a scale |
| Placebo | Bath Ankylosing Functional Index (BASFI): Independent Components at Weeks 2, 4, 8, 12 | Week 4 C8: Looking Over Shoulder | 71.6 units on a scale |
| Placebo | Bath Ankylosing Functional Index (BASFI): Independent Components at Weeks 2, 4, 8, 12 | Baseline C1: Putting on Socks or Tights | 43.8 units on a scale |
| Placebo | Bath Ankylosing Functional Index (BASFI): Independent Components at Weeks 2, 4, 8, 12 | Week 2 C1: Putting on Socks or Tights | 36.5 units on a scale |
| Placebo | Bath Ankylosing Functional Index (BASFI): Independent Components at Weeks 2, 4, 8, 12 | Baseline C9: Physically Demanding Act | 65.4 units on a scale |
| Placebo | Bath Ankylosing Functional Index (BASFI): Independent Components at Weeks 2, 4, 8, 12 | Week 2 C9: Physically Demanding Act | 58.4 units on a scale |
| Placebo | Bath Ankylosing Functional Index (BASFI): Independent Components at Weeks 2, 4, 8, 12 | Week 4 C9: Physically Demanding Act | 53.6 units on a scale |
| Placebo | Bath Ankylosing Functional Index (BASFI): Independent Components at Weeks 2, 4, 8, 12 | Week 8 C9: Physically Demanding Act | 47.8 units on a scale |
| Placebo | Bath Ankylosing Functional Index (BASFI): Independent Components at Weeks 2, 4, 8, 12 | Week 12 C9: Physically Demanding Act | 54.9 units on a scale |
| Placebo | Bath Ankylosing Functional Index (BASFI): Independent Components at Weeks 2, 4, 8, 12 | Baseline C10: Full Days Act | 57.1 units on a scale |
| Placebo | Bath Ankylosing Functional Index (BASFI): Independent Components at Weeks 2, 4, 8, 12 | Week 2 C10: Full Days Act | 49.3 units on a scale |
| Placebo | Bath Ankylosing Functional Index (BASFI): Independent Components at Weeks 2, 4, 8, 12 | Week 4 C10: Full Days Act | 51.6 units on a scale |
| Placebo | Bath Ankylosing Functional Index (BASFI): Independent Components at Weeks 2, 4, 8, 12 | Week 8 C10: Full Days Act | 44.4 units on a scale |
| Placebo | Bath Ankylosing Functional Index (BASFI): Independent Components at Weeks 2, 4, 8, 12 | Week 8 C8: Looking Over Shoulder | 71.1 units on a scale |
| Placebo | Bath Ankylosing Functional Index (BASFI): Independent Components at Weeks 2, 4, 8, 12 | Week 12: C8: Looking Over Shoulder | 68.1 units on a scale |
Secondary
Bath Ankylosing Spondylitis (AS) Disease Activity Index (BASDAI) Independent Components at Weeks 14, 18, 24
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
Population: Open-label population; in case of missing data, no replacement or imputation method was performed. Abbreviations: C=component, AS=Ankylosing Spondylitis.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Etanercept | Bath Ankylosing Spondylitis (AS) Disease Activity Index (BASDAI) Independent Components at Weeks 14, 18, 24 | Week 24 C3: Pain/Swelling in Other Joints | 21.0 units on scale |
| Etanercept | Bath Ankylosing Spondylitis (AS) Disease Activity Index (BASDAI) Independent Components at Weeks 14, 18, 24 | Week 24 C4: Discomfort Areas Tender to Touch | 19.3 units on scale |
| Etanercept | Bath Ankylosing Spondylitis (AS) Disease Activity Index (BASDAI) Independent Components at Weeks 14, 18, 24 | Week 24 C1: Fatigue/Tiredness | 28.0 units on scale |
| Etanercept | Bath Ankylosing Spondylitis (AS) Disease Activity Index (BASDAI) Independent Components at Weeks 14, 18, 24 | Week 14 C5: Morning Stiffness | 35.8 units on scale |
| Etanercept | Bath Ankylosing Spondylitis (AS) Disease Activity Index (BASDAI) Independent Components at Weeks 14, 18, 24 | Week 18 C2: AS Neck, Back or Hip Pain | 35.1 units on scale |
| Etanercept | Bath Ankylosing Spondylitis (AS) Disease Activity Index (BASDAI) Independent Components at Weeks 14, 18, 24 | Week 18 C5: Morning Stiffness | 31.4 units on scale |
| Etanercept | Bath Ankylosing Spondylitis (AS) Disease Activity Index (BASDAI) Independent Components at Weeks 14, 18, 24 | Week 18 C1: Fatigue/Tiredness | 33.1 units on scale |
| Etanercept | Bath Ankylosing Spondylitis (AS) Disease Activity Index (BASDAI) Independent Components at Weeks 14, 18, 24 | Week 24 C5: Morning Stiffness | 26.4 units on scale |
| Etanercept | Bath Ankylosing Spondylitis (AS) Disease Activity Index (BASDAI) Independent Components at Weeks 14, 18, 24 | Week 24 C2: AS Neck, Back or Hip Pain | 28.2 units on scale |
| Etanercept | Bath Ankylosing Spondylitis (AS) Disease Activity Index (BASDAI) Independent Components at Weeks 14, 18, 24 | Week 14 C6: Duration Morning Stiffness | 31.3 units on scale |
| Etanercept | Bath Ankylosing Spondylitis (AS) Disease Activity Index (BASDAI) Independent Components at Weeks 14, 18, 24 | Week 18 C3: Pain/Swelling in Other Joints | 23.8 units on scale |
| Etanercept | Bath Ankylosing Spondylitis (AS) Disease Activity Index (BASDAI) Independent Components at Weeks 14, 18, 24 | Week 18 C6: Duration Morning Stiffness | 31.3 units on scale |
| Etanercept | Bath Ankylosing Spondylitis (AS) Disease Activity Index (BASDAI) Independent Components at Weeks 14, 18, 24 | Week 14 C3: Pain/Swelling in Other Joints | 27.0 units on scale |
| Etanercept | Bath Ankylosing Spondylitis (AS) Disease Activity Index (BASDAI) Independent Components at Weeks 14, 18, 24 | Week 24 C6: Duration Morning Stiffness | 24.9 units on scale |
| Etanercept | Bath Ankylosing Spondylitis (AS) Disease Activity Index (BASDAI) Independent Components at Weeks 14, 18, 24 | Week 14 C4: Discomfort Areas Tender to Touch | 30.0 units on scale |
| Etanercept | Bath Ankylosing Spondylitis (AS) Disease Activity Index (BASDAI) Independent Components at Weeks 14, 18, 24 | Week 14: Subscore Morning Stiffness | 33.5 units on scale |
| Etanercept | Bath Ankylosing Spondylitis (AS) Disease Activity Index (BASDAI) Independent Components at Weeks 14, 18, 24 | Week 14 C2: AS Neck, Back or Hip Pain | 39.9 units on scale |
| Etanercept | Bath Ankylosing Spondylitis (AS) Disease Activity Index (BASDAI) Independent Components at Weeks 14, 18, 24 | Week 18: Subscore Morning Stiffness | 31.38 units on scale |
| Etanercept | Bath Ankylosing Spondylitis (AS) Disease Activity Index (BASDAI) Independent Components at Weeks 14, 18, 24 | Week 18 C4: Discomfort Areas Tender to Touch | 24.1 units on scale |
| Etanercept | Bath Ankylosing Spondylitis (AS) Disease Activity Index (BASDAI) Independent Components at Weeks 14, 18, 24 | Week 24: Subscore Morning Stiffness | 25.40 units on scale |
| Etanercept | Bath Ankylosing Spondylitis (AS) Disease Activity Index (BASDAI) Independent Components at Weeks 14, 18, 24 | Week 14 C1: Fatigue/Tiredness | 41.7 units on scale |
| Placebo | Bath Ankylosing Spondylitis (AS) Disease Activity Index (BASDAI) Independent Components at Weeks 14, 18, 24 | Week 24: Subscore Morning Stiffness | 24.55 units on scale |
| Placebo | Bath Ankylosing Spondylitis (AS) Disease Activity Index (BASDAI) Independent Components at Weeks 14, 18, 24 | Week 14 C1: Fatigue/Tiredness | 38.3 units on scale |
| Placebo | Bath Ankylosing Spondylitis (AS) Disease Activity Index (BASDAI) Independent Components at Weeks 14, 18, 24 | Week 18 C1: Fatigue/Tiredness | 38.9 units on scale |
| Placebo | Bath Ankylosing Spondylitis (AS) Disease Activity Index (BASDAI) Independent Components at Weeks 14, 18, 24 | Week 24 C1: Fatigue/Tiredness | 35.3 units on scale |
| Placebo | Bath Ankylosing Spondylitis (AS) Disease Activity Index (BASDAI) Independent Components at Weeks 14, 18, 24 | Week 14 C2: AS Neck, Back or Hip Pain | 35.0 units on scale |
| Placebo | Bath Ankylosing Spondylitis (AS) Disease Activity Index (BASDAI) Independent Components at Weeks 14, 18, 24 | Week 14 C3: Pain/Swelling in Other Joints | 28.4 units on scale |
| Placebo | Bath Ankylosing Spondylitis (AS) Disease Activity Index (BASDAI) Independent Components at Weeks 14, 18, 24 | Week 18 C3: Pain/Swelling in Other Joints | 26.4 units on scale |
| Placebo | Bath Ankylosing Spondylitis (AS) Disease Activity Index (BASDAI) Independent Components at Weeks 14, 18, 24 | Week 24 C3: Pain/Swelling in Other Joints | 24.9 units on scale |
| Placebo | Bath Ankylosing Spondylitis (AS) Disease Activity Index (BASDAI) Independent Components at Weeks 14, 18, 24 | Week 18 C2: AS Neck, Back or Hip Pain | 35.0 units on scale |
| Placebo | Bath Ankylosing Spondylitis (AS) Disease Activity Index (BASDAI) Independent Components at Weeks 14, 18, 24 | Week 24 C2: AS Neck, Back or Hip Pain | 30.0 units on scale |
| Placebo | Bath Ankylosing Spondylitis (AS) Disease Activity Index (BASDAI) Independent Components at Weeks 14, 18, 24 | Week 14 C4: Discomfort Areas Tender to Touch | 29.1 units on scale |
| Placebo | Bath Ankylosing Spondylitis (AS) Disease Activity Index (BASDAI) Independent Components at Weeks 14, 18, 24 | Week 18 C4: Discomfort Areas Tender to Touch | 28.7 units on scale |
| Placebo | Bath Ankylosing Spondylitis (AS) Disease Activity Index (BASDAI) Independent Components at Weeks 14, 18, 24 | Week 24 C4: Discomfort Areas Tender to Touch | 25.6 units on scale |
| Placebo | Bath Ankylosing Spondylitis (AS) Disease Activity Index (BASDAI) Independent Components at Weeks 14, 18, 24 | Week 14 C5: Morning Stiffness | 28.5 units on scale |
| Placebo | Bath Ankylosing Spondylitis (AS) Disease Activity Index (BASDAI) Independent Components at Weeks 14, 18, 24 | Week 18 C5: Morning Stiffness | 28.6 units on scale |
| Placebo | Bath Ankylosing Spondylitis (AS) Disease Activity Index (BASDAI) Independent Components at Weeks 14, 18, 24 | Week 24 C5: Morning Stiffness | 24.7 units on scale |
| Placebo | Bath Ankylosing Spondylitis (AS) Disease Activity Index (BASDAI) Independent Components at Weeks 14, 18, 24 | Week 14 C6: Duration Morning Stiffness | 27.7 units on scale |
| Placebo | Bath Ankylosing Spondylitis (AS) Disease Activity Index (BASDAI) Independent Components at Weeks 14, 18, 24 | Week 18 C6: Duration Morning Stiffness | 25.7 units on scale |
| Placebo | Bath Ankylosing Spondylitis (AS) Disease Activity Index (BASDAI) Independent Components at Weeks 14, 18, 24 | Week 24 C6: Duration Morning Stiffness | 24.4 units on scale |
| Placebo | Bath Ankylosing Spondylitis (AS) Disease Activity Index (BASDAI) Independent Components at Weeks 14, 18, 24 | Week 14: Subscore Morning Stiffness | 28.09 units on scale |
| Placebo | Bath Ankylosing Spondylitis (AS) Disease Activity Index (BASDAI) Independent Components at Weeks 14, 18, 24 | Week 18: Subscore Morning Stiffness | 27.17 units on scale |
Secondary
Bath Ankylosing Spondylitis (AS) Disease Activity Index (BASDAI) Independent Components at Weeks 2, 4, 8, 12
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
Population: mITT; in case of mising data, no replacement or imputation method was performed. Abbreviations: C=component, AS=Ankylosing Spondylitis.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Etanercept | Bath Ankylosing Spondylitis (AS) Disease Activity Index (BASDAI) Independent Components at Weeks 2, 4, 8, 12 | Week 4: Subscore Morning Stiffness | 44.34 units on scale |
| Etanercept | Bath Ankylosing Spondylitis (AS) Disease Activity Index (BASDAI) Independent Components at Weeks 2, 4, 8, 12 | Week 8 C1: Fatigue/Tiredness | 44.4 units on scale |
| Etanercept | Bath Ankylosing Spondylitis (AS) Disease Activity Index (BASDAI) Independent Components at Weeks 2, 4, 8, 12 | Week 2 C2: AS Neck, Back or Hip Pain | 53.9 units on scale |
| Etanercept | Bath Ankylosing Spondylitis (AS) Disease Activity Index (BASDAI) Independent Components at Weeks 2, 4, 8, 12 | Week 4 C2: AS Neck, Back or Hip Pain | 51.5 units on scale |
| Etanercept | Bath Ankylosing Spondylitis (AS) Disease Activity Index (BASDAI) Independent Components at Weeks 2, 4, 8, 12 | Week 8 C2: AS Neck, Back or Hip Pain | 41.4 units on scale |
| Etanercept | Bath Ankylosing Spondylitis (AS) Disease Activity Index (BASDAI) Independent Components at Weeks 2, 4, 8, 12 | Week 2 C3: Pain/Swelling in Other Joints | 39.2 units on scale |
| Etanercept | Bath Ankylosing Spondylitis (AS) Disease Activity Index (BASDAI) Independent Components at Weeks 2, 4, 8, 12 | Week 4 C3: Pain/Swelling in Other Joints | 37.3 units on scale |
| Etanercept | Bath Ankylosing Spondylitis (AS) Disease Activity Index (BASDAI) Independent Components at Weeks 2, 4, 8, 12 | Week 8 C3: Pain/Swelling in Other Joints | 30.1 units on scale |
| Etanercept | Bath Ankylosing Spondylitis (AS) Disease Activity Index (BASDAI) Independent Components at Weeks 2, 4, 8, 12 | Week 12 C3: Pain/Swelling in Other Joints | 31.8 units on scale |
| Etanercept | Bath Ankylosing Spondylitis (AS) Disease Activity Index (BASDAI) Independent Components at Weeks 2, 4, 8, 12 | Baseline C4: Discomfort Areas Tender to Touch | 62.3 units on scale |
| Etanercept | Bath Ankylosing Spondylitis (AS) Disease Activity Index (BASDAI) Independent Components at Weeks 2, 4, 8, 12 | Week 2 C4: Discomfort Areas Tender to Touch | 42.1 units on scale |
| Etanercept | Bath Ankylosing Spondylitis (AS) Disease Activity Index (BASDAI) Independent Components at Weeks 2, 4, 8, 12 | Week 4 C4: Discomfort Areas Tender to Touch | 38.3 units on scale |
| Etanercept | Bath Ankylosing Spondylitis (AS) Disease Activity Index (BASDAI) Independent Components at Weeks 2, 4, 8, 12 | Week 8 C4: Discomfort Areas Tender to Touch | 31.2 units on scale |
| Etanercept | Bath Ankylosing Spondylitis (AS) Disease Activity Index (BASDAI) Independent Components at Weeks 2, 4, 8, 12 | Week 12 C4: Discomfort Areas Tender to Touch | 28.8 units on scale |
| Etanercept | Bath Ankylosing Spondylitis (AS) Disease Activity Index (BASDAI) Independent Components at Weeks 2, 4, 8, 12 | Baseline C5: Morning Stiffness | 70.8 units on scale |
| Etanercept | Bath Ankylosing Spondylitis (AS) Disease Activity Index (BASDAI) Independent Components at Weeks 2, 4, 8, 12 | Week 4 C5: Morning Stiffness | 46.5 units on scale |
| Etanercept | Bath Ankylosing Spondylitis (AS) Disease Activity Index (BASDAI) Independent Components at Weeks 2, 4, 8, 12 | Week 8 C5: Morning Stiffness | 38.1 units on scale |
| Etanercept | Bath Ankylosing Spondylitis (AS) Disease Activity Index (BASDAI) Independent Components at Weeks 2, 4, 8, 12 | Week 12 C5: Morning Stiffness | 37.8 units on scale |
| Etanercept | Bath Ankylosing Spondylitis (AS) Disease Activity Index (BASDAI) Independent Components at Weeks 2, 4, 8, 12 | Baseline C6: Duration Morning Stiffness | 62.1 units on scale |
| Etanercept | Bath Ankylosing Spondylitis (AS) Disease Activity Index (BASDAI) Independent Components at Weeks 2, 4, 8, 12 | Week 2 C6: Duration Morning Stiffness | 46.8 units on scale |
| Etanercept | Bath Ankylosing Spondylitis (AS) Disease Activity Index (BASDAI) Independent Components at Weeks 2, 4, 8, 12 | Week 4 C6: Duration Morning Stiffness | 42.2 units on scale |
| Etanercept | Bath Ankylosing Spondylitis (AS) Disease Activity Index (BASDAI) Independent Components at Weeks 2, 4, 8, 12 | Week 8 C6: Duration Morning Stiffness | 34.6 units on scale |
| Etanercept | Bath Ankylosing Spondylitis (AS) Disease Activity Index (BASDAI) Independent Components at Weeks 2, 4, 8, 12 | Week 12 C6: Duration Morning Stiffness | 34.9 units on scale |
| Etanercept | Bath Ankylosing Spondylitis (AS) Disease Activity Index (BASDAI) Independent Components at Weeks 2, 4, 8, 12 | Baseline: Subscore Morning Stiffness (n=39, 43) | 66.45 units on scale |
| Etanercept | Bath Ankylosing Spondylitis (AS) Disease Activity Index (BASDAI) Independent Components at Weeks 2, 4, 8, 12 | Week 8: Subscore Morning Stiffness | 36.34 units on scale |
| Etanercept | Bath Ankylosing Spondylitis (AS) Disease Activity Index (BASDAI) Independent Components at Weeks 2, 4, 8, 12 | Week 12: Subscore Morning Stiffness | 36.39 units on scale |
| Etanercept | Bath Ankylosing Spondylitis (AS) Disease Activity Index (BASDAI) Independent Components at Weeks 2, 4, 8, 12 | Baseline C1: Fatigue/Tiredness | 68.2 units on scale |
| Etanercept | Bath Ankylosing Spondylitis (AS) Disease Activity Index (BASDAI) Independent Components at Weeks 2, 4, 8, 12 | Week 2 C1: Fatigue/Tiredness | 56.6 units on scale |
| Etanercept | Bath Ankylosing Spondylitis (AS) Disease Activity Index (BASDAI) Independent Components at Weeks 2, 4, 8, 12 | Week 4 C1: Fatigue/Tiredness | 51.4 units on scale |
| Etanercept | Bath Ankylosing Spondylitis (AS) Disease Activity Index (BASDAI) Independent Components at Weeks 2, 4, 8, 12 | Week 12 C1: Fatigue/Tiredness | 43.9 units on scale |
| Etanercept | Bath Ankylosing Spondylitis (AS) Disease Activity Index (BASDAI) Independent Components at Weeks 2, 4, 8, 12 | Baseline C2: AS Neck, Back or Hip Pain | 73.0 units on scale |
| Etanercept | Bath Ankylosing Spondylitis (AS) Disease Activity Index (BASDAI) Independent Components at Weeks 2, 4, 8, 12 | Week 12 C2: AS Neck, Back or Hip Pain | 41.0 units on scale |
| Etanercept | Bath Ankylosing Spondylitis (AS) Disease Activity Index (BASDAI) Independent Components at Weeks 2, 4, 8, 12 | Baseline C3: Pain/Swelling in Other Joints | 49.3 units on scale |
| Etanercept | Bath Ankylosing Spondylitis (AS) Disease Activity Index (BASDAI) Independent Components at Weeks 2, 4, 8, 12 | Week 2 C5: Morning Stiffness | 51.3 units on scale |
| Etanercept | Bath Ankylosing Spondylitis (AS) Disease Activity Index (BASDAI) Independent Components at Weeks 2, 4, 8, 12 | Week 2: Subscore Morning Stiffness | 49.72 units on scale |
| Placebo | Bath Ankylosing Spondylitis (AS) Disease Activity Index (BASDAI) Independent Components at Weeks 2, 4, 8, 12 | Baseline C1: Fatigue/Tiredness | 61.9 units on scale |
| Placebo | Bath Ankylosing Spondylitis (AS) Disease Activity Index (BASDAI) Independent Components at Weeks 2, 4, 8, 12 | Baseline C6: Duration Morning Stiffness | 52.4 units on scale |
| Placebo | Bath Ankylosing Spondylitis (AS) Disease Activity Index (BASDAI) Independent Components at Weeks 2, 4, 8, 12 | Baseline C2: AS Neck, Back or Hip Pain | 68.1 units on scale |
| Placebo | Bath Ankylosing Spondylitis (AS) Disease Activity Index (BASDAI) Independent Components at Weeks 2, 4, 8, 12 | Week 12 C2: AS Neck, Back or Hip Pain | 52.0 units on scale |
| Placebo | Bath Ankylosing Spondylitis (AS) Disease Activity Index (BASDAI) Independent Components at Weeks 2, 4, 8, 12 | Week 2 C2: AS Neck, Back or Hip Pain | 57.6 units on scale |
| Placebo | Bath Ankylosing Spondylitis (AS) Disease Activity Index (BASDAI) Independent Components at Weeks 2, 4, 8, 12 | Week 2 C6: Duration Morning Stiffness | 44.0 units on scale |
| Placebo | Bath Ankylosing Spondylitis (AS) Disease Activity Index (BASDAI) Independent Components at Weeks 2, 4, 8, 12 | Week 4 C2: AS Neck, Back or Hip Pain | 55.0 units on scale |
| Placebo | Bath Ankylosing Spondylitis (AS) Disease Activity Index (BASDAI) Independent Components at Weeks 2, 4, 8, 12 | Week 2 C1: Fatigue/Tiredness | 55.8 units on scale |
| Placebo | Bath Ankylosing Spondylitis (AS) Disease Activity Index (BASDAI) Independent Components at Weeks 2, 4, 8, 12 | Week 8 C2: AS Neck, Back or Hip Pain | 52.1 units on scale |
| Placebo | Bath Ankylosing Spondylitis (AS) Disease Activity Index (BASDAI) Independent Components at Weeks 2, 4, 8, 12 | Baseline C3: Pain/Swelling in Other Joints | 45.3 units on scale |
| Placebo | Bath Ankylosing Spondylitis (AS) Disease Activity Index (BASDAI) Independent Components at Weeks 2, 4, 8, 12 | Week 4 C6: Duration Morning Stiffness | 43.0 units on scale |
| Placebo | Bath Ankylosing Spondylitis (AS) Disease Activity Index (BASDAI) Independent Components at Weeks 2, 4, 8, 12 | Week 2 C3: Pain/Swelling in Other Joints | 41.7 units on scale |
| Placebo | Bath Ankylosing Spondylitis (AS) Disease Activity Index (BASDAI) Independent Components at Weeks 2, 4, 8, 12 | Week 4 C1: Fatigue/Tiredness | 54.2 units on scale |
| Placebo | Bath Ankylosing Spondylitis (AS) Disease Activity Index (BASDAI) Independent Components at Weeks 2, 4, 8, 12 | Week 4 C3: Pain/Swelling in Other Joints | 38.2 units on scale |
| Placebo | Bath Ankylosing Spondylitis (AS) Disease Activity Index (BASDAI) Independent Components at Weeks 2, 4, 8, 12 | Week 8 C6: Duration Morning Stiffness | 43.7 units on scale |
| Placebo | Bath Ankylosing Spondylitis (AS) Disease Activity Index (BASDAI) Independent Components at Weeks 2, 4, 8, 12 | Week 8 C3: Pain/Swelling in Other Joints | 40.4 units on scale |
| Placebo | Bath Ankylosing Spondylitis (AS) Disease Activity Index (BASDAI) Independent Components at Weeks 2, 4, 8, 12 | Week 8 C1: Fatigue/Tiredness | 50.9 units on scale |
| Placebo | Bath Ankylosing Spondylitis (AS) Disease Activity Index (BASDAI) Independent Components at Weeks 2, 4, 8, 12 | Week 12 C3: Pain/Swelling in Other Joints | 37.9 units on scale |
| Placebo | Bath Ankylosing Spondylitis (AS) Disease Activity Index (BASDAI) Independent Components at Weeks 2, 4, 8, 12 | Week 12 C6: Duration Morning Stiffness | 44.7 units on scale |
| Placebo | Bath Ankylosing Spondylitis (AS) Disease Activity Index (BASDAI) Independent Components at Weeks 2, 4, 8, 12 | Baseline C4: Discomfort Areas Tender to Touch | 57.2 units on scale |
| Placebo | Bath Ankylosing Spondylitis (AS) Disease Activity Index (BASDAI) Independent Components at Weeks 2, 4, 8, 12 | Week 2 C4: Discomfort Areas Tender to Touch | 51.9 units on scale |
| Placebo | Bath Ankylosing Spondylitis (AS) Disease Activity Index (BASDAI) Independent Components at Weeks 2, 4, 8, 12 | Baseline: Subscore Morning Stiffness (n=39, 43) | 59.34 units on scale |
| Placebo | Bath Ankylosing Spondylitis (AS) Disease Activity Index (BASDAI) Independent Components at Weeks 2, 4, 8, 12 | Week 4 C4: Discomfort Areas Tender to Touch | 41.5 units on scale |
| Placebo | Bath Ankylosing Spondylitis (AS) Disease Activity Index (BASDAI) Independent Components at Weeks 2, 4, 8, 12 | Week 4: Subscore Morning Stiffness | 46.87 units on scale |
| Placebo | Bath Ankylosing Spondylitis (AS) Disease Activity Index (BASDAI) Independent Components at Weeks 2, 4, 8, 12 | Week 8 C4: Discomfort Areas Tender to Touch | 40.7 units on scale |
| Placebo | Bath Ankylosing Spondylitis (AS) Disease Activity Index (BASDAI) Independent Components at Weeks 2, 4, 8, 12 | Week 12 C1: Fatigue/Tiredness | 48.5 units on scale |
| Placebo | Bath Ankylosing Spondylitis (AS) Disease Activity Index (BASDAI) Independent Components at Weeks 2, 4, 8, 12 | Week 12 C4: Discomfort Areas Tender to Touch | 38.0 units on scale |
| Placebo | Bath Ankylosing Spondylitis (AS) Disease Activity Index (BASDAI) Independent Components at Weeks 2, 4, 8, 12 | Week 8: Subscore Morning Stiffness | 44.22 units on scale |
| Placebo | Bath Ankylosing Spondylitis (AS) Disease Activity Index (BASDAI) Independent Components at Weeks 2, 4, 8, 12 | Baseline C5: Morning Stiffness | 66.3 units on scale |
| Placebo | Bath Ankylosing Spondylitis (AS) Disease Activity Index (BASDAI) Independent Components at Weeks 2, 4, 8, 12 | Week 2: Subscore Morning Stiffness | 49.78 units on scale |
| Placebo | Bath Ankylosing Spondylitis (AS) Disease Activity Index (BASDAI) Independent Components at Weeks 2, 4, 8, 12 | Week 4 C5: Morning Stiffness | 50.7 units on scale |
| Placebo | Bath Ankylosing Spondylitis (AS) Disease Activity Index (BASDAI) Independent Components at Weeks 2, 4, 8, 12 | Week 12: Subscore Morning Stiffness | 44.77 units on scale |
| Placebo | Bath Ankylosing Spondylitis (AS) Disease Activity Index (BASDAI) Independent Components at Weeks 2, 4, 8, 12 | Week 8 C5: Morning Stiffness | 44.7 units on scale |
| Placebo | Bath Ankylosing Spondylitis (AS) Disease Activity Index (BASDAI) Independent Components at Weeks 2, 4, 8, 12 | Week 2 C5: Morning Stiffness | 55.6 units on scale |
| Placebo | Bath Ankylosing Spondylitis (AS) Disease Activity Index (BASDAI) Independent Components at Weeks 2, 4, 8, 12 | Week 12 C5: Morning Stiffness | 44.8 units on scale |
Secondary
Bath Ankylosing Spondylitis Global Score (BAS-G) Independent Component: Effect of Disease on Well-being at Weeks 2, 4, 8, 12
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
Population: mITT; LOCF.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Etanercept | Bath Ankylosing Spondylitis Global Score (BAS-G) Independent Component: Effect of Disease on Well-being at Weeks 2, 4, 8, 12 | Week 2 | 57.8 units on scale |
| Etanercept | Bath Ankylosing Spondylitis Global Score (BAS-G) Independent Component: Effect of Disease on Well-being at Weeks 2, 4, 8, 12 | Week 8 | 43.3 units on scale |
| Etanercept | Bath Ankylosing Spondylitis Global Score (BAS-G) Independent Component: Effect of Disease on Well-being at Weeks 2, 4, 8, 12 | Week 4 | 51.4 units on scale |
| Etanercept | Bath Ankylosing Spondylitis Global Score (BAS-G) Independent Component: Effect of Disease on Well-being at Weeks 2, 4, 8, 12 | Week 12 | 42.1 units on scale |
| Etanercept | Bath Ankylosing Spondylitis Global Score (BAS-G) Independent Component: Effect of Disease on Well-being at Weeks 2, 4, 8, 12 | Baseline | 72.1 units on scale |
| Placebo | Bath Ankylosing Spondylitis Global Score (BAS-G) Independent Component: Effect of Disease on Well-being at Weeks 2, 4, 8, 12 | Week 12 | 52.9 units on scale |
| Placebo | Bath Ankylosing Spondylitis Global Score (BAS-G) Independent Component: Effect of Disease on Well-being at Weeks 2, 4, 8, 12 | Baseline | 68.3 units on scale |
| Placebo | Bath Ankylosing Spondylitis Global Score (BAS-G) Independent Component: Effect of Disease on Well-being at Weeks 2, 4, 8, 12 | Week 2 | 54.4 units on scale |
| Placebo | Bath Ankylosing Spondylitis Global Score (BAS-G) Independent Component: Effect of Disease on Well-being at Weeks 2, 4, 8, 12 | Week 4 | 54.0 units on scale |
| Placebo | Bath Ankylosing Spondylitis Global Score (BAS-G) Independent Component: Effect of Disease on Well-being at Weeks 2, 4, 8, 12 | Week 8 | 50.8 units on scale |
Secondary
Bath Ankylosing Spondylitis Metrology Index (BASMI) Independent Component: Cervical Rotation at Weeks 2, 4, 8, 12
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
Population: mITT; LOCF. In the case of missing data, no replacement or imputation method was performed.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Etanercept | Bath Ankylosing Spondylitis Metrology Index (BASMI) Independent Component: Cervical Rotation at Weeks 2, 4, 8, 12 | Week 2 | 43.05 units on scale |
| Etanercept | Bath Ankylosing Spondylitis Metrology Index (BASMI) Independent Component: Cervical Rotation at Weeks 2, 4, 8, 12 | Week 8 | 44.34 units on scale |
| Etanercept | Bath Ankylosing Spondylitis Metrology Index (BASMI) Independent Component: Cervical Rotation at Weeks 2, 4, 8, 12 | Week 4 | 42.55 units on scale |
| Etanercept | Bath Ankylosing Spondylitis Metrology Index (BASMI) Independent Component: Cervical Rotation at Weeks 2, 4, 8, 12 | Week 12 | 46.39 units on scale |
| Etanercept | Bath Ankylosing Spondylitis Metrology Index (BASMI) Independent Component: Cervical Rotation at Weeks 2, 4, 8, 12 | Baseline | 39.85 units on scale |
| Placebo | Bath Ankylosing Spondylitis Metrology Index (BASMI) Independent Component: Cervical Rotation at Weeks 2, 4, 8, 12 | Week 12 | 42.67 units on scale |
| Placebo | Bath Ankylosing Spondylitis Metrology Index (BASMI) Independent Component: Cervical Rotation at Weeks 2, 4, 8, 12 | Baseline | 37.14 units on scale |
| Placebo | Bath Ankylosing Spondylitis Metrology Index (BASMI) Independent Component: Cervical Rotation at Weeks 2, 4, 8, 12 | Week 2 | 38.34 units on scale |
| Placebo | Bath Ankylosing Spondylitis Metrology Index (BASMI) Independent Component: Cervical Rotation at Weeks 2, 4, 8, 12 | Week 4 | 39.67 units on scale |
| Placebo | Bath Ankylosing Spondylitis Metrology Index (BASMI) Independent Component: Cervical Rotation at Weeks 2, 4, 8, 12 | Week 8 | 39.79 units on scale |
Secondary
Bath Ankylosing Spondylitis Metrology Index (BASMI) Independent Component: Spinal Mobility Measured With Intermalleolar Distance at Baseline and Weeks 2, 4, 8, 12
Measurement in centimeters (cm) of the distance between the medial malleoli when subject is lying supine with knees and feet straight up with legs separated as far as possible. Measurement of two attempts. Mean of ordinal scores from 0: \>= 120 cm, to 9: 30 to 39.9 cm.
Time frame: Baseline, Week 2, Week 4, Week 8, Week 12
Population: mITT. In the case of missing data, no replacement or imputation method was performed.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Etanercept | Bath Ankylosing Spondylitis Metrology Index (BASMI) Independent Component: Spinal Mobility Measured With Intermalleolar Distance at Baseline and Weeks 2, 4, 8, 12 | Week 2 | 87.89 centimeters |
| Etanercept | Bath Ankylosing Spondylitis Metrology Index (BASMI) Independent Component: Spinal Mobility Measured With Intermalleolar Distance at Baseline and Weeks 2, 4, 8, 12 | Week 8 | 93.56 centimeters |
| Etanercept | Bath Ankylosing Spondylitis Metrology Index (BASMI) Independent Component: Spinal Mobility Measured With Intermalleolar Distance at Baseline and Weeks 2, 4, 8, 12 | Week 4 | 90.86 centimeters |
| Etanercept | Bath Ankylosing Spondylitis Metrology Index (BASMI) Independent Component: Spinal Mobility Measured With Intermalleolar Distance at Baseline and Weeks 2, 4, 8, 12 | Week 12 | 94.46 centimeters |
| Etanercept | Bath Ankylosing Spondylitis Metrology Index (BASMI) Independent Component: Spinal Mobility Measured With Intermalleolar Distance at Baseline and Weeks 2, 4, 8, 12 | Baseline | 82.31 centimeters |
| Placebo | Bath Ankylosing Spondylitis Metrology Index (BASMI) Independent Component: Spinal Mobility Measured With Intermalleolar Distance at Baseline and Weeks 2, 4, 8, 12 | Week 12 | 91.72 centimeters |
| Placebo | Bath Ankylosing Spondylitis Metrology Index (BASMI) Independent Component: Spinal Mobility Measured With Intermalleolar Distance at Baseline and Weeks 2, 4, 8, 12 | Baseline | 89.30 centimeters |
| Placebo | Bath Ankylosing Spondylitis Metrology Index (BASMI) Independent Component: Spinal Mobility Measured With Intermalleolar Distance at Baseline and Weeks 2, 4, 8, 12 | Week 2 | 92.08 centimeters |
| Placebo | Bath Ankylosing Spondylitis Metrology Index (BASMI) Independent Component: Spinal Mobility Measured With Intermalleolar Distance at Baseline and Weeks 2, 4, 8, 12 | Week 4 | 91.53 centimeters |
| Placebo | Bath Ankylosing Spondylitis Metrology Index (BASMI) Independent Component: Spinal Mobility Measured With Intermalleolar Distance at Baseline and Weeks 2, 4, 8, 12 | Week 8 | 91.58 centimeters |
Secondary
Bath Ankylosing Spondylitis Metrology Index (BASMI) Independent Component: Spinal Mobility Measured With Lateral Flexion at Baseline and Weeks 2, 4, 8, and 12
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
Population: mITT. In the case of missing data, no replacement or imputation method was performed.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Etanercept | Bath Ankylosing Spondylitis Metrology Index (BASMI) Independent Component: Spinal Mobility Measured With Lateral Flexion at Baseline and Weeks 2, 4, 8, and 12 | Week 2 | 13.58 centimeters |
| Etanercept | Bath Ankylosing Spondylitis Metrology Index (BASMI) Independent Component: Spinal Mobility Measured With Lateral Flexion at Baseline and Weeks 2, 4, 8, and 12 | Week 8 | 12.19 centimeters |
| Etanercept | Bath Ankylosing Spondylitis Metrology Index (BASMI) Independent Component: Spinal Mobility Measured With Lateral Flexion at Baseline and Weeks 2, 4, 8, and 12 | Week 4 | 13.01 centimeters |
| Etanercept | Bath Ankylosing Spondylitis Metrology Index (BASMI) Independent Component: Spinal Mobility Measured With Lateral Flexion at Baseline and Weeks 2, 4, 8, and 12 | Week 12 | 12.41 centimeters |
| Etanercept | Bath Ankylosing Spondylitis Metrology Index (BASMI) Independent Component: Spinal Mobility Measured With Lateral Flexion at Baseline and Weeks 2, 4, 8, and 12 | Baseline | 13.79 centimeters |
| Placebo | Bath Ankylosing Spondylitis Metrology Index (BASMI) Independent Component: Spinal Mobility Measured With Lateral Flexion at Baseline and Weeks 2, 4, 8, and 12 | Week 12 | 8.56 centimeters |
| Placebo | Bath Ankylosing Spondylitis Metrology Index (BASMI) Independent Component: Spinal Mobility Measured With Lateral Flexion at Baseline and Weeks 2, 4, 8, and 12 | Baseline | 9.80 centimeters |
| Placebo | Bath Ankylosing Spondylitis Metrology Index (BASMI) Independent Component: Spinal Mobility Measured With Lateral Flexion at Baseline and Weeks 2, 4, 8, and 12 | Week 2 | 10.62 centimeters |
| Placebo | Bath Ankylosing Spondylitis Metrology Index (BASMI) Independent Component: Spinal Mobility Measured With Lateral Flexion at Baseline and Weeks 2, 4, 8, and 12 | Week 4 | 10.60 centimeters |
| Placebo | Bath Ankylosing Spondylitis Metrology Index (BASMI) Independent Component: Spinal Mobility Measured With Lateral Flexion at Baseline and Weeks 2, 4, 8, and 12 | Week 8 | 10.21 centimeters |
Secondary
Bath Ankylosing Spondylitis Metrology Index (BASMI) Independent Component: Spinal Mobility Measured With Modified Schober's Test at Baseline and Weeks 2, 4, 8, 12
Measurement in centimeters of the distance between marks originally placed while the subject was standing erect 10 centimeters (cm) above and 5 cm below the midpoint of a line that joints the posterior superior iliac spines. Distance between marks was remeasured with subject maximally bend forward, knees fully extended, with spine in full flexion. Measurement of two attempts. Mean of ordinal scores from 1: 5.7 to 6.3 cm, to 10: \<=0.7 cm.
Time frame: Baseline, Week 2, Week 4, Week 8, Week 12
Population: mITT. In the case of missing data, no replacement or imputation method was performed.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Etanercept | Bath Ankylosing Spondylitis Metrology Index (BASMI) Independent Component: Spinal Mobility Measured With Modified Schober's Test at Baseline and Weeks 2, 4, 8, 12 | Week 12 | 1.88 centimeters |
| Etanercept | Bath Ankylosing Spondylitis Metrology Index (BASMI) Independent Component: Spinal Mobility Measured With Modified Schober's Test at Baseline and Weeks 2, 4, 8, 12 | Baseline | 1.63 centimeters |
| Etanercept | Bath Ankylosing Spondylitis Metrology Index (BASMI) Independent Component: Spinal Mobility Measured With Modified Schober's Test at Baseline and Weeks 2, 4, 8, 12 | Week 2 | 1.73 centimeters |
| Etanercept | Bath Ankylosing Spondylitis Metrology Index (BASMI) Independent Component: Spinal Mobility Measured With Modified Schober's Test at Baseline and Weeks 2, 4, 8, 12 | Week 4 | 1.85 centimeters |
| Etanercept | Bath Ankylosing Spondylitis Metrology Index (BASMI) Independent Component: Spinal Mobility Measured With Modified Schober's Test at Baseline and Weeks 2, 4, 8, 12 | Week 8 | 1.95 centimeters |
| Placebo | Bath Ankylosing Spondylitis Metrology Index (BASMI) Independent Component: Spinal Mobility Measured With Modified Schober's Test at Baseline and Weeks 2, 4, 8, 12 | Week 8 | 1.57 centimeters |
| Placebo | Bath Ankylosing Spondylitis Metrology Index (BASMI) Independent Component: Spinal Mobility Measured With Modified Schober's Test at Baseline and Weeks 2, 4, 8, 12 | Week 4 | 1.77 centimeters |
| Placebo | Bath Ankylosing Spondylitis Metrology Index (BASMI) Independent Component: Spinal Mobility Measured With Modified Schober's Test at Baseline and Weeks 2, 4, 8, 12 | Baseline | 1.52 centimeters |
| Placebo | Bath Ankylosing Spondylitis Metrology Index (BASMI) Independent Component: Spinal Mobility Measured With Modified Schober's Test at Baseline and Weeks 2, 4, 8, 12 | Week 12 | 1.51 centimeters |
| Placebo | Bath Ankylosing Spondylitis Metrology Index (BASMI) Independent Component: Spinal Mobility Measured With Modified Schober's Test at Baseline and Weeks 2, 4, 8, 12 | Week 2 | 1.57 centimeters |
Secondary
Bath Ankylosing Spondylitis Metrology Index (BASMI) Independent Component: Spinal Mobility Measured With Tragus-to-wall Distance at Baseline and Weeks 2, 4, 8, 12
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
Population: mITT. In the case of missing data, no replacement or imputation method was performed.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Etanercept | Bath Ankylosing Spondylitis Metrology Index (BASMI) Independent Component: Spinal Mobility Measured With Tragus-to-wall Distance at Baseline and Weeks 2, 4, 8, 12 | Week 2 | 19.69 centimeters |
| Etanercept | Bath Ankylosing Spondylitis Metrology Index (BASMI) Independent Component: Spinal Mobility Measured With Tragus-to-wall Distance at Baseline and Weeks 2, 4, 8, 12 | Week 8 | 18.70 centimeters |
| Etanercept | Bath Ankylosing Spondylitis Metrology Index (BASMI) Independent Component: Spinal Mobility Measured With Tragus-to-wall Distance at Baseline and Weeks 2, 4, 8, 12 | Week 4 | 19.19 centimeters |
| Etanercept | Bath Ankylosing Spondylitis Metrology Index (BASMI) Independent Component: Spinal Mobility Measured With Tragus-to-wall Distance at Baseline and Weeks 2, 4, 8, 12 | Week 12 | 18.54 centimeters |
| Etanercept | Bath Ankylosing Spondylitis Metrology Index (BASMI) Independent Component: Spinal Mobility Measured With Tragus-to-wall Distance at Baseline and Weeks 2, 4, 8, 12 | Baseline | 20.18 centimeters |
| Placebo | Bath Ankylosing Spondylitis Metrology Index (BASMI) Independent Component: Spinal Mobility Measured With Tragus-to-wall Distance at Baseline and Weeks 2, 4, 8, 12 | Week 12 | 18.45 centimeters |
| Placebo | Bath Ankylosing Spondylitis Metrology Index (BASMI) Independent Component: Spinal Mobility Measured With Tragus-to-wall Distance at Baseline and Weeks 2, 4, 8, 12 | Baseline | 19.76 centimeters |
| Placebo | Bath Ankylosing Spondylitis Metrology Index (BASMI) Independent Component: Spinal Mobility Measured With Tragus-to-wall Distance at Baseline and Weeks 2, 4, 8, 12 | Week 2 | 18.81 centimeters |
| Placebo | Bath Ankylosing Spondylitis Metrology Index (BASMI) Independent Component: Spinal Mobility Measured With Tragus-to-wall Distance at Baseline and Weeks 2, 4, 8, 12 | Week 4 | 18.82 centimeters |
| Placebo | Bath Ankylosing Spondylitis Metrology Index (BASMI) Independent Component: Spinal Mobility Measured With Tragus-to-wall Distance at Baseline and Weeks 2, 4, 8, 12 | Week 8 | 20.03 centimeters |
Secondary
Bath Ankylosing Spondylitis Metrology Index (BASMI): Spinal Mobility Measured With Cervical Rotation at Weeks 14, 18, 24
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
Population: Open-label population; in the case of missing data, no replacement or imputation method was performed.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Etanercept | Bath Ankylosing Spondylitis Metrology Index (BASMI): Spinal Mobility Measured With Cervical Rotation at Weeks 14, 18, 24 | Week 14 | 47.75 units on scale |
| Etanercept | Bath Ankylosing Spondylitis Metrology Index (BASMI): Spinal Mobility Measured With Cervical Rotation at Weeks 14, 18, 24 | Week 18 | 44.62 units on scale |
| Etanercept | Bath Ankylosing Spondylitis Metrology Index (BASMI): Spinal Mobility Measured With Cervical Rotation at Weeks 14, 18, 24 | Week 24 | 48.74 units on scale |
| Placebo | Bath Ankylosing Spondylitis Metrology Index (BASMI): Spinal Mobility Measured With Cervical Rotation at Weeks 14, 18, 24 | Week 14 | 44.78 units on scale |
| Placebo | Bath Ankylosing Spondylitis Metrology Index (BASMI): Spinal Mobility Measured With Cervical Rotation at Weeks 14, 18, 24 | Week 18 | 43.92 units on scale |
| Placebo | Bath Ankylosing Spondylitis Metrology Index (BASMI): Spinal Mobility Measured With Cervical Rotation at Weeks 14, 18, 24 | Week 24 | 43.82 units on scale |
Secondary
Bath Ankylosing Spondylitis Metrology Index (BASMI): Spinal Mobility Measured With Intermalleolar Distance at Weeks 14, 18, 24
Measurement in centimeters (cm) of the distance between the medial malleoli when subject is lying supine with knees and feet straight up with legs separated as far as possible. Measurement of two attempts. Mean of ordinal scores from 0: \>= 120 cm, to 9: 30 to 39.9 cm.
Time frame: Week 14, Week 18, Week 24
Population: Open-label population; in the case of missing data, no replacement or imputation method was performed.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Etanercept | Bath Ankylosing Spondylitis Metrology Index (BASMI): Spinal Mobility Measured With Intermalleolar Distance at Weeks 14, 18, 24 | Week 14 | 95.79 centimeters |
| Etanercept | Bath Ankylosing Spondylitis Metrology Index (BASMI): Spinal Mobility Measured With Intermalleolar Distance at Weeks 14, 18, 24 | Week 18 | 96.27 centimeters |
| Etanercept | Bath Ankylosing Spondylitis Metrology Index (BASMI): Spinal Mobility Measured With Intermalleolar Distance at Weeks 14, 18, 24 | Week 24 | 95.71 centimeters |
| Placebo | Bath Ankylosing Spondylitis Metrology Index (BASMI): Spinal Mobility Measured With Intermalleolar Distance at Weeks 14, 18, 24 | Week 14 | 98.03 centimeters |
| Placebo | Bath Ankylosing Spondylitis Metrology Index (BASMI): Spinal Mobility Measured With Intermalleolar Distance at Weeks 14, 18, 24 | Week 18 | 96.66 centimeters |
| Placebo | Bath Ankylosing Spondylitis Metrology Index (BASMI): Spinal Mobility Measured With Intermalleolar Distance at Weeks 14, 18, 24 | Week 24 | 96.41 centimeters |
Secondary
Bath Ankylosing Spondylitis Metrology Index (BASMI): Spinal Mobility Measured With Lateral Flexion at Weeks 14, 18, 24
Measurement in centimters (cm) of distance between subject's middle fingertip and the floor after bending sideways, without bending knees or lifting heels, while attempting 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: Week 14, Week 18, Week 24
Population: Open-label population; in the case of missing data, no replacement or imputation method was performed.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Etanercept | Bath Ankylosing Spondylitis Metrology Index (BASMI): Spinal Mobility Measured With Lateral Flexion at Weeks 14, 18, 24 | Week 14 | 12.93 centimeters |
| Etanercept | Bath Ankylosing Spondylitis Metrology Index (BASMI): Spinal Mobility Measured With Lateral Flexion at Weeks 14, 18, 24 | Week 18 | 12.02 centimeters |
| Etanercept | Bath Ankylosing Spondylitis Metrology Index (BASMI): Spinal Mobility Measured With Lateral Flexion at Weeks 14, 18, 24 | Week 24 | 10.95 centimeters |
| Placebo | Bath Ankylosing Spondylitis Metrology Index (BASMI): Spinal Mobility Measured With Lateral Flexion at Weeks 14, 18, 24 | Week 14 | 8.19 centimeters |
| Placebo | Bath Ankylosing Spondylitis Metrology Index (BASMI): Spinal Mobility Measured With Lateral Flexion at Weeks 14, 18, 24 | Week 18 | 8.08 centimeters |
| Placebo | Bath Ankylosing Spondylitis Metrology Index (BASMI): Spinal Mobility Measured With Lateral Flexion at Weeks 14, 18, 24 | Week 24 | 10.48 centimeters |
Secondary
Bath Ankylosing Spondylitis Metrology Index (BASMI): Spinal Mobility Measured With Modified Schober's Test at Weeks 14, 18, 24
Measurement in centimeters of the distance between marks originally placed while the subject was standing erect 10 centimeters (cm) above and 5 cm below the midpoint of a line that joints the posterior superior iliac spines. Distance between marks was remeasured with subject maximally bend forward, knees fully extended, with spine in full flexion. Measurement of two attempts. Mean of ordinal scores from 1: 5.7 to 6.3 cm, to 10: \<=0.7 cm.
Time frame: Week 14, Week 18, Week 24
Population: Open-label population; in the case of missing data, no replacement or imputation method was performed.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Etanercept | Bath Ankylosing Spondylitis Metrology Index (BASMI): Spinal Mobility Measured With Modified Schober's Test at Weeks 14, 18, 24 | Week 14 | 1.87 centimeters |
| Etanercept | Bath Ankylosing Spondylitis Metrology Index (BASMI): Spinal Mobility Measured With Modified Schober's Test at Weeks 14, 18, 24 | Week 18 | 1.71 centimeters |
| Etanercept | Bath Ankylosing Spondylitis Metrology Index (BASMI): Spinal Mobility Measured With Modified Schober's Test at Weeks 14, 18, 24 | Week 24 | 1.92 centimeters |
| Placebo | Bath Ankylosing Spondylitis Metrology Index (BASMI): Spinal Mobility Measured With Modified Schober's Test at Weeks 14, 18, 24 | Week 14 | 1.63 centimeters |
| Placebo | Bath Ankylosing Spondylitis Metrology Index (BASMI): Spinal Mobility Measured With Modified Schober's Test at Weeks 14, 18, 24 | Week 18 | 1.69 centimeters |
| Placebo | Bath Ankylosing Spondylitis Metrology Index (BASMI): Spinal Mobility Measured With Modified Schober's Test at Weeks 14, 18, 24 | Week 24 | 1.79 centimeters |
Secondary
Bath Ankylosing Spondylitis Metrology Index (BASMI): Spinal Mobility Measured With Tragus-to-wall Measurement at Weeks 14, 18, 24
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
Population: Open-label population; in the case of missing data, no replacement or imputation method was performed.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Etanercept | Bath Ankylosing Spondylitis Metrology Index (BASMI): Spinal Mobility Measured With Tragus-to-wall Measurement at Weeks 14, 18, 24 | Week 14 | 19.12 centimeters |
| Etanercept | Bath Ankylosing Spondylitis Metrology Index (BASMI): Spinal Mobility Measured With Tragus-to-wall Measurement at Weeks 14, 18, 24 | Week 18 | 19.86 centimeters |
| Etanercept | Bath Ankylosing Spondylitis Metrology Index (BASMI): Spinal Mobility Measured With Tragus-to-wall Measurement at Weeks 14, 18, 24 | Week 24 | 18.99 centimeters |
| Placebo | Bath Ankylosing Spondylitis Metrology Index (BASMI): Spinal Mobility Measured With Tragus-to-wall Measurement at Weeks 14, 18, 24 | Week 14 | 18.38 centimeters |
| Placebo | Bath Ankylosing Spondylitis Metrology Index (BASMI): Spinal Mobility Measured With Tragus-to-wall Measurement at Weeks 14, 18, 24 | Week 18 | 18.55 centimeters |
| Placebo | Bath Ankylosing Spondylitis Metrology Index (BASMI): Spinal Mobility Measured With Tragus-to-wall Measurement at Weeks 14, 18, 24 | Week 24 | 18.60 centimeters |
Secondary
Change From Baseline in C-reactive Protein (CRP) at Weeks 14, 18, 24
Change from baseline in C-reactive Protein (CRP).
Time frame: Week 14, Week 18, Week 24
Population: Open-label population; LOCF.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Etanercept | Change From Baseline in C-reactive Protein (CRP) at Weeks 14, 18, 24 | Week 14 | -18.11 milligrams per liter |
| Etanercept | Change From Baseline in C-reactive Protein (CRP) at Weeks 14, 18, 24 | Week 18 | -17.15 milligrams per liter |
| Etanercept | Change From Baseline in C-reactive Protein (CRP) at Weeks 14, 18, 24 | Week 24 | -16.05 milligrams per liter |
| Placebo | Change From Baseline in C-reactive Protein (CRP) at Weeks 14, 18, 24 | Week 14 | -10.04 milligrams per liter |
| Placebo | Change From Baseline in C-reactive Protein (CRP) at Weeks 14, 18, 24 | Week 18 | -9.47 milligrams per liter |
| Placebo | Change From Baseline in C-reactive Protein (CRP) at Weeks 14, 18, 24 | Week 24 | -9.62 milligrams per liter |
Secondary
Change From Baseline in C-reactive Protein (CRP) at Weeks 2, 4, 8, 12
CRP is a marker of inflammation. A higher level is consistent with inflammation.
Time frame: Baseline, Week 2, Week 4, Week 8, Week 12
Population: mITT. LOCF.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Etanercept | Change From Baseline in C-reactive Protein (CRP) at Weeks 2, 4, 8, 12 | Week 2 | -15.37 milligrams per liter |
| Etanercept | Change From Baseline in C-reactive Protein (CRP) at Weeks 2, 4, 8, 12 | Week 4 | -16.99 milligrams per liter |
| Etanercept | Change From Baseline in C-reactive Protein (CRP) at Weeks 2, 4, 8, 12 | Week 8 | -16.19 milligrams per liter |
| Etanercept | Change From Baseline in C-reactive Protein (CRP) at Weeks 2, 4, 8, 12 | Week 12 | -15.69 milligrams per liter |
| Placebo | Change From Baseline in C-reactive Protein (CRP) at Weeks 2, 4, 8, 12 | Week 12 | -1.28 milligrams per liter |
| Placebo | Change From Baseline in C-reactive Protein (CRP) at Weeks 2, 4, 8, 12 | Week 2 | -1.05 milligrams per liter |
| Placebo | Change From Baseline in C-reactive Protein (CRP) at Weeks 2, 4, 8, 12 | Week 8 | -1.01 milligrams per liter |
| Placebo | Change From Baseline in C-reactive Protein (CRP) at Weeks 2, 4, 8, 12 | Week 4 | -2.01 milligrams per liter |
Comparison: Week 2: Mixed model analysis of covariance (ANCOVA), using an auto-regressive correlation structure, with treatment groups, visits and their interactions as fixed factors, baseline as a covariate and patients as a random factor.p-value: <0.000195% CI: [-20.55, -8.1]ANCOVA
Comparison: Week 4: Mixed model analysis of covariance (ANCOVA), using an auto-regressive correlation structure, with treatment groups, visits and their interactions as fixed factors, baseline as a covariate and patients as a random factor.p-value: <0.000195% CI: [-21.2, -8.76]ANCOVA
Comparison: Week 8: Mixed model analysis of covariance (ANCOVA), using an auto-regressive correlation structure, with treatment groups, visits and their interactions as fixed factors, baseline as a covariate and patients as a random factor.p-value: <0.000195% CI: [-21.41, -8.96]ANCOVA
Comparison: Week 12: Mixed model analysis of covariance (ANCOVA), using an auto-regressive correlation structure, with treatment groups, visits and their interactions as fixed factors, baseline as a covariate and patients as a random factor.p-value: <0.000195% CI: [-20.63, -8.19]ANCOVA
Secondary
Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Weeks 14, 18, 24
ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. A higher rate is consistent with inflammation.
Time frame: Week 14, Week 18, Week 24
Population: Open-label population; LOCF.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Etanercept | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Weeks 14, 18, 24 | Week 14 | -20.32 millimeters per hour |
| Etanercept | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Weeks 14, 18, 24 | Week 18 | -17.95 millimeters per hour |
| Etanercept | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Weeks 14, 18, 24 | Week 24 | -18.53 millimeters per hour |
| Placebo | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Weeks 14, 18, 24 | Week 14 | -10.21 millimeters per hour |
| Placebo | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Weeks 14, 18, 24 | Week 18 | -12.32 millimeters per hour |
| Placebo | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Weeks 14, 18, 24 | Week 24 | -14.61 millimeters per hour |
Secondary
Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Weeks 2, 4, 8, 12
ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. A higher rate is consistent with inflammation.
Time frame: Week 2, Week 4, Week 8, Week 12
Population: mITT; LOCF. N = number of subjects with evaluable data.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Etanercept | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Weeks 2, 4, 8, 12 | Week 2 | -15.00 millimeters per hour |
| Etanercept | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Weeks 2, 4, 8, 12 | Week 4 | -20.05 millimeters per hour |
| Etanercept | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Weeks 2, 4, 8, 12 | Week 8 | -17.02 millimeters per hour |
| Etanercept | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Weeks 2, 4, 8, 12 | Week 12 | -20.33 millimeters per hour |
| Placebo | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Weeks 2, 4, 8, 12 | Week 12 | -2.17 millimeters per hour |
| Placebo | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Weeks 2, 4, 8, 12 | Week 2 | -2.62 millimeters per hour |
| Placebo | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Weeks 2, 4, 8, 12 | Week 8 | -0.07 millimeters per hour |
| Placebo | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Weeks 2, 4, 8, 12 | Week 4 | -2.60 millimeters per hour |
Comparison: 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 atients as a random factor.p-value: <0.000195% CI: [-18.17, -6.58]ANCOVA
Comparison: 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.p-value: <0.000195% CI: [-23.25, -11.65]ANCOVA
Comparison: 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.p-value: <0.000195% CI: [-22.75, -11.15]ANCOVA
Comparison: 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.p-value: <0.000195% CI: [-23.96, -12.36]ANCOVA
Secondary
Change From Baseline in Level of Difficulty to Perform Physically Demanding Activities Due to Ankylosing Spondylitis at Weeks 2, 4, 8, 12
Subject evaluation of level of difficulty to perform daily physical activities and/or kinesitherapy for ankylosing spondylitis (AS) because of AS using a 100 millimeter Visual Analog Scale (VAS) ranging from 0=easy to 100=impossible. Subgroup of subjects who responded that they were able to perform daily physical activities and/or kinesitherapy for their ankylosing spondylitis at each visit.
Time frame: Baseline, Week 2, Week 4, Week 8, Week 12
Population: mITT; LOCF. N = subgroup of subjects who reported performing daily physical activities and/or kinesitherapy for their ankylosing spondylitis at each visit (Week 2 through Week 12).
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Etanercept | Change From Baseline in Level of Difficulty to Perform Physically Demanding Activities Due to Ankylosing Spondylitis at Weeks 2, 4, 8, 12 | Week 2 | -11.88 units on scale |
| Etanercept | Change From Baseline in Level of Difficulty to Perform Physically Demanding Activities Due to Ankylosing Spondylitis at Weeks 2, 4, 8, 12 | Week 4 | -15.14 units on scale |
| Etanercept | Change From Baseline in Level of Difficulty to Perform Physically Demanding Activities Due to Ankylosing Spondylitis at Weeks 2, 4, 8, 12 | Week 8 | -18.65 units on scale |
| Etanercept | Change From Baseline in Level of Difficulty to Perform Physically Demanding Activities Due to Ankylosing Spondylitis at Weeks 2, 4, 8, 12 | Week 12 | -22.55 units on scale |
| Placebo | Change From Baseline in Level of Difficulty to Perform Physically Demanding Activities Due to Ankylosing Spondylitis at Weeks 2, 4, 8, 12 | Week 12 | -18.53 units on scale |
| Placebo | Change From Baseline in Level of Difficulty to Perform Physically Demanding Activities Due to Ankylosing Spondylitis at Weeks 2, 4, 8, 12 | Week 2 | -7.16 units on scale |
| Placebo | Change From Baseline in Level of Difficulty to Perform Physically Demanding Activities Due to Ankylosing Spondylitis at Weeks 2, 4, 8, 12 | Week 8 | -17.25 units on scale |
| Placebo | Change From Baseline in Level of Difficulty to Perform Physically Demanding Activities Due to Ankylosing Spondylitis at Weeks 2, 4, 8, 12 | Week 4 | -12.04 units on scale |
Comparison: 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.p-value: 0.4995% CI: [-18.35, 8.91]ANCOVA
Comparison: 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.p-value: 0.65195% CI: [-16.73, 10.54]ANCOVA
Comparison: 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.p-value: 0.8495% CI: [-15.12, 12.34]ANCOVA
Comparison: 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.p-value: 0.56295% CI: [-17.81, 9.77]ANCOVA
Secondary
Change From Baseline in Nocturnal Back Pain at Weeks 14, 18, 24
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
Population: Open-label population; LOCF.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Etanercept | Change From Baseline in Nocturnal Back Pain at Weeks 14, 18, 24 | Week 14 | -36.92 units on scale |
| Etanercept | Change From Baseline in Nocturnal Back Pain at Weeks 14, 18, 24 | Week 18 | -41.73 units on scale |
| Etanercept | Change From Baseline in Nocturnal Back Pain at Weeks 14, 18, 24 | Week 24 | -45.26 units on scale |
| Placebo | Change From Baseline in Nocturnal Back Pain at Weeks 14, 18, 24 | Week 14 | -27.76 units on scale |
| Placebo | Change From Baseline in Nocturnal Back Pain at Weeks 14, 18, 24 | Week 18 | -27.89 units on scale |
| Placebo | Change From Baseline in Nocturnal Back Pain at Weeks 14, 18, 24 | Week 24 | -28.44 units on scale |
Secondary
Change From Baseline in Nocturnal Back Pain at Weeks 2, 4, 8, 12
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
Population: mITT; LOCF.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Etanercept | Change From Baseline in Nocturnal Back Pain at Weeks 2, 4, 8, 12 | Week 2 | -19.41 units on scale |
| Etanercept | Change From Baseline in Nocturnal Back Pain at Weeks 2, 4, 8, 12 | Week 8 | -29.27 units on scale |
| Etanercept | Change From Baseline in Nocturnal Back Pain at Weeks 2, 4, 8, 12 | Week 4 | -20.90 units on scale |
| Etanercept | Change From Baseline in Nocturnal Back Pain at Weeks 2, 4, 8, 12 | Week 12 | -32.07 units on scale |
| Placebo | Change From Baseline in Nocturnal Back Pain at Weeks 2, 4, 8, 12 | Week 12 | -12.38 units on scale |
| Placebo | Change From Baseline in Nocturnal Back Pain at Weeks 2, 4, 8, 12 | Week 2 | -13.12 units on scale |
| Placebo | Change From Baseline in Nocturnal Back Pain at Weeks 2, 4, 8, 12 | Week 4 | -15.72 units on scale |
| Placebo | Change From Baseline in Nocturnal Back Pain at Weeks 2, 4, 8, 12 | Week 8 | -15.54 units on scale |
Comparison: 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.p-value: 0.25495% CI: [-17.13, 4.57]ANCOVA
Comparison: 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.p-value: 0.34895% CI: [-16.02, 5.68]ANCOVA
Comparison: 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.p-value: 0.01495% CI: [-24.57, -2.88]ANCOVA
Comparison: 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.p-value: <0.00195% CI: [-30.54, -8.84]ANCOVA
Secondary
Change From Baseline in Patient Global Assessment at Weeks 14, 18, 24
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
Population: Open-label population; LOCF.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Etanercept | Change From Baseline in Patient Global Assessment at Weeks 14, 18, 24 | Week 14 | -31.26 units on scale |
| Etanercept | Change From Baseline in Patient Global Assessment at Weeks 14, 18, 24 | Week 18 | -35.50 units on scale |
| Etanercept | Change From Baseline in Patient Global Assessment at Weeks 14, 18, 24 | Week 24 | -40.70 units on scale |
| Placebo | Change From Baseline in Patient Global Assessment at Weeks 14, 18, 24 | Week 14 | -31.20 units on scale |
| Placebo | Change From Baseline in Patient Global Assessment at Weeks 14, 18, 24 | Week 18 | -31.92 units on scale |
| Placebo | Change From Baseline in Patient Global Assessment at Weeks 14, 18, 24 | Week 24 | -34.19 units on scale |
Secondary
Change From Baseline in Patient Global Assessment Visual Analog Scale (VAS) at Weeks 2, 4, 8, 12
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
Population: mITT; LOCF.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Etanercept | Change From Baseline in Patient Global Assessment Visual Analog Scale (VAS) at Weeks 2, 4, 8, 12 | Week 2 | -16.90 units on scale |
| Etanercept | Change From Baseline in Patient Global Assessment Visual Analog Scale (VAS) at Weeks 2, 4, 8, 12 | Week 4 | -19.06 units on scale |
| Etanercept | Change From Baseline in Patient Global Assessment Visual Analog Scale (VAS) at Weeks 2, 4, 8, 12 | Week 8 | -25.29 units on scale |
| Etanercept | Change From Baseline in Patient Global Assessment Visual Analog Scale (VAS) at Weeks 2, 4, 8, 12 | Week 12 | -25.79 units on scale |
| Placebo | Change From Baseline in Patient Global Assessment Visual Analog Scale (VAS) at Weeks 2, 4, 8, 12 | Week 12 | -16.52 units on scale |
| Placebo | Change From Baseline in Patient Global Assessment Visual Analog Scale (VAS) at Weeks 2, 4, 8, 12 | Week 2 | -8.36 units on scale |
| Placebo | Change From Baseline in Patient Global Assessment Visual Analog Scale (VAS) at Weeks 2, 4, 8, 12 | Week 8 | -10.56 units on scale |
| Placebo | Change From Baseline in Patient Global Assessment Visual Analog Scale (VAS) at Weeks 2, 4, 8, 12 | Week 4 | -11.04 units on scale |
Comparison: 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.p-value: 0.08995% CI: [-18.4, 1.33]ANCOVA
Comparison: 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.p-value: 0.1195% CI: [-17.89, 1.85]ANCOVA
Comparison: 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.p-value: 0.00495% CI: [-24.6, -4.86]ANCOVA
Comparison: 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.p-value: 0.06595% CI: [-19.14, 0.59]ANCOVA
Secondary
Change From Baseline in Physician Global Assessment at Weeks 14, 18, 24
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
Population: Open-label population; LOCF.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Etanercept | Change From Baseline in Physician Global Assessment at Weeks 14, 18, 24 | Week 14 | -37.66 units on scale |
| Etanercept | Change From Baseline in Physician Global Assessment at Weeks 14, 18, 24 | Week 18 | -43.22 units on scale |
| Etanercept | Change From Baseline in Physician Global Assessment at Weeks 14, 18, 24 | Week 24 | -42.68 units on scale |
| Placebo | Change From Baseline in Physician Global Assessment at Weeks 14, 18, 24 | Week 14 | -35.57 units on scale |
| Placebo | Change From Baseline in Physician Global Assessment at Weeks 14, 18, 24 | Week 18 | -37.05 units on scale |
| Placebo | Change From Baseline in Physician Global Assessment at Weeks 14, 18, 24 | Week 24 | -40.41 units on scale |
Secondary
Change From Baseline in Physician Global Assessment Visual Analog Scale at Weeks 2, 4, 8, 12
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
Population: mITT; LOCF. N = number of subjects with evaluable data.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Etanercept | Change From Baseline in Physician Global Assessment Visual Analog Scale at Weeks 2, 4, 8, 12 | Week 2 | -15.77 units on scale |
| Etanercept | Change From Baseline in Physician Global Assessment Visual Analog Scale at Weeks 2, 4, 8, 12 | Week 4 | -26.25 units on scale |
| Etanercept | Change From Baseline in Physician Global Assessment Visual Analog Scale at Weeks 2, 4, 8, 12 | Week 8 | -28.80 units on scale |
| Etanercept | Change From Baseline in Physician Global Assessment Visual Analog Scale at Weeks 2, 4, 8, 12 | Week 12 | -32.62 units on scale |
| Placebo | Change From Baseline in Physician Global Assessment Visual Analog Scale at Weeks 2, 4, 8, 12 | Week 12 | -17.32 units on scale |
| Placebo | Change From Baseline in Physician Global Assessment Visual Analog Scale at Weeks 2, 4, 8, 12 | Week 2 | -7.43 units on scale |
| Placebo | Change From Baseline in Physician Global Assessment Visual Analog Scale at Weeks 2, 4, 8, 12 | Week 8 | -16.05 units on scale |
| Placebo | Change From Baseline in Physician Global Assessment Visual Analog Scale at Weeks 2, 4, 8, 12 | Week 4 | -15.23 units on scale |
Comparison: 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.p-value: 0.05495% CI: [-16.81, 0.15]ANCOVA
Comparison: 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.p-value: 0.01195% CI: [-19.5, -2.54]ANCOVA
Comparison: 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.p-value: 0.00395% CI: [-21.23, -4.27]ANCOVA
Comparison: 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.p-value: <0.00195% CI: [-23.7, -6.82]ANCOVA
Secondary
Change From Baseline in Self Assessment of Ability and or Easiness to Perform Physically Demanding Activities at Weeks 14, 18, 24
Subject evaluation of level of difficulty to perform daily physical activities and/or kinesitherapy for ankylosing spondylitis (AS) due to AS using a 100 millimeter Visual Analog Scale (VAS) ranging from 0=easy to 100=impossible. Subgroup of subjects who responded that they were able to perform daily physical activities and/or kinesitherapy for their ankylosing spondylitis at each visit.
Time frame: Week 14, Week 18, Week 24
Population: Open-label population; LOCF.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Etanercept | Change From Baseline in Self Assessment of Ability and or Easiness to Perform Physically Demanding Activities at Weeks 14, 18, 24 | Week 14 | -20.01 units on scale |
| Etanercept | Change From Baseline in Self Assessment of Ability and or Easiness to Perform Physically Demanding Activities at Weeks 14, 18, 24 | Week 18 | -22.39 units on scale |
| Etanercept | Change From Baseline in Self Assessment of Ability and or Easiness to Perform Physically Demanding Activities at Weeks 14, 18, 24 | Week 24 | -24.21 units on scale |
| Placebo | Change From Baseline in Self Assessment of Ability and or Easiness to Perform Physically Demanding Activities at Weeks 14, 18, 24 | Week 14 | -22.95 units on scale |
| Placebo | Change From Baseline in Self Assessment of Ability and or Easiness to Perform Physically Demanding Activities at Weeks 14, 18, 24 | Week 18 | -27.80 units on scale |
| Placebo | Change From Baseline in Self Assessment of Ability and or Easiness to Perform Physically Demanding Activities at Weeks 14, 18, 24 | Week 24 | -25.55 units on scale |
Secondary
Change From Baseline in Spinal Mobility Measured With the Bath Ankylosing Spondylitis Metrology Index (BASMI) at Weeks 14, 18, 24
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
Population: Open-label population; LOCF.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Etanercept | Change From Baseline in Spinal Mobility Measured With the Bath Ankylosing Spondylitis Metrology Index (BASMI) at Weeks 14, 18, 24 | Week 14 | -0.73 units on scale |
| Etanercept | Change From Baseline in Spinal Mobility Measured With the Bath Ankylosing Spondylitis Metrology Index (BASMI) at Weeks 14, 18, 24 | Week 18 | -0.65 units on scale |
| Etanercept | Change From Baseline in Spinal Mobility Measured With the Bath Ankylosing Spondylitis Metrology Index (BASMI) at Weeks 14, 18, 24 | Week 24 | -0.80 units on scale |
| Placebo | Change From Baseline in Spinal Mobility Measured With the Bath Ankylosing Spondylitis Metrology Index (BASMI) at Weeks 14, 18, 24 | Week 14 | -0.49 units on scale |
| Placebo | Change From Baseline in Spinal Mobility Measured With the Bath Ankylosing Spondylitis Metrology Index (BASMI) at Weeks 14, 18, 24 | Week 18 | -0.49 units on scale |
| Placebo | Change From Baseline in Spinal Mobility Measured With the Bath Ankylosing Spondylitis Metrology Index (BASMI) at Weeks 14, 18, 24 | Week 24 | -0.50 units on scale |
Secondary
Change From Baseline in Spinal Mobility Measured With the Bath Ankylosing Spondylitis Metrology Index (BASMI) at Weeks 2, 4, 8, 12
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
Population: mITT; LOCF.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Etanercept | Change From Baseline in Spinal Mobility Measured With the Bath Ankylosing Spondylitis Metrology Index (BASMI) at Weeks 2, 4, 8, 12 | Week 2 | -0.27 units on scale |
| Etanercept | Change From Baseline in Spinal Mobility Measured With the Bath Ankylosing Spondylitis Metrology Index (BASMI) at Weeks 2, 4, 8, 12 | Week 4 | -0.37 units on scale |
| Etanercept | Change From Baseline in Spinal Mobility Measured With the Bath Ankylosing Spondylitis Metrology Index (BASMI) at Weeks 2, 4, 8, 12 | Week 8 | -0.57 units on scale |
| Etanercept | Change From Baseline in Spinal Mobility Measured With the Bath Ankylosing Spondylitis Metrology Index (BASMI) at Weeks 2, 4, 8, 12 | Week 12 | -0.57 units on scale |
| Placebo | Change From Baseline in Spinal Mobility Measured With the Bath Ankylosing Spondylitis Metrology Index (BASMI) at Weeks 2, 4, 8, 12 | Week 12 | -0.20 units on scale |
| Placebo | Change From Baseline in Spinal Mobility Measured With the Bath Ankylosing Spondylitis Metrology Index (BASMI) at Weeks 2, 4, 8, 12 | Week 2 | -0.17 units on scale |
| Placebo | Change From Baseline in Spinal Mobility Measured With the Bath Ankylosing Spondylitis Metrology Index (BASMI) at Weeks 2, 4, 8, 12 | Week 8 | -0.18 units on scale |
| Placebo | Change From Baseline in Spinal Mobility Measured With the Bath Ankylosing Spondylitis Metrology Index (BASMI) at Weeks 2, 4, 8, 12 | Week 4 | -0.23 units on scale |
Comparison: 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.p-value: 0.51595% CI: [-0.38, 0.19]ANCOVA
Comparison: 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.p-value: 0.31695% CI: [-0.43, 0.14]ANCOVA
Comparison: 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.p-value: 0.00895% CI: [-0.67, -0.1]ANCOVA
Comparison: 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.p-value: 0.01195% CI: [-0.65, -0.08]ANCOVA
Secondary
Change From Baseline in the Bath Ankylosing Spondylitis (AS) Disease Activity Index (BASDAI) at Weeks 14, 18, 24
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
Population: Open-label population; LOCF.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Etanercept | Change From Baseline in the Bath Ankylosing Spondylitis (AS) Disease Activity Index (BASDAI) at Weeks 14, 18, 24 | Week 14 | -29.26 units on scale |
| Etanercept | Change From Baseline in the Bath Ankylosing Spondylitis (AS) Disease Activity Index (BASDAI) at Weeks 14, 18, 24 | Week 18 | -34.20 units on scale |
| Etanercept | Change From Baseline in the Bath Ankylosing Spondylitis (AS) Disease Activity Index (BASDAI) at Weeks 14, 18, 24 | Week 24 | -37.62 units on scale |
| Placebo | Change From Baseline in the Bath Ankylosing Spondylitis (AS) Disease Activity Index (BASDAI) at Weeks 14, 18, 24 | Week 14 | -27.41 units on scale |
| Placebo | Change From Baseline in the Bath Ankylosing Spondylitis (AS) Disease Activity Index (BASDAI) at Weeks 14, 18, 24 | Week 18 | -28.21 units on scale |
| Placebo | Change From Baseline in the Bath Ankylosing Spondylitis (AS) Disease Activity Index (BASDAI) at Weeks 14, 18, 24 | Week 24 | -28.62 units on scale |
Secondary
Change From Baseline in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Weeks 2, 4, 8, 12
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
Population: mITT; LOCF.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Etanercept | Change From Baseline in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Weeks 2, 4, 8, 12 | Week 2 | -14.25 units on a scale |
| Etanercept | Change From Baseline in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Weeks 2, 4, 8, 12 | Week 4 | -18.41 units on a scale |
| Etanercept | Change From Baseline in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Weeks 2, 4, 8, 12 | Week 8 | -26.06 units on a scale |
| Etanercept | Change From Baseline in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Weeks 2, 4, 8, 12 | Week 12 | -26.38 units on a scale |
| Placebo | Change From Baseline in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Weeks 2, 4, 8, 12 | Week 12 | -14.43 units on a scale |
| Placebo | Change From Baseline in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Weeks 2, 4, 8, 12 | Week 2 | -7.39 units on a scale |
| Placebo | Change From Baseline in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Weeks 2, 4, 8, 12 | Week 8 | -13.51 units on a scale |
| Placebo | Change From Baseline in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Weeks 2, 4, 8, 12 | Week 4 | -11.97 units on a scale |
Comparison: 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.p-value: 0.12295% CI: [-15.57, 1.85]ANCOVA
Comparison: 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.p-value: 0.14595% CI: [-15.16, 2.26]ANCOVA
Comparison: 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.p-value: 0.00595% CI: [-21.26, -3.84]ANCOVA
Comparison: 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.p-value: 0.00895% CI: [-20.66, -3.24]ANCOVA
Secondary
Change From Baseline in the Bath Ankylosing Spondylitis Functional Index (BASFI) at Weeks 2, 4, 8, 12
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
Population: mITT; LOCF. N = number of subjects with evaluable data.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Etanercept | Change From Baseline in the Bath Ankylosing Spondylitis Functional Index (BASFI) at Weeks 2, 4, 8, 12 | Week 2 | -8.23 units on scale |
| Etanercept | Change From Baseline in the Bath Ankylosing Spondylitis Functional Index (BASFI) at Weeks 2, 4, 8, 12 | Week 4 | -12.44 units on scale |
| Etanercept | Change From Baseline in the Bath Ankylosing Spondylitis Functional Index (BASFI) at Weeks 2, 4, 8, 12 | Week 8 | -19.75 units on scale |
| Etanercept | Change From Baseline in the Bath Ankylosing Spondylitis Functional Index (BASFI) at Weeks 2, 4, 8, 12 | Week 12 | -21.63 units on scale |
| Placebo | Change From Baseline in the Bath Ankylosing Spondylitis Functional Index (BASFI) at Weeks 2, 4, 8, 12 | Week 12 | -10.09 units on scale |
| Placebo | Change From Baseline in the Bath Ankylosing Spondylitis Functional Index (BASFI) at Weeks 2, 4, 8, 12 | Week 2 | -7.80 units on scale |
| Placebo | Change From Baseline in the Bath Ankylosing Spondylitis Functional Index (BASFI) at Weeks 2, 4, 8, 12 | Week 8 | -11.54 units on scale |
| Placebo | Change From Baseline in the Bath Ankylosing Spondylitis Functional Index (BASFI) at Weeks 2, 4, 8, 12 | Week 4 | -10.04 units on scale |
Comparison: 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.p-value: 0.91495% CI: [-8.23, 7.38]ANCOVA
Comparison: 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.p-value: 0.54495% CI: [-10.21, 5.41]ANCOVA
Comparison: 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.p-value: 0.03995% CI: [-16.02, -0.4]ANCOVA
Comparison: 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.p-value: 0.00495% CI: [-19.35, -3.73]ANCOVA
Secondary
Change From Baseline in the Bath Ankylosing Spondylitis-Global Score (BAS-G) at Weeks 14, 18, 24
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
Population: Open-label population; LOCF.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Etanercept | Change From Baseline in the Bath Ankylosing Spondylitis-Global Score (BAS-G) at Weeks 14, 18, 24 | Week 14 | -34.29 units on scale |
| Etanercept | Change From Baseline in the Bath Ankylosing Spondylitis-Global Score (BAS-G) at Weeks 14, 18, 24 | Week 18 | -36.93 units on scale |
| Etanercept | Change From Baseline in the Bath Ankylosing Spondylitis-Global Score (BAS-G) at Weeks 14, 18, 24 | Week 24 | -42.35 units on scale |
| Placebo | Change From Baseline in the Bath Ankylosing Spondylitis-Global Score (BAS-G) at Weeks 14, 18, 24 | Week 14 | -34.93 units on scale |
| Placebo | Change From Baseline in the Bath Ankylosing Spondylitis-Global Score (BAS-G) at Weeks 14, 18, 24 | Week 18 | -35.98 units on scale |
| Placebo | Change From Baseline in the Bath Ankylosing Spondylitis-Global Score (BAS-G) at Weeks 14, 18, 24 | Week 24 | -35.89 units on scale |
Secondary
Change From Baseline in the Bath Ankylosing Spondylitis-Global Score (BAS-G) at Weeks 2, 4, 8, 12
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
Population: mITT; LOCF. N=number of subjects with evaluable data.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Etanercept | Change From Baseline in the Bath Ankylosing Spondylitis-Global Score (BAS-G) at Weeks 2, 4, 8, 12 | Week 2 | -13.74 units on scale |
| Etanercept | Change From Baseline in the Bath Ankylosing Spondylitis-Global Score (BAS-G) at Weeks 2, 4, 8, 12 | Week 4 | -20.09 units on scale |
| Etanercept | Change From Baseline in the Bath Ankylosing Spondylitis-Global Score (BAS-G) at Weeks 2, 4, 8, 12 | Week 8 | -28.17 units on scale |
| Etanercept | Change From Baseline in the Bath Ankylosing Spondylitis-Global Score (BAS-G) at Weeks 2, 4, 8, 12 | Week 12 | -29.78 units on scale |
| Placebo | Change From Baseline in the Bath Ankylosing Spondylitis-Global Score (BAS-G) at Weeks 2, 4, 8, 12 | Week 12 | -16.12 units on scale |
| Placebo | Change From Baseline in the Bath Ankylosing Spondylitis-Global Score (BAS-G) at Weeks 2, 4, 8, 12 | Week 2 | -14.64 units on scale |
| Placebo | Change From Baseline in the Bath Ankylosing Spondylitis-Global Score (BAS-G) at Weeks 2, 4, 8, 12 | Week 8 | -18.27 units on scale |
| Placebo | Change From Baseline in the Bath Ankylosing Spondylitis-Global Score (BAS-G) at Weeks 2, 4, 8, 12 | Week 4 | -14.99 units on scale |
Comparison: 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.p-value: 0.85795% CI: [-8.88, 10.67]ANCOVA
Comparison: 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.p-value: 0.30495% CI: [-14.88, 4.67]ANCOVA
Comparison: 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.p-value: 0.04795% CI: [-19.68, -0.13]ANCOVA
Comparison: 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.p-value: 0.00795% CI: [-23.43, -3.88]ANCOVA
Secondary
Change From Baseline in the Chest Expansion Test at Weeks 14, 18, 24
Measurement and remeasurement of standing maximal inspiration; chest circumference at nipple line or at 4th intercostal space in centimeters (cm).
Time frame: Week 14, Week 18, Week 24
Population: Open-label population; LOCF.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Etanercept | Change From Baseline in the Chest Expansion Test at Weeks 14, 18, 24 | Week 14 | 0.26 centimeters |
| Etanercept | Change From Baseline in the Chest Expansion Test at Weeks 14, 18, 24 | Week 18 | 0.22 centimeters |
| Etanercept | Change From Baseline in the Chest Expansion Test at Weeks 14, 18, 24 | Week 24 | 0.46 centimeters |
| Placebo | Change From Baseline in the Chest Expansion Test at Weeks 14, 18, 24 | Week 14 | 0.22 centimeters |
| Placebo | Change From Baseline in the Chest Expansion Test at Weeks 14, 18, 24 | Week 18 | 0.33 centimeters |
| Placebo | Change From Baseline in the Chest Expansion Test at Weeks 14, 18, 24 | Week 24 | 0.44 centimeters |
Secondary
Change From Baseline in the Chest Expansion Test at Weeks 2, 4, 8, 12
Measurement and remeasurement of standing maximal inspiration; chest circumference at nipple line or at 4th intercostal space in centimeters.
Time frame: Week 2, Week 4, Week 8, Week 12
Population: mITT; LOCF. N=number of subjects with evaluable data.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Etanercept | Change From Baseline in the Chest Expansion Test at Weeks 2, 4, 8, 12 | Week 2 | 0.17 centimeters |
| Etanercept | Change From Baseline in the Chest Expansion Test at Weeks 2, 4, 8, 12 | Week 4 | 0.09 centimeters |
| Etanercept | Change From Baseline in the Chest Expansion Test at Weeks 2, 4, 8, 12 | Week 8 | 0.43 centimeters |
| Etanercept | Change From Baseline in the Chest Expansion Test at Weeks 2, 4, 8, 12 | Week 12 | 0.39 centimeters |
| Placebo | Change From Baseline in the Chest Expansion Test at Weeks 2, 4, 8, 12 | Week 12 | 0.33 centimeters |
| Placebo | Change From Baseline in the Chest Expansion Test at Weeks 2, 4, 8, 12 | Week 2 | 0.10 centimeters |
| Placebo | Change From Baseline in the Chest Expansion Test at Weeks 2, 4, 8, 12 | Week 8 | 0.23 centimeters |
| Placebo | Change From Baseline in the Chest Expansion Test at Weeks 2, 4, 8, 12 | Week 4 | 0.19 centimeters |
Comparison: 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.p-value: 0.62595% CI: [-0.5, 0.3]ANCOVA
Comparison: 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.p-value: 0.74495% CI: [-0.34, 0.47]ANCOVA
Comparison: 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.p-value: 0.32595% CI: [-0.2, 0.6]ANCOVA
Comparison: 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.p-value: 0.7695% CI: [-0.34, 0.46]ANCOVA
Secondary
Change From Baseline in Total Back Pain at Weeks 14, 18, 24
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
Population: Open-label population; LOCF.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Etanercept | Change From Baseline in Total Back Pain at Weeks 14, 18, 24 | Week 14 | -35.21 units on scale |
| Etanercept | Change From Baseline in Total Back Pain at Weeks 14, 18, 24 | Week 18 | -40.02 units on scale |
| Etanercept | Change From Baseline in Total Back Pain at Weeks 14, 18, 24 | Week 24 | -44.50 units on scale |
| Placebo | Change From Baseline in Total Back Pain at Weeks 14, 18, 24 | Week 14 | -30.29 units on scale |
| Placebo | Change From Baseline in Total Back Pain at Weeks 14, 18, 24 | Week 18 | -31.19 units on scale |
| Placebo | Change From Baseline in Total Back Pain at Weeks 14, 18, 24 | Week 24 | -32.27 units on scale |
Secondary
Change From Baseline in Total Back Pain at Weeks 2, 4, 8, 12
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
Population: mITT; LOCF.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Etanercept | Change From Baseline in Total Back Pain at Weeks 2, 4, 8, 12 | Week 2 | -15.37 units on scale |
| Etanercept | Change From Baseline in Total Back Pain at Weeks 2, 4, 8, 12 | Week 4 | -18.93 units on scale |
| Etanercept | Change From Baseline in Total Back Pain at Weeks 2, 4, 8, 12 | Week 8 | -28.24 units on scale |
| Etanercept | Change From Baseline in Total Back Pain at Weeks 2, 4, 8, 12 | Week 12 | -29.18 units on scale |
| Placebo | Change From Baseline in Total Back Pain at Weeks 2, 4, 8, 12 | Week 12 | -14.93 units on scale |
| Placebo | Change From Baseline in Total Back Pain at Weeks 2, 4, 8, 12 | Week 2 | -11.80 units on scale |
| Placebo | Change From Baseline in Total Back Pain at Weeks 2, 4, 8, 12 | Week 8 | -15.78 units on scale |
| Placebo | Change From Baseline in Total Back Pain at Weeks 2, 4, 8, 12 | Week 4 | -14.36 units on scale |
Comparison: 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.p-value: 0.51195% CI: [-14.31, 7.17]ANCOVA
Comparison: 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.p-value: 0.40195% CI: [-15.31, 6.17]ANCOVA
Comparison: 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.p-value: 0.02395% CI: [-23.19, -1.71]ANCOVA
Comparison: 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.p-value: 0.0195% CI: [-24.99, -3.51]ANCOVA
Secondary
Change From Baseline to Week 12 in Forced Vital Capacity (FVC), Vital Capacity (VC), and Forced Expiratory Volume in One Second (FEV1)
Time frame: Baseline, Week 12
Population: mITT. In the case of missing data, no replacement or imputation method was performed.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Etanercept | Change From Baseline to Week 12 in Forced Vital Capacity (FVC), Vital Capacity (VC), and Forced Expiratory Volume in One Second (FEV1) | Vital Capacity | 0.14 liters |
| Etanercept | Change From Baseline to Week 12 in Forced Vital Capacity (FVC), Vital Capacity (VC), and Forced Expiratory Volume in One Second (FEV1) | Forced Vital Capacity (FVC) | 0.16 liters |
| Etanercept | Change From Baseline to Week 12 in Forced Vital Capacity (FVC), Vital Capacity (VC), and Forced Expiratory Volume in One Second (FEV1) | Forced Expiratory Volume in 1 Second | 0.05 liters |
| Placebo | Change From Baseline to Week 12 in Forced Vital Capacity (FVC), Vital Capacity (VC), and Forced Expiratory Volume in One Second (FEV1) | Vital Capacity | -0.05 liters |
| Placebo | Change From Baseline to Week 12 in Forced Vital Capacity (FVC), Vital Capacity (VC), and Forced Expiratory Volume in One Second (FEV1) | Forced Vital Capacity (FVC) | -0.02 liters |
| Placebo | Change From Baseline to Week 12 in Forced Vital Capacity (FVC), Vital Capacity (VC), and Forced Expiratory Volume in One Second (FEV1) | Forced Expiratory Volume in 1 Second | -0.02 liters |
Comparison: Vital Capacity: Analysis of covariance (ANCOVA) with treatment as a factor and baseline value as a covariate.p-value: 0.00395% CI: [0.06, 0.31]ANCOVA
Comparison: Forced Vital Capacity: Analysis of covariance (ANCOVA) with treatment as a factor and baseline value as a covariate.p-value: 0.00695% CI: [0.05, 0.31]ANCOVA
Comparison: Forced Expitatory Volume in 1 second: Analysis of covariance (ANCOVA) with treatment as a factor and baseline value as a covariate.p-value: 0.20595% CI: [-0.04, 0.17]ANCOVA
Secondary
Change From Baseline to Week 12 in Ratio Forced Expitatory Volume in One Second (FEV1)/Forced Vital Capacity (FVC) (%)
Time frame: Baseline, Week 12
Population: mITT; N=number of subjects with evaluable data. In the case of missing data, no replacement or imputation method was performed.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Etanercept | Change From Baseline to Week 12 in Ratio Forced Expitatory Volume in One Second (FEV1)/Forced Vital Capacity (FVC) (%) | -2.49 percent |
| Placebo | Change From Baseline to Week 12 in Ratio Forced Expitatory Volume in One Second (FEV1)/Forced Vital Capacity (FVC) (%) | 0.10 percent |
Comparison: Analysis oaf covariance (ANCOVA) with treatment as a factor and baseline value as a covariate.p-value: 0.0395% CI: [-4.93, -0.26]ANCOVA
Secondary
Normalized Net Incremental Area Under the Curve (AUC) for Bath Ankylosing Spondylitis-Global Score (BAS-G) Visual Analog Scale Between Baseline and Week 12
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
Population: mITT; LOCF. N=number of subjects with evaluable data.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Etanercept | Normalized Net Incremental Area Under the Curve (AUC) for Bath Ankylosing Spondylitis-Global Score (BAS-G) Visual Analog Scale Between Baseline and Week 12 | -21.36 millimeters |
| Placebo | Normalized Net Incremental Area Under the Curve (AUC) for Bath Ankylosing Spondylitis-Global Score (BAS-G) Visual Analog Scale Between Baseline and Week 12 | -15.43 millimeters |
Comparison: Analysis of covariance (ANCOVA) with treatment as a factor and baseline value as a covariate.p-value: 0.13995% CI: [-13.84, 1.96]ANCOVA
Secondary
Normalized Net Incremental Area Under the Curve (AUC) for C-reactive Protein Between Baseline and Week 12
Normalized net incremental area under the curve (AUC) = area between baseline and the C-reactive Protein 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
Population: mITT; LOCF.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Etanercept | Normalized Net Incremental Area Under the Curve (AUC) for C-reactive Protein Between Baseline and Week 12 | -14.41 milligrams per liter |
| Placebo | Normalized Net Incremental Area Under the Curve (AUC) for C-reactive Protein Between Baseline and Week 12 | -1.17 milligrams per liter |
Comparison: Analysis of covariance (ANCOVA), with treatment as a factor and baseline value as a covariate.p-value: <0.000195% CI: [-18.23, -8.25]ANCOVA
Secondary
Normalized Net Incremental Area Under the Curve (AUC) for Erythtocyte Sedimentation Rate Between Baseline and Week 12
Normalized net incremental area under the curve (AUC) = area between baseline and the Erythrocyte Sedimentation Rate 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
Population: mITT; LOCF. N=number of subjects with evaluable data.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Etanercept | Normalized Net Incremental Area Under the Curve (AUC) for Erythtocyte Sedimentation Rate Between Baseline and Week 12 | -16.18 millimeters per hour |
| Placebo | Normalized Net Incremental Area Under the Curve (AUC) for Erythtocyte Sedimentation Rate Between Baseline and Week 12 | -1.45 millimeters per hour |
Comparison: Analysis of covariance (ANCOVA)with treatment as a factor and baseline vlue as a covariate.p-value: <0.000195% CI: [-19.44, -10.03]ANCOVA
Secondary
Normalized Net Incremental Area Under the Curve (AUC) for Nocturnal Back Pain Between Baseline and Week 12
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
Population: mITT; LOCF. N=number of subjects with evaluable data.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Etanercept | Normalized Net Incremental Area Under the Curve (AUC) for Nocturnal Back Pain Between Baseline and Week 12 | -23.23 millimeters |
| Placebo | Normalized Net Incremental Area Under the Curve (AUC) for Nocturnal Back Pain Between Baseline and Week 12 | -13.64 millimeters |
Comparison: Analysis of covariance (ANCOVA) with treatment as a factor and baseline value as a covariate.p-value: 0.03995% CI: [-18.69, -0.49]ANCOVA
Secondary
Normalized Net Incremental Area Under the Curve (AUC) for Patient Global Assessment (PGA) Between Baseline and Week 12
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
Population: mITT; LOCF. N = number of subjects with evaluable data.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Etanercept | Normalized Net Incremental Area Under the Curve (AUC) for Patient Global Assessment (PGA) Between Baseline and Week 12 | -20.35 millimeters |
| Placebo | Normalized Net Incremental Area Under the Curve (AUC) for Patient Global Assessment (PGA) Between Baseline and Week 12 | -10.39 millimeters |
Comparison: Analysis of covariance (ANCOVA) with treatment as a factor and baseline value as a covariate.p-value: 0.01895% CI: [-18.19, -1.72]ANCOVA
Secondary
Normalized Net Incremental Area Under the Curve (AUC) for Physician Global Assessment (PGA) Between Baseline and Week 12
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
Population: mITT; LOCF. N= number of subjects with evaluable data.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Etanercept | Normalized Net Incremental Area Under the Curve (AUC) for Physician Global Assessment (PGA) Between Baseline and Week 12 | -24.14 millimeters |
| Placebo | Normalized Net Incremental Area Under the Curve (AUC) for Physician Global Assessment (PGA) Between Baseline and Week 12 | -13.15 millimeters |
Comparison: Analysis of covariance (ANCOVA) with treatment as a factor and baseline value as a covariate.p-value: 0.00295% CI: [-17.7, -4.28]ANCOVA
Secondary
Normalized Net Incremental Area Under the Curve (AUC) for the Bath Ankylosing Spondylitis Functional Index (BASFI) Between Baseline and Week 12
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
Population: mITT; LOCF. N=number of subjects with evaluable data.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Etanercept | Normalized Net Incremental Area Under the Curve (AUC) for the Bath Ankylosing Spondylitis Functional Index (BASFI) Between Baseline and Week 12 | -14.59 millimeters |
| Placebo | Normalized Net Incremental Area Under the Curve (AUC) for the Bath Ankylosing Spondylitis Functional Index (BASFI) Between Baseline and Week 12 | -9.34 millimeters |
Comparison: Analysis of covariance (ANCOVA) with treatment as a factor and baseline as a covariate.p-value: 0.12795% CI: [-12.03, 1.53]ANCOVA
Secondary
Normalized Net Incremental Area Under the Curve (AUC) for the Bath Ankylosing Spondylitis Metrology Index (BASMI) Between Baseline and Week 12
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
Population: mITT; LOCF.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Etanercept | Normalized Net Incremental Area Under the Curve (AUC) for the Bath Ankylosing Spondylitis Metrology Index (BASMI) Between Baseline and Week 12 | -0.41 millimeters |
| Placebo | Normalized Net Incremental Area Under the Curve (AUC) for the Bath Ankylosing Spondylitis Metrology Index (BASMI) Between Baseline and Week 12 | -0.18 millimeters |
Comparison: Analysis of covariance (ANCOVA) with treatment as a factor and baseline value as covariate.p-value: 0.03595% CI: [-0.45, -0.02]ANCOVA
Secondary
Normalized Net Incremental Area Under the Curve (AUC) for the Chest Expansion Test Between Baseline and Week 12
Normalized net incremental area under the curve (AUC) = area between baseline and the Chest Expansion Test 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
Population: mITT; LOCF. N=number of subjects with evaluable data.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Etanercept | Normalized Net Incremental Area Under the Curve (AUC) for the Chest Expansion Test Between Baseline and Week 12 | 0.26 centimeters |
| Placebo | Normalized Net Incremental Area Under the Curve (AUC) for the Chest Expansion Test Between Baseline and Week 12 | 0.19 centimeters |
Comparison: Analysis of covariance (ANCOVA) with treatment as a factor and baseline value as a covariate.p-value: 0.61395% CI: [-0.22, 0.37]ANCOVA
Secondary
Normalized Net Incremental Area Under the Curve (AUC) for Total Back Pain Between Baseline and Week 12
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
Population: mITT; LOCF. N=number of subjects with evaluable data.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Etanercept | Normalized Net Incremental Area Under the Curve (AUC) for Total Back Pain Between Baseline and Week 12 | -21.73 millimeters |
| Placebo | Normalized Net Incremental Area Under the Curve (AUC) for Total Back Pain Between Baseline and Week 12 | -13.24 millimeters |
Comparison: Analysis of covariance (ANCOVA) with treatment as a factor and baseline value as a covariate.p-value: 0.07195% CI: [-17.73, 0.75]ANCOVA
Secondary
Percent of Subjects Acheiving Assessment Ankylosing Spondylitis (ASAS) 20 at Weeks 14, 18, 24
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
Population: Open-label population: all subjects who received at least 1 dose of open test article (Etanercept). LOCF.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etanercept | Percent of Subjects Acheiving Assessment Ankylosing Spondylitis (ASAS) 20 at Weeks 14, 18, 24 | Week 18 | 71.05 percent of participants |
| Etanercept | Percent of Subjects Acheiving Assessment Ankylosing Spondylitis (ASAS) 20 at Weeks 14, 18, 24 | Week 14 | 71.05 percent of participants |
| Etanercept | Percent of Subjects Acheiving Assessment Ankylosing Spondylitis (ASAS) 20 at Weeks 14, 18, 24 | Week 24 | 84.21 percent of participants |
| Placebo | Percent of Subjects Acheiving Assessment Ankylosing Spondylitis (ASAS) 20 at Weeks 14, 18, 24 | Week 18 | 64.10 percent of participants |
| Placebo | Percent of Subjects Acheiving Assessment Ankylosing Spondylitis (ASAS) 20 at Weeks 14, 18, 24 | Week 14 | 53.85 percent of participants |
| Placebo | Percent of Subjects Acheiving Assessment Ankylosing Spondylitis (ASAS) 20 at Weeks 14, 18, 24 | Week 24 | 66.67 percent of participants |
Secondary
Percent of Subjects Achieiving Assessment Ankylosing Spondylitis (ASAS) 70 at Weeks 14, 18, 24
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
Population: Open-label population; LOCF.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etanercept | Percent of Subjects Achieiving Assessment Ankylosing Spondylitis (ASAS) 70 at Weeks 14, 18, 24 | Week 14 | 31.58 percent of participants |
| Etanercept | Percent of Subjects Achieiving Assessment Ankylosing Spondylitis (ASAS) 70 at Weeks 14, 18, 24 | Week 18 | 31.58 percent of participants |
| Etanercept | Percent of Subjects Achieiving Assessment Ankylosing Spondylitis (ASAS) 70 at Weeks 14, 18, 24 | Week 24 | 36.84 percent of participants |
| Placebo | Percent of Subjects Achieiving Assessment Ankylosing Spondylitis (ASAS) 70 at Weeks 14, 18, 24 | Week 14 | 33.33 percent of participants |
| Placebo | Percent of Subjects Achieiving Assessment Ankylosing Spondylitis (ASAS) 70 at Weeks 14, 18, 24 | Week 18 | 30.77 percent of participants |
| Placebo | Percent of Subjects Achieiving Assessment Ankylosing Spondylitis (ASAS) 70 at Weeks 14, 18, 24 | Week 24 | 35.90 percent of participants |
Secondary
Percent of Subjects Achieving Assessment Ankylosing Spondylitis (ASAS) 20 at Weeks 2, 4, 8, 12
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
Population: mITT; LOCF.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etanercept | Percent of Subjects Achieving Assessment Ankylosing Spondylitis (ASAS) 20 at Weeks 2, 4, 8, 12 | Week 2 | 30.77 percent of participants |
| Etanercept | Percent of Subjects Achieving Assessment Ankylosing Spondylitis (ASAS) 20 at Weeks 2, 4, 8, 12 | Week 4 | 41.03 percent of participants |
| Etanercept | Percent of Subjects Achieving Assessment Ankylosing Spondylitis (ASAS) 20 at Weeks 2, 4, 8, 12 | Week 8 | 64.10 percent of participants |
| Etanercept | Percent of Subjects Achieving Assessment Ankylosing Spondylitis (ASAS) 20 at Weeks 2, 4, 8, 12 | Week 12 | 66.67 percent of participants |
| Placebo | Percent of Subjects Achieving Assessment Ankylosing Spondylitis (ASAS) 20 at Weeks 2, 4, 8, 12 | Week 12 | 32.56 percent of participants |
| Placebo | Percent of Subjects Achieving Assessment Ankylosing Spondylitis (ASAS) 20 at Weeks 2, 4, 8, 12 | Week 2 | 20.93 percent of participants |
| Placebo | Percent of Subjects Achieving Assessment Ankylosing Spondylitis (ASAS) 20 at Weeks 2, 4, 8, 12 | Week 8 | 27.91 percent of participants |
| Placebo | Percent of Subjects Achieving Assessment Ankylosing Spondylitis (ASAS) 20 at Weeks 2, 4, 8, 12 | Week 4 | 30.23 percent of participants |
Comparison: 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.p-value: 0.3195% CI: [0.62, 4.57]GEE model
Comparison: 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.p-value: 0.30995% CI: [0.65, 3.99]GEE model
Comparison: 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.p-value: 0.00195% CI: [1.81, 11.74]GEE model
Comparison: 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.p-value: 0.00395% CI: [1.65, 10.42]GEE model
Secondary
Percent of Subjects Achieving Assessment Ankylosing Spondylitis (ASAS) 50 at Weeks 14, 18, 24
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
Population: Open-label population; LOCF.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etanercept | Percent of Subjects Achieving Assessment Ankylosing Spondylitis (ASAS) 50 at Weeks 14, 18, 24 | Week 14 | 44.74 percent of particpants |
| Etanercept | Percent of Subjects Achieving Assessment Ankylosing Spondylitis (ASAS) 50 at Weeks 14, 18, 24 | Week 18 | 50.00 percent of particpants |
| Etanercept | Percent of Subjects Achieving Assessment Ankylosing Spondylitis (ASAS) 50 at Weeks 14, 18, 24 | Week 24 | 60.53 percent of particpants |
| Placebo | Percent of Subjects Achieving Assessment Ankylosing Spondylitis (ASAS) 50 at Weeks 14, 18, 24 | Week 18 | 48.72 percent of particpants |
| Placebo | Percent of Subjects Achieving Assessment Ankylosing Spondylitis (ASAS) 50 at Weeks 14, 18, 24 | Week 14 | 43.59 percent of particpants |
| Placebo | Percent of Subjects Achieving Assessment Ankylosing Spondylitis (ASAS) 50 at Weeks 14, 18, 24 | Week 24 | 51.28 percent of particpants |
Secondary
Percent of Subjects Achieving Assessment Ankylosing Spondylitis (ASAS) 50 at Weeks 2, 4, 8, 12
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
Population: mITT; LOCF.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etanercept | Percent of Subjects Achieving Assessment Ankylosing Spondylitis (ASAS) 50 at Weeks 2, 4, 8, 12 | Week 2 | 17.95 percent of participants |
| Etanercept | Percent of Subjects Achieving Assessment Ankylosing Spondylitis (ASAS) 50 at Weeks 2, 4, 8, 12 | Week 4 | 23.08 percent of participants |
| Etanercept | Percent of Subjects Achieving Assessment Ankylosing Spondylitis (ASAS) 50 at Weeks 2, 4, 8, 12 | Week 8 | 35.90 percent of participants |
| Etanercept | Percent of Subjects Achieving Assessment Ankylosing Spondylitis (ASAS) 50 at Weeks 2, 4, 8, 12 | Week 12 | 38.46 percent of participants |
| Placebo | Percent of Subjects Achieving Assessment Ankylosing Spondylitis (ASAS) 50 at Weeks 2, 4, 8, 12 | Week 12 | 13.95 percent of participants |
| Placebo | Percent of Subjects Achieving Assessment Ankylosing Spondylitis (ASAS) 50 at Weeks 2, 4, 8, 12 | Week 2 | 9.30 percent of participants |
| Placebo | Percent of Subjects Achieving Assessment Ankylosing Spondylitis (ASAS) 50 at Weeks 2, 4, 8, 12 | Week 8 | 16.28 percent of participants |
| Placebo | Percent of Subjects Achieving Assessment Ankylosing Spondylitis (ASAS) 50 at Weeks 2, 4, 8, 12 | Week 4 | 16.28 percent of participants |
Comparison: 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.p-value: 0.25995% CI: [0.57, 7.94]GEE model
Comparison: 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.p-value: 0.4495% CI: [0.51, 4.64]GEE model
Comparison: 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.p-value: 0.04695% CI: [1.02, 8.16]GEE model
Comparison: 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.p-value: 0.01495% CI: [1.31, 11.32]GEE model
Secondary
Percent of Subjects Achieving Assessment Ankylosing Spondylitis (ASAS) 70 at Weeks 2, 4, 8, 12
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
Population: mITT; LOCF.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etanercept | Percent of Subjects Achieving Assessment Ankylosing Spondylitis (ASAS) 70 at Weeks 2, 4, 8, 12 | Week 2 | 12.82 percent of participants |
| Etanercept | Percent of Subjects Achieving Assessment Ankylosing Spondylitis (ASAS) 70 at Weeks 2, 4, 8, 12 | Week 4 | 17.95 percent of participants |
| Etanercept | Percent of Subjects Achieving Assessment Ankylosing Spondylitis (ASAS) 70 at Weeks 2, 4, 8, 12 | Week 8 | 15.38 percent of participants |
| Etanercept | Percent of Subjects Achieving Assessment Ankylosing Spondylitis (ASAS) 70 at Weeks 2, 4, 8, 12 | Week 12 | 25.64 percent of participants |
| Placebo | Percent of Subjects Achieving Assessment Ankylosing Spondylitis (ASAS) 70 at Weeks 2, 4, 8, 12 | Week 12 | 9.30 percent of participants |
| Placebo | Percent of Subjects Achieving Assessment Ankylosing Spondylitis (ASAS) 70 at Weeks 2, 4, 8, 12 | Week 2 | 4.65 percent of participants |
| Placebo | Percent of Subjects Achieving Assessment Ankylosing Spondylitis (ASAS) 70 at Weeks 2, 4, 8, 12 | Week 8 | 4.65 percent of participants |
| Placebo | Percent of Subjects Achieving Assessment Ankylosing Spondylitis (ASAS) 70 at Weeks 2, 4, 8, 12 | Week 4 | 4.65 percent of participants |
Comparison: 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.p-value: 0.20495% CI: [0.55, 16.53]GEE model
Comparison: 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.p-value: 0.07395% CI: [0.87, 23.07]GEE model
Comparison: 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.p-value: 0.12195% CI: [0.71, 19.69]GEE model
Comparison: 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.p-value: 0.05895% CI: [0.96, 11.8]GEE model
Secondary
Percent of Subjects Achieving Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 Response
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
Population: mITT; LOCF.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etanercept | Percent of Subjects Achieving Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 Response | Week 4 | 28.21 percent of participants |
| Etanercept | Percent of Subjects Achieving Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 Response | Week 2 | 23.08 percent of participants |
| Etanercept | Percent of Subjects Achieving Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 Response | Week 8 | 41.03 percent of participants |
| Etanercept | Percent of Subjects Achieving Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 Response | Week 12 | 46.15 percent of participants |
| Placebo | Percent of Subjects Achieving Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 Response | Week 12 | 23.26 percent of participants |
| Placebo | Percent of Subjects Achieving Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 Response | Week 8 | 23.26 percent of participants |
| Placebo | Percent of Subjects Achieving Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 Response | Week 2 | 9.30 percent of participants |
| Placebo | Percent of Subjects Achieving Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 Response | Week 4 | 16.28 percent of participants |
Comparison: 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.p-value: 0.09895% CI: [0.82, 10.42]GEE model
Comparison: 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.p-value: 0.19795% CI: [0.69, 5.88]GEE model
Comparison: 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.p-value: 0.08795% CI: [0.89, 5.95]GEE model
Comparison: 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.p-value: 0.03195% CI: [1.1, 7.29]GEE model
Secondary
Percent of Subjects Achieving Partial Remission at Weeks 14, 18, 24
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
Population: Open-label population; LOCF.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etanercept | Percent of Subjects Achieving Partial Remission at Weeks 14, 18, 24 | Week 14 | 28.95 percent of participants |
| Etanercept | Percent of Subjects Achieving Partial Remission at Weeks 14, 18, 24 | Week 18 | 31.58 percent of participants |
| Etanercept | Percent of Subjects Achieving Partial Remission at Weeks 14, 18, 24 | Week 24 | 28.95 percent of participants |
| Placebo | Percent of Subjects Achieving Partial Remission at Weeks 14, 18, 24 | Week 14 | 23.08 percent of participants |
| Placebo | Percent of Subjects Achieving Partial Remission at Weeks 14, 18, 24 | Week 18 | 25.64 percent of participants |
| Placebo | Percent of Subjects Achieving Partial Remission at Weeks 14, 18, 24 | Week 24 | 23.08 percent of participants |
Secondary
Percent of Subjects Achieving Partial Remission at Weeks 2, 4, 8, 12
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
Population: mITT; LOCF.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etanercept | Percent of Subjects Achieving Partial Remission at Weeks 2, 4, 8, 12 | Week 2 | 7.69 percent of participants |
| Etanercept | Percent of Subjects Achieving Partial Remission at Weeks 2, 4, 8, 12 | Week 4 | 10.26 percent of participants |
| Etanercept | Percent of Subjects Achieving Partial Remission at Weeks 2, 4, 8, 12 | Week 8 | 17.95 percent of participants |
| Etanercept | Percent of Subjects Achieving Partial Remission at Weeks 2, 4, 8, 12 | Week 12 | 17.95 percent of participants |
| Placebo | Percent of Subjects Achieving Partial Remission at Weeks 2, 4, 8, 12 | Week 12 | 4.65 percent of participants |
| Placebo | Percent of Subjects Achieving Partial Remission at Weeks 2, 4, 8, 12 | Week 2 | 2.33 percent of participants |
| Placebo | Percent of Subjects Achieving Partial Remission at Weeks 2, 4, 8, 12 | Week 8 | 4.65 percent of participants |
| Placebo | Percent of Subjects Achieving Partial Remission at Weeks 2, 4, 8, 12 | Week 4 | 2.33 percent of participants |
Comparison: 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.p-value: 0.28795% CI: [0.35, 35.14]GEE model
Comparison: 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.p-value: 0.16995% CI: [0.51, 44.94]GEE model
Comparison: 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.p-value: 0.07395% CI: [0.87, 23.07]GEE model
Comparison: 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.p-value: 0.07395% CI: [0.87, 23.07]GEE model
Secondary
Percent of Subjects With Minimum Clinially Important Improvement (MCII) at Weeks 14, 18, 24
Subjects were asked how their pain had been during the last 48 hours compared to baseline. Those subjects that reported improvement assessed how important this improvement was to them; range: very important, moderately important, slightly important, or not at all important. Binary response options: 1=improved very important, or improved moderately important; 2=slightly important, not at all important, no change, or worse-more pain.
Time frame: Week 14, Week 18, Week 24
Population: Open-label population; in the case of missing data, no replacement or imputation method was performed. Abbreviation: Mod = moderately.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etanercept | Percent of Subjects With Minimum Clinially Important Improvement (MCII) at Weeks 14, 18, 24 | Week 14: Improvement Very/Mod. Important | 77.78 percent of participants |
| Etanercept | Percent of Subjects With Minimum Clinially Important Improvement (MCII) at Weeks 14, 18, 24 | Week 14: Improvement Slightly/Not Important | 22.22 percent of participants |
| Etanercept | Percent of Subjects With Minimum Clinially Important Improvement (MCII) at Weeks 14, 18, 24 | Week 18: Improvement Very/Mod. Important | 94.12 percent of participants |
| Etanercept | Percent of Subjects With Minimum Clinially Important Improvement (MCII) at Weeks 14, 18, 24 | Week 18: Improvement Slightly/Not Important | 5.88 percent of participants |
| Etanercept | Percent of Subjects With Minimum Clinially Important Improvement (MCII) at Weeks 14, 18, 24 | Week 24: Improvement Very/Mod. Important | 91.43 percent of participants |
| Etanercept | Percent of Subjects With Minimum Clinially Important Improvement (MCII) at Weeks 14, 18, 24 | Week 24: Improvement Slightly/Not Important | 8.57 percent of participants |
| Placebo | Percent of Subjects With Minimum Clinially Important Improvement (MCII) at Weeks 14, 18, 24 | Week 24: Improvement Very/Mod. Important | 86.11 percent of participants |
| Placebo | Percent of Subjects With Minimum Clinially Important Improvement (MCII) at Weeks 14, 18, 24 | Week 14: Improvement Very/Mod. Important | 77.14 percent of participants |
| Placebo | Percent of Subjects With Minimum Clinially Important Improvement (MCII) at Weeks 14, 18, 24 | Week 18: Improvement Slightly/Not Important | 21.62 percent of participants |
| Placebo | Percent of Subjects With Minimum Clinially Important Improvement (MCII) at Weeks 14, 18, 24 | Week 14: Improvement Slightly/Not Important | 22.86 percent of participants |
| Placebo | Percent of Subjects With Minimum Clinially Important Improvement (MCII) at Weeks 14, 18, 24 | Week 24: Improvement Slightly/Not Important | 13.89 percent of participants |
| Placebo | Percent of Subjects With Minimum Clinially Important Improvement (MCII) at Weeks 14, 18, 24 | Week 18: Improvement Very/Mod. Important | 78.38 percent of participants |
Secondary
Percent of Subjects With Minimum Clinically Important Improvement (MCII) in Pain Rating at Weeks 2, 4, 8, 12
Subjects were asked how their pain had been during the last 48 hours compared to baseline. Those subjects that reported improvement assessed how important this improvement was to them; range: very important, moderately important, slightly important, or not at all important. Binary response options: 1=improved very important, or improved moderately important; 2=slightly important, not at all important, no change, or worse-more pain.
Time frame: Week 2, Week 4, Week 8, Week 12
Population: mITT; in the case of missing data, no replacement or imputation method was performed. Abbreviation: Mod = moderately.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etanercept | Percent of Subjects With Minimum Clinically Important Improvement (MCII) in Pain Rating at Weeks 2, 4, 8, 12 | Week 2: Improvement Very/Mod. Important | 50.00 percent of participants |
| Etanercept | Percent of Subjects With Minimum Clinically Important Improvement (MCII) in Pain Rating at Weeks 2, 4, 8, 12 | Week 2 : Improvement Slightly/Not Important | 50.00 percent of participants |
| Etanercept | Percent of Subjects With Minimum Clinically Important Improvement (MCII) in Pain Rating at Weeks 2, 4, 8, 12 | Week 4: Improvement Very/Mod. Important | 52.63 percent of participants |
| Etanercept | Percent of Subjects With Minimum Clinically Important Improvement (MCII) in Pain Rating at Weeks 2, 4, 8, 12 | Week 4: Improvement Slightly/Not Important | 47.37 percent of participants |
| Etanercept | Percent of Subjects With Minimum Clinically Important Improvement (MCII) in Pain Rating at Weeks 2, 4, 8, 12 | Week 8: Improvement Very/Mod. Important | 75.00 percent of participants |
| Etanercept | Percent of Subjects With Minimum Clinically Important Improvement (MCII) in Pain Rating at Weeks 2, 4, 8, 12 | Week 8: Improvement Slightly/Not Important | 25.00 percent of participants |
| Etanercept | Percent of Subjects With Minimum Clinically Important Improvement (MCII) in Pain Rating at Weeks 2, 4, 8, 12 | Week 12: Improvement Very/Mod. Important | 63.16 percent of participants |
| Etanercept | Percent of Subjects With Minimum Clinically Important Improvement (MCII) in Pain Rating at Weeks 2, 4, 8, 12 | Week 12: Improvement Slightly/Not Important | 36.84 percent of participants |
| Placebo | Percent of Subjects With Minimum Clinically Important Improvement (MCII) in Pain Rating at Weeks 2, 4, 8, 12 | Week 12: Improvement Slightly/Not Important | 62.16 percent of participants |
| Placebo | Percent of Subjects With Minimum Clinically Important Improvement (MCII) in Pain Rating at Weeks 2, 4, 8, 12 | Week 2: Improvement Very/Mod. Important | 20.00 percent of participants |
| Placebo | Percent of Subjects With Minimum Clinically Important Improvement (MCII) in Pain Rating at Weeks 2, 4, 8, 12 | Week 8: Improvement Very/Mod. Important | 35.90 percent of participants |
| Placebo | Percent of Subjects With Minimum Clinically Important Improvement (MCII) in Pain Rating at Weeks 2, 4, 8, 12 | Week 2 : Improvement Slightly/Not Important | 80.00 percent of participants |
| Placebo | Percent of Subjects With Minimum Clinically Important Improvement (MCII) in Pain Rating at Weeks 2, 4, 8, 12 | Week 12: Improvement Very/Mod. Important | 37.84 percent of participants |
| Placebo | Percent of Subjects With Minimum Clinically Important Improvement (MCII) in Pain Rating at Weeks 2, 4, 8, 12 | Week 4: Improvement Very/Mod. Important | 30.95 percent of participants |
| Placebo | Percent of Subjects With Minimum Clinically Important Improvement (MCII) in Pain Rating at Weeks 2, 4, 8, 12 | Week 8: Improvement Slightly/Not Important | 64.10 percent of participants |
| Placebo | Percent of Subjects With Minimum Clinically Important Improvement (MCII) in Pain Rating at Weeks 2, 4, 8, 12 | Week 4: Improvement Slightly/Not Important | 69.05 percent of participants |
Comparison: Week 2: Generalized estimating equation (GEE) model, using a logit link, binomial distribution and an auto-regressive correlation structure, with treatment groups, visits and their interaction as fixed factors.p-value: 0.00495% CI: [1.64, 12.74]GEE model
Comparison: Week 4: Generalized estimating equation (GEE) model, using a logit link, binomial distribution and an auto-regressive correlation structure, with treatment groups, visits and their interaction as fixed factors.p-value: 0.05495% CI: [0.99, 6.12]GEE model
Comparison: Week 8: Generalized estimating equation (GEE) model, using a logit link, binomial distribution and an auto-regressive correlation structure, with treatment groups, visits and their interaction as fixed factors.p-value: <0.00195% CI: [2.27, 17.31]GEE model
Comparison: Week 12: Generalized estimating equation (GEE) model, using a logit link, binomial distribution and an auto-regressive correlation structure, with treatment groups, visits and their interaction as fixed factors.p-value: 0.02595% CI: [1.14, 7.27]GEE model
Secondary
Percent of Subjects With Normal and Abnormal C-Reactive Protein at Weeks 14, 18, 24
Percent of participants with normal (\<6 milligrams per liter) and abnormal (\>= 6 milligrams per liter) C-Reactive Protein.
Time frame: Week 14, Week 18, Week 24
Population: Open-label population; LOCF.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etanercept | Percent of Subjects With Normal and Abnormal C-Reactive Protein at Weeks 14, 18, 24 | Week 24: Normal | 68.42 percent of participants |
| Etanercept | Percent of Subjects With Normal and Abnormal C-Reactive Protein at Weeks 14, 18, 24 | Week 14: Normal | 60.53 percent of participants |
| Etanercept | Percent of Subjects With Normal and Abnormal C-Reactive Protein at Weeks 14, 18, 24 | Week 18: Normal | 63.16 percent of participants |
| Etanercept | Percent of Subjects With Normal and Abnormal C-Reactive Protein at Weeks 14, 18, 24 | Week 24: Abnormal | 31.58 percent of participants |
| Etanercept | Percent of Subjects With Normal and Abnormal C-Reactive Protein at Weeks 14, 18, 24 | Week 18: Abnormal | 36.84 percent of participants |
| Etanercept | Percent of Subjects With Normal and Abnormal C-Reactive Protein at Weeks 14, 18, 24 | Week 14: Abnormal | 39.47 percent of participants |
| Placebo | Percent of Subjects With Normal and Abnormal C-Reactive Protein at Weeks 14, 18, 24 | Week 18: Abnormal | 33.33 percent of participants |
| Placebo | Percent of Subjects With Normal and Abnormal C-Reactive Protein at Weeks 14, 18, 24 | Week 14: Abnormal | 29.41 percent of participants |
| Placebo | Percent of Subjects With Normal and Abnormal C-Reactive Protein at Weeks 14, 18, 24 | Week 24: Normal | 82.05 percent of participants |
| Placebo | Percent of Subjects With Normal and Abnormal C-Reactive Protein at Weeks 14, 18, 24 | Week 24: Abnormal | 17.95 percent of participants |
| Placebo | Percent of Subjects With Normal and Abnormal C-Reactive Protein at Weeks 14, 18, 24 | Week 14: Normal | 70.59 percent of participants |
| Placebo | Percent of Subjects With Normal and Abnormal C-Reactive Protein at Weeks 14, 18, 24 | Week 18: Normal | 66.67 percent of participants |
Secondary
Percent of Subjects With Patient Acceptable and Unacceptable Symptom State (PASS) at Weeks 14, 18, 24
Percent of subjects reporting acceptable symptom state: acceptance to remain for the rest of their lives with the level of pain they had during the last 48 hours; and unacceptable symptom state: not able to remain for the rest of their lives with the level of pain they had during the last 48 hours. In the case of missing data, subjects who withdrew from the study because of inefficacy or toxicity were considered unacceptable.
Time frame: Week 14, Week 18, Week 24
Population: Open-label population. In the case of missing data, no replacement or imputation method was performed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etanercept | Percent of Subjects With Patient Acceptable and Unacceptable Symptom State (PASS) at Weeks 14, 18, 24 | Week 18: Unacceptable | 25.71 percent of participants |
| Etanercept | Percent of Subjects With Patient Acceptable and Unacceptable Symptom State (PASS) at Weeks 14, 18, 24 | Week 14: Unacceptable | 30.56 percent of participants |
| Etanercept | Percent of Subjects With Patient Acceptable and Unacceptable Symptom State (PASS) at Weeks 14, 18, 24 | Week 24: Acceptable | 77.14 percent of participants |
| Etanercept | Percent of Subjects With Patient Acceptable and Unacceptable Symptom State (PASS) at Weeks 14, 18, 24 | Week 18: Acceptable | 74.29 percent of participants |
| Etanercept | Percent of Subjects With Patient Acceptable and Unacceptable Symptom State (PASS) at Weeks 14, 18, 24 | Week 24: Unacceptable | 22.86 percent of participants |
| Etanercept | Percent of Subjects With Patient Acceptable and Unacceptable Symptom State (PASS) at Weeks 14, 18, 24 | Week 14: Acceptable | 69.44 percent of participants |
| Placebo | Percent of Subjects With Patient Acceptable and Unacceptable Symptom State (PASS) at Weeks 14, 18, 24 | Week 24: Unacceptable | 19.44 percent of participants |
| Placebo | Percent of Subjects With Patient Acceptable and Unacceptable Symptom State (PASS) at Weeks 14, 18, 24 | Week 14: Acceptable | 64.71 percent of participants |
| Placebo | Percent of Subjects With Patient Acceptable and Unacceptable Symptom State (PASS) at Weeks 14, 18, 24 | Week 18: Acceptable | 66.67 percent of participants |
| Placebo | Percent of Subjects With Patient Acceptable and Unacceptable Symptom State (PASS) at Weeks 14, 18, 24 | Week 18: Unacceptable | 33.33 percent of participants |
| Placebo | Percent of Subjects With Patient Acceptable and Unacceptable Symptom State (PASS) at Weeks 14, 18, 24 | Week 24: Acceptable | 80.56 percent of participants |
| Placebo | Percent of Subjects With Patient Acceptable and Unacceptable Symptom State (PASS) at Weeks 14, 18, 24 | Week 14: Unacceptable | 35.29 percent of participants |
Secondary
Percent of Subjects With Patient Acceptable and Unacceptable Symptom State (PASS) at Weeks 2, 4, 8, 12
Percent of subjects reporting acceptable symptom state: acceptance to remain for the rest of their lives with the level of pain they had during the last 48 hours; and unacceptable symptom state: not able to remain for the rest of their lives with the level of pain they had during the last 48 hours. In the case of missing data, subjects who withdrew from the study because of inefficacy or toxicity were considered unacceptable.
Time frame: Week 2, Week 4, Week 8, Week 12
Population: mITT. In the case of missing data, no replacement or imputation method was performed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etanercept | Percent of Subjects With Patient Acceptable and Unacceptable Symptom State (PASS) at Weeks 2, 4, 8, 12 | Week 4: Unacceptable | 42.11 percent of participants |
| Etanercept | Percent of Subjects With Patient Acceptable and Unacceptable Symptom State (PASS) at Weeks 2, 4, 8, 12 | Week 8: Acceptable | 68.42 percent of participants |
| Etanercept | Percent of Subjects With Patient Acceptable and Unacceptable Symptom State (PASS) at Weeks 2, 4, 8, 12 | Week 2: Acceptable | 43.24 percent of participants |
| Etanercept | Percent of Subjects With Patient Acceptable and Unacceptable Symptom State (PASS) at Weeks 2, 4, 8, 12 | Week 2: Unacceptable | 56.76 percent of participants |
| Etanercept | Percent of Subjects With Patient Acceptable and Unacceptable Symptom State (PASS) at Weeks 2, 4, 8, 12 | Week 4: Acceptable | 57.89 percent of participants |
| Etanercept | Percent of Subjects With Patient Acceptable and Unacceptable Symptom State (PASS) at Weeks 2, 4, 8, 12 | Week 8: Unacceptable | 31.58 percent of participants |
| Etanercept | Percent of Subjects With Patient Acceptable and Unacceptable Symptom State (PASS) at Weeks 2, 4, 8, 12 | Week 12: Acceptable | 60.53 percent of participants |
| Etanercept | Percent of Subjects With Patient Acceptable and Unacceptable Symptom State (PASS) at Weeks 2, 4, 8, 12 | Week 12: Unacceptable | 39.47 percent of participants |
| Placebo | Percent of Subjects With Patient Acceptable and Unacceptable Symptom State (PASS) at Weeks 2, 4, 8, 12 | Week 12: Unacceptable | 59.46 percent of participants |
| Placebo | Percent of Subjects With Patient Acceptable and Unacceptable Symptom State (PASS) at Weeks 2, 4, 8, 12 | Week 4: Unacceptable | 64.29 percent of participants |
| Placebo | Percent of Subjects With Patient Acceptable and Unacceptable Symptom State (PASS) at Weeks 2, 4, 8, 12 | Week 4: Acceptable | 35.71 percent of participants |
| Placebo | Percent of Subjects With Patient Acceptable and Unacceptable Symptom State (PASS) at Weeks 2, 4, 8, 12 | Week 8: Acceptable | 33.33 percent of participants |
| Placebo | Percent of Subjects With Patient Acceptable and Unacceptable Symptom State (PASS) at Weeks 2, 4, 8, 12 | Week 12: Acceptable | 40.54 percent of participants |
| Placebo | Percent of Subjects With Patient Acceptable and Unacceptable Symptom State (PASS) at Weeks 2, 4, 8, 12 | Week 2: Acceptable | 30.00 percent of participants |
| Placebo | Percent of Subjects With Patient Acceptable and Unacceptable Symptom State (PASS) at Weeks 2, 4, 8, 12 | Week 8: Unacceptable | 66.67 percent of participants |
| Placebo | Percent of Subjects With Patient Acceptable and Unacceptable Symptom State (PASS) at Weeks 2, 4, 8, 12 | Week 2: Unacceptable | 70.00 percent of participants |
Comparison: Week 2: Generalized estimating equation (GEE) model, using a logit link, binomial distribution and an auto-regressive correlation structure, with treatment groups, visits and their interaction as fixed factors.p-value: 0.18495% CI: [0.74, 4.7]GEE model
Comparison: Week 4: Generalized estimating equation (GEE) model, using a logit link, binomial distribution and an auto-regressive correlation structure, with treatment groups, visits and their interaction as fixed factors.p-value: 0.03695% CI: [1.06, 6.46]GEE model
Comparison: Week 8: Generalized estimating equation (GEE) model, using a logit link, binomial distribution and an auto-regressive correlation structure, with treatment groups, visits and their interaction as fixed factors.p-value: 0.00195% CI: [1.89, 13.03]GEE model
Comparison: Week 12: Generalized estimating equation (GEE) model, using a logit link, binomial distribution and an auto-regressive correlation structure, with treatment groups, visits and their interaction as fixed factors.p-value: 0.06595% CI: [0.95, 5.96]GEE model