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

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

Population: 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.

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

Population: 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.

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

Population: 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 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

Population: 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.

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

Population: 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 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

Population: 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.

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

Population: 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.

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

Population: 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.

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

Population: 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.

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

Population: 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.

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

Population: 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 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

Population: 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 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

Population: 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.

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

Population: 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.

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

Population: 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.

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

Population: 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.

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

Population: 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.

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

Population: 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.

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

Population: 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.

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

Population: 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.

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

Population: 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 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

Population: 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.

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

Population: 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.

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

Population: 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.

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

Population: 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.

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

Population: 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.

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

Population: 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

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

Population: 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.

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

Population: 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.

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

Population: 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.

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

Population: 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.

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

Population: 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.

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

Population: 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.

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

Population: 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.

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

Population: 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.

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

Population: 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.

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

Population: 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.

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

Population: 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.

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

Population: 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.

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

Population: 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.