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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Change From Baseline to Week 12 in Ratio Forced Expitatory Volume in One Second (FEV1)/Forced Vital Capacity (FVC) (%)

Time frame: Baseline, Week 12

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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