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EMBARK: Study Comparing Etanercept (ETN) Against a Placebo for Etanercept on a Background Nonsteroidal Anti Inflammatory Drug (NSAIDs) in the Treatment of Early Spondyloarthritis (SpA) Patients Who do Not Have X-ray Structural Changes

Sponsor
Pfizer (Industry)
Overall Status
Completed
CT.gov ID
NCT01258738
Collaborator
(none)
225
Enrollment
50
Locations
2
Arms
44
Duration (Months)
4.5
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a two part study. During period one there will be a comparison of Etanercept (ETN) against a placebo with both arms maintaining the background anti inflammatory drug prescribed by their Physician. The hypothesis is that Etanercept will be superior to the placebo arm as determined by the proportion of subjects achieving Assessments in Ankylosing Spondylitis (ASAS)40 improvement at 12 weeks. This will be followed by 92 weeks extension where everyone in the trial receives Etanercept (ETN) and a background non steroidal anti inflammatory drug(NSAID).

Condition or Disease Intervention/Treatment Phase
  • Biological: etanercept
  • Drug: Background NSAID
  • Other: PLACEBO
  • Drug: Background NSAID
 Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
225 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
Official Title:
A Multicentre, 12 Week Double Blind Placebo Controlled Randomized Study Of Etanercept On A Background Nsaid In The Treatment Of Adult Subjects With Non Radiographic Axial Spondyloarthritis With A 92 Week Open Label Extension
Study Start Date :
Feb 1, 2011
Actual Primary Completion Date :
Nov 1, 2012
Actual Study Completion Date :
Oct 1, 2014

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: etanercept

In Period 1 : Subjects will receive via a prefilled syringe an active dose equivalent to 1.0ml of Etanercept solution once weekly SC once weekly. Additionally they will continue to take the background non steroidal anti inflammatory drug(NSAID) in the tolerated dose agreed upon by the attending Physician.

Biological: etanercept
In Period 1, subjects will receive in a prefilled syringe with 1.0 ml (test article Etanercept (SC) once weekly . Additionally they will continue to take the background non steroidal anti inflammatory drug(NSAID) in the tolerated dose agreed upon by the attending Physician.
Other Names:
  • ENBREL

    • Drug: Background NSAID
    Subject will continue to take a concomitant background non steroidal anti inflammatory drug(NSAID)as prescribed by their attending physician. The name and dose of this NSAID is the decision of the attending physician.
    Placebo Comparator: PLACEBO

    In Period 1: Subjects will receive in a prefilled syringe with a PLACEBO dose equivalent to 1.0 ml of placebo solution once weekly SC Additionally they will continue to take the background non steroidal anti inflammatory drug(NSAID) in the tolerated dose agreed upon by the attending Physician.

    Other: PLACEBO
    In Period 1 will receive a prefilled syringe of Placebo for Etanercept Additionally they will continue to take the background non steroidal anti inflammatory drug(NSAID) in the tolerated dose agreed upon by the attending Physician.

    Drug: Background NSAID
    Subject will continue to take a concomitant background non steroidal anti inflammatory drug(NSAID)as prescribed by attending physician (dose drug selection as tolerated and agreed upon by the attending Physician).

    Outcome Measures

    Primary Outcome Measures

    1. Percentage of Participants Achieving Ankylosing Spondylitis (ASAS) 40 Response at Week 12 [Week 12]

      ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) in 4 domains: participant global assessment of disease activity, pain, function, inflammation. ASAS 40 = 40% improvement from baseline and an absolute change ≥ 20 units on a 0-100 scale (0 = no disease activity, 100 = high disease activity) for ≥ 3 domains, and no worsening in remaining domain.

    Secondary Outcome Measures

    1. Percentage of Participants Achieving ASAS 40 Response at Time Points [Baseline to Week 104]

      ASAS measures symptomatic improvement in AS in 4 domains: participant global assessment of disease activity, pain, function, inflammation. ASAS 40 = 40% improvement from baseline and an absolute change ≥ 20 units on a 0-100 scale (0 = no disease activity, 100 = high disease activity) for ≥ 3 domains, and no worsening in remaining domain.

    2. Percentage of Participants Achieving ASAS 20 Response at Time Points [Baseline to Week 104]

      ASAS measures symptomatic improvement in AS in 4 domains: participant global assessment of disease activity, pain, function, inflammation. ASAS 20 = 20% improvement from baseline and an absolute change ≥ 10 units on a 0-100 scale (0=no disease activity; 100 = high disease activity) for ≥ 3 domains, and no worsening in remaining domain.

    3. Percentage of Participants Achieving ASAS 5/6 Response at Time Points [Baseline to Week 104]

      ASAS 5/6 consists of 6 domains: the 4 used in ASAS 20 (participant global assessment of disease activity, pain, function, inflammation measured on a 0-100 scale, where 0 = no disease activity and 100 = high disease activity) plus spinal mobility and an acute phase reactant, C Reactive Protein (CRP). Achieving ASAS 5/6 requires a 20% improvement compared to baseline in ≥ 5 domains and no worsening in the remaining domain.

    4. Mean Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) High Sensitivity CRP (hsCRP) Score at Time Points [Baseline to Week 104]

      ASDAS includes CRP (mg/L) or ESR (mm/hr); Apart from the value of CRP or ESR, the four additional self-reported items (rated on 0-10cm VAS or 0-10 numerical rating scale [NRS]) included in this index are back pain, duration of morning stiffness, peripheral pain/swelling and patient global assessment of disease activity. The ASDAS scores are then calculated as follows: ASDAS_CRP = (0.121 x total back pain) + (0.110 x subject global) + (0.073 x peripheral pain/swelling) + (0.058 x duration of morning stiffness) + (0.579 x Ln(CRP+1)). And ASDAS_ESR: (0.079 x total back pain) + (0.113 x subject global) + (0.086 x peripheral pain/swelling) + (0.069 x duration of morning stiffness) + (0.293 x √ESR). In addition, the proportion of participants who achieve inactive disease based on the ASDAS will be determined for each group. Inactive disease is defined as an ASDAS score <1.3.

    5. Percentage of Participants Achieving ASAS Partial Remission at Time Points [Baseline to Week 104]

      Partial remission defined as a score of 20 units or less (on a scale of 0-100, where 0 = no disease activity and 100 = high disease activity) in each of the 4 Assessment in ASAS domains: participant global assessment of disease activity, pain, function, and inflammation. For scale, 100 = high disease activity.

    6. Time to ASAS Partial Remission [Week 12]

      The median time to partial remission was not reached at Week 12. Hence, we report an estimate of the percentage of participants, estimated using Kaplan-Meier approach.

    7. Mean Change From Baseline in Visual Analogue Scale (VAS) Physician Global Assessments at Time Points [Baseline to Week 104]

      The Investigator estimated the participant's overall disease activity over the previous 48 hours (this was independent of the Subject Assessment of Disease Activity) using a scale between 0 mm (none) and 100 mm (severe).

    8. Mean Change From Baseline in VAS Score for Subject Assessment of Disease Activity at Time Points [Baseline to Week 104]

      Participants to assess their overall disease activity over the last 48 hours using a pain scale between 0 mm (none) and 100 mm (severe), which corresponded to the magnitude of their pain.

    9. Changes From Baseline in VAS Score for Nocturnal Back Pain at Time Points [Baseline to Week 104]

      The VAS scale was used to assess the level of nocturnal pain during the past 48 hours. For this, participants marked their level of pain on a 100 mm VAS anchored by 0 for "No pain " to 100 mm for "Most Severe Pain."

    10. Changes From Baseline in VAS Score for Total Back Pain at Time Points [Baseline to Week 104]

      The VAS scale was used to assess the level of total back pain during the past 48 hours. For this, participants marked their level of pain on a 100 mm VAS anchored by 0 for "No pain " to 100 mm for "Most Severe Pain."

    11. Changes From Baseline in the Bath Ankylosing Spondylitis Functional Index (BASFI) Total Score at Time Points [Baseline to Week 104]

      BASFI is a validated self assessment tool that determines the degree of functional limitation in AS. Utilizing a VAS of 0-10 (0 = easy, 10 = impossible), participants answered 10 questions assessing their ability in completing normal daily activities or physically demanding activities. The BASFI score is a mean score of the 10 questions.

    12. Mean Change From Baseline in BASFI Full Day Activities at Time Points [Baseline to Week 104]

      BASFI is a validated self assessment tool that determines the degree of functional limitation in AS. Utilizing a VAS of 0-10 (0 = easy, 10 = impossible), participants answered 10 questions assessing their ability in completing normal daily activities or physically demanding activities. The BASFI score is a mean score of the 10 questions.

    13. Mean Change From Baseline in BASFI Bending Forward at Time Points [Baseline to Week 104]

      BASFI is a validated self assessment tool that determines the degree of functional limitation in AS. Utilizing a VAS of 0-10 (0 = easy, 10 = impossible), participants answered 10 questions assessing their ability in completing normal daily activities or physically demanding activities. The BASFI score is a mean score of the 10 questions.

    14. Mean Change From Baseline in BASFI Getting Out of an Arm-less Chair at Time Points [Baseline to Week 104]

      BASFI is a validated self assessment tool that determines the degree of functional limitation in AS. Utilizing a VAS of 0-10 (0 = easy, 10 = impossible), participants answered 10 questions assessing their ability in completing normal daily activities or physically demanding activities. The BASFI score is a mean score of the 10 questions.

    15. Mean Change From Baseline in BASFI Physically Demanding Activities at Time Points [Baseline to Week 104]

      BASFI is a validated self assessment tool that determines the degree of functional limitation in AS. Utilizing a VAS of 0-10 (0 = easy, 10 = impossible), participants answered 10 questions assessing their ability in completing normal daily activities or physically demanding activities. The BASFI score is a mean score of the 10 questions.

    16. Mean Change From Baseline in BASFI Reaching up High at Time Points [Baseline to Week 104]

      BASFI is a validated self assessment tool that determines the degree of functional limitation in AS. Utilizing a VAS of 0-10 (0 = easy, 10 = impossible), participants answered 10 questions assessing their ability in completing normal daily activities or physically demanding activities. The BASFI score is a mean score of the 10 questions.

    17. Mean Change From Baseline in BASFI Climbing Steps Without Aid at Time Points [Baseline to Week 104]

      BASFI is a validated self assessment tool that determines the degree of functional limitation in AS. Utilizing a VAS of 0-10 (0 = easy, 10 = impossible), participants answered 10 questions assessing their ability in completing normal daily activities or physically demanding activities. The BASFI score is a mean score of the 10 questions.

    18. Mean Change From Baseline in BASFI Getting-up Off-floor From Back at Time Points [Baseline to Week 104]

      BASFI is a validated self assessment tool that determines the degree of functional limitation in AS. Utilizing a VAS of 0-10 (0 = easy, 10 = impossible), participants answered 10 questions assessing their ability in completing normal daily activities or physically demanding activities. The BASFI score is a mean score of the 10 questions.

    19. Mean Change From Baseline in BASFI Standing Unsupported for 10 Minutes at Time Points [Baseline to Week 104]

      BASFI is a validated self assessment tool that determines the degree of functional limitation in AS. Utilizing a VAS of 0-10 (0 = easy, 10 = impossible), participants answered 10 questions assessing their ability in completing normal daily activities or physically demanding activities. The BASFI score is a mean score of the 10 questions.

    20. Mean Change From Baseline in BASFI Looking Over Shoulder at Time Points [Baseline to Week 104]

      BASFI is a validated self assessment tool that determines the degree of functional limitation in AS. Utilizing a VAS of 0-10 (0 = easy, 10 = impossible), participants answered 10 questions assessing their ability in completing normal daily activities or physically demanding activities. The BASFI score is a mean score of the 10 questions.

    21. Mean Change From Baseline in BASFI Putting on Socks at Time Points [Baseline to Week 104]

      BASFI is a validated self assessment tool that determines the degree of functional limitation in AS. Utilizing a VAS of 0-10 (0 = easy, 10 = impossible), participants answered 10 questions assessing their ability in completing normal daily activities or physically demanding activities. The BASFI score is a mean score of the 10 questions.

    22. Changes From Baseline in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Total Score at Time Points [Baseline to Week 104]

      BASDAI is a validated self assessment tool used to determine disease activity in participant with Ankylosing Spondylitis (AS). Utilizing a VAS of 0-10 (0 = none and 10 = very severe) participant's answered 6 questions measuring discomfort, pain and fatigue. The BASDAI score is obtained by computing the mean score for the 2 questions related to morning stiffness (questions 5 and 6) and then adding that value to the sum of the scores for the first 4 questions and then dividing the total by 5. This can be written as BASDAI=(Q1+Q2+Q3+Q4+(Q5+Q6)/2)/5. The final BASDAI score averages the individual assessments for a final score range of 0-10.

    23. Mean Change From Baseline in BASDAI Level of Morning Stiffness at Time Points [Baseline to Week 104]

      BASDAI is a validated self assessment tool used to determine disease activity in participant with Ankylosing Spondylitis (AS). Utilizing a VAS of 0-10 (0 = none and 10 = very severe) participant's answered 6 questions measuring discomfort, pain and fatigue. The BASDAI score is obtained by computing the mean score for the 2 questions related to morning stiffness (questions 5 and 6) and then adding that value to the sum of the scores for the first 4 questions and then dividing the total by 5. This can be written as BASDAI=(Q1+Q2+Q3+Q4+(Q5+Q6)/2)/5. The final BASDAI score averages the individual assessments for a final score range of 0-10.

    24. Mean Change From Baseline in BASDAI Level of Fatigue/Tiredness at Time Points [Baseline to Week 104]

      BASDAI is a validated self assessment tool used to determine disease activity in participant with Ankylosing Spondylitis (AS). Utilizing a VAS of 0-10 (0 = none and 10 = very severe) participant's answered 6 questions measuring discomfort, pain and fatigue. The BASDAI score is obtained by computing the mean score for the 2 questions related to morning stiffness (questions 5 and 6) and then adding that value to the sum of the scores for the first 4 questions and then dividing the total by 5. This can be written as BASDAI=(Q1+Q2+Q3+Q4+(Q5+Q6)/2)/5. The final BASDAI score averages the individual assessments for a final score range of 0-10.

    25. Mean Change From Baseline in BASDAI Level of Discomfort at Time Points [Baseline to Week 104]

      BASDAI is a validated self assessment tool used to determine disease activity in participant with Ankylosing Spondylitis (AS). Utilizing a VAS of 0-10 (0 = none and 10 = very severe) participant's answered 6 questions measuring discomfort, pain and fatigue. The BASDAI score is obtained by computing the mean score for the 2 questions related to morning stiffness (questions 5 and 6) and then adding that value to the sum of the scores for the first 4 questions and then dividing the total by 5. This can be written as BASDAI=(Q1+Q2+Q3+Q4+(Q5+Q6)/2)/5. The final BASDAI score averages the individual assessments for a final score range of 0-10.

    26. Mean Change From Baseline in BASDAI Level of How Long Stiffness Lasts at Time Points [Baseline to Week 104]

      BASDAI is a validated self assessment tool used to determine disease activity in participant with Ankylosing Spondylitis (AS). Utilizing a VAS of 0-10 (0 = none and 10 = very severe) participant's answered 6 questions measuring discomfort, pain and fatigue. The BASDAI score is obtained by computing the mean score for the 2 questions related to morning stiffness (questions 5 and 6) and then adding that value to the sum of the scores for the first 4 questions and then dividing the total by 5. This can be written as BASDAI=(Q1+Q2+Q3+Q4+(Q5+Q6)/2)/5. The final BASDAI score averages the individual assessments for a final score range of 0-10.

    27. Mean Change From Baseline in BASDAI Level of Pain/Swelling at Time Points [Baseline to Week 104]

      BASDAI is a validated self assessment tool used to determine disease activity in participant with Ankylosing Spondylitis (AS). Utilizing a VAS of 0-10 (0 = none and 10 = very severe) participant's answered 6 questions measuring discomfort, pain and fatigue. The BASDAI score is obtained by computing the mean score for the 2 questions related to morning stiffness (questions 5 and 6) and then adding that value to the sum of the scores for the first 4 questions and then dividing the total by 5. This can be written as BASDAI=(Q1+Q2+Q3+Q4+(Q5+Q6)/2)/5. The final BASDAI score averages the individual assessments for a final score range of 0-10.

    28. Mean Change From Baseline in BASDAI Level of Neck/Back/Hip Pain at Time Points [Baseline to Week 104]

      BASDAI is a validated self assessment tool used to determine disease activity in participant with Ankylosing Spondylitis (AS). Utilizing a VAS of 0-10 (0 = none and 10 = very severe) participant's answered 6 questions measuring discomfort, pain and fatigue. The BASDAI score is obtained by computing the mean score for the 2 questions related to morning stiffness (questions 5 and 6) and then adding that value to the sum of the scores for the first 4 questions and then dividing the total by 5. This can be written as BASDAI=(Q1+Q2+Q3+Q4+(Q5+Q6)/2)/5. The final BASDAI score averages the individual assessments for a final score range of 0-10.

    29. Percentage of Participants With BASDAI 50 at Time Points [Baseline to Week 104]

      Response was defined as a 50% improvement of the Baseline BASDAI to 104 weeks of study treatment, respectively. The BASDAI score is obtained by computing the mean score for the 2 questions related to morning stiffness (questions 5 and 6) and then adding that value to the sum of the scores for the first 4 questions and then dividing the total by 5. This can be written as BASDAI=(Q1+Q2+Q3+Q4+(Q5+Q6)/2)/5.

    30. Percentage of Participants With BASDAI 20 at Time Points [Baseline to Week 104]

      Response was defined as a 20% improvement of the Baseline BASDAI to 104 weeks of study treatment. The BASDAI score is obtained by computing the mean score for the 2 questions related to morning stiffness (questions 5 and 6) and then adding that value to the sum of the scores for the first 4 questions and then dividing the total by 5. This can be written as BASDAI=(Q1+Q2+Q3+Q4+(Q5+Q6)/2)/5.

    31. Change From Baseline in Bath Ankylosing Spondylitis Global Index (BAS-G) Total Score at Time Points [Baseline to Week 104]

      The BAS-G was a 2 question assessment evaluating the effect of AS on the participants well-being over the last week and last 6 months. The 2 questions were: How have you been over the last week? and How have you been over the last six months?. Each question is scored by the participant on a 100 mm scale ranging from 0 (Very Good) to 100 (Very Bad). The two values are averaged to obtain the BAS-G score.

    32. Mean Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) Total Score at Time Points [Baseline to Week 104]

      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.

    33. Mean Change From Baseline in BASMI Lateral Side Flexion Score by Time Point [Baseline to Week 104]

      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.

    34. Mean Change From Baseline in BASMI Cervical Rotation Degree by Time Point [Baseline to Week 104]

      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.

    35. Mean Change From Baseline in BASMI Modified Schobers Test Score by Time Point [Baseline to Week 104]

      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.

    36. Mean Change From Baseline in BASMI Intermalleolar Distance Score by Time Point [Baseline to Week 104]

      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.

    37. Mean Change From Baseline in BASMI Tragus to Wall Score by Time Point [Baseline to Week 104]

      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.

    38. Change From Baseline in Chest Expansion at Time Points [Baseline to Week 104]

      Chest expansion, measured in cm, is defined as the difference in thoracic circumference during full expiration versus full inspiration, measured at the fourth intercostal space (nipple line). At maximal inspiration, the chest circumference was measured at nipple line or at the 4th intercostal space (in cm to the nearest 0.1 cm).

    39. Mean Change From Baseline in Occiput-to-wall Test at Time Points [Baseline to Week 104]

      Occiput-to-wall distance: distance between the occiput (posterior or back portion of the head) and the wall when the participant stood with heels and shoulder against the wall and the back straight.

    40. Change From Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) - Spine 6 Discovertebral Units (DVU) Total Score at 12 Weeks [Week 12]

      The change from baseline in the MRI score of spine was assessed using SPARCC method. The scores of the 6 most severely affected spinal levels (discovertebral units/DVUs) was selected. Each DVU was divided into 4 quadrants. Each quadrant was assigned a score of 0 = no lesion or 1 = increased signal. This was repeated for each of 3 consecutive sagittal slices resulting in a score of up to 12 per DVU. On each slice, the presence of a lesion exhibiting an intense signal in any quadrant was assigned an additional score of 1 for that slice. Additionally, on each slice the presence of a lesion exhibiting depth ≥ 1 cm in any quadrant was given an additional score of 1. The maximum score for 6 DVU Spine Total Score is 108.

    41. Mean Change From Baseline in SPARCC Score for the Sacroiliac Joint at Time Points [Weeks 12 and 104]

      The change from baseline in the MRI score of sacroiliac joints was assessed using SPARCC method. Scoring was based on 6 consecutive coronal slices from posterior to anterior. Each joint was divided into 4 quadrants. Each quadrant was assigned a score of 0 = no lesion/1 = increased signal. For each slice, the score is increased by 1 for each joint that exhibits an intense signal in any quadrant. Also, for each slice, an additional score of 1 will be given for each joint that includes a lesion demonstrating continuous increased signal of a depth ≥1 cm from the articular surface. The maximum possible score is 72.

    42. Mean Change From Baseline in SPARCC - Spine 6 Discovertebral Units (DVU) Total Score at Time Points [Weeks 12 and 104]

      The change from baseline in the MRI score of spine was assessed using SPARCC method. The scores of the 6 most severely affected spinal levels (discovertebral units/DVUs) was selected. Each DVU was divided into 4 quadrants. Each quadrant was assigned a score of 0 = no lesion or 1 = increased signal. This was repeated for each of 3 consecutive sagittal slices resulting in a score of up to 12 per DVU. On each slice, the presence of a lesion exhibiting an intense signal in any quadrant was assigned an additional score of 1 for that slice. Additionally, on each slice the presence of a lesion exhibiting depth ≥ 1 cm in any quadrant was given an additional score of 1. The maximum score for 6 DVU Spine Total Score is 108.

    43. Mean Change From Baseline in Ankylosing Spondylitis Spine Magnetic Resonance Imaging-Activity (ASspiMRI-a) Total Score [Weeks 12 and 104]

      ASspiMRI-a measures acute lesion scores as determined by short-tau inversion recovery (STIR) and gadolinium-enhanced T1 (Gd-DTPA). All 23 disco-vertebral units (DVU) of the spine (from C2 to S1), defined as the region between 2 virtual lines through the middle of each vertebra, are scored in a single dimension, which is representing the highest level of inflammation in that particular DVU. Enhancement and bone marrow edema are graded (0-3) for each DVU, with 3 more grades (4-6) if, in addition to the signs of acute inflammation defined for grades 1-3, erosions are visualized, leading to a maximum score of 138 for the entire spine. Acute spinal changes were assessed by using STIR sagittal views of the cervical, thoracic and lumbar spine. The total score ranges from 0 (no inflammation) to 138 (high inflammation).

    44. Mean Change From Baseline in Number of Swollen Joints at Time Points [Baseline to Week 104]

      Forty-four (44) joints were assessed by the Investigator to determine the number of joints that were considered swollen (artificial joints were not assessed). The response to pressure/motion on each joint was assessed using the following scale: Present/Absent/Not Done. The 44 joints to be assessed were:sternoclavicular, acromioclavicular, shoulder, elbow, wrist (includes radiocarpal, carpal and carpometacarpal considered as one unit), metacarpophalangeals (I, II, III, IV, V), thumb interphalangeal (IP), proximal IPs (II, III, IV, V), knee, ankle, metatarsophalangeals (I, II, III, IV, V).

    45. Mean Change From Baseline in Number of Tender Joints at Time Points [Baseline to Week 104]

      Forty-four (44) joints were assessed by the Investigator to determine the number of joints that were considered tender or painful. The response to pressure/motion on each joint was assessed using the following scale: Present/Absent/Not Done/Not Applicable (to be considered for artificial joints). The 44 joints to be assessed were:sternoclavicular, acromioclavicular, shoulder, elbow, wrist (includes radiocarpal, carpal and carpometacarpal considered as one unit), metacarpophalangeals (I, II, III, IV, V), thumb interphalangeal (IP), proximal IPs (II, III, IV, V), knee, ankle, metatarsophalangeals (I, II, III, IV, V).

    46. Mean Change From Baseline in Dactylitis Score at Time Points [Baseline to Week 104]

      Each of the 10 fingers and 10 toes is evaluated for dactylitis. A score of 0, 1, 2 or 3 (where 0 = none, 1= mild, 2 = moderate, 3 = severe) is assigned to each. A total score which can range from 0 to 60 is obtained by adding the scores for the 20 digits

    47. Changes From Baseline in Maastricht Ankylosing Spondylitis Enthesis Score (MASES) at Time Points [Baseline to Week 104]

      Assessment of enthesitis was performed in the following 7 domains: 1) 1st costochondral joint left and right, 2) 7th costochondral joint left and right, 3) posterior superior iliac spine left and right, 4) anterior superior iliac spine left and right, 5) iliac crest left and right, 6) 5th lumbar spinous process and 7) proximal insertion of Achilles tendon left and right. Each domain was graded for the presence (1) and absence (0) of tenderness yielding total MASES ranging from 0 (no tenderness) to 13 (worst possible score; severe tenderness).

    48. Change From Baseline in C-reactive Protein (CRP) Concentration Time Points [Baseline to Week 104]

      The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.

    49. Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Time Points [Baseline to Week 104]

      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. Normal range is 0-30 mm/hr. A higher rate is consistent with inflammation.

    50. Change From Baseline in Euro Quality of Life (EQ)-5D VAS Score Time Points [Baseline to Week 104]

      EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.

    51. Change From Baseline in EQ-5D Health State Profile Utility Score at Time Points [Baseline to Week 104]

      EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.

    52. Change From Baseline in Short Form-36 (SF-36) Physical Component Summary (PCS) at Time Points [Baseline to Week 104]

      SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100 = highest level of functioning).

    53. Change From Baseline in SF-36 Mental Component Summary (MCS) at Time Points [Baseline to Week 104]

      SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).

    54. Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Depression Score at Time Points [Baseline to Week 104]

      This outcome measure is describing the HADS subscale of depression. HADS is a participant rated questionnaire with 2 subscales. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). Each subscale comprised of 7 items with range 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score 0 to 21 for each subscale; higher score indicates greater severity of anxiety and depression symptoms. There is no Total Score for HADS.

    55. Change From Baseline in HADS Anxiety Score at Time Points [Baseline to Week 104]

      This outcome measure is describing the HADS subscale of anxiety. HADS is a participant rated questionnaire with 2 subscales. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). Each subscale comprised of 7 items with range 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score 0 to 21 for each subscale; higher score indicates greater severity of anxiety and depression symptoms. There is no Total Score for HADS.

    56. Change From Baseline in Ankylosing Spondylitis Quality of Life (ASQoL) Score at Time Points [Baseline to Week 104]

      ASQoL is a questionnaire that assesses disease-specific quality of life (QoL). It consists of 18 statements that are relevant to the physical and mental conditions for a participant with Ankylosing Spondylitis (AS): mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each statement is answered by the participant as a 'Yes' (scored as 1) or 'No' (scored as 0). All item scores are summed to give a total score. Total score can range from 0 (good QoL) to 18 (poor QoL).

    57. Change From Baseline in Ankylosing Spondylitis Work Instability Index (AS-WIS) Score at Time Points [Baseline to Week 104]

      The AS-WIS is a 20 item questionnaire to assess work disability and risk of unemployment due to AS. Higher scores indicate greater work impairment and instability that results from a mismatch between an individual's ability levels given their AS and their job. Each question is assigned a score of 1 for a response of "True" and 0 for a response of "Not True". All item scores are summed to give a total score that can range from 0 to 20. If a subject has ≥ 5 missing responses (ie more than 20%), then a total score is not calculated. For subjects with ≥ 1 but ≤ 4 missing responses, the total score is calculated as follows: T=20x/(20-m) where: T is the total score, x is the total score for the items answered and n is the number of non-missing items.

    58. Change From Baseline in Work Productivity and Activity Impairment (WPAI): Percent Work Time Missed Due to Health Problems at Time Points [Baseline to Week 104]

      The WPAI assesses work productivity and impairment. It is a 6-item questionnaire used to assess the degree to which a specified health problem affected work productivity and regular activities over the past 7 days. The questions are: Q1 = currently employed. Q2 = hours missed due to health problems. Q3 = hours missed other reasons. Q4 = hours actually worked. Q5 = degree health affected productivity while working (0-10 scale). Q6 = degree health affected regular activities (0-10 scale). Subscale scores are calculated: Percent work time missed due to health problem: Q2/(Q2+Q4). The computed percentage range for each sub-scale is 0-100, where higher numbers indicate greater impairment and less productivity.

    59. Change From Baseline in WPAI: Percent Impairment While Working Due to Health Problems at Time Points [Baseline to Week 104]

      The WPAI assesses work productivity and impairment. It is a 6-item questionnaire used to assess the degree to which a specified health problem affected work productivity and regular activities over the past 7 days. The questions are: Q1 = currently employed. Q2 = hours missed due to health problems. Q3 = hours missed other reasons. Q4 = hours actually worked. Q5 = degree health affected productivity while working (0-10 scale). Q6 = degree health affected regular activities (0-10 scale). Subscale scores are calculated: Percent impairment while working due to health problem: Q5/10. The computed percentage range for each sub-scale is 0-100, where higher numbers indicate greater impairment and less productivity.

    60. Changes From Baseline in WPAI - Activity Impairment Due to Health Problems at Time Points [Baseline to Week 104]

      The WPAI assesses work productivity and impairment. It is a 6-item questionnaire used to assess the degree to which a specified health problem affected work productivity and regular activities over the past 7 days. The questions are: Q1 = currently employed. Q2 = hours missed due to health problems. Q3 = hours missed other reasons. Q4 = hours actually worked. Q5 = degree health affected productivity while working (0-10 scale). Q6 = degree health affected regular activities (0-10 scale). Subscale scores are calculated: Percent activity impairment due to health problem: Q6/10. The computed percentage range for each sub-scale is 0-100, where higher numbers indicate greater impairment and less productivity.

    61. Changes From Baseline in WPAI - Overall Work Impairment Due to Health Problems at Time Points [Baseline to Week 104]

      The WPAI assesses work productivity and impairment. It is a 6-item questionnaire used to assess the degree to which a specified health problem affected work productivity and regular activities over the past 7 days. The questions are: Q1 = currently employed. Q2 = hours missed due to health problems. Q3 = hours missed other reasons. Q4 = hours actually worked. Q5 = degree health affected productivity while working (0-10 scale). Q6 = degree health affected regular activities (0-10 scale). Subscale scores are calculated: Percent overall work impairment due to health problem: Q2/(Q2+Q4)+[(1-Q2/(Q2+Q4))*(Q5/10)]. The computed percentage range for each sub-scale is 0-100, where higher numbers indicate greater impairment and less productivity.

    62. Change From Baseline in Multidimensional Fatigue Inventory (MFI) Score at Time Points [Baseline to Week 104]

      The MFI is a 20-item questionnaire that evaluates several aspects of fatigue. The General Fatigue Item is disclosed here. The general fatigue item contains four items, two of which are indicative for fatigue and two items contra-indicative for fatigue. Indicative items (eg, "I tire easily") are formulated in such a way that a high score suggests a high degree of fatigue. In case of contra-indicative items (eg, "I feel fit") a high score indicates a low degree of fatigue. Each item is scored on a 5-point numeric rating scale anchored at each end by "Yes, that is true" (scored 1) to "No, that is not true" (scored 5). Scoring for the MFI is done in such a way that higher scores indicate greater fatigue. Therefore, the items indicative for fatigue need to be recoded (1=5, 2=4, 3=3, 4=2, 5=1). For each scale a total score is calculated by summation of the scores of the individual items. Scores can range from the minimum of 4 to the maximum of 20. MFI-20 scale is copyrighted.

    63. Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale Score From Baseline to Week 104 [Baseline to Week 104]

      The MOS sleep scale consists of 12 items to measure 6 sleep dimensions: initiation (time to fall asleep), quantity (hours of sleep each night), maintenance, respiratory problems, perceived adequacy, somnolence (the last 4 items reported using a 6-item Likert scale ranging from 1 [all of the time] to 6 [none of the time]). The raw scores ranging from 1 to 6 are transformed to scores ranging from 0 to 100 before the indices are calculated. Therefore the reported scores, consisting of means of converted items, also range from 0 to 100. However, two indexes can be derived: Sleep problems index I (short form) and sleep problems index II (long form). Additional subscales can be derived: sleep disturbance, snoring, awaken shortness of breath or headache, sleep adequacy, sleep somnolence, sleep quantity, and optimal sleep. However, data for two indexes and additional subscales is not reported.

    64. Percentage of Participants With Minimally Clinically Important Improvement (MCII) at Time Points [Weeks 12 and 104]

      The MCII asks participants to rate the level of improvement they have experienced in the 48 hours compared to when they started the study. Response options are "Improved - less pain", "No change", and "Worse - more pain." If the participant indicates that improvement has occurred, then they are asked to indicate how important that improvement is to them from "Not at all important" to "Very important'.

    65. Percentage of Participants Achieving Patient Acceptable Symptom State (PASS) at Time Points [Weeks 12 and 104]

      PASS is defined as a symptom state that the participants consider acceptable.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 49 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Diagnosis of axial spondyloarthritis as defined by Assessments in Ankylosing Spondylitis (ASAS)criteria

    • Active symptoms defined as Ankylosing Spondylitis Disease Activity Index{BASDAI) > or = 4

    • Axial symptoms of back pain with a less than favorable response to on steroidal anti inflammatory drugs at optimal dosage for greater than 4 weeks

    Exclusion Criteria:

    • Evidence of current or recent episode of uveitis

    • Evidence of IBD flare within 6 months

    • Previous treatment with an anti Tumor necrosis factor(TNF)

    • Active tuberculosis

    • Radiographic sacroiliitis grade 3-4 unilaterally or >= 2 bilaterally

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Centro Medico Privado de Reumatologia San Miguel de Tucuman Tucuman Argentina T4000AXL
    2 Consultorios Reumatológicos Pampa Buenos Aires Argentina C1428DZF
    3 Universitair Ziekenhuis Gent Gent Belgium 9000
    4 Reuma Instituut Hasselt Belgium 3500
    5 AZ Groeninge Kortrijk Belgium 8500
    6 Preventive Care Ltda. Chia Cundinamarca Colombia
    7 Ips Medicity S.A.S Bucaramanga Santander Colombia
    8 Servimed Sas Bucaramanga Santander Colombia
    9 Mediscan Group, s.r.o. Praha 11 - Chodov Czech Republic 14800
    10 Revmatologicky ustav Praha 2 Czech Republic 128 50
    11 Medical Plus s.r.o. Uherske Hradiste Czech Republic 68601
    12 Meilahden kolmiosairaala Helsinki Finland 00029
    13 Kiljavan Lääketutkimus Hyvinkää Finland 05800
    14 Hopital de Bicetre LE KREMLIN-BICETRE Cedex France 94270
    15 CHU Lapeyronie, Immuno-Rhumatologie Montpellier France 34000
    16 Hôpital Cochin Paris France 75014
    17 CHU de Tours Tours Cedex 9 France 37044
    18 Charite - Campus Benjamin Franklin, Medizinische Klinik I - Rheumatologie Berlin Germany 12203
    19 Studienambulanz, Medizinische Klinik 3, Universitaetsklinikum Erlangen Erlangen Germany 91054
    20 Schoen Klinik Hamburg-Eilbek, Abt. Rheumatologie und Klin. Immunologie Hamburg Germany 22081
    21 Rheumazentrum Ruhrgebiet Herne Germany 44649
    22 MEDIGREIF Verwaltungs- und Betriebsgesellschaft Fachkrankenhaus Vogelsang-Gommern mbH Vogelsang-Gommern Germany 39245
    23 Orszagos Reumatologiai es Fizioterapias Intezet/Klinikai Immunologiai es Reumatologiai Osztaly Budapest Hungary 1023
    24 Budai Irgalmasrendi Korhaz Budapest Hungary 1027
    25 Qualiclinic Egeszsegugyi Szolgaltato es Kutatasszervezo Kft. Budapest Hungary 1036
    26 Synexus Magyarorszag Egeszsegugyi Szolgaltato Kft. Budapest Hungary 1036
    27 Kenezy Gyula Korhaz es Rendelointezet Debrecen Hungary 4031
    28 Csolnoky Ferenc Korhaz Veszprem Hungary 8200
    29 Gachon University Gil Hospital Incheon Gwangyeogsiv Korea, Republic of 405-760
    30 Chonnam National University Hospital Gwangju Korea, Republic of 501-757
    31 Hanyang University Hospital Seoul Korea, Republic of 133-792
    32 Academic Medical Centre (AMC) / Division of Clinical Immunology and Rheumatology Amsterdam North-Holland Netherlands 1105 AZ
    33 Leiden University Medical Center, Reumatologie Leiden Netherlands 2333 ZA
    34 Rheumatology Research Institute of Russian Academy of Medical Sciences Moscow Russian Federation 115522
    35 Russian Cardiology Research-and-Production Complex Moscow Russian Federation 121552
    36 Saint-Petersburg State Budgetary Healthcare Institution Saint-Petersburg Russian Federation 190068
    37 Limited Liability Company NMC Tomography Saint-Petersburg Russian Federation 191014
    38 Leningrad Regional Clinical Hospital Saint-Petersburg Russian Federation 194291
    39 Hospital Virgen Macarena Sevilla Andalucia Spain 41009
    40 Fundacion Hospital Alcorcon Alcorcon Madrid Spain 28922
    41 Hospital Reina Sofia Cordoba Spain 14004
    42 Complexo Hospitalario Universitario A Coruña La Coruña Spain 15006
    43 Chung-Ho Memorial Hospital, Kaohsiung Medical University Kaohsiung Taiwan 807
    44 Chung Shan Medical University Hospital Taichung Taiwan 40201
    45 Taipei Veterans General Hospital Taipei Taiwan 112
    46 Rhuematology Clinical Research Unit Cambridge Cambridgeshire United Kingdom CB2 0QQ
    47 Hampshire Hospitals NHS Foundation Trust Basingstoke Hants. United Kingdom RG24 9NA
    48 Norfolk and Norwich University Hospital NHS Trust Norwich Norfolk United Kingdom NR4 7UY
    49 Russells Hall Hospital Dudley West Midlands United Kingdom DY1 2HQ
    50 Whipps Cross University Hospital, London United Kingdom E11 1NR

    Sponsors and Collaborators

    • Pfizer

    Investigators

    • Study Director: Pfizer CT.gov Call Center, Pfizer

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Pfizer
    ClinicalTrials.gov Identifier:
    NCT01258738
    Other Study ID Numbers:
    • B1801031
    • 0881A3-4725
    • 2010-020077-16
    First Posted:
    Dec 13, 2010
    Last Update Posted:
    Oct 19, 2015
    Last Verified:
    Sep 1, 2015
    Keywords provided by Pfizer
    Early ankylosing spondylitis (SpA) study; efficacy and safety and health out comes
    Additional relevant MeSH terms:
    Spondylitis
    Spondylarthritis
    Spondylitis, Ankylosing
    Etanercept
    Anti-Inflammatory Agents, Non-Steroidal

    Study Results

    Participant Flow

    Recruitment Details This was a multicenter study conducted at 48 centers in 14 countries.
    Pre-assignment Detail Eligible participants were randomized to receive etanercept or placebo for 12 week controlled (double-blind) period. Participants completing 12 week period entered a 92 week open-label period.
    Arm/Group Title Etanercept Placebo
    Arm/Group Description Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID. Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
    Period Title: Double-blind Period
    STARTED 111 114
    Treated 111 113
    COMPLETED 102 107
    NOT COMPLETED 9 7
    Period Title: Double-blind Period
    STARTED 102 106
    COMPLETED 85 85
    NOT COMPLETED 17 21

    Baseline Characteristics

    Arm/Group Title Etanercept Placebo Total
    Arm/Group Description Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID. Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID. Total of all reporting groups
    Overall Participants 111 113 224
    Age (Years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [Years]
    31.7
    (7.8)
    32.0
    (7.8)
    31.9
    (7.8)
    Sex: Female, Male (Count of Participants)
    Female
    41
    36.9%
    50
    44.2%
    91
    40.6%
    Male
    70
    63.1%
    63
    55.8%
    133
    59.4%

    Outcome Measures

    1. Primary Outcome
    Title Percentage of Participants Achieving Ankylosing Spondylitis (ASAS) 40 Response at Week 12
    Description ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) in 4 domains: participant global assessment of disease activity, pain, function, inflammation. ASAS 40 = 40% improvement from baseline and an absolute change ≥ 20 units on a 0-100 scale (0 = no disease activity, 100 = high disease activity) for ≥ 3 domains, and no worsening in remaining domain.
    Time Frame Week 12

    Outcome Measure Data

    Analysis Population Description
    Modified intent-to-treat (mITT) population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for axial spondyloarthritis (AxSpA). Missing data were imputed through last observation carried forward (LOCF) approach.
    Arm/Group Title Etanercept Placebo
    Arm/Group Description Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID. Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
    Measure Participants 105 108
    Number [Percentage of participants]
    32.38
    29.2%
    15.74
    13.9%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments The null hypothesis was that the efficacy of etanercept was not different from placebo as measured by the proportion of subjects achieving an ASAS 40 response after 12 weeks of treatment. The alternative hypothesis was that the efficacy of etanercept was different from placebo. The primary endpoint was tested at 2-sided alpha = 0.05 significance level. Comparative analysis was carried out for Week 12 data only.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0062
    Comments P-value <0.05 was required to declare statistical significance.
    Method Cochran-Mantel-Haenszel
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 16.64
    Confidence Interval (2-Sided) 95%
    5.36 to 27.92
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    2. Secondary Outcome
    Title Percentage of Participants Achieving ASAS 40 Response at Time Points
    Description ASAS measures symptomatic improvement in AS in 4 domains: participant global assessment of disease activity, pain, function, inflammation. ASAS 40 = 40% improvement from baseline and an absolute change ≥ 20 units on a 0-100 scale (0 = no disease activity, 100 = high disease activity) for ≥ 3 domains, and no worsening in remaining domain.
    Time Frame Baseline to Week 104

    Outcome Measure Data

    Analysis Population Description
    mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.
    Arm/Group Title Etanercept Placebo
    Arm/Group Description Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID. Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
    Measure Participants 105 108
    Week 2 (N=105, 106)
    15.24
    13.7%
    3.77
    3.3%
    Week 4 (N=105, 108)
    20.00
    18%
    14.81
    13.1%
    Week 8 (N=105, 108)
    28.57
    25.7%
    15.74
    13.9%
    Week 12 (N= 105, 108)
    33.33
    30%
    14.81
    13.1%
    Week 16 (N= 100, 105)
    42.00
    37.8%
    38.10
    33.7%
    Week 24 (N= 100, 105)
    44.00
    39.6%
    51.43
    45.5%
    Week 32 (N= 100, 105)
    47.00
    42.3%
    52.38
    46.4%
    Week 40 (N= 100, 105)
    55.00
    49.5%
    53.33
    47.2%
    Week 48 (N= 100, 105)
    52.00
    46.8%
    53.33
    47.2%
    Week 56 (N= 100, 105)
    52.00
    46.8%
    59.05
    52.3%
    Week 68 (N= 100, 105)
    54.00
    48.6%
    58.10
    51.4%
    Week 80 (N= 100, 105)
    49.00
    44.1%
    58.10
    51.4%
    Week 92 (N= 100, 105)
    57.00
    51.4%
    61.90
    54.8%
    Week 104 (N= 100, 105)
    56.00
    50.5%
    61.90
    54.8%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0059
    Comments
    Method Cochran-Mantel-Haenszel
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 11.46
    Confidence Interval (2-Sided) 95%
    3.69 to 19.24
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.3786
    Comments
    Method Cochran-Mantel-Haenszel
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 5.19
    Confidence Interval (2-Sided) 95%
    -4.98 to 15.35
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0304
    Comments
    Method Cochran-Mantel-Haenszel
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 12.83
    Confidence Interval (2-Sided) 95%
    1.79 to 23.87
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0023
    Comments
    Method Cochran-Mantel-Haenszel
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 18.52
    Confidence Interval (2-Sided) 95%
    7.29 to 29.75
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    3. Secondary Outcome
    Title Percentage of Participants Achieving ASAS 20 Response at Time Points
    Description ASAS measures symptomatic improvement in AS in 4 domains: participant global assessment of disease activity, pain, function, inflammation. ASAS 20 = 20% improvement from baseline and an absolute change ≥ 10 units on a 0-100 scale (0=no disease activity; 100 = high disease activity) for ≥ 3 domains, and no worsening in remaining domain.
    Time Frame Baseline to Week 104

    Outcome Measure Data

    Analysis Population Description
    mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.
    Arm/Group Title Etanercept Placebo
    Arm/Group Description Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID. Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
    Measure Participants 105 109
    Week 2 (N = 105, 106)
    30.48
    27.5%
    16.04
    14.2%
    Week 4 (N = 105, 108)
    37.14
    33.5%
    26.85
    23.8%
    Week 8 (N = 105, 108)
    48.57
    43.8%
    37.96
    33.6%
    Week 12 (N = 105, 109)
    52.38
    47.2%
    36.70
    32.5%
    Week 16 (N= 100, 105)
    64.00
    57.7%
    65.71
    58.2%
    Week 24 (N = 100, 105)
    65.00
    58.6%
    71.43
    63.2%
    Week 32 (N = 100, 105)
    64.00
    57.7%
    71.43
    63.2%
    Week 40 (N = 100, 105)
    73.00
    65.8%
    73.33
    64.9%
    Week 48 (N = 100, 105)
    71.00
    64%
    72.38
    64.1%
    Week 56 (N = 100, 105)
    70.00
    63.1%
    76.19
    67.4%
    Week 68 (N = 100, 105)
    69.00
    62.2%
    76.19
    67.4%
    Week 80 (N = 100, 105)
    65.00
    58.6%
    70.48
    62.4%
    Week 92 (N = 100, 105)
    71.00
    64%
    74.29
    65.7%
    Week 104 (N = 100, 105)
    70.00
    63.1%
    79.05
    70%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0189
    Comments
    Method Cochran-Mantel-Haenszel
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 14.44
    Confidence Interval (2-Sided) 95%
    3.20 to 25.68
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0983
    Comments
    Method Cochran-Mantel-Haenszel
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 10.29
    Confidence Interval (2-Sided) 95%
    -2.17 to 22.75
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0867
    Comments
    Method Cochran-Mantel-Haenszel
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 10.61
    Confidence Interval (2-Sided) 95%
    -2.63 to 23.84
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0195
    Comments
    Method Cochran-Mantel-Haenszel
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 16.27
    Confidence Interval (2-Sided) 95%
    3.10 to 29.43
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    4. Secondary Outcome
    Title Percentage of Participants Achieving ASAS 5/6 Response at Time Points
    Description ASAS 5/6 consists of 6 domains: the 4 used in ASAS 20 (participant global assessment of disease activity, pain, function, inflammation measured on a 0-100 scale, where 0 = no disease activity and 100 = high disease activity) plus spinal mobility and an acute phase reactant, C Reactive Protein (CRP). Achieving ASAS 5/6 requires a 20% improvement compared to baseline in ≥ 5 domains and no worsening in the remaining domain.
    Time Frame Baseline to Week 104

    Outcome Measure Data

    Analysis Population Description
    mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.
    Arm/Group Title Etanercept Placebo
    Arm/Group Description Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID. Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
    Measure Participants 105 109
    Week 2 (N = 102, 105)
    15.69
    14.1%
    2.86
    2.5%
    Week 4 (N = 103, 107)
    23.30
    21%
    8.41
    7.4%
    Week 8 (N = 103, 107)
    33.01
    29.7%
    11.21
    9.9%
    Week 12 (N = 105, 109)
    33.01
    29.7%
    10.38
    9.2%
    Week 16 (N = 100, 105)
    37.00
    33.3%
    34.29
    30.3%
    Week 24 (N = 100, 105)
    41.00
    36.9%
    42.86
    37.9%
    Week 32 (N = 100, 105)
    40.00
    36%
    40.95
    36.2%
    Week 40 (N = 100, 105)
    45.00
    40.5%
    40.95
    36.2%
    Week 48 (N = 100, 105)
    49.00
    44.1%
    45.71
    40.5%
    Week 56 (N = 100, 105)
    42.00
    37.8%
    45.71
    40.5%
    Week 68 (N = 100, 105)
    42.00
    37.8%
    43.81
    38.8%
    Week 80 (N = 100, 105)
    39.00
    35.1%
    37.14
    32.9%
    Week 92 (N = 100, 105)
    46.00
    41.4%
    47.62
    42.1%
    Week 104 (N = 100, 105)
    43.00
    38.7%
    40.95
    36.2%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments
    Method Cochran-Mantel-Haenszel
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 22.63
    Confidence Interval (2-Sided) 95%
    11.85 to 33.41
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0021
    Comments
    Method Cochran-Mantel-Haenszel
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 12.83
    Confidence Interval (2-Sided) 95%
    5.09 to 20.57
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0020
    Comments
    Method Cochran-Mantel-Haenszel
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 14.89
    Confidence Interval (2-Sided) 95%
    5.18 to 24.60
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments
    Method Cochran-Mantel-Haenszel
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 21.79
    Confidence Interval (2-Sided) 95%
    10.92 to 32.67
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    5. Secondary Outcome
    Title Mean Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) High Sensitivity CRP (hsCRP) Score at Time Points
    Description ASDAS includes CRP (mg/L) or ESR (mm/hr); Apart from the value of CRP or ESR, the four additional self-reported items (rated on 0-10cm VAS or 0-10 numerical rating scale [NRS]) included in this index are back pain, duration of morning stiffness, peripheral pain/swelling and patient global assessment of disease activity. The ASDAS scores are then calculated as follows: ASDAS_CRP = (0.121 x total back pain) + (0.110 x subject global) + (0.073 x peripheral pain/swelling) + (0.058 x duration of morning stiffness) + (0.579 x Ln(CRP+1)). And ASDAS_ESR: (0.079 x total back pain) + (0.113 x subject global) + (0.086 x peripheral pain/swelling) + (0.069 x duration of morning stiffness) + (0.293 x √ESR). In addition, the proportion of participants who achieve inactive disease based on the ASDAS will be determined for each group. Inactive disease is defined as an ASDAS score <1.3.
    Time Frame Baseline to Week 104

    Outcome Measure Data

    Analysis Population Description
    mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.
    Arm/Group Title Etanercept Placebo
    Arm/Group Description Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID. Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
    Measure Participants 105 108
    Week 2 (N = 104, 106)
    -0.74
    (0.10)
    -0.20
    (0.10)
    Week 4 (N = 104, 108)
    -0.92
    (0.11)
    -0.30
    (0.10)
    Week 8 (N = 104, 108)
    -1.09
    (0.13)
    -0.48
    (0.12)
    Week 12 (N= 104, 108)
    -1.27
    (0.11)
    -0.63
    (0.08)
    Week 16 (N= 99, 104)
    -1.41
    (0.11)
    -1.35
    (0.11)
    Week 24 (N= 99, 104)
    -1.48
    (0.11)
    -1.55
    (0.11)
    Week 32 (N= 99, 104)
    -1.44
    (0.11)
    -1.52
    (0.11)
    Week 40 (N= 99, 104)
    -1.64
    (0.11)
    -1.60
    (0.12)
    Week 48 (N= 99, 104)
    -1.62
    (0.11)
    -1.63
    (0.12)
    Week 56 (N= 99, 104)
    -1.61
    (0.12)
    -1.65
    (0.11)
    Week 68 (N= 99, 104)
    -1.60
    (0.11)
    -1.65
    (0.11)
    Week 80 (N= 99, 104)
    -1.53
    (0.12)
    -1.61
    (0.12)
    Week 92 (N= 99, 104)
    -1.63
    (0.12)
    -1.70
    (0.12)
    Week 104 (N= 99, 104)
    -1.59
    (0.12)
    -1.68
    (0.12)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments All within group comparisons to baseline were <0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method t-test, 2 sided
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.54
    Confidence Interval (2-Sided) 95%
    -0.74 to -0.34
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.61
    Confidence Interval (2-Sided) 95%
    -0.81 to -0.41
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.61
    Confidence Interval (2-Sided) 95%
    -0.85 to -0.37
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    6. Secondary Outcome
    Title Percentage of Participants Achieving ASAS Partial Remission at Time Points
    Description Partial remission defined as a score of 20 units or less (on a scale of 0-100, where 0 = no disease activity and 100 = high disease activity) in each of the 4 Assessment in ASAS domains: participant global assessment of disease activity, pain, function, and inflammation. For scale, 100 = high disease activity.
    Time Frame Baseline to Week 104

    Outcome Measure Data

    Analysis Population Description
    mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.
    Arm/Group Title Etanercept Placebo
    Arm/Group Description Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID. Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
    Measure Participants 105 109
    Week 2 (N = 105, 108)
    11.43
    10.3%
    2.78
    2.5%
    Week 4 (N = 105, 109)
    10.48
    9.4%
    3.67
    3.2%
    Week 8 (N = 105, 109)
    21.90
    19.7%
    9.17
    8.1%
    Week 12 (N = 105, 109)
    24.76
    22.3%
    11.93
    10.6%
    Week 16 (N = 100, 105)
    29.00
    26.1%
    28.57
    25.3%
    Week 24 (N = 100, 105)
    32.00
    28.8%
    42.86
    37.9%
    Week 32 (N = 100, 105)
    28.00
    25.2%
    41.90
    37.1%
    Week 40 (N = 100, 105)
    40.00
    36%
    45.71
    40.5%
    Week 48 (N = 100, 105)
    38.00
    34.2%
    37.14
    32.9%
    Week 56 (N = 100, 105)
    40.00
    36%
    43.81
    38.8%
    Week 68 (N = 100, 105)
    37.00
    33.3%
    48.57
    43%
    Week 80 (N = 100, 105)
    34.00
    30.6%
    49.52
    43.8%
    Week 92 (N = 100, 105)
    39.00
    35.1%
    49.52
    43.8%
    Week 104 (N = 100, 105)
    40.00
    36%
    57.14
    50.6%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0209
    Comments
    Method Cochran-Mantel-Haenszel
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 12.84
    Confidence Interval (2-Sided) 95%
    2.58 to 23.09
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0179
    Comments
    Method Cochran-Mantel-Haenszel
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 8.65
    Confidence Interval (2-Sided) 95%
    1.82 to 15.48
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0611
    Comments
    Method Cochran-Mantel-Haenszel
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 6.81
    Confidence Interval (2-Sided) 95%
    -0.03 to 13.65
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0141
    Comments
    Method Cochran-Mantel-Haenszel
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 12.73
    Confidence Interval (2-Sided) 95%
    3.14 to 22.32
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments All within group comparisons to baseline were <0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method t-test, 2 sided
    Comments
    7. Secondary Outcome
    Title Time to ASAS Partial Remission
    Description The median time to partial remission was not reached at Week 12. Hence, we report an estimate of the percentage of participants, estimated using Kaplan-Meier approach.
    Time Frame Week 12

    Outcome Measure Data

    Analysis Population Description
    mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA.
    Arm/Group Title Etanercept Placebo
    Arm/Group Description Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID. Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
    Measure Participants 105 109
    Number (95% Confidence Interval) [percentage of participants]
    43.3
    39%
    22.3
    19.7%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 12 data only.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0022
    Comments
    Method Log Rank
    Comments
    8. Secondary Outcome
    Title Mean Change From Baseline in Visual Analogue Scale (VAS) Physician Global Assessments at Time Points
    Description The Investigator estimated the participant's overall disease activity over the previous 48 hours (this was independent of the Subject Assessment of Disease Activity) using a scale between 0 mm (none) and 100 mm (severe).
    Time Frame Baseline to Week 104

    Outcome Measure Data

    Analysis Population Description
    mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach. The values were converted to cm for analysis purposes.
    Arm/Group Title Etanercept Placebo
    Arm/Group Description Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID. Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
    Measure Participants 102 105
    Week 2 (N = 101, 104)
    -1.40
    (0.24)
    -0.80
    (0.23)
    Week 4 (N = 101, 105)
    -1.91
    (0.25)
    -1.49
    (0.24)
    Week 8 (N = 101, 105)
    -2.39
    (0.27)
    -2.10
    (0.25)
    Week 12 (N = 100, 105)
    -2.74
    (0.29)
    -2.04
    (0.28)
    Week 16 (N = 96, 101)
    -3.36
    (0.23)
    -2.78
    (0.23)
    Week 24 (N = 96, 101)
    -3.66
    (0.20)
    -3.25
    (0.23)
    Week 32 (N = 96, 101)
    -3.66
    (0.21)
    -3.38
    (0.22)
    Week 40 (N = 96, 101)
    -3.83
    (0.21)
    -3.44
    (0.21)
    Week 48 (N = 96, 101)
    -3.93
    (0.23)
    -3.53
    (0.21)
    Week 56 (N = 96, 101)
    -3.98
    (0.24)
    -3.67
    (0.22)
    Week 68 (N = 96, 101)
    -3.98
    (0.22)
    -3.60
    (0.22)
    Week 80 (N = 96, 101)
    -4.03
    (0.22)
    -3.54
    (0.24)
    Week 92 (N = 96, 101)
    -4.00
    (0.22)
    -3.43
    (0.24)
    Week 104 (N = 96, 101)
    -4.12
    (0.23)
    -3.78
    (0.22)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments All within group comparisons to baseline were <0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method t-test, 2 sided
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0156
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.70
    Confidence Interval (2-Sided) 95%
    -1.26 to -0.13
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0111
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.60
    Confidence Interval (2-Sided) 95%
    -1.06 to -0.14
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0936
    Comments
    Method Cochran-Mantel-Haenszel
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.42
    Confidence Interval (2-Sided) 95%
    -0.91 to 0.07
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.2678
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.29
    Confidence Interval (2-Sided) 95%
    -0.81 to 0.23
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    9. Secondary Outcome
    Title Mean Change From Baseline in VAS Score for Subject Assessment of Disease Activity at Time Points
    Description Participants to assess their overall disease activity over the last 48 hours using a pain scale between 0 mm (none) and 100 mm (severe), which corresponded to the magnitude of their pain.
    Time Frame Baseline to Week 104

    Outcome Measure Data

    Analysis Population Description
    mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach. The values were converted to cm for analysis purposes.
    Arm/Group Title Etanercept Placebo
    Arm/Group Description Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID. Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
    Measure Participants 106 109
    Week 2 (N = 105, 108)
    -1.00
    (0.27)
    -0.08
    (0.26)
    Week 4 (N = 105, 109)
    -1.34
    (0.29)
    -0.55
    (0.27)
    Week 8 (N = 105, 109)
    -1.85
    (0.32)
    -1.02
    (0.30)
    Week 12 (N = 105, 109)
    -2.06
    (0.31)
    -1.26
    (0.30)
    Week 16 (N = 100, 105)
    -2.81
    (0.27)
    -2.65
    (0.24)
    Week 24 (N = 100, 105)
    -2.92
    (0.28)
    -3.21
    (0.23)
    Week 32 (N = 100, 105)
    -2.99
    (0.27)
    -3.23
    (0.27)
    Week 40 (N = 100, 105)
    -3.38
    (0.27)
    -3.33
    (0.25)
    Week 48 (N = 100, 105)
    -3.24
    (0.28)
    -3.36
    (0.27)
    Week 56 (N = 100, 105)
    -3.30
    (0.28)
    -3.45
    (0.25)
    Week 68 (N = 100, 105)
    -3.31
    (0.28)
    -3.57
    (0.25)
    Week 80 (N = 100, 105)
    -3.10
    (0.27)
    -3.49
    (0.25)
    Week 92 (N = 100, 105)
    -3.34
    (0.28)
    -3.65
    (0.25)
    Week 104 (N = 100, 105)
    -3.33
    (0.30)
    -3.75
    (0.24)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments All within group comparisons to baseline were <0.001, from paired t-test. For open-label period results included unadjusted mean changes and standard errors, no covariate adjustments were applied.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method t-test, 2 sided
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0102
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.80
    Confidence Interval (2-Sided) 95%
    -1.40 to -0.19
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0007
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.92
    Confidence Interval (2-Sided) 95%
    -1.44 to -0.39
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0057
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.79
    Confidence Interval (2-Sided) 95%
    -1.35 to -0.23
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0077
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.83
    Confidence Interval (2-Sided) 95%
    -1.44 to -0.22
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    10. Secondary Outcome
    Title Changes From Baseline in VAS Score for Nocturnal Back Pain at Time Points
    Description The VAS scale was used to assess the level of nocturnal pain during the past 48 hours. For this, participants marked their level of pain on a 100 mm VAS anchored by 0 for "No pain " to 100 mm for "Most Severe Pain."
    Time Frame Baseline to Week 104

    Outcome Measure Data

    Analysis Population Description
    mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach. The values were converted to cm for analysis purposes.
    Arm/Group Title Etanercept Placebo
    Arm/Group Description Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID. Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
    Measure Participants 106 109
    Week 2 (N = 105, 107)
    -1.10
    (0.31)
    -0.31
    (0.29)
    Week 4 (N = 105, 109)
    -1.54
    (0.33)
    -0.71
    (0.31)
    Week 8 (N = 105, 109)
    -2.31
    (0.33)
    -1.34
    (0.31)
    Week 12 (N = 105, 109)
    -1.96
    (0.36)
    -1.03
    (0.34)
    Week 16 (N = 100, 105)
    -2.97
    (0.31)
    -2.63
    (0.26)
    Week 24 (N = 100, 105)
    -2.79
    (0.30)
    -3.25
    (0.26)
    Week 32 (N = 100, 105)
    -2.69
    (0.31)
    -3.11
    (0.29)
    Week 40 (N = 100, 105)
    -3.34
    (0.31)
    -3.30
    (0.26)
    Week 48 (N = 100, 105)
    -3.22
    (0.31)
    -3.21
    (0.27)
    Week 56 (N = 100, 105)
    -3.15
    (0.33)
    -3.40
    (0.27)
    Week 68 (N = 100, 105)
    -3.07
    (0.33)
    -3.27
    (0.26)
    Week 80 (N = 100, 105)
    -3.01
    (0.31)
    -3.32
    (0.27)
    Week 92 (N = 100, 105)
    -3.26
    (0.32)
    -3.43
    (0.27)
    Week 104 (N = 100, 105)
    -3.28
    (0.34)
    -3.59
    (0.27)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments All within group comparisons to baseline were <0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method t-test, 2 sided
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0091
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.93
    Confidence Interval (2-Sided) 95%
    -1.62 to -0.23
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0097
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.79
    Confidence Interval (2-Sided) 95%
    -1.38 to -0.19
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0101
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.82
    Confidence Interval (2-Sided) 95%
    -1.45 to -0.20
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0031
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.97
    Confidence Interval (2-Sided) 95%
    -1.61 to -0.33
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    11. Secondary Outcome
    Title Changes From Baseline in VAS Score for Total Back Pain at Time Points
    Description The VAS scale was used to assess the level of total back pain during the past 48 hours. For this, participants marked their level of pain on a 100 mm VAS anchored by 0 for "No pain " to 100 mm for "Most Severe Pain."
    Time Frame Baseline to Week 104

    Outcome Measure Data

    Analysis Population Description
    mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach. The values were converted to cm for analysis purposes.
    Arm/Group Title Etanercept Placebo
    Arm/Group Description Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID. Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
    Measure Participants 106 109
    Week 2 (N = 105, 107)
    -0.95
    (0.29)
    -0.37
    (0.27)
    Week 4 (N = 105, 109)
    -1.52
    (0.31)
    -0.88
    (0.29)
    Week 8 (N = 105, 109)
    -2.19
    (0.33)
    -1.18
    (0.31)
    Week 12 (n = 105, 109)
    -2.32
    (0.28)
    -1.39
    (0.21)
    Week 16 (n = 100, 105)
    -2.73
    (0.29)
    -2.64
    (0.25)
    Week 24 (n = 100, 105)
    -2.76
    (0.28)
    -2.92
    (0.24)
    Week 32 (n = 100, 105)
    -2.58
    (0.29)
    -2.87
    (0.26)
    Week 40 (n = 100, 105)
    -3.30
    (0.28)
    -3.20
    (0.24)
    Week 48 (n = 100, 105)
    -3.09
    (0.29)
    -3.14
    (0.25)
    Week 56 (n = 100, 105)
    -3.10
    (0.29)
    -3.17
    (0.26)
    Week 68 (n = 100, 105)
    -3.02
    (0.31)
    -3.23
    (0.26)
    Week 80 (n = 100, 105)
    -2.95
    (0.29)
    -3.17
    (0.26)
    Week 92 (n = 100, 105)
    -3.30
    (0.29)
    -3.33
    (0.27)
    Week 104 (n = 100, 105)
    -3.22
    (0.32)
    -3.47
    (0.26)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments All within group comparisons to baseline were <0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method t-test, 2 sided
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0064
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.87
    Confidence Interval (2-Sided) 95%
    -1.49 to -0.25
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0407
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.57
    Confidence Interval (2-Sided) 95%
    -1.12 to -0.02
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0349
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.64
    Confidence Interval (2-Sided) 95%
    -1.24 to -0.05
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0021
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -1.01
    Confidence Interval (2-Sided) 95%
    -1.65 to -0.37
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    12. Secondary Outcome
    Title Changes From Baseline in the Bath Ankylosing Spondylitis Functional Index (BASFI) Total Score at Time Points
    Description BASFI is a validated self assessment tool that determines the degree of functional limitation in AS. Utilizing a VAS of 0-10 (0 = easy, 10 = impossible), participants answered 10 questions assessing their ability in completing normal daily activities or physically demanding activities. The BASFI score is a mean score of the 10 questions.
    Time Frame Baseline to Week 104

    Outcome Measure Data

    Analysis Population Description
    mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.
    Arm/Group Title Etanercept Placebo
    Arm/Group Description Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID. Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
    Measure Participants 106 109
    Week 2 (N = 105, 107)
    -0.82
    (0.21)
    -0.27
    (0.20)
    Week 4 (N = 105, 108)
    -0.99
    (0.22)
    -0.44
    (0.21)
    Week 8 (N = 105, 108)
    -1.28
    (0.23)
    -0.73
    (0.22)
    Week 12 (N = 105, 109)
    -1.41
    (0.24)
    -0.84
    (0.23)
    Week 16 (N = 100, 105)
    -1.78
    (0.23)
    -1.75
    (0.19)
    Week 24 (N = 100, 105)
    -1.89
    (0.22)
    -1.85
    (0.20)
    Week 32 (N = 100, 105)
    -1.81
    (0.22)
    -1.98
    (0.21)
    Week 40 (N = 100, 105)
    -2.19
    (0.23)
    -2.13
    (0.21)
    Week 48 (N = 100, 105)
    -2.19
    (0.23)
    -2.10
    (0.22)
    Week 56 (N = 100, 105)
    -2.15
    (0.22)
    -2.30
    (0.21)
    Week 68 (N = 100, 105)
    -2.21
    (0.21)
    -2.31
    (0.22)
    Week 80 (N = 100, 105)
    -2.23
    (0.21)
    -2.19
    (0.22)
    Week 92 (N = 100, 105)
    -2.31
    (0.23)
    -2.35
    (0.22)
    Week 104 (N = 100, 105)
    -2.40
    (0.23)
    -2.36
    (0.23)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments All within group comparisons to baseline were <0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method t-test, 2 sided
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0164
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.57
    Confidence Interval (2-Sided) 95%
    -1.04 to -0.11
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0095
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.54
    Confidence Interval (2-Sided) 95%
    -0.95 to -0.13
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0127
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.55
    Confidence Interval (2-Sided) 95%
    -0.99 to -0.12
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0166
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.55
    Confidence Interval (2-Sided) 95%
    -0.99 to -0.10
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    13. Secondary Outcome
    Title Mean Change From Baseline in BASFI Full Day Activities at Time Points
    Description BASFI is a validated self assessment tool that determines the degree of functional limitation in AS. Utilizing a VAS of 0-10 (0 = easy, 10 = impossible), participants answered 10 questions assessing their ability in completing normal daily activities or physically demanding activities. The BASFI score is a mean score of the 10 questions.
    Time Frame Baseline to Week 104

    Outcome Measure Data

    Analysis Population Description
    mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.
    Arm/Group Title Etanercept Placebo
    Arm/Group Description Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID. Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
    Measure Participants 106 109
    Week 2 (N= 104, 107)
    -0.99
    (0.26)
    -0.21
    (0.25)
    Week 4 (N= 104, 108)
    -1.37
    (0.28)
    -0.70
    (0.26)
    Week 8 (N= 104, 108)
    -1.80
    (0.27)
    -1.05
    (0.26)
    Week 12 (N = 104, 108)
    -2.11
    (0.29)
    -1.16
    (0.27)
    Week 16 (N = 99, 105)
    -2.37
    (0.25)
    -2.03
    (0.24)
    Week 24 (N = 99, 105)
    -2.42
    (0.25)
    -2.13
    (0.25)
    Week 32 (N = 99, 105)
    -2.43
    (0.23)
    -2.38
    (0.25)
    Week 40 (N = 99, 105)
    -2.93
    (0.26)
    -2.30
    (0.25)
    Week 48 (N = 99, 105)
    -2.73
    (0.25)
    -2.34
    (0.27)
    Week 56 (N = 99, 105)
    -2.66
    (0.25)
    -2.59
    (0.26)
    Week 68 (N = 99, 105)
    -2.82
    (0.25)
    -2.71
    (0.27)
    Week 80 (N = 99, 105)
    -2.75
    (0.25)
    -2.58
    (0.27)
    Week 92 (N = 99, 105)
    -2.93
    (0.27)
    -2.70
    (0.27)
    Week 104 (N = 99, 105)
    -3.04
    (0.27)
    -2.66
    (0.27)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments All within group comparisons to baseline were <0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method t-test, 2 sided
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0029
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.78
    Confidence Interval (2-Sided) 95%
    -1.28 to -0.27
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0147
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.67
    Confidence Interval (2-Sided) 95%
    -1.21 to -0.13
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0056
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.75
    Confidence Interval (2-Sided) 95%
    -1.28 to -0.22
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0010
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.95
    Confidence Interval (2-Sided) 95%
    -1.52 to -0.39
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    14. Secondary Outcome
    Title Mean Change From Baseline in BASFI Bending Forward at Time Points
    Description BASFI is a validated self assessment tool that determines the degree of functional limitation in AS. Utilizing a VAS of 0-10 (0 = easy, 10 = impossible), participants answered 10 questions assessing their ability in completing normal daily activities or physically demanding activities. The BASFI score is a mean score of the 10 questions.
    Time Frame Baseline to Week 104

    Outcome Measure Data

    Analysis Population Description
    mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.
    Arm/Group Title Etanercept Placebo
    Arm/Group Description Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID. Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
    Measure Participants 106 109
    Week 2 (N= 105, 107)
    -1.05
    (0.28)
    -0.40
    (0.26)
    Week 4 (N= 105, 108)
    -0.96
    (0.29)
    -0.56
    (0.28)
    Week 8 (N= 105, 108)
    -1.34
    (0.29)
    -0.65
    (0.27)
    Week 12 (N = 105, 109)
    -1.34
    (0.29)
    -0.85
    (0.27)
    Week 16 (N = 100, 105)
    -1.76
    (0.28)
    -1.57
    (0.21)
    Week 24 (N = 100, 105)
    -2.00
    (0.29)
    -1.64
    (0.23)
    Week 32 (N = 100, 105)
    -1.78
    (0.28)
    -1.69
    (0.23)
    Week 40 (N = 100, 105)
    -2.12
    (0.29)
    -1.82
    (0.24)
    Week 48 (N = 100, 105)
    -2.17
    (0.29)
    -1.83
    (0.25)
    Week 56 (N = 100, 105)
    -2.13
    (0.28)
    -2.09
    (0.25)
    Week 68 (N = 100, 105)
    -2.15
    (0.27)
    -1.92
    (0.25)
    Week 80 (N = 100, 105)
    -2.18
    (0.28)
    -1.99
    (0.26)
    Week 92 (N = 100, 105)
    -2.33
    (0.30)
    -2.04
    (0.26)
    Week 104 (N = 100, 105)
    -2.37
    (0.31)
    -2.16
    (0.27)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments All within group comparisons to baseline were <0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method t-test, 2 sided
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0173
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.65
    Confidence Interval (2-Sided) 95%
    -1.19 to -0.12
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.1618
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.40
    Confidence Interval (2-Sided) 95%
    -0.97 to 0.16
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0153
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.69
    Confidence Interval (2-Sided) 95%
    -1.25 to -0.13
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0866
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.49
    Confidence Interval (2-Sided) 95%
    -1.05 to 0.07
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    15. Secondary Outcome
    Title Mean Change From Baseline in BASFI Getting Out of an Arm-less Chair at Time Points
    Description BASFI is a validated self assessment tool that determines the degree of functional limitation in AS. Utilizing a VAS of 0-10 (0 = easy, 10 = impossible), participants answered 10 questions assessing their ability in completing normal daily activities or physically demanding activities. The BASFI score is a mean score of the 10 questions.
    Time Frame Baseline to Week 104

    Outcome Measure Data

    Analysis Population Description
    mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.
    Arm/Group Title Etanercept Placebo
    Arm/Group Description Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID. Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
    Measure Participants 106 109
    Week 2 (N= 105, 107)
    -0.94
    (0.28)
    -0.53
    (0.27)
    Week 4 (N= 105, 108)
    -1.44
    (0.28)
    -0.84
    (0.27)
    Week 8 (N= 105, 108)
    -1.54
    (0.29)
    -1.02
    (0.27)
    Week 12 (N = 105, 108)
    -1.79
    (0.28)
    -1.07
    (0.27)
    Week 16 (N = 100, 105)
    -2.04
    (0.29)
    -1.90
    (0.23)
    Week 24 (N = 100, 105)
    -2.20
    (0.29)
    -2.12
    (0.23)
    Week 32 (N = 100, 105)
    -2.04
    (0.29)
    -2.18
    (0.25)
    Week 40 (N = 100, 105)
    -2.40
    (0.30)
    -2.38
    (0.25)
    Week 48 (N = 100, 105)
    -2.40
    (0.29)
    -2.25
    (0.26)
    Week 56 (N = 100, 105)
    -2.27
    (0.28)
    -2.47
    (0.25)
    Week 68 (N = 100, 105)
    -2.45
    (0.28)
    -2.46
    (0.25)
    Week 80 (N = 100, 105)
    -2.52
    (0.28)
    -2.33
    (0.25)
    Week 92 (N = 100, 105)
    -2.60
    (0.29)
    -2.48
    (0.25)
    Week 104 (N = 100, 105)
    -2.65
    (0.29)
    -2.48
    (0.25)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments All within group comparisons to baseline were <0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method t-test, 2 sided
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.1413
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.41
    Confidence Interval (2-Sided) 95%
    -0.95 to 0.14
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0284
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.60
    Confidence Interval (2-Sided) 95%
    -1.14 to -0.06
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0659
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.52
    Confidence Interval (2-Sided) 95%
    -1.07 to 0.03
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0098
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.72
    Confidence Interval (2-Sided) 95%
    -1.26 to -0.18
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    16. Secondary Outcome
    Title Mean Change From Baseline in BASFI Physically Demanding Activities at Time Points
    Description BASFI is a validated self assessment tool that determines the degree of functional limitation in AS. Utilizing a VAS of 0-10 (0 = easy, 10 = impossible), participants answered 10 questions assessing their ability in completing normal daily activities or physically demanding activities. The BASFI score is a mean score of the 10 questions.
    Time Frame Baseline to Week 104

    Outcome Measure Data

    Analysis Population Description
    mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.
    Arm/Group Title Etanercept Placebo
    Arm/Group Description Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID. Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
    Measure Participants 106 109
    Week 2 (N= 104, 107)
    -0.88
    (0.26)
    -0.13
    (0.25)
    Week 4 (N= 104, 108)
    -1.06
    (0.28)
    -0.26
    (0.27)
    Week 8 (N= 104, 108)
    -1.51
    (0.28)
    -0.80
    (0.26)
    Week 12 (N = 104, 109)
    -1.69
    (0.29)
    -0.91
    (0.27)
    Week 16 (N = 99, 105)
    -2.12
    (0.26)
    -1.79
    (0.25)
    Week 24 (N = 99, 105)
    -2.23
    (0.26)
    -2.05
    (0.26)
    Week 32 (N = 99, 105)
    -2.20
    (0.25)
    -2.19
    (0.24)
    Week 40 (N = 99, 105)
    -2.79
    (0.26)
    -2.24
    (0.27)
    Week 48 (N = 99, 105)
    -2.71
    (0.27)
    -2.25
    (0.26)
    Week 56 (N = 99, 105)
    -2.66
    (0.27)
    -2.37
    (0.28)
    Week 68 (N = 99, 105)
    -2.67
    (0.26)
    -2.60
    (0.29)
    Week 80 (N = 99, 105)
    -2.70
    (0.26)
    -2.39
    (0.28)
    Week 92 (N = 99, 105)
    -2.91
    (0.27)
    -2.59
    (0.28)
    Week 104 (N = 99, 105)
    -3.02
    (0.27)
    -2.59
    (0.30)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments All within group comparisons to baseline were <0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method t-test, 2 sided
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0037
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.75
    Confidence Interval (2-Sided) 95%
    -1.26 to -0.25
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0044
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.80
    Confidence Interval (2-Sided) 95%
    -1.35 to -0.25
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0104
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.71
    Confidence Interval (2-Sided) 95%
    -1.26 to -0.17
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0060
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.78
    Confidence Interval (2-Sided) 95%
    -1.33 to -0.22
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    17. Secondary Outcome
    Title Mean Change From Baseline in BASFI Reaching up High at Time Points
    Description BASFI is a validated self assessment tool that determines the degree of functional limitation in AS. Utilizing a VAS of 0-10 (0 = easy, 10 = impossible), participants answered 10 questions assessing their ability in completing normal daily activities or physically demanding activities. The BASFI score is a mean score of the 10 questions.
    Time Frame Baseline to Week 104

    Outcome Measure Data

    Analysis Population Description
    mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.
    Arm/Group Title Etanercept Placebo
    Arm/Group Description Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID. Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
    Measure Participants 106 109
    Week 2 (N= 105, 107)
    -0.33
    (0.26)
    -0.02
    (0.24)
    Week 4 (N= 105, 108)
    -0.63
    (0.27)
    -0.21
    (0.26)
    Week 8 (N= 105, 108)
    -0.81
    (0.26)
    -0.31
    (0.25)
    Week 12 (N = 105, 109)
    -0.70
    (0.27)
    -0.20
    (0.25)
    Week 16 (N = 100, 105)
    -1.09
    (0.26)
    -1.34
    (0.22)
    Week 24 (N = 100, 105)
    -1.26
    (0.26)
    -1.46
    (0.22)
    Week 32 (N = 100, 105)
    -1.00
    (0.27)
    -1.46
    (0.23)
    Week 40 (N = 100, 105)
    -1.30
    (0.25)
    -1.66
    (0.24)
    Week 48 (N = 100, 105)
    -1.38
    (0.26)
    -1.67
    (0.25)
    Week 56 (N = 100, 105)
    -1.34
    (0.25)
    -1.76
    (0.24)
    Week 68 (N = 100, 105)
    -1.42
    (0.24)
    -1.77
    (0.24)
    Week 80 (N = 100, 105)
    -1.37
    (0.24)
    -1.63
    (0.24)
    Week 92 (N = 100, 105)
    -1.55
    (0.25)
    -1.83
    (0.24)
    Week 104 (N = 100, 105)
    -1.62
    (0.25)
    -1.76
    (0.24)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments All within group comparisons to baseline were <0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method t-test, 2 sided
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.2268
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.30
    Confidence Interval (2-Sided) 95%
    -0.80 to 0.19
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.1145
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.42
    Confidence Interval (2-Sided) 95%
    -0.93 to 0.10
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0512
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.50
    Confidence Interval (2-Sided) 95%
    -1.00 to 0.00
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0509
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.51
    Confidence Interval (2-Sided) 95%
    -1.02 to 0.00
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    18. Secondary Outcome
    Title Mean Change From Baseline in BASFI Climbing Steps Without Aid at Time Points
    Description BASFI is a validated self assessment tool that determines the degree of functional limitation in AS. Utilizing a VAS of 0-10 (0 = easy, 10 = impossible), participants answered 10 questions assessing their ability in completing normal daily activities or physically demanding activities. The BASFI score is a mean score of the 10 questions.
    Time Frame Baseline to Week 104

    Outcome Measure Data

    Analysis Population Description
    mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.
    Arm/Group Title Etanercept Placebo
    Arm/Group Description Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID. Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
    Measure Participants 106 109
    Week 2 (N= 105, 107)
    -0.46
    (0.26)
    -0.16
    (0.24)
    Week 4 (N= 105, 108)
    -0.65
    (0.28)
    -0.09
    (0.26)
    Week 8 (N= 105, 108)
    -0.92
    (0.28)
    -0.44
    (0.27)
    Week 12 (N = 105, 109)
    -0.93
    (0.29)
    -0.58
    (0.27)
    Week 16 (N = 100, 105)
    -1.48
    (0.28)
    -1.64
    (0.24)
    Week 24 (N = 100, 105)
    -1.54
    (0.27)
    -1.65
    (0.25)
    Week 32 (N = 100, 105)
    -1.57
    (0.28)
    -1.97
    (0.25)
    Week 40 (N = 100, 105)
    -1.84
    (0.28)
    -2.19
    (0.26)
    Week 48 (N = 100, 105)
    -1.78
    (0.28)
    -2.05
    (0.28)
    Week 56 (N = 100, 105)
    -1.81
    (0.27)
    -2.26
    (0.26)
    Week 68 (N = 100, 105)
    -1.88
    (0.28)
    -2.34
    (0.28)
    Week 80 (N = 100, 105)
    -1.89
    (0.28)
    -2.16
    (0.26)
    Week 92 (N = 100, 105)
    -1.91
    (0.29)
    -2.38
    (0.28)
    Week 104 (N = 100, 105)
    -2.01
    (0.29)
    -2.42
    (0.28)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments All within group comparisons to baseline were <0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method t-test, 2 sided
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.2430
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.29
    Confidence Interval (2-Sided) 95%
    -0.79 to 0.20
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0384
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.56
    Confidence Interval (2-Sided) 95%
    -1.09 to -0.03
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0797
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.48
    Confidence Interval (2-Sided) 95%
    -1.03 to 0.06
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.2186
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.35
    Confidence Interval (2-Sided) 95%
    -0.90 to 0.21
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    19. Secondary Outcome
    Title Mean Change From Baseline in BASFI Getting-up Off-floor From Back at Time Points
    Description BASFI is a validated self assessment tool that determines the degree of functional limitation in AS. Utilizing a VAS of 0-10 (0 = easy, 10 = impossible), participants answered 10 questions assessing their ability in completing normal daily activities or physically demanding activities. The BASFI score is a mean score of the 10 questions.
    Time Frame Baseline to Week 104

    Outcome Measure Data

    Analysis Population Description
    mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.
    Arm/Group Title Etanercept Placebo
    Arm/Group Description Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID. Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
    Measure Participants 106 109
    Week 2 (N= 105, 107)
    -0.95
    (0.28)
    -0.53
    (0.27)
    Week 8 (N= 105, 108)
    -1.10
    (0.28)
    -0.77
    (0.27)
    Week 12 (N = 105, 109)
    -1.58
    (0.31)
    -1.18
    (0.29)
    Week 12 (N= 105, 108)
    -1.34
    (0.30)
    -1.05
    (0.28)
    Week 16 (N = 100, 105)
    -1.97
    (0.28)
    -2.18
    (0.26)
    Week 24 (N = 100, 105)
    -2.07
    (0.26)
    -2.18
    (0.25)
    Week 32 (N = 100, 105)
    -2.05
    (0.27)
    -2.31
    (0.27)
    Week 40 (N = 100, 105)
    -2.52
    (0.27)
    -2.59
    (0.27)
    Week 48 (N = 100, 105)
    -2.40
    (0.28)
    -2.51
    (0.27)
    Week 56 (N = 100, 105)
    -2.48
    (0.27)
    -2.81
    (0.27)
    Week 68 (N = 100, 105)
    -2.50
    (0.27)
    -2.75
    (0.28)
    Week 80 (N = 100, 105)
    -2.50
    (0.26)
    -2.63
    (0.27)
    Week 92 (N = 100, 105)
    -2.55
    (0.29)
    -2.84
    (0.28)
    Week 104 (N = 100, 105)
    -2.71
    (0.29)
    -2.90
    (0.27)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments All within group comparisons to baseline were <0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method t-test, 2 sided
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.1410
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.41
    Confidence Interval (2-Sided) 95%
    -0.96 to 0.14
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.2299
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.33
    Confidence Interval (2-Sided) 95%
    -0.88 to 0.21
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.3221
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.29
    Confidence Interval (2-Sided) 95%
    -0.87 to 0.29
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.1891
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.40
    Confidence Interval (2-Sided) 95%
    -0.99 to 0.20
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    20. Secondary Outcome
    Title Mean Change From Baseline in BASFI Standing Unsupported for 10 Minutes at Time Points
    Description BASFI is a validated self assessment tool that determines the degree of functional limitation in AS. Utilizing a VAS of 0-10 (0 = easy, 10 = impossible), participants answered 10 questions assessing their ability in completing normal daily activities or physically demanding activities. The BASFI score is a mean score of the 10 questions.
    Time Frame Baseline to Week 104

    Outcome Measure Data

    Analysis Population Description
    mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.
    Arm/Group Title Etanercept Placebo
    Arm/Group Description Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID. Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
    Measure Participants 106 109
    Week 2 (N= 105, 107)
    -0.58
    (0.26)
    -0.17
    (0.24)
    Week 4 (N= 105, 108)
    -0.80
    (0.27)
    -0.25
    (0.25)
    Week 8 (N= 105, 108)
    -1.03
    (0.28)
    -0.60
    (0.27)
    Week 12 (N = 105, 109)
    -1.33
    (0.30)
    -0.97
    (0.29)
    Week 16 (N = 100, 105)
    -1.88
    (0.26)
    -1.93
    (0.23)
    Week 24 (N = 100, 105)
    -1.96
    (0.26)
    -1.98
    (0.25)
    Week 32 (N = 100, 105)
    -1.84
    (0.26)
    -2.19
    (0.25)
    Week 40 (N = 100, 105)
    -2.17
    (0.27)
    -2.44
    (0.26)
    Week 48 (N = 100, 105)
    -2.30
    (0.28)
    -2.41
    (0.28)
    Week 56 (N = 100, 105)
    -2.26
    (0.25)
    -2.63
    (0.26)
    Week 68 (N = 100, 105)
    -2.37
    (0.27)
    -2.64
    (0.27)
    Week 80 (N = 100, 105)
    -2.41
    (0.26)
    -2.56
    (0.26)
    Week 92 (N = 100, 105)
    -2.42
    (0.27)
    -2.72
    (0.28)
    Week 104 (N = 100, 105)
    -2.53
    (0.27)
    -2.74
    (0.27)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments All within group comparisons to baseline were <0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method t-test, 2 sided
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.1080
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.40
    Confidence Interval (2-Sided) 95%
    -0.90 to 0.09
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0389
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.54
    Confidence Interval (2-Sided) 95%
    -1.06 to -0.03
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.1181
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.44
    Confidence Interval (2-Sided) 95%
    -0.98 to 0.11
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.2271
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.36
    Confidence Interval (2-Sided) 95%
    -0.94 to 0.22
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    21. Secondary Outcome
    Title Mean Change From Baseline in BASFI Looking Over Shoulder at Time Points
    Description BASFI is a validated self assessment tool that determines the degree of functional limitation in AS. Utilizing a VAS of 0-10 (0 = easy, 10 = impossible), participants answered 10 questions assessing their ability in completing normal daily activities or physically demanding activities. The BASFI score is a mean score of the 10 questions.
    Time Frame Baseline to Week 104

    Outcome Measure Data

    Analysis Population Description
    mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.
    Arm/Group Title Etanercept Placebo
    Arm/Group Description Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID. Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
    Measure Participants 106 109
    Week 8 (N= 105, 108)
    -1.21
    (0.28)
    -0.84
    (0.26)
    Week 12 (N = 105, 108)
    -1.40
    (0.28)
    -0.82
    (0.27)
    Week 16 (N = 100, 105)
    -1.63
    (0.28)
    -1.69
    (0.26)
    Week 24 (N = 100, 105)
    -1.59
    (0.28)
    -1.84
    (0.27)
    Week 32 (N = 100, 105)
    -1.61
    (0.29)
    -1.92
    (0.26)
    Week 40 (N = 100, 105)
    -1.91
    (0.28)
    -2.03
    (0.27)
    Week 48 (N = 100, 105)
    -1.97
    (0.28)
    -2.08
    (0.27)
    Week 56 (N = 100, 105)
    -1.99
    (0.27)
    -2.27
    (0.26)
    Week 68 (N = 100, 105)
    -2.05
    (0.27)
    -2.25
    (0.27)
    Week 80 (N = 100, 105)
    -2.03
    (0.27)
    -1.94
    (0.29)
    Week 92 (N = 100, 105)
    -1.97
    (0.28)
    -2.19
    (0.27)
    Week 104 (N = 100, 105)
    -2.14
    (0.27)
    -2.16
    (0.28)
    Week 2 (N= 105, 107)
    -0.83
    (0.27)
    -0.07
    (0.25)
    Week 4 (N= 105, 108)
    -0.88
    (0.28)
    -0.33
    (0.27)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments All within group comparisons to baseline were <0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method t-test, 2 sided
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0044
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.75
    Confidence Interval (2-Sided) 95%
    -1.27 to -0.24
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0455
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.55
    Confidence Interval (2-Sided) 95%
    -1.09 to -0.01
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.1750
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.37
    Confidence Interval (2-Sided) 95%
    -0.91 to 0.17
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0379
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.58
    Confidence Interval (2-Sided) 95%
    -1.12 to -0.03
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    22. Secondary Outcome
    Title Mean Change From Baseline in BASFI Putting on Socks at Time Points
    Description BASFI is a validated self assessment tool that determines the degree of functional limitation in AS. Utilizing a VAS of 0-10 (0 = easy, 10 = impossible), participants answered 10 questions assessing their ability in completing normal daily activities or physically demanding activities. The BASFI score is a mean score of the 10 questions.
    Time Frame Baseline to Week 104

    Outcome Measure Data

    Analysis Population Description
    mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.
    Arm/Group Title Etanercept Placebo
    Arm/Group Description Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID. Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
    Measure Participants 106 109
    Week 2 (N= 105, 107)
    -0.94
    (0.27)
    -0.47
    (0.26)
    Week 4 (N= 105, 108)
    -0.74
    (0.29)
    -0.34
    (0.27)
    Week 8 (N= 105, 108)
    -1.04
    (0.28)
    -0.54
    (0.27)
    Week 12 (N = 105, 108)
    -1.02
    (0.28)
    -0.57
    (0.26)
    Week 16 (N = 100, 105)
    -1.52
    (0.29)
    -1.36
    (0.21)
    Week 24 (N = 100, 105)
    -1.65
    (0.29)
    -1.44
    (0.21)
    Week 32 (N = 100, 105)
    -1.55
    (0.29)
    -1.49
    (0.21)
    Week 40 (N = 100, 105)
    -1.92
    (0.28)
    -1.64
    (0.23)
    Week 48 (N = 100, 105)
    -1.95
    (0.28)
    -1.60
    (0.23)
    Week 56 (N = 100, 105)
    -1.85
    (0.29)
    -1.75
    (0.21)
    Week 68 (N = 100, 105)
    -1.80
    (0.27)
    -1.62
    (0.22)
    Week 80 (N = 100, 105)
    -1.92
    (0.29)
    -1.66
    (0.22)
    Week 92 (N = 100, 105)
    -1.93
    (0.29)
    -1.70
    (0.22)
    Week 104 (N = 100, 105)
    -1.95
    (0.29)
    -1.71
    (0.23)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments All within group comparisons to baseline were <0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method t-test, 2 sided
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0826
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.46
    Confidence Interval (2-Sided) 95%
    -0.98 to 0.06
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.1538
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.40
    Confidence Interval (2-Sided) 95%
    -0.96 to 0.15
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0728
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.50
    Confidence Interval (2-Sided) 95%
    -1.04 to 0.05
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0975
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.45
    Confidence Interval (2-Sided) 95%
    -0.99 to 0.08
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    23. Secondary Outcome
    Title Changes From Baseline in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Total Score at Time Points
    Description BASDAI is a validated self assessment tool used to determine disease activity in participant with Ankylosing Spondylitis (AS). Utilizing a VAS of 0-10 (0 = none and 10 = very severe) participant's answered 6 questions measuring discomfort, pain and fatigue. The BASDAI score is obtained by computing the mean score for the 2 questions related to morning stiffness (questions 5 and 6) and then adding that value to the sum of the scores for the first 4 questions and then dividing the total by 5. This can be written as BASDAI=(Q1+Q2+Q3+Q4+(Q5+Q6)/2)/5. The final BASDAI score averages the individual assessments for a final score range of 0-10.
    Time Frame Baseline to Week 104

    Outcome Measure Data

    Analysis Population Description
    mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.
    Arm/Group Title Etanercept Placebo
    Arm/Group Description Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID. Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
    Measure Participants 106 109
    Week 2 (N = 105, 108)
    -0.96
    (0.23)
    -0.39
    (0.22)
    Week 4 (N = 105, 109)
    -1.63
    (0.24)
    -0.97
    (0.22)
    Week 8 (N = 105, 109)
    -2.05
    (0.26)
    -1.24
    (0.25)
    Week 12 (N = 105, 109)
    -1.96
    (0.28)
    -1.31
    (0.27)
    Week 16 (N = 100, 105)
    -2.70
    (0.21)
    -2.98
    (0.20)
    Week 24 (N = 100, 105)
    -2.86
    (0.22)
    -3.26
    (0.19)
    Week 32 (N = 100, 105)
    -2.72
    (0.22)
    -3.24
    (0.22)
    Week 40 (N = 100, 105)
    -3.22
    (0.22)
    -3.41
    (0.21)
    Week 48 (N = 100, 105)
    -3.18
    (0.23)
    -3.47
    (0.22)
    Week 56 (N = 100, 105)
    -3.21
    (0.24)
    -3.50
    (0.21)
    Week 68 (N = 100, 105)
    -3.17
    (0.23)
    -3.69
    (0.22)
    Week 80 (N = 100, 105)
    -3.12
    (0.24)
    -3.59
    (0.22)
    Week 92 (N = 100, 105)
    -3.35
    (0.25)
    -3.77
    (0.23)
    Week 104 (N = 100, 105)
    -3.41
    (0.24)
    -3.87
    (0.23)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments All within group comparisons to baseline were <0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method t-test, 2 sided
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0186
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.65
    Confidence Interval (2-Sided) 95%
    -1.18 to -0.11
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0106
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.57
    Confidence Interval (2-Sided) 95%
    -1.01 to -0.13
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0048
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.66
    Confidence Interval (2-Sided) 95%
    -1.11 to -0.20
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0016
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.81
    Confidence Interval (2-Sided) 95%
    -1.31 to -0.31
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    24. Secondary Outcome
    Title Mean Change From Baseline in BASDAI Level of Morning Stiffness at Time Points
    Description BASDAI is a validated self assessment tool used to determine disease activity in participant with Ankylosing Spondylitis (AS). Utilizing a VAS of 0-10 (0 = none and 10 = very severe) participant's answered 6 questions measuring discomfort, pain and fatigue. The BASDAI score is obtained by computing the mean score for the 2 questions related to morning stiffness (questions 5 and 6) and then adding that value to the sum of the scores for the first 4 questions and then dividing the total by 5. This can be written as BASDAI=(Q1+Q2+Q3+Q4+(Q5+Q6)/2)/5. The final BASDAI score averages the individual assessments for a final score range of 0-10.
    Time Frame Baseline to Week 104

    Outcome Measure Data

    Analysis Population Description
    mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.
    Arm/Group Title Etanercept Placebo
    Arm/Group Description Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID. Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
    Measure Participants 106 109
    Week 2 (N= 105, 108)
    -1.26
    (0.29)
    -0.45
    (0.28)
    Week 4 (N= 105, 108)
    -1.83
    (0.31)
    -1.00
    (0.29)
    Week 8 (N= 101, 106)
    -2.46
    (0.33)
    -1.24
    (0.31)
    Week 12 (N = 101, 106)
    -2.26
    (0.34)
    -1.43
    (0.32)
    Week 16 (N = 100, 105)
    -3.50
    (0.29)
    -3.40
    (0.25)
    Week 24 (N = 100, 105)
    -3.71
    (0.28)
    -4.00
    (0.25)
    Week 32 (N = 100, 105)
    -3.45
    (0.28)
    -3.84
    (0.26)
    Week 40 (N = 100, 105)
    -3.93
    (0.28)
    -4.23
    (0.24)
    Week 48 (N = 100, 105)
    -3.91
    (0.30)
    -4.06
    (0.25)
    Week 56 (N = 100, 105)
    -3.89
    (0.31)
    -4.28
    (0.25)
    Week 68 (N = 100, 105)
    -3.99
    (0.28)
    -4.41
    (0.26)
    Week 80 (N = 100, 105)
    -3.74
    (0.29)
    -4.30
    (0.26)
    Week 92 (N = 100, 105)
    -3.99
    (0.31)
    -4.42
    (0.25)
    Week 104 (N = 100, 105)
    -4.09
    (0.30)
    -4.66
    (0.24)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments All within group comparisons to baseline were <0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method t-test, 2 sided
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0058
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.80
    Confidence Interval (2-Sided) 95%
    -1.37 to -0.24
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0064
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.83
    Confidence Interval (2-Sided) 95%
    -1.42 to -0.24
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0002
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -1.23
    Confidence Interval (2-Sided) 95%
    -1.85 to -0.60
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0134
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.83
    Confidence Interval (2-Sided) 95%
    -1.49 to -0.17
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    25. Secondary Outcome
    Title Mean Change From Baseline in BASDAI Level of Fatigue/Tiredness at Time Points
    Description BASDAI is a validated self assessment tool used to determine disease activity in participant with Ankylosing Spondylitis (AS). Utilizing a VAS of 0-10 (0 = none and 10 = very severe) participant's answered 6 questions measuring discomfort, pain and fatigue. The BASDAI score is obtained by computing the mean score for the 2 questions related to morning stiffness (questions 5 and 6) and then adding that value to the sum of the scores for the first 4 questions and then dividing the total by 5. This can be written as BASDAI=(Q1+Q2+Q3+Q4+(Q5+Q6)/2)/5. The final BASDAI score averages the individual assessments for a final score range of 0-10.
    Time Frame Baseline to Week 104

    Outcome Measure Data

    Analysis Population Description
    mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.
    Arm/Group Title Etanercept Placebo
    Arm/Group Description Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID. Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
    Measure Participants 106 109
    Week 2 (N= 105, 108)
    -0.80
    (0.27)
    -0.23
    (0.26)
    Week 4 (N= 105, 109)
    -1.71
    (0.28)
    -1.26
    (0.26)
    Week 8 (N= 105, 109)
    -1.98
    (0.30)
    -1.29
    (0.29)
    Week 12 (N = 105, 109)
    -1.70
    (0.34)
    -1.32
    (0.32)
    Week 16 (N = 100, 105)
    -2.29
    (0.24)
    -2.89
    (0.25)
    Week 24 (N = 100, 105)
    -2.48
    (0.27)
    -2.95
    (0.23)
    Week 32 (N = 100, 105)
    -2.22
    (0.26)
    -2.74
    (0.26)
    Week 40 (N = 100, 105)
    -2.82
    (0.26)
    -2.93
    (0.26)
    Week 48 (N = 100, 105)
    -2.86
    (0.25)
    -3.19
    (0.26)
    Week 56 (N = 100, 105)
    -3.03
    (0.26)
    -3.20
    (0.26)
    Week 68 (N = 100, 105)
    -2.92
    (0.27)
    -3.48
    (0.24)
    Week 80 (N = 100, 105)
    -3.15
    (0.28)
    -3.36
    (0.26)
    Week 92 (N = 100, 105)
    -3.20
    (0.27)
    -3.68
    (0.25)
    Week 104 (N = 100, 105)
    -3.18
    (0.27)
    -3.63
    (0.28)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments All within group comparisons to baseline were <0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method t-test, 2 sided
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0316
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.57
    Confidence Interval (2-Sided) 95%
    -1.09 to -0.05
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0973
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.45
    Confidence Interval (2-Sided) 95%
    -0.99 to 0.08
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0216
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.68
    Confidence Interval (2-Sided) 95%
    -1.27 to -0.10
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.2425
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.39
    Confidence Interval (2-Sided) 95%
    -1.03 to 0.26
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    26. Secondary Outcome
    Title Mean Change From Baseline in BASDAI Level of Discomfort at Time Points
    Description BASDAI is a validated self assessment tool used to determine disease activity in participant with Ankylosing Spondylitis (AS). Utilizing a VAS of 0-10 (0 = none and 10 = very severe) participant's answered 6 questions measuring discomfort, pain and fatigue. The BASDAI score is obtained by computing the mean score for the 2 questions related to morning stiffness (questions 5 and 6) and then adding that value to the sum of the scores for the first 4 questions and then dividing the total by 5. This can be written as BASDAI=(Q1+Q2+Q3+Q4+(Q5+Q6)/2)/5. The final BASDAI score averages the individual assessments for a final score range of 0-10.
    Time Frame Baseline to Week 104

    Outcome Measure Data

    Analysis Population Description
    mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.
    Arm/Group Title Etanercept Placebo
    Arm/Group Description Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID. Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
    Measure Participants 106 109
    Week 2 (N= 105, 108)
    -0.81
    (0.31)
    -0.48
    (0.29)
    Week 8 (N= 105, 109)
    -1.31
    (0.33)
    -0.77
    (0.31)
    Week 12 (N= 105, 109)
    -1.91
    (0.33)
    -1.20
    (0.31)
    Week 12 (N = 105, 109)
    -1.68
    (0.34)
    -1.29
    (0.32)
    Week 16 (N = 100, 105)
    -2.65
    (0.30)
    -2.82
    (0.25)
    Week 24 (N = 100, 105)
    -2.71
    (0.31)
    -3.07
    (0.26)
    Week 32 (N = 100, 105)
    -2.64
    (0.31)
    -3.25
    (0.27)
    Week 40 (N = 100, 105)
    -3.09
    (0.30)
    -3.25
    (0.27)
    Week 48 (N = 100, 105)
    -2.97
    (0.33)
    -3.27
    (0.29)
    Week 56 (N = 100, 105)
    -3.13
    (0.34)
    -3.24
    (0.29)
    Week 68 (N = 100, 105)
    -3.01
    (0.32)
    -3.49
    (0.31)
    Week 80 (N = 100, 105)
    -2.87
    (0.33)
    -3.50
    (0.28)
    Week 92 (N = 100, 105)
    -3.21
    (0.33)
    -3.57
    (0.30)
    Week 104 (N = 100, 105)
    -3.31
    (0.34)
    -3.72
    (0.29)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments All within group comparisons to baseline were <0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method t-test, 2 sided
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.2688
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.33
    Confidence Interval (2-Sided) 95%
    -0.92 to 0.26
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0866
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.54
    Confidence Interval (2-Sided) 95%
    -1.17 to 0.08
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0277
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.71
    Confidence Interval (2-Sided) 95%
    -1.34 to -0.08
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.2390
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.39
    Confidence Interval (2-Sided) 95%
    -1.04 to 0.26
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    27. Secondary Outcome
    Title Mean Change From Baseline in BASDAI Level of How Long Stiffness Lasts at Time Points
    Description BASDAI is a validated self assessment tool used to determine disease activity in participant with Ankylosing Spondylitis (AS). Utilizing a VAS of 0-10 (0 = none and 10 = very severe) participant's answered 6 questions measuring discomfort, pain and fatigue. The BASDAI score is obtained by computing the mean score for the 2 questions related to morning stiffness (questions 5 and 6) and then adding that value to the sum of the scores for the first 4 questions and then dividing the total by 5. This can be written as BASDAI=(Q1+Q2+Q3+Q4+(Q5+Q6)/2)/5. The final BASDAI score averages the individual assessments for a final score range of 0-10.
    Time Frame Baseline to Week 104

    Outcome Measure Data

    Analysis Population Description
    mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.
    Arm/Group Title Etanercept Placebo
    Arm/Group Description Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID. Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
    Measure Participants 106 109
    Week 2 (N= 105, 108)
    -0.61
    (0.28)
    -0.15
    (0.26)
    Week 4 (N= 105, 109)
    -1.33
    (0.29)
    -0.62
    (0.28)
    Week 8 (N= 105, 109)
    -1.62
    (0.30)
    -0.68
    (0.29)
    Week 12 (N = 105, 109)
    -1.98
    (0.31)
    -0.97
    (0.29)
    Week 16 (N = 100, 105)
    -2.63
    (0.27)
    -2.60
    (0.26)
    Week 24 (N = 100, 105)
    -2.84
    (0.29)
    -3.04
    (0.29)
    Week 32 (N = 100, 105)
    -2.54
    (0.29)
    -3.06
    (0.30)
    Week 40 (N = 100, 105)
    -2.94
    (0.30)
    -3.28
    (0.30)
    Week 48 (N = 100, 105)
    -2.90
    (0.30)
    -3.09
    (0.32)
    Week 56 (N = 100, 105)
    -2.92
    (0.33)
    -3.17
    (0.30)
    Week 68 (N = 100, 105)
    -2.91
    (0.32)
    -3.50
    (0.32)
    Week 80 (N = 100, 105)
    -2.77
    (0.30)
    -3.24
    (0.31)
    Week 92 (N = 100, 105)
    -2.89
    (0.33)
    -3.36
    (0.31)
    Week 104 (N = 100, 105)
    -2.95
    (0.32)
    -3.38
    (0.31)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments All within group comparisons to baseline were <0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method t-test, 2 sided
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0928
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.46
    Confidence Interval (2-Sided) 95%
    -1.00 to 0.08
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0139
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.71
    Confidence Interval (2-Sided) 95%
    -1.27 to -0.15
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0017
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.94
    Confidence Interval (2-Sided) 95%
    -1.53 to -0.36
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0008
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -1.02
    Confidence Interval (2-Sided) 95%
    -1.61 to -0.43
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    28. Secondary Outcome
    Title Mean Change From Baseline in BASDAI Level of Pain/Swelling at Time Points
    Description BASDAI is a validated self assessment tool used to determine disease activity in participant with Ankylosing Spondylitis (AS). Utilizing a VAS of 0-10 (0 = none and 10 = very severe) participant's answered 6 questions measuring discomfort, pain and fatigue. The BASDAI score is obtained by computing the mean score for the 2 questions related to morning stiffness (questions 5 and 6) and then adding that value to the sum of the scores for the first 4 questions and then dividing the total by 5. This can be written as BASDAI=(Q1+Q2+Q3+Q4+(Q5+Q6)/2)/5. The final BASDAI score averages the individual assessments for a final score range of 0-10.
    Time Frame Baseline to Week 104

    Outcome Measure Data

    Analysis Population Description
    mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.
    Arm/Group Title Etanercept Placebo
    Arm/Group Description Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID. Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
    Measure Participants 106 109
    Week 2 (N= 105, 107)
    -0.64
    (0.32)
    -0.41
    (0.30)
    Week 4 (N= 105, 109)
    -1.35
    (0.32)
    -0.68
    (0.31)
    Week 8 (N= 105, 109)
    -1.69
    (0.33)
    -1.01
    (0.31)
    Week 12 (N = 105, 109)
    -1.47
    (0.33)
    -0.87
    (0.32)
    Week 16 (N = 100, 105)
    -2.38
    (0.28)
    -2.66
    (0.28)
    Week 24 (N = 100, 105)
    -2.49
    (0.29)
    -2.92
    (0.28)
    Week 32 (N = 100, 105)
    -2.47
    (0.30)
    -3.10
    (0.29)
    Week 40 (N = 100, 105)
    2.91
    (0.27)
    -3.21
    (0.28)
    Week 48 (N = 100, 105)
    -2.80
    (0.30)
    -3.21
    (0.30)
    Week 56 (N = 100, 105)
    -2.66
    (0.31)
    -3.13
    (0.29)
    Week 68 (N = 100, 105)
    -2.60
    (0.32)
    -3.24
    (0.32)
    Week 80 (N = 100, 105)
    -2.67
    (0.32)
    -3.19
    (0.31)
    Week 92 (N = 100, 105)
    -2.96
    (0.31)
    -3.40
    (0.32)
    Week 104 (N = 100, 105)
    -3.07
    (0.31)
    -3.51
    (0.31)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments All within group comparisons to baseline were <0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method t-test, 2 sided
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.4559
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.23
    Confidence Interval (2-Sided) 95%
    -0.84 to 0.38
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0345
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.66
    Confidence Interval (2-Sided) 95%
    -1.28 to -0.05
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0340
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.68
    Confidence Interval (2-Sided) 95%
    -1.30 to -0.05
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0634
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.60
    Confidence Interval (2-Sided) 95%
    -1.24 to 0.03
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    29. Secondary Outcome
    Title Mean Change From Baseline in BASDAI Level of Neck/Back/Hip Pain at Time Points
    Description BASDAI is a validated self assessment tool used to determine disease activity in participant with Ankylosing Spondylitis (AS). Utilizing a VAS of 0-10 (0 = none and 10 = very severe) participant's answered 6 questions measuring discomfort, pain and fatigue. The BASDAI score is obtained by computing the mean score for the 2 questions related to morning stiffness (questions 5 and 6) and then adding that value to the sum of the scores for the first 4 questions and then dividing the total by 5. This can be written as BASDAI=(Q1+Q2+Q3+Q4+(Q5+Q6)/2)/5. The final BASDAI score averages the individual assessments for a final score range of 0-10.
    Time Frame Baseline to Week 104

    Outcome Measure Data

    Analysis Population Description
    mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.
    Arm/Group Title Etanercept Placebo
    Arm/Group Description Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID. Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
    Measure Participants 106 109
    Week 2 (N= 105, 108)
    -1.34
    (0.29)
    -0.34
    (0.28)
    Week 4 (N= 105, 109)
    -1.91
    (0.31)
    -1.10
    (0.29)
    Week 8 (N= 105, 109)
    -2.32
    (0.33)
    -1.48
    (0.31)
    Week 12 (N = 105, 109)
    -2.44
    (0.35)
    -1.58
    (0.33)
    Week 16 (N = 100, 105)
    -3.13
    (0.28)
    -3.55
    (0.28)
    Week 24 (N = 100, 105)
    -3.32
    (0.27)
    -3.82
    (0.26)
    Week 32 (N = 100, 105)
    -3.27
    (0.26)
    -3.65
    (0.27)
    Week 40 (N = 100, 105)
    -3.81
    (0.27)
    -3.92
    (0.27)
    Week 48 (N = 100, 105)
    -3.85
    (0.27)
    -4.10
    (0.26)
    Week 56 (N = 100, 105)
    -3.82
    (0.27)
    -4.22
    (0.27)
    Week 68 (N = 100, 105)
    -3.83
    (0.26)
    -4.28
    (0.27)
    Week 80 (N = 100, 105)
    -3.60
    (0.28)
    -4.11
    (0.28)
    Week 92 (N = 100, 105)
    -3.88
    (0.29)
    -4.29
    (0.28)
    Week 104 (N = 100, 105)
    -3.96
    (0.29)
    -4.48
    (0.27)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments All within group comparisons to baseline were <0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method t-test, 2 sided
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0007
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -1.00
    Confidence Interval (2-Sided) 95%
    -1.56 to -0.43
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0073
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.81
    Confidence Interval (2-Sided) 95%
    -1.39 to -0.22
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0094
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.85
    Confidence Interval (2-Sided) 95%
    -1.48 to -0.21
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0120
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.87
    Confidence Interval (2-Sided) 95%
    -1.54 to -0.19
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    30. Secondary Outcome
    Title Percentage of Participants With BASDAI 50 at Time Points
    Description Response was defined as a 50% improvement of the Baseline BASDAI to 104 weeks of study treatment, respectively. The BASDAI score is obtained by computing the mean score for the 2 questions related to morning stiffness (questions 5 and 6) and then adding that value to the sum of the scores for the first 4 questions and then dividing the total by 5. This can be written as BASDAI=(Q1+Q2+Q3+Q4+(Q5+Q6)/2)/5.
    Time Frame Baseline to Week 104

    Outcome Measure Data

    Analysis Population Description
    mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.
    Arm/Group Title Etanercept Placebo
    Arm/Group Description Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID. Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
    Measure Participants 105 109
    Week 2 (N = 105, 108)
    17.14
    15.4%
    5.56
    4.9%
    Week 4 (N = 105, 109)
    24.76
    22.3%
    11.01
    9.7%
    Week 8 (N = 105, 109)
    37.14
    33.5%
    22.02
    19.5%
    Week 12 (N = 105, 109)
    43.81
    39.5%
    23.85
    21.1%
    Week 16 (N = 100, 105)
    45.00
    40.5%
    59.05
    52.3%
    Week 24 (N = 100, 105)
    50.00
    45%
    62.86
    55.6%
    Week 32 (N = 100, 105)
    49.00
    44.1%
    59.05
    52.3%
    Week 40 (N = 100, 105)
    58.00
    52.3%
    61.90
    54.8%
    Week 48 (N = 100, 105)
    60.00
    54.1%
    64.76
    57.3%
    Week 56 (N = 100, 105)
    59.00
    53.2%
    65.71
    58.2%
    Week 68 (N = 100, 105)
    61.00
    55%
    66.67
    59%
    Week 80 (N = 100, 105)
    56.00
    50.5%
    66.67
    59%
    Week 92 (N = 100, 105)
    62.00
    55.9%
    71.43
    63.2%
    Week 104 (N = 100, 105)
    64.00
    57.7%
    70.48
    62.4%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0029
    Comments
    Method Cochran-Mantel-Haenszel
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 19.96
    Confidence Interval (2-Sided) 95%
    7.54 to 32.37
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0100
    Comments
    Method Cochran-Mantel-Haenszel
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 11.59
    Confidence Interval (2-Sided) 95%
    3.18 to 19.99
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0120
    Comments
    Method Cochran-Mantel-Haenszel
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 13.75
    Confidence Interval (2-Sided) 95%
    3.62 to 23.89
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0213
    Comments
    Method Cochran-Mantel-Haenszel
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 15.12
    Confidence Interval (2-Sided) 95%
    3.04 to 27.20
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    31. Secondary Outcome
    Title Percentage of Participants With BASDAI 20 at Time Points
    Description Response was defined as a 20% improvement of the Baseline BASDAI to 104 weeks of study treatment. The BASDAI score is obtained by computing the mean score for the 2 questions related to morning stiffness (questions 5 and 6) and then adding that value to the sum of the scores for the first 4 questions and then dividing the total by 5. This can be written as BASDAI=(Q1+Q2+Q3+Q4+(Q5+Q6)/2)/5.
    Time Frame Baseline to Week 104

    Outcome Measure Data

    Analysis Population Description
    mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.
    Arm/Group Title Etanercept Placebo
    Arm/Group Description Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID. Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
    Measure Participants 105 109
    Week 2 (N = 105, 108)
    41.90
    37.7%
    33.33
    29.5%
    Week 4 (N = 105, 109)
    56.19
    50.6%
    42.20
    37.3%
    Week 8 (N = 105, 109)
    66.67
    60.1%
    51.38
    45.5%
    Week 12 (N = 105, 109)
    64.76
    58.3%
    56.88
    50.3%
    Week 16 (N = 100, 105)
    73.00
    65.8%
    82.86
    73.3%
    Week 24 (N = 100, 105)
    77.00
    69.4%
    86.67
    76.7%
    Week 32 (N = 100, 105)
    77.00
    69.4%
    84.76
    75%
    Week 40 (N = 100, 105)
    86.00
    77.5%
    87.62
    77.5%
    Week 48 (N = 100, 105)
    81.00
    73%
    87.62
    77.5%
    Week 56 (N = 100, 105)
    81.00
    73%
    85.71
    75.8%
    Week 68 (N = 100, 105)
    80.00
    72.1%
    90.48
    80.1%
    Week 80 (N = 100, 105)
    81.00
    73%
    88.57
    78.4%
    Week 92 (N = 100, 105)
    82.00
    73.9%
    88.57
    78.4%
    Week 104 (N = 100, 105)
    84.00
    75.7%
    90.48
    80.1%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.2755
    Comments
    Method Cochran-Mantel-Haenszel
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 7.88
    Confidence Interval (2-Sided) 95%
    -5.15 to 20.92
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.1950
    Comments
    Method Cochran-Mantel-Haenszel
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 8.57
    Confidence Interval (2-Sided) 95%
    -4.39 to 21.54
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0278
    Comments
    Method Cochran-Mantel-Haenszel
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 13.99
    Confidence Interval (2-Sided) 95%
    0.72 to 27.26
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0174
    Comments
    Method Cochran-Mantel-Haenszel
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 15.29
    Confidence Interval (2-Sided) 95%
    2.28 to 28.30
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    32. Secondary Outcome
    Title Change From Baseline in Bath Ankylosing Spondylitis Global Index (BAS-G) Total Score at Time Points
    Description The BAS-G was a 2 question assessment evaluating the effect of AS on the participants well-being over the last week and last 6 months. The 2 questions were: How have you been over the last week? and How have you been over the last six months?. Each question is scored by the participant on a 100 mm scale ranging from 0 (Very Good) to 100 (Very Bad). The two values are averaged to obtain the BAS-G score.
    Time Frame Baseline to Week 104

    Outcome Measure Data

    Analysis Population Description
    mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.
    Arm/Group Title Etanercept Placebo
    Arm/Group Description Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID. Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
    Measure Participants 106 109
    Week 4 (N = 105, 109)
    -1.29
    (0.24)
    -0.75
    (0.22)
    Week 12 (N = 105, 109)
    -1.85
    (0.27)
    -1.35
    (0.25)
    Week 24 (N = 100, 105)
    -2.80
    (0.24)
    -2.87
    (0.19)
    Week 48 (N = 105, 109)
    -3.20
    (0.25)
    -3.51
    (0.22)
    Week 68 (N = 105, 109)
    -3.28
    (0.25)
    -3.77
    (0.23)
    Week 92 (N = 105, 109)
    -3.55
    (0.25)
    -3.81
    (0.23)
    Week 104 (N = 105, 109)
    -3.59
    (0.26)
    -3.92
    (0.24)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments All within group comparisons to baseline were <0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method t-test, 2 sided
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 4 and 12 data only. Week 4
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0201
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.54
    Confidence Interval (2-Sided) 95%
    -0.99 to -0.09
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 4 and 12 data only. Week 12
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0558
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.50
    Confidence Interval (2-Sided) 95%
    -1.02 to 0.01
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    33. Secondary Outcome
    Title Mean Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) Total Score at Time Points
    Description BASMI is an objective measure of spinal mobility. The BASMI score is composed of 5 measures: cervical rotation, intermalleolar distance, modified Schober's test, lateral flexion and tragus to wall distance. Each measure was scored 0-2 (0=normal mobility, 2=severe reduction) to give a final score ranging 0 to 10.
    Time Frame Baseline to Week 104

    Outcome Measure Data

    Analysis Population Description
    mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.
    Arm/Group Title Etanercept Placebo
    Arm/Group Description Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID. Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
    Measure Participants 104 109
    Week 2 (N = 103, 108)
    -0.08
    (0.12)
    -0.13
    (0.11)
    Week 4 (N = 103, 109)
    -0.30
    (0.12)
    -0.20
    (0.11)
    Week 8 (N = 103, 109)
    -0.36
    (0.14)
    -0.41
    (0.13)
    Week 12 (N = 103, 109)
    -0.34
    (0.14)
    -0.19
    (0.10)
    Week 16 (N = 98, 105)
    -0.44
    (0.14)
    -0.35
    (0.10)
    Week 24 (N = 98, 105)
    -0.48
    (0.13)
    -0.34
    (0.10)
    Week 40 (N = 98, 105)
    -0.49
    (0.14)
    -0.49
    (0.11)
    Week 32 (N = 98, 105)
    -0.55
    (0.14)
    -0.47
    (0.11)
    Week 48 (N = 98, 105)
    -0.54
    (0.13)
    -0.44
    (0.11)
    Week 56 (N = 98, 105)
    -0.56
    (0.13)
    -0.49
    (0.11)
    Week 68 (N = 98, 105)
    -0.60
    (0.13)
    -0.58
    (0.11)
    Week 80 (N = 98, 105)
    -0.64
    (0.14)
    -0.62
    (0.11)
    Week 92 (N = 98, 105)
    -0.61
    (0.13)
    -0.62
    (0.11)
    Week 104 (N = 98, 105)
    -0.61
    (0.14)
    -0.55
    (0.11)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments All within group comparisons to baseline were <0.001, from paired t-test, after Week 24. For label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method t-test, 2 sided
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.6741
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 0.05
    Confidence Interval (2-Sided) 95%
    -0.18 to 0.28
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.3896
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.10
    Confidence Interval (2-Sided) 95%
    -0.33 to 0.13
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.7468
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 0.04
    Confidence Interval (2-Sided) 95%
    -0.22 to 0.31
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.6871
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.06
    Confidence Interval (2-Sided) 95%
    -0.35 to 0.23
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    34. Secondary Outcome
    Title Mean Change From Baseline in BASMI Lateral Side Flexion Score by Time Point
    Description BASMI is an objective measure of spinal mobility. The BASMI score is composed of 5 measures: cervical rotation, intermalleolar distance, modified Schober's test, lateral flexion and tragus to wall distance. Each measure was scored 0-2 (0=normal mobility, 2=severe reduction) to give a final score ranging 0 to 10.
    Time Frame Baseline to Week 104

    Outcome Measure Data

    Analysis Population Description
    mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.
    Arm/Group Title Etanercept Placebo
    Arm/Group Description Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID. Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
    Measure Participants 104 109
    Week 2 (N= 100, 105)
    1.06
    (0.49)
    0.69
    (0.46)
    Week 4 (N= 100, 106)
    1.49
    (0.51)
    1.49
    (0.48)
    Week 8 (N= 100, 106)
    1.64
    (0.53)
    0.91
    (0.50)
    Week 12 (N = 100, 106)
    1.64
    (0.62)
    0.43
    (0.58)
    Week 16 (N = 98, 105)
    1.35
    (0.55)
    1.02
    (0.32)
    Week 24 (N = 98, 105)
    1.97
    (0.66)
    1.29
    (0.34)
    Week 32 (N = 98, 105)
    2.03
    (0.57)
    1.62
    (0.35)
    Week 40 (N = 98, 105)
    1.86
    (0.59)
    1.57
    (0.38)
    Week 48 (N = 98, 105)
    2.20
    (0.55)
    1.36
    (0.34)
    Week 56 (N = 98, 105)
    1.82
    (0.54)
    1.43
    (0.36)
    Week 68 (N = 98, 105)
    2.24
    (0.58)
    1.54
    (0.41)
    Week 80 (N = 98, 105)
    1.96
    (0.59)
    1.52
    (0.40)
    Week 92 (N = 98, 105)
    2.14
    (0.60)
    1.50
    (0.38)
    Week 104 (N = 98, 105)
    1.97
    (0.59)
    1.65
    (0.37)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments All within group comparisons to baseline were <0.001, from paired t-test, after Week 24. For label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method t-test, 2 sided
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.4332
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 0.37
    Confidence Interval (2-Sided) 95%
    -0.57 to 1.32
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.9947
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.00
    Confidence Interval (2-Sided) 95%
    -0.98 to 0.98
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.1558
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 0.74
    Confidence Interval (2-Sided) 95%
    -0.28 to 1.75
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0488
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 1.21
    Confidence Interval (2-Sided) 95%
    0.03 to 2.39
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    35. Secondary Outcome
    Title Mean Change From Baseline in BASMI Cervical Rotation Degree by Time Point
    Description BASMI is an objective measure of spinal mobility. The BASMI score is composed of 5 measures: cervical rotation, intermalleolar distance, modified Schober's test, lateral flexion and tragus to wall distance. Each measure was scored 0-2 (0=normal mobility, 2=severe reduction) to give a final score ranging 0 to 10.
    Time Frame Baseline to Week 104

    Outcome Measure Data

    Analysis Population Description
    mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.
    Arm/Group Title Etanercept Placebo
    Arm/Group Description Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID. Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
    Measure Participants 106 109
    Week 2 (N= 105, 108)
    1.35
    (1.26)
    0.98
    (1.19)
    Week 4 (N= 105, 109)
    3.52
    (1.31)
    2.49
    (1.23)
    Week 8 (N= 105, 109)
    4.92
    (1.42)
    3.86
    (1.34)
    Week 12 (N = 105, 109)
    4.46
    (1.52)
    2.07
    (1.44)
    Week 16 (N = 100, 105)
    5.13
    (1.37)
    4.73
    (1.09)
    Week 24 (N = 100, 105)
    5.00
    (1.35)
    5.10
    (1.18)
    Week 32 (N = 100, 105)
    5.32
    (1.43)
    6.00
    (1.25)
    Week 40 (N = 100, 105)
    5.56
    (1.51)
    5.61
    (1.19)
    Week 48 (N = 100, 105)
    5.04
    (1.48)
    6.90
    (1.19)
    Week 56 (N = 100, 105)
    5.70
    (1.44)
    6.92
    (1.31)
    Week 68 (N = 100, 105)
    6.47
    (1.43)
    8.10
    (1.23)
    Week 80 (N = 100, 105)
    6.14
    (1.45)
    7.96
    (1.23)
    Week 92 (N = 100, 105)
    6.26
    (1.50)
    8.25
    (1.24)
    Week 104 (N = 100, 105)
    5.92
    (1.57)
    8.55
    (1.22)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments All within group comparisons to baseline were <0.001, from paired t-test, after Week 24. For label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method t-test, 2 sided
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.7645
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 0.37
    Confidence Interval (2-Sided) 95%
    -2.06 to 2.80
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.4178
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 1.03
    Confidence Interval (2-Sided) 95%
    -1.48 to 3.55
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.4430
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 1.06
    Confidence Interval (2-Sided) 95%
    -1.67 to 3.79
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.1095
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 2.39
    Confidence Interval (2-Sided) 95%
    -0.54 to 5.31
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    36. Secondary Outcome
    Title Mean Change From Baseline in BASMI Modified Schobers Test Score by Time Point
    Description BASMI is an objective measure of spinal mobility. The BASMI score is composed of 5 measures: cervical rotation, intermalleolar distance, modified Schober's test, lateral flexion and tragus to wall distance. Each measure was scored 0-2 (0=normal mobility, 2=severe reduction) to give a final score ranging 0 to 10.
    Time Frame Baseline to Week 104

    Outcome Measure Data

    Analysis Population Description
    mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.
    Arm/Group Title Etanercept Placebo
    Arm/Group Description Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID. Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
    Measure Participants 104 109
    Week 2 (N= 89, 90)
    0.17
    (0.24)
    0.16
    (0.23)
    Week 4 (N= 89, 90)
    0.02
    (0.26)
    0.20
    (0.25)
    Week 8 (N= 89, 90)
    0.15
    (0.26)
    0.12
    (0.25)
    Week 12 (N = 89, 90)
    0.05
    (0.31)
    0.04
    (0.30)
    Week 16 (N = 86, 86)
    0.71
    (0.23)
    0.37
    (0.24)
    Week 24 (N = 86, 86)
    0.98
    (0.27)
    0.54
    (0.25)
    Week 32 (N = 86, 86)
    0.73
    (0.30)
    0.54
    (0.28)
    Week 40 (N = 86, 86)
    0.68
    (0.24)
    0.77
    (0.25)
    Week 48 (N = 86, 86)
    0.75
    (0.26)
    0.63
    (0.26)
    Week 56 (N = 86, 86)
    1.16
    (0.36)
    0.79
    (0.32)
    Week 68 (N = 86, 86)
    1.34
    (0.35)
    0.89
    (0.31)
    Week 80 (N = 86, 86)
    1.38
    (0.38)
    0.97
    (0.31)
    Week 92 (N = 86, 86)
    1.03
    (0.35)
    0.88
    (0.29)
    Week 104 (N = 86, 86)
    0.99
    (0.36)
    0.92
    (0.33)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments All within group comparisons to baseline were <0.001, from paired t-test, after Week 24. For label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method t-test, 2 sided
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.9504
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 0.01
    Confidence Interval (2-Sided) 95%
    -0.46 to 0.49
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.4971
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.18
    Confidence Interval (2-Sided) 95%
    -0.70 to 0.34
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.8999
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 0.03
    Confidence Interval (2-Sided) 95%
    -0.47 to 0.54
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.9712
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 0.01
    Confidence Interval (2-Sided) 95%
    -0.60 to 0.62
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    37. Secondary Outcome
    Title Mean Change From Baseline in BASMI Intermalleolar Distance Score by Time Point
    Description BASMI is an objective measure of spinal mobility. The BASMI score is composed of 5 measures: cervical rotation, intermalleolar distance, modified Schober's test, lateral flexion and tragus to wall distance. Each measure was scored 0-2 (0=normal mobility, 2=severe reduction) to give a final score ranging 0 to 10.
    Time Frame Baseline to Week 104

    Outcome Measure Data

    Analysis Population Description
    mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.
    Arm/Group Title Etanercept Placebo
    Arm/Group Description Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID. Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
    Measure Participants 104 109
    Week 2 (N= 105, 108)
    0.75
    (1.22)
    -0.15
    (1.15)
    Week 4 (N= 105, 109)
    4.02
    (1.50)
    1.17
    (1.42)
    Week 8 (N= 105, 109)
    4.25
    (1.70)
    1.99
    (1.61)
    Week 12 (N = 105, 109)
    3.25
    (1.75)
    1.81
    (1.66)
    Week 16 (N = 100, 105)
    6.28
    (1.44)
    3.73
    (1.27)
    Week 24 (N = 100, 105)
    7.48
    (1.41)
    4.76
    (1.30)
    Week 32 (N = 100, 105)
    8.09
    (1.38)
    5.01
    (1.35)
    Week 40 (N = 100, 105)
    8.38
    (1.38)
    5.61
    (1.34)
    Week 48 (N = 100, 105)
    8.35
    (1.50)
    6.32
    (1.33)
    Week 56 (N = 100, 105)
    9.31
    (1.48)
    7.42
    (1.38)
    Week 68 (N = 100, 105)
    9.26
    (1.55)
    7.92
    (1.37)
    Week 80 (N = 100, 105)
    9.17
    (1.55)
    8.73
    (1.32)
    Week 92 (N = 100, 105)
    9.80
    (1.55)
    9.05
    (1.34)
    Week 104 (N = 100, 105)
    8.91
    (1.57)
    8.72
    (1.35)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments All within group comparisons to baseline were <0.001, from paired t-test, after Week 24. For label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method t-test, 2 sided
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.4556
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 0.89
    Confidence Interval (2-Sided) 95%
    -1.46 to 3.24
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0543
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 2.85
    Confidence Interval (2-Sided) 95%
    -0.05 to 5.75
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.1754
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 2.26
    Confidence Interval (2-Sided) 95%
    -1.02 to 5.53
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.3985
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 1.45
    Confidence Interval (2-Sided) 95%
    -1.93 to 4.82
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    38. Secondary Outcome
    Title Mean Change From Baseline in BASMI Tragus to Wall Score by Time Point
    Description BASMI is an objective measure of spinal mobility. The BASMI score is composed of 5 measures: cervical rotation, intermalleolar distance, modified Schober's test, lateral flexion and tragus to wall distance. Each measure was scored 0-2 (0=normal mobility, 2=severe reduction) to give a final score ranging 0 to 10.
    Time Frame Baseline to Week 104

    Outcome Measure Data

    Analysis Population Description
    mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.
    Arm/Group Title Etanercept Placebo
    Arm/Group Description Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID. Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
    Measure Participants 104 109
    Week 2 (N= 105, 108)
    0.02
    (0.21)
    -0.20
    (0.20)
    Week 4 (N= 105, 109)
    -0.20
    (0.21)
    -0.37
    (0.20)
    Week 8 (N= 105, 109)
    -0.31
    (0.20)
    -0.44
    (0.19)
    Week 12 (N = 105, 109)
    -0.29
    (0.23)
    -0.41
    (0.22)
    Week 16 (N = 100, 105)
    0.14
    (0.22)
    -0.02
    (0.16)
    Week 24 (N = 100, 105)
    0.28
    (0.24)
    0.01
    (0.17)
    Week 32 (N = 100, 105)
    0.02
    (0.27)
    0.01
    (0.16)
    Week 40 (N = 100, 105)
    -0.07
    (0.25)
    -0.08
    (0.21)
    Week 48 (N = 100, 105)
    -0.16
    (0.27)
    0.03
    (0.16)
    Week 68 (N = 100, 105)
    -0.28
    (0.27)
    0.08
    (0.18)
    Week 56 (N = 100, 105)
    0.01
    (0.26)
    -0.00
    (0.17)
    Week 80 (N = 100, 105)
    -0.24
    (0.26)
    -0.00
    (0.16)
    Week 92 (N = 100, 105)
    -0.17
    (0.27)
    -0.02
    (0.18)
    Week 104 (N = 100, 105)
    -0.39
    (0.25)
    -0.15
    (0.18)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments All within group comparisons to baseline were <0.001, from paired t-test, after Week 24. For label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method t-test, 2 sided
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.2823
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 0.22
    Confidence Interval (2-Sided) 95%
    -0.18 to 0.62
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.4029
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 0.17
    Confidence Interval (2-Sided) 95%
    -0.23 to 0.58
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.5110
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 0.13
    Confidence Interval (2-Sided) 95%
    -0.25 to 0.51
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.5844
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 0.12
    Confidence Interval (2-Sided) 95%
    -0.32 to 0.56
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    39. Secondary Outcome
    Title Change From Baseline in Chest Expansion at Time Points
    Description Chest expansion, measured in cm, is defined as the difference in thoracic circumference during full expiration versus full inspiration, measured at the fourth intercostal space (nipple line). At maximal inspiration, the chest circumference was measured at nipple line or at the 4th intercostal space (in cm to the nearest 0.1 cm).
    Time Frame Baseline to Week 104

    Outcome Measure Data

    Analysis Population Description
    mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.
    Arm/Group Title Etanercept Placebo
    Arm/Group Description Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID. Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
    Measure Participants 105 108
    Week 2 (N = 104, 105)
    0.16
    (0.22)
    0.69
    (0.20)
    Week 4 (N = 104, 108)
    0.31
    (0.25)
    0.44
    (0.23)
    Week 8 (N = 104, 108)
    0.20
    (0.25)
    0.61
    (0.23)
    Week 12 (N = 104, 108)
    0.12
    (0.25)
    0.37
    (0.24)
    Week 16 (N = 99, 104)
    0.43
    (0.19)
    0.68
    (0.19)
    Week 24 (N = 99, 104)
    0.38
    (0.17)
    0.69
    (0.19)
    Week 32 (N = 99, 104)
    0.49
    (0.18)
    0.62
    (0.18)
    Week 40 (N = 99, 104)
    0.55
    (0.17)
    0.71
    (0.17)
    Week 48 (N = 99, 104)
    0.63
    (0.17)
    0.80
    (0.21)
    Week 56 (N = 99, 104)
    0.49
    (0.18)
    0.72
    (0.19)
    Week 68 (N = 99, 104)
    0.61
    (0.17)
    0.56
    (0.18)
    Week 80 (N = 99, 104)
    0.32
    (0.18)
    0.74
    (0.20)
    Week 92 (N = 99, 104)
    0.52
    (0.18)
    0.56
    (0.20)
    Week 104 (N = 99, 104)
    0.67
    (0.18)
    0.63
    (0.20)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Most within group comparisons to baseline were <0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method t-test, 2 sided
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0129
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.53
    Confidence Interval (2-Sided) 95%
    -0.95 to -0.11
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.6003
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.13
    Confidence Interval (2-Sided) 95%
    -0.61 to 0.35
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0911
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.41
    Confidence Interval (2-Sided) 95%
    -0.89 to 0.07
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.3144
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.25
    Confidence Interval (2-Sided) 95%
    -0.73 to 0.24
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    40. Secondary Outcome
    Title Mean Change From Baseline in Occiput-to-wall Test at Time Points
    Description Occiput-to-wall distance: distance between the occiput (posterior or back portion of the head) and the wall when the participant stood with heels and shoulder against the wall and the back straight.
    Time Frame Baseline to Week 104

    Outcome Measure Data

    Analysis Population Description
    mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.
    Arm/Group Title Etanercept Placebo
    Arm/Group Description Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID. Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
    Measure Participants 105 108
    Week 2 (N = 104, 106)
    -0.21
    (0.19)
    -0.12
    (0.19)
    Week 4 (N = 104, 108)
    -0.37
    (0.20)
    -0.36
    (0.19)
    Week 8 (N = 104, 108)
    -0.09
    (0.24)
    -0.27
    (0.23)
    Week 12 (N = 104, 108)
    -0.28
    (0.24)
    -0.41
    (0.23)
    Week 16 (N = 99, 104)
    -0.24
    (0.25)
    -0.29
    (0.11)
    Week 24 (N = 99, 104)
    -0.11
    (0.25)
    -0.38
    (0.18)
    Week 32 (N = 99, 104)
    -0.20
    (0.25)
    -0.31
    (0.16)
    Week 40 (N = 99, 104)
    -0.34
    (0.22)
    -0.24
    (0.17)
    Week 48 (N = 99, 104)
    -0.25
    (0.24)
    -0.42
    (0.13)
    Week 56 (N = 99, 104)
    -0.42
    (0.22)
    -0.26
    (0.14)
    Week 68 (N = 99, 104)
    -0.42
    (0.23)
    -0.21
    (0.16)
    Week 80 (N = 99, 104)
    -0.34
    (0.24)
    -0.55
    (0.17)
    Week 92 (N = 99, 104)
    -0.29
    (0.24)
    -0.49
    (0.15)
    Week 104 (N = 99, 104)
    -0.73
    (0.26)
    -0.52
    (0.19)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Most within group comparisons to baseline were <0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method t-test, 2 sided
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12, data only. Week 2
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.6476
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.09
    Confidence Interval (2-Sided) 95%
    -0.46 to 0.29
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12, data only. Week 4
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.9777
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.01
    Confidence Interval (2-Sided) 95%
    -0.40 to 0.39
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12, data only. Week 8
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.4453
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 0.18
    Confidence Interval (2-Sided) 95%
    -0.28 to 0.65
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12, data only. Week 12
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.5782
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 0.13
    Confidence Interval (2-Sided) 95%
    -0.33 to 0.60
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    41. Secondary Outcome
    Title Change From Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) - Spine 6 Discovertebral Units (DVU) Total Score at 12 Weeks
    Description The change from baseline in the MRI score of spine was assessed using SPARCC method. The scores of the 6 most severely affected spinal levels (discovertebral units/DVUs) was selected. Each DVU was divided into 4 quadrants. Each quadrant was assigned a score of 0 = no lesion or 1 = increased signal. This was repeated for each of 3 consecutive sagittal slices resulting in a score of up to 12 per DVU. On each slice, the presence of a lesion exhibiting an intense signal in any quadrant was assigned an additional score of 1 for that slice. Additionally, on each slice the presence of a lesion exhibiting depth ≥ 1 cm in any quadrant was given an additional score of 1. The maximum score for 6 DVU Spine Total Score is 108.
    Time Frame Week 12

    Outcome Measure Data

    Analysis Population Description
    mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through observed cases.
    Arm/Group Title Etanercept Placebo
    Arm/Group Description Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID. Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
    Measure Participants 95 105
    Mean (Standard Error) [units on a scale]
    -2.12
    (0.72)
    -2.12
    (0.43)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 12 data only.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0414
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.96
    Confidence Interval (2-Sided) 95%
    -1.88 to -0.04
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    42. Secondary Outcome
    Title Mean Change From Baseline in SPARCC Score for the Sacroiliac Joint at Time Points
    Description The change from baseline in the MRI score of sacroiliac joints was assessed using SPARCC method. Scoring was based on 6 consecutive coronal slices from posterior to anterior. Each joint was divided into 4 quadrants. Each quadrant was assigned a score of 0 = no lesion/1 = increased signal. For each slice, the score is increased by 1 for each joint that exhibits an intense signal in any quadrant. Also, for each slice, an additional score of 1 will be given for each joint that includes a lesion demonstrating continuous increased signal of a depth ≥1 cm from the articular surface. The maximum possible score is 72.
    Time Frame Weeks 12 and 104

    Outcome Measure Data

    Analysis Population Description
    mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through observed cases.
    Arm/Group Title Etanercept Placebo
    Arm/Group Description Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID. Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
    Measure Participants 95 105
    Week 12 (N = 97, 105)
    -3.99
    (0.72)
    -0.86
    (0.43)
    Week 104 (N = 74, 79)
    -6.00
    (1.15)
    -3.36
    (0.84)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Within group comparisons to baseline were <0.001, from paired t-test.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method t-test, 2 sided
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 12 data only.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -2.93
    Confidence Interval (2-Sided) 95%
    -4.16 to -1.70
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    43. Secondary Outcome
    Title Mean Change From Baseline in SPARCC - Spine 6 Discovertebral Units (DVU) Total Score at Time Points
    Description The change from baseline in the MRI score of spine was assessed using SPARCC method. The scores of the 6 most severely affected spinal levels (discovertebral units/DVUs) was selected. Each DVU was divided into 4 quadrants. Each quadrant was assigned a score of 0 = no lesion or 1 = increased signal. This was repeated for each of 3 consecutive sagittal slices resulting in a score of up to 12 per DVU. On each slice, the presence of a lesion exhibiting an intense signal in any quadrant was assigned an additional score of 1 for that slice. Additionally, on each slice the presence of a lesion exhibiting depth ≥ 1 cm in any quadrant was given an additional score of 1. The maximum score for 6 DVU Spine Total Score is 108.
    Time Frame Weeks 12 and 104

    Outcome Measure Data

    Analysis Population Description
    mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through observed cases.
    Arm/Group Title Etanercept Placebo
    Arm/Group Description Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID. Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
    Measure Participants 95 105
    Week 12 (N= 95, 105)
    -2.12
    (0.49)
    -1.16
    (0.47)
    Week 104 (N= 74, 80)
    -2.08
    (0.91)
    -0.78
    (0.49)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Within group comparisons to baseline were <0.001, from paired t-test.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method t-test, 2 sided
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 12 data only.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0414
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.96
    Confidence Interval (2-Sided) 95%
    -1.88 to -0.04
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    44. Secondary Outcome
    Title Mean Change From Baseline in Ankylosing Spondylitis Spine Magnetic Resonance Imaging-Activity (ASspiMRI-a) Total Score
    Description ASspiMRI-a measures acute lesion scores as determined by short-tau inversion recovery (STIR) and gadolinium-enhanced T1 (Gd-DTPA). All 23 disco-vertebral units (DVU) of the spine (from C2 to S1), defined as the region between 2 virtual lines through the middle of each vertebra, are scored in a single dimension, which is representing the highest level of inflammation in that particular DVU. Enhancement and bone marrow edema are graded (0-3) for each DVU, with 3 more grades (4-6) if, in addition to the signs of acute inflammation defined for grades 1-3, erosions are visualized, leading to a maximum score of 138 for the entire spine. Acute spinal changes were assessed by using STIR sagittal views of the cervical, thoracic and lumbar spine. The total score ranges from 0 (no inflammation) to 138 (high inflammation).
    Time Frame Weeks 12 and 104

    Outcome Measure Data

    Analysis Population Description
    mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through observed cases
    Arm/Group Title Etanercept Placebo
    Arm/Group Description Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID. Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
    Measure Participants 95 105
    Week 12 (N= 95 105)
    -0.73
    (0.17)
    -0.33
    (0.16)
    Week 104 (N= 73, 80)
    -0.79
    (0.29)
    -0.28
    (0.16)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 12 data only.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0132
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.40
    Confidence Interval (2-Sided) 95%
    -0.72 to -0.08
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    45. Secondary Outcome
    Title Mean Change From Baseline in Number of Swollen Joints at Time Points
    Description Forty-four (44) joints were assessed by the Investigator to determine the number of joints that were considered swollen (artificial joints were not assessed). The response to pressure/motion on each joint was assessed using the following scale: Present/Absent/Not Done. The 44 joints to be assessed were:sternoclavicular, acromioclavicular, shoulder, elbow, wrist (includes radiocarpal, carpal and carpometacarpal considered as one unit), metacarpophalangeals (I, II, III, IV, V), thumb interphalangeal (IP), proximal IPs (II, III, IV, V), knee, ankle, metatarsophalangeals (I, II, III, IV, V).
    Time Frame Baseline to Week 104

    Outcome Measure Data

    Analysis Population Description
    mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.
    Arm/Group Title Etanercept Placebo
    Arm/Group Description Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID. Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
    Measure Participants 102 105
    Week 2 (N = 100, 102)
    -0.27
    (0.17)
    -0.08
    (0.16)
    Week 4 (N = 100, 105)
    -0.62
    (0.13)
    -0.45
    (0.13)
    Week 8 (N = 101, 105)
    -0.71
    (0.14)
    -0.52
    (0.13)
    Week 12 (N = 101, 105)
    -0.60
    (0.12)
    -0.29
    (0.11)
    Week 16 (N = 96, 102)
    -0.76
    (0.17)
    -0.59
    (0.19)
    Week 24 (N = 96, 102)
    -0.80
    (0.20)
    -0.68
    (0.22)
    Week 32 (N= 96, 102)
    -0.75
    (0.23)
    -0.64
    (0.20)
    Week 40 (N= 96, 102)
    -0.80
    (0.21)
    -0.71
    (0.20)
    Week 48 (N= 96, 102)
    -0.83
    (0.21)
    -0.83
    (0.22)
    Week 56 (N= 96, 102)
    -0.86
    (0.21)
    -0.76
    (0.21)
    Week 68 (N= 96, 102)
    -0.86
    (0.21)
    -0.82
    (0.22)
    Week 80 (N= 96, 102)
    -0.85
    (0.21)
    -0.79
    (0.22)
    Week 92 (N= 96, 102)
    -0.83
    (0.21)
    -0.76
    (0.23)
    Week 104 (N= 96, 102)
    -0.89
    (0.21)
    -0.84
    (0.22)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Within group comparisons to baseline were <0.001, from paired t-test.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method t-test, 2 sided
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.2438
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.19
    Confidence Interval (2-Sided) 95%
    -0.52 to 0.13
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.1958
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.17
    Confidence Interval (2-Sided) 95%
    -0.42 to 0.09
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.1624
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.19
    Confidence Interval (2-Sided) 95%
    -0.46 to 0.08
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0091
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.31
    Confidence Interval (2-Sided) 95%
    -0.54 to -0.08
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    46. Secondary Outcome
    Title Mean Change From Baseline in Number of Tender Joints at Time Points
    Description Forty-four (44) joints were assessed by the Investigator to determine the number of joints that were considered tender or painful. The response to pressure/motion on each joint was assessed using the following scale: Present/Absent/Not Done/Not Applicable (to be considered for artificial joints). The 44 joints to be assessed were:sternoclavicular, acromioclavicular, shoulder, elbow, wrist (includes radiocarpal, carpal and carpometacarpal considered as one unit), metacarpophalangeals (I, II, III, IV, V), thumb interphalangeal (IP), proximal IPs (II, III, IV, V), knee, ankle, metatarsophalangeals (I, II, III, IV, V).
    Time Frame Baseline to Week 104

    Outcome Measure Data

    Analysis Population Description
    mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.
    Arm/Group Title Etanercept Placebo
    Arm/Group Description Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID. Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
    Measure Participants 102 105
    Week 2 (N = 100, 102)
    -1.99
    (0.36)
    -1.38
    (0.35)
    Week 4 (N = 100, 105)
    1.52
    (0.41)
    -1.27
    (0.39)
    Week 8 (N = 101, 105)
    -1.93
    (0.41)
    -2.02
    (0.39)
    Week 12 (N = 101, 105)
    -1.55
    (0.38)
    -1.56
    (0.36)
    Week 16 (N = 96, 102)
    -1.93
    (0.39)
    -2.35
    (0.49)
    Week 24 (N = 96, 102)
    -2.46
    (0.43)
    -2.83
    (0.57)
    Week 32 (N = 96, 102)
    -1.96
    (0.42)
    -3.09
    (0.55)
    Week 40 (N = 96, 102)
    -2.42
    (0.42)
    -3.16
    (0.53)
    Week 48 (N = 96, 102)
    -2.65
    (0.42)
    -2.95
    (0.55)
    Week 56 (N = 96, 102)
    -2.44
    (0.43)
    -3.25
    (0.58)
    Week 68 (N = 96, 102)
    -2.43
    (0.40)
    -3.30
    (0.61)
    Week 80 (N = 96, 102)
    -2.60
    (0.43)
    -3.07
    (0.60)
    Week 92 (N = 96, 102)
    -2.45
    (0.37)
    -3.29
    (0.58)
    Week 104 (N = 96, 102)
    -2.72
    (0.42)
    -3.48
    (0.58)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Within group comparisons to baseline were <0.001, from paired t-test.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method t-test, 2 sided
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0836
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.62
    Confidence Interval (2-Sided) 95%
    -1.32 to 0.08
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.5402
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.24
    Confidence Interval (2-Sided) 95%
    -1.02 to 0.54
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.8167
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 0.09
    Confidence Interval (2-Sided) 95%
    -0.69 to 0.87
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.9891
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 0.01
    Confidence Interval (2-Sided) 95%
    -0.72 to 0.73
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    47. Secondary Outcome
    Title Mean Change From Baseline in Dactylitis Score at Time Points
    Description Each of the 10 fingers and 10 toes is evaluated for dactylitis. A score of 0, 1, 2 or 3 (where 0 = none, 1= mild, 2 = moderate, 3 = severe) is assigned to each. A total score which can range from 0 to 60 is obtained by adding the scores for the 20 digits
    Time Frame Baseline to Week 104

    Outcome Measure Data

    Analysis Population Description
    mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.
    Arm/Group Title Etanercept Placebo
    Arm/Group Description Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID. Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
    Measure Participants 106 108
    Week 2 (N = 105, 107)
    -0.00
    (0.03)
    0.02
    (0.03)
    Week 4 (N = 105, 108)
    -0.09
    (0.03)
    -0.05
    (0.03)
    Week 8 (N = 105, 108)
    -0.19
    (0.02)
    -0.16
    (0.02)
    Week 12 (N = 105, 108)
    -0.19
    (0.08)
    -0.21
    (0.07)
    Week 16 (N = 100, 104)
    -0.21
    (0.13)
    -0.20
    (0.10)
    Week 24 (N = 100, 104)
    -0.23
    (0.13)
    -0.20
    (0.10)
    Week 32 (N = 100, 104)
    -0.23
    (0.13)
    -0.21
    (0.10)
    Week 40 (N = 100, 104)
    -0.22
    (0.13)
    -0.23
    (0.10)
    Week 48 (N = 100, 104)
    -0.22
    (0.13)
    -0.22
    (0.09)
    Week 56 (N = 100, 104)
    -0.23
    (0.13)
    -0.22
    (0.10)
    Week 68 (N = 100, 104)
    -0.20
    (0.11)
    -0.23
    (0.10)
    Week 80 (N = 100, 104)
    -0.23
    (0.13)
    -0.23
    (0.10)
    Week 92 (N = 100, 104)
    -0.17
    (0.10)
    -0.23
    (0.10)
    Week 104 (N = 100, 104)
    -0.23
    (0.13)
    -0.23
    (0.10)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments All within group comparisons to baseline were <0.001, from paired t-test.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method t-test, 2 sided
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.6148
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.02
    Confidence Interval (2-Sided) 95%
    -0.08 to 0.05
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.2547
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.04
    Confidence Interval (2-Sided) 95%
    -0.11 to 0.03
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.1208
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.04
    Confidence Interval (2-Sided) 95%
    -0.08 to 0.01
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.8291
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 0.02
    Confidence Interval (2-Sided) 95%
    -0.13 to 0.17
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    48. Secondary Outcome
    Title Changes From Baseline in Maastricht Ankylosing Spondylitis Enthesis Score (MASES) at Time Points
    Description Assessment of enthesitis was performed in the following 7 domains: 1) 1st costochondral joint left and right, 2) 7th costochondral joint left and right, 3) posterior superior iliac spine left and right, 4) anterior superior iliac spine left and right, 5) iliac crest left and right, 6) 5th lumbar spinous process and 7) proximal insertion of Achilles tendon left and right. Each domain was graded for the presence (1) and absence (0) of tenderness yielding total MASES ranging from 0 (no tenderness) to 13 (worst possible score; severe tenderness).
    Time Frame Baseline to Week 104

    Outcome Measure Data

    Analysis Population Description
    mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.
    Arm/Group Title Etanercept Placebo
    Arm/Group Description Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID. Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
    Measure Participants 105 108
    Week 2 (N = 104, 107)
    -0.94
    (0.23)
    -0.74
    (0.22)
    Week 4 (N = 104, 108)
    -1.11
    (0.27)
    -0.65
    (0.25)
    Week 8 (N = 104, 108)
    -1.39
    (0.27)
    -1.20
    (0.25)
    Week 12 (N = 104, 108)
    -1.40
    (0.28)
    -0.74
    (0.26)
    Week 16 (N = 99, 104)
    -1.64
    (0.24)
    -1.50
    (0.26)
    Week 24 (N = 99, 104)
    -1.78
    (0.25)
    -1.34
    (0.27)
    Week 32 (N = 99, 104)
    -1.59
    (0.26)
    -1.66
    (0.28)
    Week 40 (N = 99, 104)
    -1.86
    (0.26)
    -1.62
    (0.27)
    Week 48 (N = 99, 104)
    -1.79
    (0.27)
    -1.73
    (0.28)
    Week 56 (N = 99, 104)
    -2.01
    (0.28)
    -1.63
    (0.30)
    Week 68 (N = 99, 104)
    -1.92
    (0.27)
    -1.73
    (0.29)
    Week 80 (N = 99, 104)
    -1.99
    (0.28)
    -1.72
    (0.32)
    Week 92 (N = 99, 104)
    -2.00
    (0.26)
    -1.65
    (0.30)
    Week 104 (N = 99, 104)
    -1.87
    (0.28)
    -1.77
    (0.29)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments All within group comparisons to baseline were <0.001, from paired t-test.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method t-test, 2 sided
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.3536
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.21
    Confidence Interval (2-Sided) 95%
    -0.64 to 0.23
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0769
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.46
    Confidence Interval (2-Sided) 95%
    -0.97 to 0.05
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.4698
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.19
    Confidence Interval (2-Sided) 95%
    -0.70 to 0.33
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0167
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.65
    Confidence Interval (2-Sided) 95%
    -1.19 to -0.12
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    49. Secondary Outcome
    Title Change From Baseline in C-reactive Protein (CRP) Concentration Time Points
    Description The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.
    Time Frame Baseline to Week 104

    Outcome Measure Data

    Analysis Population Description
    mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.
    Arm/Group Title Etanercept Placebo
    Arm/Group Description Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID. Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
    Measure Participants 106 108
    Week 2 (N = 105, 107)
    -4.49
    (0.71)
    -1.46
    (0.67)
    Week 4 (N = 105, 108)
    -3.61
    (1.16)
    0.25
    (1.10)
    Week 8 (N = 105, 108)
    -4.07
    (1.33)
    -0.97
    (1.27)
    Week 12 (N = 105, 108)
    -2.78
    (1.14)
    0.65
    (1.08)
    Week 16 (N = 100, 104)
    -4.84
    (1.07)
    -3.82
    (1.08)
    Week 24 (N = 100, 104)
    -4.62
    (1.10)
    -4.56
    (1.04)
    Week 32 (N = 100, 104)
    -4.97
    (1.01)
    -3.88
    (1.01)
    Week 40 (N = 100, 104)
    -4.88
    (1.10)
    -4.26
    (1.08)
    Week 48 (N = 100, 104)
    -4.94
    (1.08)
    -4.64
    (1.06)
    Week 56 (N = 100, 104)
    -5.20
    (1.04)
    -4.59
    (1.02)
    Week 68 (N = 100, 104)
    -5.03
    (1.01)
    -3.93
    (1.09)
    Week 80 (N = 100, 104)
    -4.29
    (1.17)
    -4.12
    (0.99)
    Week 92 (N = 100, 104)
    -5.10
    (1.06)
    -4.44
    (1.04)
    Week 104 (N = 100, 104)
    -4.28
    (1.16)
    -3.65
    (1.12)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Most within group comparisons to baseline were <0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method t-test, 2 sided
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -3.02
    Confidence Interval (2-Sided) 95%
    -4.39 to -1.66
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0008
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -3.86
    Confidence Interval (2-Sided) 95%
    -6.09 to -1.62
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0143
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -3.04
    Confidence Interval (2-Sided) 95%
    -5.47 to -0.61
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0038
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -3.12
    Confidence Interval (2-Sided) 95%
    -5.23 to -1.02
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    50. Secondary Outcome
    Title Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Time Points
    Description 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. Normal range is 0-30 mm/hr. A higher rate is consistent with inflammation.
    Time Frame Baseline to Week 104

    Outcome Measure Data

    Analysis Population Description
    mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.
    Arm/Group Title Etanercept Placebo
    Arm/Group Description Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID. Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
    Measure Participants 101 106
    Week 2 (N = 100, 104)
    -9.02
    (1.61)
    -1.30
    (1.53)
    Week 4 (N = 100, 106)
    -10.00
    (1.57)
    -3.98
    (1.48)
    Week 8 (N = 100, 106)
    -10.79
    (1.84)
    -4.81
    (1.76)
    Week 12 (N = 100, 106)
    -11.34
    (1.80)
    -2.68
    (1.39)
    Week 16 (N = 95, 102)
    -12.75
    (2.03)
    -9.77
    (1.62)
    Week 24 (N = 95, 102)
    -14.22
    (1.96)
    -8.82
    (1.77)
    Week 32 (N = 95, 102)
    -12.76
    (2.04)
    -10.13
    (1.76)
    Week 40 (N = 95, 102)
    -11.49
    (2.22)
    -10.48
    (1.74)
    Week 48 (N = 95, 102)
    -12.20
    (2.05)
    -9.91
    (1.90)
    Week 56 (N = 95, 102)
    -13.03
    (2.18)
    -8.91
    (1.70)
    Week 68 (N = 95, 102)
    -10.80
    (2.17)
    -9.48
    (1.74)
    Week 80 (N = 95, 102)
    -10.74
    (2.14)
    -8.15
    (1.74)
    Week 92 (N = 95, 102)
    -10.84
    (2.28)
    -8.79
    (1.79)
    Week 104 (N = 95, 102)
    -10.51
    (2.15)
    -5.73
    (2.05)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments All within group comparisons to baseline were <0.001, from paired t-test
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method t-test, 2 sided
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -7.71
    Confidence Interval (2-Sided) 95%
    -10.85 to -4.58
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -6.12
    Confidence Interval (2-Sided) 95%
    -9.16 to -3.09
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0009
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -5.78
    Confidence Interval (2-Sided) 95%
    -9.15 to -2.41
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -7.03
    Confidence Interval (2-Sided) 95%
    -10.34 to -3.73
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    51. Secondary Outcome
    Title Change From Baseline in Euro Quality of Life (EQ)-5D VAS Score Time Points
    Description EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
    Time Frame Baseline to Week 104

    Outcome Measure Data

    Analysis Population Description
    mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA.
    Arm/Group Title Etanercept Placebo
    Arm/Group Description Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID. Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
    Measure Participants 90 96
    Week 4 (N = 86, 93)
    4.76
    (2.20)
    4.77
    (2.03)
    Week 8 (N = 85, 93)
    6.66
    (2.84)
    3.05
    (2.65)
    Week 12 (N = 84, 92)
    9.33
    (2.97)
    3.26
    (2.77)
    Week 16 (N = 82, 91)
    12.72
    (2.16)
    11.56
    (2.44)
    Week 24 (N = 82, 90)
    13.21
    (2.23)
    16.61
    (2.26)
    Week 40 (N = 79, 86)
    16.62
    (2.13)
    14.67
    (2.64)
    Week 48 (N = 75, 86)
    16.29
    (2.37)
    18.72
    (2.37)
    Week 68 (N = 72, 82)
    17.26
    (2.18)
    17.90
    (2.60)
    Week 92 (N = 69, 77)
    16.32
    (2.33)
    21.08
    (2.73)
    Week 104 (N = 64, 75)
    19.81
    (2.45)
    23.69
    (2.71)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments With the exception of change from Baseline in the placebo group at Week 12, within group comparisons to baseline for all other treatment groups and time points were <0.001, from paired t-test.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0370
    Comments
    Method t-test, 2 sided
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 4, 8, 12 data only. Week 4
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.9965
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.01
    Confidence Interval (2-Sided) 95%
    -4.39 to 4.37
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 4, 8, 12 data only. Week 8
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.1970
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 3.61
    Confidence Interval (2-Sided) 95%
    -1.89 to 9.10
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 4, 8, 12 data only. Week 12
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0394
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 6.07
    Confidence Interval (2-Sided) 95%
    0.30 to 11.84
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    52. Secondary Outcome
    Title Change From Baseline in EQ-5D Health State Profile Utility Score at Time Points
    Description EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
    Time Frame Baseline to Week 104

    Outcome Measure Data

    Analysis Population Description
    mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA.
    Arm/Group Title Etanercept Placebo
    Arm/Group Description Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID. Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
    Measure Participants 90 96
    Week 4 (N = 89, 96)
    0.14
    (0.03)
    0.09
    (0.03)
    Week 8 (N = 86, 94)
    0.13
    (0.04)
    0.08
    (0.03)
    Week 12 (N = 85, 93)
    0.19
    (0.04)
    0.08
    (0.03)
    Week 16 (N = 83, 90)
    0.19
    (0.04)
    0.17
    (0.03)
    Week 24 (N = 82, 90)
    0.21
    (0.03)
    0.20
    (0.03)
    Week 40 (N = 79, 86)
    0.24
    (0.04)
    0.18
    (0.03)
    Week 48 (N= 75, 86)
    0.23
    (0.03)
    0.22
    (0.03)
    Week 68 (N= 72, 83)
    0.24
    (0.04)
    0.22
    (0.03)
    Week 92 (N= 69, 78)
    0.24
    (0.04)
    0.22
    (0.03)
    Week 104 (N= 64, 75)
    0.29
    (0.04)
    0.25
    (0.03)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Within group comparisons to baseline were <0.01 at Week 12 and <0.001 thereafter, from paired t-test.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.01
    Comments
    Method t-test, 2 sided
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 4, 8, 12 data only. Week 4
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.1341
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 0.05
    Confidence Interval (2-Sided) 95%
    -0.02 to 0.21
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 4, 8, 12 data only. Week 8
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0447
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 0.07
    Confidence Interval (2-Sided) 95%
    0.00 to 0.14
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 4, 8, 12 data only. Week 12
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.1345
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 0.06
    Confidence Interval (2-Sided) 95%
    -0.02 to 0.13
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    53. Secondary Outcome
    Title Change From Baseline in Short Form-36 (SF-36) Physical Component Summary (PCS) at Time Points
    Description SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100 = highest level of functioning).
    Time Frame Baseline to Week 104

    Outcome Measure Data

    Analysis Population Description
    mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA.
    Arm/Group Title Etanercept Placebo
    Arm/Group Description Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID. Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
    Measure Participants 90 96
    Week 4 (N = 89, 96)
    4.04
    (0.79)
    2.72
    (0.74)
    Week 12 (N = 85, 94)
    6.18
    (0.97)
    3.80
    (0.91)
    Week 24 (N = 83, 91)
    6.67
    (0.93)
    7.29
    (0.78)
    Week 48 (N = 77, 86)
    8.03
    (0.96)
    8.51
    (0.85)
    Week 68 (N = 72, 83)
    8.97
    (0.98)
    9.42
    (0.94)
    Week 92 (N = 69, 78)
    8.35
    (1.15)
    9.28
    (0.93)
    Week 104 (N = 65, 75)
    9.98
    (1.03)
    10.38
    (1.01)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Within group comparisons to baseline were <0.001, from paired t-test.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method t-test, 2 sided
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 4, 12 data only. Week 4
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.1035
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 1.31
    Confidence Interval (2-Sided) 95%
    -0.27 to 2.90
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 4, 12 data only. Week 12
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0134
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 2.38
    Confidence Interval (2-Sided) 95%
    0.50 to 4.26
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    54. Secondary Outcome
    Title Change From Baseline in SF-36 Mental Component Summary (MCS) at Time Points
    Description SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).
    Time Frame Baseline to Week 104

    Outcome Measure Data

    Analysis Population Description
    mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA.
    Arm/Group Title Etanercept Placebo
    Arm/Group Description Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID. Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
    Measure Participants 90 96
    Week 4 (N = 89, 96)
    2.65
    (1.02)
    1.47
    (0.94)
    Week 12 (N = 85, 94)
    2.44
    (1.29)
    1.58
    (1.20)
    Week 24 (N = 83, 91)
    3.52
    (1.30)
    4.36
    (0.99)
    Week 48 (N = 77, 86)
    3.47
    (1.18)
    3.54
    (1.07)
    Week 68 (N = 72, 83)
    3.65
    (1.23)
    4.44
    (1.05)
    Week 92 (N = 69, 78)
    4.18
    (1.48)
    4.77
    (1.19)
    Week 104 (N= 65, 75)
    4.90
    (1.34)
    3.74
    (1.06)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Within group comparisons to baseline were <0.05, from paired t-test.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.05
    Comments
    Method t-test, 2 sided
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 4, 12 data only. Week 4
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.2520
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 1.18
    Confidence Interval (2-Sided) 95%
    -0.84 to 3.19
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 4, 12 data only. Week 12
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.4981
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 0.85
    Confidence Interval (2-Sided) 95%
    -1.63 to 3.34
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    55. Secondary Outcome
    Title Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Depression Score at Time Points
    Description This outcome measure is describing the HADS subscale of depression. HADS is a participant rated questionnaire with 2 subscales. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). Each subscale comprised of 7 items with range 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score 0 to 21 for each subscale; higher score indicates greater severity of anxiety and depression symptoms. There is no Total Score for HADS.
    Time Frame Baseline to Week 104

    Outcome Measure Data

    Analysis Population Description
    mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.
    Arm/Group Title Etanercept Placebo
    Arm/Group Description Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID. Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
    Measure Participants 90 96
    Week 4 (N = 89, 96)
    -0.63
    (0.33)
    -0.39
    (0.31)
    Week 12 (N = 85, 94)
    -0.45
    (0.46)
    -0.05
    (0.43)
    Week 24 (N = 83, 91)
    -1.22
    (0.35)
    -1.04
    (0.31)
    Week 48 (N = 77, 85)
    -1.42
    (0.38)
    -1.04
    (0.36)
    Week 68 (N = 72, 82)
    -1.61
    (0.33)
    -1.35
    (0.36)
    Week 92 (N = 69, 78)
    -1.29
    (0.39)
    -1.47
    (0.38)
    Week 104 (N = 65, 74)
    -1.91
    (0.40)
    -1.61
    (0.35)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Within group comparisons to baseline were <0.001, from paired t-test.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method t-test, 2 sided
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 4, 12 data only. Week 4
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.4621
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.24
    Confidence Interval (2-Sided) 95%
    -0.90 to 0.41
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 4, 12 data only. Week 12
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.3842
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.39
    Confidence Interval (2-Sided) 95%
    -1.28 to 0.50
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    56. Secondary Outcome
    Title Change From Baseline in HADS Anxiety Score at Time Points
    Description This outcome measure is describing the HADS subscale of anxiety. HADS is a participant rated questionnaire with 2 subscales. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). Each subscale comprised of 7 items with range 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score 0 to 21 for each subscale; higher score indicates greater severity of anxiety and depression symptoms. There is no Total Score for HADS.
    Time Frame Baseline to Week 104

    Outcome Measure Data

    Analysis Population Description
    mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.
    Arm/Group Title Etanercept Placebo
    Arm/Group Description Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID. Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
    Measure Participants 90 96
    Week 4 (N = 89, 96)
    -0.73
    (0.35)
    -0.89
    (0.32)
    Week 12 (N = 85, 94)
    -1.33
    (0.45)
    -0.81
    (0.43)
    Week 24 (N = 83, 91)
    -0.89
    (0.40)
    -1.66
    (0.33)
    Week 48 (N = 77, 85)
    -1.03
    (0.38)
    -1.40
    (0.34)
    Week 68 (N = 72, 82)
    -1.24
    (0.39)
    -1.76
    (0.41)
    Week 92 (N = 69, 78)
    -0.96
    (0.46)
    -2.24
    (0.35)
    Week 104 (N = 65, 74)
    -1.80
    (0.40)
    -1.74
    (0.39)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Within group comparisons to baseline were <0.001, from paired t-test.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method t-test, 2 sided
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 4, 12 data only. Week 4
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.6357
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 0.17
    Confidence Interval (2-Sided) 95%
    -0.52 to 0.86
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 4, 12 data only. Week 12
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.2439
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.52
    Confidence Interval (2-Sided) 95%
    -1.39 to 0.36
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    57. Secondary Outcome
    Title Change From Baseline in Ankylosing Spondylitis Quality of Life (ASQoL) Score at Time Points
    Description ASQoL is a questionnaire that assesses disease-specific quality of life (QoL). It consists of 18 statements that are relevant to the physical and mental conditions for a participant with Ankylosing Spondylitis (AS): mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each statement is answered by the participant as a 'Yes' (scored as 1) or 'No' (scored as 0). All item scores are summed to give a total score. Total score can range from 0 (good QoL) to 18 (poor QoL).
    Time Frame Baseline to Week 104

    Outcome Measure Data

    Analysis Population Description
    mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA.
    Arm/Group Title Etanercept Placebo
    Arm/Group Description Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID. Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
    Measure Participants 90 96
    Week 12 (N = 88, 94)
    -1.93
    (0.54)
    -1.42
    (0.51)
    Week 24 (N = 83, 91)
    -3.12
    (0.47)
    -3.16
    (0.41)
    Week 48 (N = 77, 86)
    -3.74
    (0.49)
    -3.67
    (0.43)
    Week 68 (N = 72, 83)
    -4.04
    (0.48)
    -4.10
    (0.46)
    Week 92 (N = 69, 77)
    -4.00
    (0.52)
    -4.10
    (0.53)
    Week 104 (N = 65, 73)
    -4.74
    (0.54)
    -3.99
    (0.54)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Within group comparisons to baseline were <0.001, from paired t-test.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method t-test, 2 sided
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Descriptive analysis was carried out for Week 12 data only.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.3286
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.52
    Confidence Interval (2-Sided) 95%
    -1.55 to 0.52
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    58. Secondary Outcome
    Title Change From Baseline in Ankylosing Spondylitis Work Instability Index (AS-WIS) Score at Time Points
    Description The AS-WIS is a 20 item questionnaire to assess work disability and risk of unemployment due to AS. Higher scores indicate greater work impairment and instability that results from a mismatch between an individual's ability levels given their AS and their job. Each question is assigned a score of 1 for a response of "True" and 0 for a response of "Not True". All item scores are summed to give a total score that can range from 0 to 20. If a subject has ≥ 5 missing responses (ie more than 20%), then a total score is not calculated. For subjects with ≥ 1 but ≤ 4 missing responses, the total score is calculated as follows: T=20x/(20-m) where: T is the total score, x is the total score for the items answered and n is the number of non-missing items.
    Time Frame Baseline to Week 104

    Outcome Measure Data

    Analysis Population Description
    mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.
    Arm/Group Title Etanercept Placebo
    Arm/Group Description Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID. Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
    Measure Participants 87 91
    Week 12 (N = 81, 84)
    -2.36
    (0.58)
    -1.58
    (0.55)
    Week 24 (N = 74, 75)
    -3.16
    (0.58)
    -2.71
    (0.60)
    Week 48 (N = 66, 75)
    -3.61
    (0.63)
    -4.01
    (0.59)
    Week 68 (N = 60, 66)
    -4.50
    (0.64)
    -5.08
    (0.71)
    Week 92 (N = 57, 60)
    -4.35
    (0.76)
    -5.27
    (0.71)
    Week 104 (N = 55, 62)
    -4.78
    (0.68)
    -5.23
    (0.74)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Within group comparisons to baseline were <0.001, from paired t-test.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method t-test, 2 sided
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 12 data only.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.1829
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.78
    Confidence Interval (2-Sided) 95%
    -1.93 to 0.37
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    59. Secondary Outcome
    Title Change From Baseline in Work Productivity and Activity Impairment (WPAI): Percent Work Time Missed Due to Health Problems at Time Points
    Description The WPAI assesses work productivity and impairment. It is a 6-item questionnaire used to assess the degree to which a specified health problem affected work productivity and regular activities over the past 7 days. The questions are: Q1 = currently employed. Q2 = hours missed due to health problems. Q3 = hours missed other reasons. Q4 = hours actually worked. Q5 = degree health affected productivity while working (0-10 scale). Q6 = degree health affected regular activities (0-10 scale). Subscale scores are calculated: Percent work time missed due to health problem: Q2/(Q2+Q4). The computed percentage range for each sub-scale is 0-100, where higher numbers indicate greater impairment and less productivity.
    Time Frame Baseline to Week 104

    Outcome Measure Data

    Analysis Population Description
    mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA.
    Arm/Group Title Etanercept Placebo
    Arm/Group Description Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID. Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
    Measure Participants 62 62
    Week 2 (N = 56, 59)
    2.83
    (3.64)
    0.46
    (3.58)
    Week 4 (N = 57, 59)
    1.74
    (3.35)
    0.12
    (3.25)
    Week 8 (N = 53, 53)
    4.19
    (4.13)
    0.67
    (4.15)
    Week 12 (N = 53, 55)
    -0.19
    (4.36)
    -4.93
    (4.25)
    Week 16 (N = 53, 52)
    -1.35
    (3.34)
    -2.03
    (4.92)
    Week 24 (N = 47, 47)
    -0.71
    (3.40)
    -7.39
    (4.61)
    Week 32 (N = 48, 46)
    -4.06
    (3.02)
    -9.76
    (4.12)
    Week 40 (N= 50, 50)
    -2.16
    (4.15)
    -9.23
    (3.73)
    Week 48 (N= 48, 47)
    -5.04
    (2.33)
    -6.12
    (3.60)
    Week 56 (N= 44, 49)
    -3.99
    (2.77)
    -9.11
    (3.79)
    Week 68 (N= 44, 44)
    -2.41
    (3.19)
    -7.51
    (3.69)
    Week 80 (N= 43, 44)
    2.92
    (2.45)
    -9.96
    (4.21)
    Week 92 (N= 45, 44)
    -1.81
    (3.31)
    -8.42
    (4.29)
    Week 104 (N= 42, 43)
    -6.35
    (3.45)
    -10.44
    (4.74)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Within group comparisons to baseline were <0.05, from paired t-test.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.05
    Comments
    Method t-test, 2 sided
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.5226
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 2.37
    Confidence Interval (2-Sided) 95%
    -4.95 to 9.68
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.6232
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 1.62
    Confidence Interval (2-Sided) 95%
    -4.90 to 8.14
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.3877
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 3.52
    Confidence Interval (2-Sided) 95%
    -4.53 to 11.57
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.2402
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 4.74
    Confidence Interval (2-Sided) 95%
    -3.22 to 12.69
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    60. Secondary Outcome
    Title Change From Baseline in WPAI: Percent Impairment While Working Due to Health Problems at Time Points
    Description The WPAI assesses work productivity and impairment. It is a 6-item questionnaire used to assess the degree to which a specified health problem affected work productivity and regular activities over the past 7 days. The questions are: Q1 = currently employed. Q2 = hours missed due to health problems. Q3 = hours missed other reasons. Q4 = hours actually worked. Q5 = degree health affected productivity while working (0-10 scale). Q6 = degree health affected regular activities (0-10 scale). Subscale scores are calculated: Percent impairment while working due to health problem: Q5/10. The computed percentage range for each sub-scale is 0-100, where higher numbers indicate greater impairment and less productivity.
    Time Frame Baseline to Week 104

    Outcome Measure Data

    Analysis Population Description
    mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA.
    Arm/Group Title Etanercept Placebo
    Arm/Group Description Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID. Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
    Measure Participants 59 58
    Week 2 (N = 53, 56)
    -11.47
    (3.71)
    -2.28
    (3.67)
    Week 4 (N = 52, 55)
    -8.88
    (3.66)
    -3.81
    (3.54)
    Week 8 (N = 47, 50)
    -12.74
    (3.94)
    -6.48
    (3.90)
    Week 12 (N = 48, 50)
    -21.22
    (4.74)
    -12.09
    (4.70)
    Week 16 (N = 49, 46)
    -16.53
    (3.69)
    -16.09
    (2.97)
    Week 24 (N = 46, 43)
    -16.52
    (4.66)
    -18.84
    (3.35)
    Week 32 (N = 46, 43)
    -18.04
    (3.76)
    -15.81
    (3.45)
    Week 40 (N = 45, 47)
    -22.89
    (4.04)
    -19.36
    (2.92)
    Week 48 (N = 45, 47)
    -22.22
    (3.55)
    -16.60
    (3.64)
    Week 56 (N = 42, 46)
    -23.81
    (3.90)
    -20.43
    (3.33)
    Week 68 (N = 43, 43)
    -22.33
    (3.96)
    -22.09
    (3.39)
    Week 80 (N = 42, 41)
    -24.29
    (4.06)
    -21.95
    (3.60)
    Week 92 (N = 42, 41)
    -23.57
    (3.47)
    -19.27
    (3.07)
    Week 104 (N = 40, 40)
    -25.50
    (3.69)
    -22.50
    (3.54)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Within group comparisons to baseline were <0.001 at Week 16 and thereafter, from paired t-test.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method t-test, 2 sided
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0193
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -9.19
    Confidence Interval (2-Sided) 95%
    -16.85 to -1.52
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.1730
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -5.08
    Confidence Interval (2-Sided) 95%
    -12.41 to 2.26
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.1224
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -6.26
    Confidence Interval (2-Sided) 95%
    -14.23 to 1.71
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0461
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -9.14
    Confidence Interval (2-Sided) 95%
    -18.11 to -0.16
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    61. Secondary Outcome
    Title Changes From Baseline in WPAI - Activity Impairment Due to Health Problems at Time Points
    Description The WPAI assesses work productivity and impairment. It is a 6-item questionnaire used to assess the degree to which a specified health problem affected work productivity and regular activities over the past 7 days. The questions are: Q1 = currently employed. Q2 = hours missed due to health problems. Q3 = hours missed other reasons. Q4 = hours actually worked. Q5 = degree health affected productivity while working (0-10 scale). Q6 = degree health affected regular activities (0-10 scale). Subscale scores are calculated: Percent activity impairment due to health problem: Q6/10. The computed percentage range for each sub-scale is 0-100, where higher numbers indicate greater impairment and less productivity.
    Time Frame Baseline to Week 104

    Outcome Measure Data

    Analysis Population Description
    mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA.
    Arm/Group Title Etanercept Placebo
    Arm/Group Description Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID. Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
    Measure Participants 90 95
    Week 2 (N = 89, 94)
    -10.70
    (2.80)
    -4.73
    (2.61)
    Week 4 (N = 89, 95)
    -11.52
    (2.45)
    -8.42
    (2.28)
    Week 8 (N = 86, 93)
    -18.35
    (3.15)
    -11.68
    (2.96)
    Week 12 (N = 85, 92)
    -18.92
    (3.35)
    -12.07
    (3.14)
    Week 16 (N = 82, 90)
    -19.88
    (2.77)
    -22.33
    (2.69)
    Week 24 (N = 82, 89)
    -20.61
    (3.14)
    -23.15
    (2.31)
    Week 32 (N = 78, 86)
    -20.26
    (2.96)
    -22.09
    (2.58)
    Week 40 (N = 77, 85)
    -27.14
    (2.85)
    -24.00
    (2.36)
    Week 48 (N = 74, 85)
    -24.46
    (2.93)
    -22.12
    (2.85)
    Week 56 (N = 74, 84)
    -25.00
    (2.80)
    -25.71
    (2.44)
    Week 68 (N = 72, 82)
    -26.53
    (2.95)
    -25.73
    (2.73)
    Week 80 (N = 69, 77)
    -27.39
    (3.17)
    -27.66
    (2.97)
    Week 92 (N = 69, 77)
    -26.96
    (3.32)
    -25.97
    (2.81)
    Week 104 (N = 65, 73)
    -30.77
    (3.01)
    -28.36
    (2.87)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Within group comparisons to baseline were <0.001, from paired t-test.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method t-test, 2 sided
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0372
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -5.97
    Confidence Interval (2-Sided) 95%
    -11.58 to -0.36
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.2126
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -3.10
    Confidence Interval (2-Sided) 95%
    -7.98 to 1.79
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0330
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -6.66
    Confidence Interval (2-Sided) 95%
    -12.79 to -0.54
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0397
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -6.85
    Confidence Interval (2-Sided) 95%
    -13.38 to -0.33
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    62. Secondary Outcome
    Title Changes From Baseline in WPAI - Overall Work Impairment Due to Health Problems at Time Points
    Description The WPAI assesses work productivity and impairment. It is a 6-item questionnaire used to assess the degree to which a specified health problem affected work productivity and regular activities over the past 7 days. The questions are: Q1 = currently employed. Q2 = hours missed due to health problems. Q3 = hours missed other reasons. Q4 = hours actually worked. Q5 = degree health affected productivity while working (0-10 scale). Q6 = degree health affected regular activities (0-10 scale). Subscale scores are calculated: Percent overall work impairment due to health problem: Q2/(Q2+Q4)+[(1-Q2/(Q2+Q4))*(Q5/10)]. The computed percentage range for each sub-scale is 0-100, where higher numbers indicate greater impairment and less productivity.
    Time Frame Baseline to Week 104

    Outcome Measure Data

    Analysis Population Description
    mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA.
    Arm/Group Title Etanercept Placebo
    Arm/Group Description Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID. Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
    Measure Participants 58 58
    Week 2 (N = 51, 56)
    -7.43
    (3.81)
    0.86
    (3.74)
    Week 4 (N = 52, 55)
    -7.07
    (3.72)
    -1.82
    (3.59)
    Week 8 (N = 47, 49)
    -10.32
    (4.04)
    -4.35
    (4.09)
    Week 12 (N = 48, 50)
    -20.77
    (4.94)
    -12.09
    (4.89)
    Week 16 (N = 49, 46)
    -16.30
    (3.83)
    -16.39
    (2.86)
    Week 24 (N = 45, 43)
    -14.85
    (4.52)
    -18.59
    (3.68)
    Week 32 (N = 46, 43)
    -17.59
    (3.79)
    -16.53
    (3.33)
    Week 40 (N = 45, 47)
    -23.74
    (4.15)
    -20.52
    (3.03)
    Week 48 (N = 45, 45)
    -23.03
    (3.61)
    -17.54
    (3.87)
    Week 56 (N = 42, 46)
    -23.60
    (4.10)
    -21.39
    (3.43)
    Week 68 (N = 43, 42)
    -21.90
    (4.26)
    -22.27
    (3.46)
    Week 80 (N = 42, 41)
    -20.66
    (4.15)
    -23.10
    (3.80)
    Week 92 (N = 42, 41)
    -24.00
    (3.52)
    -19.39
    (3.24)
    Week 104 (N = 40, 40)
    -25.76
    (3.73)
    -23.01
    (3.80)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Within group comparisons to baseline were <0.001 at Week 16 and at Week 32 and thereafter, from paired t test.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method t-test, 2 sided
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0382
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -8.29
    Confidence Interval (2-Sided) 95%
    -16.12 to -0.46
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.1648
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -5.25
    Confidence Interval (2-Sided) 95%
    -12.69 to 2.19
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.1476
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -5.98
    Confidence Interval (2-Sided) 95%
    -14.11 to 2.15
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0687
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -8.68
    Confidence Interval (2-Sided) 95%
    -18.03 to 0.68
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    63. Secondary Outcome
    Title Change From Baseline in Multidimensional Fatigue Inventory (MFI) Score at Time Points
    Description The MFI is a 20-item questionnaire that evaluates several aspects of fatigue. The General Fatigue Item is disclosed here. The general fatigue item contains four items, two of which are indicative for fatigue and two items contra-indicative for fatigue. Indicative items (eg, "I tire easily") are formulated in such a way that a high score suggests a high degree of fatigue. In case of contra-indicative items (eg, "I feel fit") a high score indicates a low degree of fatigue. Each item is scored on a 5-point numeric rating scale anchored at each end by "Yes, that is true" (scored 1) to "No, that is not true" (scored 5). Scoring for the MFI is done in such a way that higher scores indicate greater fatigue. Therefore, the items indicative for fatigue need to be recoded (1=5, 2=4, 3=3, 4=2, 5=1). For each scale a total score is calculated by summation of the scores of the individual items. Scores can range from the minimum of 4 to the maximum of 20. MFI-20 scale is copyrighted.
    Time Frame Baseline to Week 104

    Outcome Measure Data

    Analysis Population Description
    mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.
    Arm/Group Title Etanercept Placebo
    Arm/Group Description Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID. Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
    Measure Participants 90 95
    Week 4 (N = 89, 95)
    -1.08
    (0.38)
    -0.64
    (0.36)
    Week 12 (N = 85, 93)
    -1.34
    (0.42)
    -1.08
    (0.39)
    Week 24 (N = 83, 89)
    -1.67
    (0.37)
    -2.69
    (0.40)
    Week 48 (N = 77, 85)
    -2.01
    (0.39)
    -2.84
    (0.39)
    Week 68 (N = 72, 82)
    -1.79
    (0.42)
    -3.01
    (0.45)
    Week 92 (N = 69, 77)
    -2.74
    (0.40)
    -3.18
    (0.52)
    Week 104 (N = 65, 73)
    -3.26
    (0.46)
    -3.04
    (0.50)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments All within group comparisons to baseline were <0.001, from paired t-test.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method t-test, 2 sided
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 4, 12 data only. Week 4
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.2578
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.44
    Confidence Interval (2-Sided) 95%
    -1.21 to 0.33
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 4, 12 data only. Week 12
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.4334
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.35
    Confidence Interval (2-Sided) 95%
    -1.21 to 0.52
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    64. Secondary Outcome
    Title Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale Score From Baseline to Week 104
    Description The MOS sleep scale consists of 12 items to measure 6 sleep dimensions: initiation (time to fall asleep), quantity (hours of sleep each night), maintenance, respiratory problems, perceived adequacy, somnolence (the last 4 items reported using a 6-item Likert scale ranging from 1 [all of the time] to 6 [none of the time]). The raw scores ranging from 1 to 6 are transformed to scores ranging from 0 to 100 before the indices are calculated. Therefore the reported scores, consisting of means of converted items, also range from 0 to 100. However, two indexes can be derived: Sleep problems index I (short form) and sleep problems index II (long form). Additional subscales can be derived: sleep disturbance, snoring, awaken shortness of breath or headache, sleep adequacy, sleep somnolence, sleep quantity, and optimal sleep. However, data for two indexes and additional subscales is not reported.
    Time Frame Baseline to Week 104

    Outcome Measure Data

    Analysis Population Description
    mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.
    Arm/Group Title Etanercept Placebo
    Arm/Group Description Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID. Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
    Measure Participants 90 95
    Week 4 (N = 89, 94)
    -2.35
    (1.59)
    -0.85
    (1.50)
    Week 12 (N = 85, 93)
    -6.01
    (2.00)
    -4.10
    (1.88)
    Week 24 (N = 83, 89)
    -11.01
    (2.64)
    -14.34
    (2.28)
    Week 32 (N = 78, 86)
    -13.17
    (2.30)
    -17.06
    (2.42)
    Week 48 (N = 76, 85)
    -11.97
    (2.60)
    -17.57
    (2.23)
    Week 68 (N = 71, 82)
    -10.40
    (2.56)
    -15.50
    (2.49)
    Week 104 (N = 66, 76)
    -17.92
    (2.78)
    -15.61
    (2.66)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments All within group comparisons to baseline were <0.001, from paired t-test.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method t-test, 2 sided
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 4, 12 data only. Week 4
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.3554
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -1.50
    Confidence Interval (2-Sided) 95%
    -4.70 to 1.70
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 4, 12 data only. Week 12
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.3350
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -1.91
    Confidence Interval (2-Sided) 95%
    -5.82 to 1.99
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    65. Secondary Outcome
    Title Percentage of Participants With Minimally Clinically Important Improvement (MCII) at Time Points
    Description The MCII asks participants to rate the level of improvement they have experienced in the 48 hours compared to when they started the study. Response options are "Improved - less pain", "No change", and "Worse - more pain." If the participant indicates that improvement has occurred, then they are asked to indicate how important that improvement is to them from "Not at all important" to "Very important'.
    Time Frame Weeks 12 and 104

    Outcome Measure Data

    Analysis Population Description
    mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.
    Arm/Group Title Etanercept Placebo
    Arm/Group Description Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID. Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
    Measure Participants 88 94
    Week 12 (N = 88, 94)
    59.09
    53.2%
    44.68
    39.5%
    Week 104 (N = 75, 79)
    76.00
    68.5%
    81.01
    71.7%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Descriptive analysis was carried out for Week 12 data only.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 14.41
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 14.41
    Confidence Interval (2-Sided) 95%
    0.04 to 28.78
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    66. Secondary Outcome
    Title Percentage of Participants Achieving Patient Acceptable Symptom State (PASS) at Time Points
    Description PASS is defined as a symptom state that the participants consider acceptable.
    Time Frame Weeks 12 and 104

    Outcome Measure Data

    Analysis Population Description
    mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.
    Arm/Group Title Etanercept Placebo
    Arm/Group Description Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID. Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
    Measure Participants 88 94
    Week 12 (N = 88, 94)
    72.73
    65.5%
    61.70
    54.6%
    Week 104 (N = 74, 80)
    79.73
    71.8%
    88.75
    78.5%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Etanercept, Placebo
    Comments Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Descriptive analysis was carried out for Week 12 data only.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.1285
    Comments
    Method Cochran-Mantel-Haenszel
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 11.03
    Confidence Interval (2-Sided) 95%
    -2.51 to 24.56
    Parameter Dispersion Type:
    Value:
    Estimation Comments

    Adverse Events

    Time Frame Adverse events were reported from the signing of the informed consent until Week 104 visit.
    Adverse Event Reporting Description The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
    Arm/Group Title Etanercept Placebo
    Arm/Group Description Participants were treated with etanercept subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period).
    All Cause Mortality
    Etanercept Placebo
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN)
    Serious Adverse Events
    Etanercept Placebo
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 9/111 (8.1%) 8/113 (7.1%)
    Cardiac disorders
    Myocarditis 1/111 (0.9%) 0/113 (0%)
    Ear and labyrinth disorders
    Hearing impaired 0/111 (0%) 1/113 (0.9%)
    Gastrointestinal disorders
    Haemorrhoids 1/111 (0.9%) 0/113 (0%)
    General disorders
    Pyrexia 0/111 (0%) 1/113 (0.9%)
    Hepatobiliary disorders
    Cholelithiasis 3/111 (2.7%) 0/113 (0%)
    Infections and infestations
    Anal abscess 0/111 (0%) 1/113 (0.9%)
    Injury, poisoning and procedural complications
    Contusion 0/111 (0%) 1/113 (0.9%)
    Ligament rupture 0/111 (0%) 1/113 (0.9%)
    Ligament sprain 0/111 (0%) 1/113 (0.9%)
    Meniscus injury 0/111 (0%) 1/113 (0.9%)
    Radius fracture 0/111 (0%) 1/113 (0.9%)
    Wound 0/111 (0%) 1/113 (0.9%)
    Musculoskeletal and connective tissue disorders
    Intervertebral disc protrusion 1/111 (0.9%) 0/113 (0%)
    Spondyloarthropathy 2/111 (1.8%) 0/113 (0%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Uterine leiomyoma 1/111 (0.9%) 0/113 (0%)
    Nervous system disorders
    Multiple sclerosis 0/111 (0%) 1/113 (0.9%)
    Renal and urinary disorders
    Calculus urinary 0/111 (0%) 1/113 (0.9%)
    Other (Not Including Serious) Adverse Events
    Etanercept Placebo
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 86/111 (77.5%) 87/113 (77%)
    Eye disorders
    Uveitis 6/111 (5.4%) 3/113 (2.7%)
    Gastrointestinal disorders
    Diarrhoea 11/111 (9.9%) 9/113 (8%)
    Nausea 2/111 (1.8%) 7/113 (6.2%)
    General disorders
    Injection site erythema 8/111 (7.2%) 6/113 (5.3%)
    Injection site reaction 7/111 (6.3%) 6/113 (5.3%)
    Infections and infestations
    Bronchitis 7/111 (6.3%) 7/113 (6.2%)
    Gastroenteritis 8/111 (7.2%) 7/113 (6.2%)
    Influenza 7/111 (6.3%) 7/113 (6.2%)
    Nasopharyngitis 26/111 (23.4%) 23/113 (20.4%)
    Pharyngitis 5/111 (4.5%) 8/113 (7.1%)
    Sinusitis 6/111 (5.4%) 4/113 (3.5%)
    Upper respiratory tract infection 10/111 (9%) 14/113 (12.4%)
    Musculoskeletal and connective tissue disorders
    Back pain 2/111 (1.8%) 7/113 (6.2%)
    Myalgia 6/111 (5.4%) 3/113 (2.7%)
    Nervous system disorders
    Headache 9/111 (8.1%) 8/113 (7.1%)
    Skin and subcutaneous tissue disorders
    Rash 9/111 (8.1%) 3/113 (2.7%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.

    Results Point of Contact

    Name/Title Pfizer ClinicalTrials.gov Call Center
    Organization Pfizer, Inc.
    Phone 1-800-718-1021
    Email ClinicalTrials.gov_Inquiries@pfizer.com
    Responsible Party:
    Pfizer
    ClinicalTrials.gov Identifier:
    NCT01258738
    Other Study ID Numbers:
    • B1801031
    • 0881A3-4725
    • 2010-020077-16
    First Posted:
    Dec 13, 2010
    Last Update Posted:
    Oct 19, 2015
    Last Verified:
    Sep 1, 2015