| Primary | Change Form Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) at Month 6 | BASMI measures the range of motion based on five clinical measurements: 1) cervical rotation, 2) tragus to wall distance, 3) lumbar side flexion, 4) lumbar flexion (modified Schober's) and 5) intermalleolar distance. The total BASMI score ranges from 0 to 10 reflecting mild to moderate disease activity and functional ability in the spinal column. The higher the BASMI score the more severe the patient's limitation of movement due to their ankylosing spondylitis | No participants had a Month 6 visit due to early study termination, hence the primary endpoint could not be assessed. | Posted | | | | | | Baseline and Month 6 | | | | ID | Title | Description |
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| OG000 | Active Supervised Training (AST) | Participants were to receive active supervised and standardized training (AST). | | OG001 | Standard of Care (SOC) Physiotherapy | Participants were to receive standard of care physiotherapy, according to the physiotherapist discretion. |
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| Secondary | Change Form Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) at Month 3 | BASMI measures the range of motion based on five clinical measurements: 1) cervical rotation, 2) tragus to wall distance, 3) lumbar side flexion, 4) lumbar flexion (modified Schober's) and 5) intermalleolar distance. The total BASMI score ranges from 0 to 10 reflecting mild to moderate disease activity and functional ability in the spinal column. The higher the BASMI score the more severe the patient's limitation of movement due to their ankylosing spondylitis. | Participants with available data | Posted | | Mean | Standard Deviation | scores on a scale | | Baseline and Month 3 | | | | ID | Title | Description |
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| OG000 | Active Supervised Training (AST) | Participants were to receive active supervised and standardized training (AST). | | OG001 | Standard of Care (SOC) Physiotherapy | Participants were to receive standard of care physiotherapy, according to the physiotherapist discretion. |
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| Secondary | Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) | The Bath Ankylosing Spondylitis Functional Index (BASFI) is a validated index to determine the degree of functional limitation in patients with AS. BASFI consists of 10 questions assessing participants' ability to perform activities, each on a numeric rating scale (NRS) ranging from 0 (easy to perform an activity) to 10 (impossible to perform an activity). The overall score is the mean of the 10 items and ranges from 0 to 10 with higher score indicating more limitations. | Participants with available data | Posted | | Mean | Standard Deviation | scores on a scale | | Baseline and Month 3 | | | | ID | Title | Description |
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| OG000 | Active Supervised Training (AST) | Participants were to receive active supervised and standardized training (AST). | | OG001 | Standard of Care (SOC) Physiotherapy | Participants were to receive standard of care physiotherapy, according to the physiotherapist discretion. |
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| Secondary | Change From Baseline in Assessment of Spondyloarthritis International Society (ASAS) Health Index (HI) | The ASAS HI measures functioning and health across 17 aspects of health in patients with AS, including pain, emotional functions, sleep, sexual function, mobility, self care, and community life. The ASAS HI consists of 17 questions, each answered by the participant as agree (1) or disagree (0). The responses to the 17 dichotomous items are summed up to give a total score ranging from 0 to 17, with a lower score indicating a better and a higher score indicating an inferior health status. | Participants with available data | Posted | | Mean | Standard Deviation | scores on a scale | | Baseline and Month 3 | | | | ID | Title | Description |
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| OG000 | Active Supervised Training (AST) | Participants were to receive active supervised and standardized training (AST). | | OG001 | Standard of Care (SOC) Physiotherapy | Participants were to receive standard of care physiotherapy, according to the physiotherapist discretion. |
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| Secondary | Change From Baseline in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) | The Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) assesses disease activity by asking the participant to answer 6 questions (each on an 11 point numeric rating scale [NRS]) pertaining to symptoms experienced for the past week. For 5 questions (level of fatigue/tiredness, level of AS neck, back or hip pain, level of pain/swelling in joints, other than neck, back or hips, level of discomfort from any areas tender to touch or pressure, and level of morning stiffness), the response is from 0 (none) to 10 (very severe); for Question 6 (duration of morning stiffness), the response is from 0 (0 hours) to 10 (≥ 2 hours). The overall BASDAI score ranges from 0 to 10 where lower scores indicate less disease activity. | Participants with available data | Posted | | Mean | Standard Deviation | scores on a scale | | Baseline and Month 3 | | | | ID | Title | Description |
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| OG000 | Active Supervised Training (AST) | Participants were to receive active supervised and standardized training (AST). | | OG001 | Standard of Care (SOC) Physiotherapy | Participants were to receive standard of care physiotherapy, according to the physiotherapist discretion. |
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| Secondary | Percentage of Participants Achieving a BASDAI 50 Response | The BASDAI assesses disease activity by asking the participant to answer 6 questions (each on an 11 point numeric rating scale [NRS]) pertaining to symptoms experienced for the past week. For 5 questions (level of fatigue/tiredness, level of AS neck, back or hip pain, level of pain/swelling in joints, other than neck, back or hips, level of discomfort from any areas tender to touch or pressure, and level of morning stiffness), the response is from 0 (none) to 10 (very severe); for Question 6 (duration of morning stiffness), the response is from 0 (0 hours) to 10 (≥ 2 hours). The overall BASDAI score ranges from 0 to 10. Lower scores indicate less disease activity. A BASDAI 50 response is defined as improvement of 50% or more from baseline in BASDAI score. | Participants with available data | Posted | | Number | | percentage of participants | | Month 3 | | | | ID | Title | Description |
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| OG000 | Active Supervised Training (AST) | Participants were to receive active supervised and standardized training (AST). | | OG001 | Standard of Care (SOC) Physiotherapy | Participants were to receive standard of care physiotherapy, according to the physiotherapist discretion. |
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| Secondary | Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) | ASDAS is a composite disease activity outcome measure which combines patient reported back pain, duration of morning stiffness, patient global assessment of disease activity, patient assessment of peripheral joint pain and swelling and an acute phase reactant (C-reactive protein [CRP]) as an objective measure of inflammation. The overall score ranges from 0 with no defined upper score; published ranges for disease activity states as defined by the ASDAS are: < 1.3 for "inactive disease"; ≥ 1.3 to < 2.1 for "moderate disease activity"; ≥ 2.1 to ≤ 3.5 for "high disease activity" and ≥ 3.5 for "very high disease activity." | Participants with available data | Posted | | Mean | Standard Deviation | scores on a scale | | Baseline and Month 3 | | | | ID | Title | Description |
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| OG000 | Active Supervised Training (AST) | Participants were to receive active supervised and standardized training (AST). | | OG001 | Standard of Care (SOC) Physiotherapy | Participants were to receive standard of care physiotherapy, according to the physiotherapist discretion. |
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| Secondary | Percentage of Participants With ASDAS Inactive Disease | ASDAS is a composite disease activity outcome measure which combines patient reported back pain, duration of morning stiffness, patient global assessment of disease activity, patient assessment of peripheral joint pain and swelling and an acute phase reactant (CRP) as an objective measure of inflammation. The overall score ranges from 0 with no defined upper score; published ranges for disease activity states as defined by the ASDAS are: < 1.3 for "inactive disease"; ≥ 1.3 to < 2.1 for "moderate disease activity"; ≥ 2.1 to ≤ 3.5 for "high disease activity" and ≥ 3.5 for "very high disease activity." The percentage of participants with ASDAS inactive disease, defined as ASDAS < 1.3, is reported. | Participants with available data | Posted | | Number | | percentage of participants | | Month 3 | | | | ID | Title | Description |
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| OG000 | Active Supervised Training (AST) | Participants were to receive active supervised and standardized training (AST). | | OG001 | Standard of Care (SOC) Physiotherapy | Participants were to receive standard of care physiotherapy, according to the physiotherapist discretion. |
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| Secondary | Percentage of Participants With ASDAS Low Disease Activity | ASDAS is a composite disease activity outcome measure which combines patient reported back pain, duration of morning stiffness, patient global assessment of disease activity, patient assessment of peripheral joint pain and swelling and an acute phase reactant (CRP) as an objective measure of inflammation. The overall score ranges from 0 with no defined upper score; published ranges for disease activity states as defined by the ASDAS are: < 1.3 for "inactive disease"; ≥ 1.3 to < 2.1 for "moderate disease activity"; ≥ 2.1 to ≤ 3.5 for "high disease activity" and ≥ 3.5 for "very high disease activity." The percentage of participants with ASDAS low disease activity, defined as ASDAS < 2.1, is reported. | Participants with available data | Posted | | Number | | percentage of participants | | Month 3 | | | | ID | Title | Description |
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| OG000 | Active Supervised Training (AST) | Participants were to receive active supervised and standardized training (AST). | | OG001 | Standard of Care (SOC) Physiotherapy | Participants were to receive standard of care physiotherapy, according to the physiotherapist discretion. |
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| Secondary | Percentage of Participants With ASDAS Moderate Disease Activity | ASDAS is a composite disease activity outcome measure which combines patient reported back pain, duration of morning stiffness, patient global assessment of disease activity, patient assessment of peripheral joint pain and swelling and an acute phase reactant (CRP) as an objective measure of inflammation. The overall score ranges from 0 with no defined upper score; published ranges for disease activity states as defined by the ASDAS are: < 1.3 for "inactive disease"; ≥ 1.3 to < 2.1 for "moderate disease activity"; ≥ 2.1 to ≤ 3.5 for "high disease activity" and ≥ 3.5 for "very high disease activity." The percentage of participants with ASDAS moderate disease activity, defined as an ASDAS ≥ 1.3 to < 2.1, is reported. | Participants with available data | Posted | | Number | | percentage of participants | | Month 3 | | | | ID | Title | Description |
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| OG000 | Active Supervised Training (AST) | Participants were to receive active supervised and standardized training (AST). | | OG001 | Standard of Care (SOC) Physiotherapy | Participants were to receive standard of care physiotherapy, according to the physiotherapist discretion. |
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| Secondary | Percentage of Participants With ASDAS High Disease Activity | ASDAS is a composite disease activity outcome measure which combines patient reported back pain, duration of morning stiffness, patient global assessment of disease activity, patient assessment of peripheral joint pain and swelling and an acute phase reactant (CRP) as an objective measure of inflammation. The overall score ranges from 0 with no defined upper score; published ranges for disease activity states as defined by the ASDAS are: < 1.3 for "inactive disease"; ≥ 1.3 to < 2.1 for "moderate disease activity"; ≥ 2.1 to ≤ 3.5 for "high disease activity" and ≥ 3.5 for "very high disease activity." The percentage of participants with high disease activity, defined as an ASDAS ≥ 2.1 to < 3.5, is reported. | Participants with available data | Posted | | Number | | percentage of participants | | Month 3 | | | | ID | Title | Description |
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| OG000 | Active Supervised Training (AST) | Participants were to receive active supervised and standardized training (AST). | | OG001 | Standard of Care (SOC) Physiotherapy | Participants were to receive standard of care physiotherapy, according to the physiotherapist discretion. |
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| Secondary | Percentage of Participants With ASDAS Very High Disease Activity | ASDAS is a composite disease activity outcome measure which combines patient reported back pain, duration of morning stiffness, patient global assessment of disease activity, patient assessment of peripheral joint pain and swelling and an acute phase reactant (CRP) as an objective measure of inflammation. The overall score ranges from 0 with no defined upper score; published ranges for disease activity states as defined by the ASDAS are: < 1.3 for "inactive disease"; ≥ 1.3 to < 2.1 for "moderate disease activity"; ≥ 2.1 to ≤ 3.5 for "high disease activity" and ≥ 3.5 for "very high disease activity." The percentage of participants with very high disease activity, defined as an ASDAS ≥ 3.5, is reported. | Participants with available data | Posted | | Number | | percentage of participants | | Month 3 | | | | ID | Title | Description |
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| OG000 | Active Supervised Training (AST) | Participants were to receive active supervised and standardized training (AST). | | OG001 | Standard of Care (SOC) Physiotherapy | Participants were to receive standard of care physiotherapy, according to the physiotherapist discretion. |
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| Secondary | Percentage of Participants Achieving ASDAS Major Improvement | ASDAS Major Improvement is defined as a change from Baseline ≥ 2.0. ASDAS is a composite disease activity outcome measure which combines patient reported back pain, duration of morning stiffness, patient global assessment of disease activity, patient assessment of peripheral joint pain and swelling and an acute phase reactant (CRP) as an objective measure of inflammation. The overall score ranges from 0 with no defined upper score; published ranges for disease activity states as defined by the ASDAS are: < 1.3 for "inactive disease"; ≥ 1.3 to < 2.1 for "moderate disease activity"; ≥ 2.1 to ≤ 3.5 for "high disease activity" and ≥ 3.5 for "very high disease activity." | Participants with available data | Posted | | Number | | percentage of participants | | Baseline and Month 3 | | | | ID | Title | Description |
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| OG000 | Active Supervised Training (AST) | Participants were to receive active supervised and standardized training (AST). | | OG001 | Standard of Care (SOC) Physiotherapy | Participants were to receive standard of care physiotherapy, according to the physiotherapist discretion. |
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| Secondary | Percentage of Participants Achieving ASDAS Clinically Important Improvement | ASDAS clinically important improvement is defined as a change from Baseline ≥ 1.1. ASDAS is a composite disease activity outcome measure which combines patient reported back pain, duration of morning stiffness, patient global assessment of disease activity, patient assessment of peripheral joint pain and swelling and an acute phase reactant (CRP) as an objective measure of inflammation. The overall score ranges from 0 with no defined upper score; published ranges for disease activity states as defined by the ASDAS are: < 1.3 for "inactive disease"; ≥ 1.3 to < 2.1 for "moderate disease activity"; ≥ 2.1 to ≤ 3.5 for "high disease activity" and ≥ 3.5 for "very high disease activity." | Participants with available data | Posted | | Number | | percentage of participants | | Baseline and Month 3 | | | | ID | Title | Description |
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| OG000 | Active Supervised Training (AST) | Participants were to receive active supervised and standardized training (AST). | | OG001 | Standard of Care (SOC) Physiotherapy | Participants were to receive standard of care physiotherapy, according to the physiotherapist discretion. |
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| Secondary | Percentage of Participants Achieving an Assessment of Spondyloarthritis International Society (ASAS) 20 Response | ASAS20 response was defined as improvement of ≥ 20% relative to Baseline and absolute improvement of ≥ 1 unit (on a scale from 0 to 10) in ≥ 3 of the following 4 domains with no deterioration (defined as a worsening of ≥ 20% and a net worsening of ≥ 1 unit) in the potential remaining domain:
- Patient's global assessment of disease activity, measured on a numeric rating scale (NRS) from 0 (none) to 10 (severe);
- Pain, measured by the total back pain NRS from 0 (no pain) to 10 (most severe);
- Function, measured by the Bath Ankylosing Spondylitis Functional Index (BASFI) which consists of 10 items assessing participants' ability to perform activities on an NRS ranging from 0 (easy) to 10 (impossible);
- Inflammation, measured by the mean of the 2 morning stiffness-related Bath AS Disease Activity Index (BASDAI) NRS scores (items 5 [level of stiffness] and 6 [duration of stiffness]) each on a scale from 0 (none/0 hours) to 10 (very severe/2 hours or more duration).
| Participants with available data | Posted | | Number | | percentage of participants | | Baseline and Month 3 | | | | ID | Title | Description |
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| OG000 | Active Supervised Training (AST) | Participants were to receive active supervised and standardized training (AST). | | OG001 | Standard of Care (SOC) Physiotherapy | Participants were to receive standard of care physiotherapy, according to the physiotherapist discretion. |
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| Secondary | Percentage of Participants Achieving an ASAS 40 Response | ASAS40 response was defined as improvement of ≥ 40% relative to baseline and absolute improvement of ≥ 2 units (on a scale from 0 to 10) in ≥ 3 of the following 4 domains with no deterioration in the potential remaining domain:
- Patient's global assessment of disease activity, measured on a numeric rating scale (NRS) from 0 (none) to 10 (severe);
- Pain, measured by the total back pain NRS from 0 (no pain) to 10 (most severe);
- Function, measured by the Bath Ankylosing Spondylitis Functional Index (BASFI) which consists of 10 items assessing participants' ability to perform activities on an NRS ranging from 0 (easy) to 10 (impossible);
- Inflammation, measured by the mean of the 2 morning stiffness-related Bath AS Disease Activity Index (BASDAI) NRS scores (items 5 [level of stiffness] and 6 [duration of stiffness]) each on a scale from 0 (none/0 hours) to 10 (very severe/2 hours or more duration).
| Participants with available data | Posted | | Number | | percentage of participants | | Baseline and Month 3 | | | | ID | Title | Description |
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| OG000 | Active Supervised Training (AST) | Participants were to receive active supervised and standardized training (AST). | | OG001 | Standard of Care (SOC) Physiotherapy | Participants were to receive standard of care physiotherapy, according to the physiotherapist discretion. |
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| Secondary | Percentage of Participants Achieving ASAS Partial Remission | ASAS partial remission is defined as an absolute score of ≤ 2 units on a 0 to 10 scale for each of the four following domains:
- Patient's global assessment of disease activity, measured on a numeric rating scale (NRS) from 0 (none) to 10 (severe);
- Pain, measured by the total back pain NRS from 0 (no pain) to 10 (most severe);
- Function, measured by the Bath Ankylosing Spondylitis Functional Index (BASFI) which consists of 10 items assessing participants' ability to perform activities on an NRS ranging from 0 (easy) to 10 (impossible);
- Inflammation, measured by the mean of the 2 morning stiffness-related Bath AS Disease Activity Index (BASDAI) NRS scores (items 5 [level of stiffness] and 6 [duration of stiffness]) each on a scale from 0 (none/0 hours) to 10 (very severe/2 hours or more duration).
| Participants with available data | Posted | | Number | | percentage of participants | | Month 3 | | | | ID | Title | Description |
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| OG000 | Active Supervised Training (AST) | Participants were to receive active supervised and standardized training (AST). | | OG001 | Standard of Care (SOC) Physiotherapy | Participants were to receive standard of care physiotherapy, according to the physiotherapist discretion. |
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| Secondary | Change From Baseline in Patient's Global Assessment of Pain | The patient's global assessment of pain was assessed on a NRS from 0 (no pain) to 10 (pain as bad as it could be). | Participants with available data | Posted | | Mean | Standard Deviation | scores on a scale | | Baseline and Month 3 | | | | ID | Title | Description |
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| OG000 | Active Supervised Training (AST) | Participants were to receive active supervised and standardized training (AST). | | OG001 | Standard of Care (SOC) Physiotherapy | Participants were to receive standard of care physiotherapy, according to the physiotherapist discretion. |
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| Secondary | Change From Baseline in Patient's Assessment of Total Back Pain | The patient's assessment of total back pain was assessed on a NRS from 0 (no pain) to 10 (most severe pain). | Participants with available data | Posted | | Mean | Standard Deviation | scores on a scale | | Baseline and Month 3 | | | | ID | Title | Description |
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| OG000 | Active Supervised Training (AST) | Participants were to receive active supervised and standardized training (AST). | | OG001 | Standard of Care (SOC) Physiotherapy | Participants were to receive standard of care physiotherapy, according to the physiotherapist discretion. |
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| Secondary | Change From Baseline in Patient's Assessment of Nocturnal Back Pain | The patient's assessment of nocturnal back pain was assessed on a NRS from 0 (no pain) to 10 (most severe pain). | Participants with available data | Posted | | Mean | Standard Deviation | scores on a scale | | Baseline and Month 3 | | | | ID | Title | Description |
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| OG000 | Active Supervised Training (AST) | Participants were to receive active supervised and standardized training (AST). | | OG001 | Standard of Care (SOC) Physiotherapy | Participants were to receive standard of care physiotherapy, according to the physiotherapist discretion. |
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| Secondary | Change From Baseline in Modified Work Ability Index (WAI) | This is used to assess participant's work ability. | No participants had available WAI data | Posted | | | | | | Baseline and Month 3 | | | | ID | Title | Description |
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| OG000 | Active Supervised Training (AST) | Participants were to receive active supervised and standardized training (AST). | | OG001 | Standard of Care (SOC) Physiotherapy | Participants were to receive standard of care physiotherapy, according to the physiotherapist discretion. |
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| Secondary | Change From Baseline in Fatigue | Fatigue was assessed as Question 1 of the BASDAI, on a NRS from 0 (none) to 10 (very severe). | Participants with available data | Posted | | Mean | Standard Deviation | scores on a scale | | Baseline and Month 3 | | | | ID | Title | Description |
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| OG000 | Active Supervised Training (AST) | Participants were to receive active supervised and standardized training (AST). | | OG001 | Standard of Care (SOC) Physiotherapy | Participants were to receive standard of care physiotherapy, according to the physiotherapist discretion. |
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| Secondary | Change From Baseline in Severity and Duration of Morning Stiffness | Morning stiffness was measured as the mean of the 2 morning stiffness-related BASDAI NRS scores: Question 5: Level of morning stiffness assessed by the patient on a scale from 0 (none) to 10 (very severe), and Question 6: Duration of morning stiffness assessed by the patient on a scale from 0 (0 hours) to 10 (2 hours or more duration). | Participants with available data | Posted | | Mean | Standard Deviation | scores on a scale | | Baseline and Month 3 | | | | ID | Title | Description |
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| OG000 | Active Supervised Training (AST) | Participants were to receive active supervised and standardized training (AST). | | OG001 | Standard of Care (SOC) Physiotherapy | Participants were to receive standard of care physiotherapy, according to the physiotherapist discretion. |
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| Secondary | Change From Baseline in Fear-Avoidance Belief Questionnaire Score (FABQ) | The FABQ measures patients' fear of pain and consequent avoidance of physical activity because of their fear. The questionnaire consists of 16 items in which a patient rates their agreement with each statement on a 7-point Likert scale, where 0 = completely disagree, 6 = completely agree. There is a maximum score of 96. A higher score indicates more strongly held fear avoidance beliefs. | No participants had available FABQ data | Posted | | | | | | Baseline and Month 3 | | | | ID | Title | Description |
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| OG000 | Active Supervised Training (AST) | Participants were to receive active supervised and standardized training (AST). | | OG001 | Standard of Care (SOC) Physiotherapy | Participants were to receive standard of care physiotherapy, according to the physiotherapist discretion. |
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