Trial Outcomes & Findings for A Post-Marketing-Observational Study (PMOS) to Determine the Effectiveness of Combined Adalimumab Treatment and Active Supervised Training in Patients With Axial Spondyloarthritis (axSpA) (NCT NCT03258814)

NCT ID: NCT03258814

Last Updated: 2019-10-02

Results Overview

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

• Recruitment status: TERMINATED
• Target enrollment: 17 participants
• Primary outcome timeframe: Baseline and Month 6
• Results posted on: 2019-10-02

Participant Flow

This study enrolled participants with axial spondyloarthritis (AS) at 7 study sites in Germany. Eligible participants were receiving treatment with adalimumab (HUMIRA®) based on therapist's decision and local label requirements, must have had a response to adalimumab and have been eligible for active physiotherapy.

An enrollment period of treatment initiation and response assessment for 3 to 5 months preceded Randomization. This study was terminated early due to slow enrollment. Up to study termination 17 patients met all inclusion and none of the exclusion criteria and were enrolled in the study. A total of 7 of these patients were randomized into the study.

Participant milestones

Measure	Active Supervised Training (AST) Participants were to receive active supervised and standardized training (AST).	Standard of Care (SOC) Physiotherapy Participants were to receive standard of care physiotherapy, according to the physiotherapist discretion.	Not Randomized Participants who were enrolled in the study but were not randomized.
Overall Study STARTED	4	3	10
Overall Study COMPLETED	0	0	0
Overall Study NOT COMPLETED	4	3	10

Reasons for withdrawal

Measure	Active Supervised Training (AST) Participants were to receive active supervised and standardized training (AST).	Standard of Care (SOC) Physiotherapy Participants were to receive standard of care physiotherapy, according to the physiotherapist discretion.	Not Randomized Participants who were enrolled in the study but were not randomized.
Overall Study Early Termination	4	3	10

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Active Supervised Training (AST) n=4 Participants Participants were to receive active supervised and standardized training (AST).	Standard of Care (SOC) Physiotherapy n=3 Participants Participants were to receive standard of care physiotherapy, according to the physiotherapist discretion.	Total n=7 Participants Total of all reporting groups
Age, Continuous	52 years n=4 Participants	31 years n=3 Participants	38 years n=7 Participants
Sex: Female, Male Female	2 Participants n=4 Participants	1 Participants n=3 Participants	3 Participants n=7 Participants
Sex: Female, Male Male	2 Participants n=4 Participants	2 Participants n=3 Participants	4 Participants n=7 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Bath Ankylosing Spondylitis Metrology Index (BASMI)	2.9 units on a scale STANDARD_DEVIATION 3.3 • n=2 Participants • Participants with available data	2.2 units on a scale STANDARD_DEVIATION 0.8 • n=2 Participants • Participants with available data	2.6 units on a scale STANDARD_DEVIATION 2.0 • n=4 Participants • Participants with available data

PRIMARY outcome

Timeframe: Baseline and Month 6

Population: No participants had a Month 6 visit due to early study termination, hence the primary endpoint could not be assessed.

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and Month 3

Population: Participants with available data

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.

Outcome measures

Measure	Active Supervised Training (AST) n=2 Participants Participants were to receive active supervised and standardized training (AST).	Standard of Care (SOC) Physiotherapy Participants were to receive standard of care physiotherapy, according to the physiotherapist discretion.
Change Form Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) at Month 3	1.1 scores on a scale Standard Deviation 0.4	—

SECONDARY outcome

Timeframe: Baseline and Month 3

Population: Participants with available data

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.

Outcome measures

Measure	Active Supervised Training (AST) n=2 Participants Participants were to receive active supervised and standardized training (AST).	Standard of Care (SOC) Physiotherapy Participants were to receive standard of care physiotherapy, according to the physiotherapist discretion.
Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI)	-0.1 scores on a scale Standard Deviation 0.1	—

SECONDARY outcome

Timeframe: Baseline and Month 3

Population: Participants with available data

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.

Outcome measures

Measure	Active Supervised Training (AST) n=2 Participants Participants were to receive active supervised and standardized training (AST).	Standard of Care (SOC) Physiotherapy Participants were to receive standard of care physiotherapy, according to the physiotherapist discretion.
Change From Baseline in Assessment of Spondyloarthritis International Society (ASAS) Health Index (HI)	0.5 scores on a scale Standard Deviation 0.7	—

SECONDARY outcome

Timeframe: Baseline and Month 3

Population: Participants with available data

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.

Outcome measures

Measure	Active Supervised Training (AST) n=2 Participants Participants were to receive active supervised and standardized training (AST).	Standard of Care (SOC) Physiotherapy Participants were to receive standard of care physiotherapy, according to the physiotherapist discretion.
Change From Baseline in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)	-0.4 scores on a scale Standard Deviation 0.2	—

SECONDARY outcome

Timeframe: Month 3

Population: Participants with available data

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.

Outcome measures

Measure	Active Supervised Training (AST) n=2 Participants Participants were to receive active supervised and standardized training (AST).	Standard of Care (SOC) Physiotherapy Participants were to receive standard of care physiotherapy, according to the physiotherapist discretion.
Percentage of Participants Achieving a BASDAI 50 Response	0.0 percentage of participants	—

SECONDARY outcome

Timeframe: Baseline and Month 3

Population: Participants with available data

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."

Outcome measures

Measure	Active Supervised Training (AST) n=2 Participants Participants were to receive active supervised and standardized training (AST).	Standard of Care (SOC) Physiotherapy Participants were to receive standard of care physiotherapy, according to the physiotherapist discretion.
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS)	-0.3 scores on a scale Standard Deviation 0.1	—

SECONDARY outcome

Timeframe: Month 3

Population: Participants with available data

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.

Outcome measures

Measure	Active Supervised Training (AST) n=2 Participants Participants were to receive active supervised and standardized training (AST).	Standard of Care (SOC) Physiotherapy Participants were to receive standard of care physiotherapy, according to the physiotherapist discretion.
Percentage of Participants With ASDAS Inactive Disease	50.0 percentage of participants	—

SECONDARY outcome

Timeframe: Month 3

Population: Participants with available data

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.

Outcome measures

Measure	Active Supervised Training (AST) n=2 Participants Participants were to receive active supervised and standardized training (AST).	Standard of Care (SOC) Physiotherapy Participants were to receive standard of care physiotherapy, according to the physiotherapist discretion.
Percentage of Participants With ASDAS Low Disease Activity	50.0 percentage of participants	—

SECONDARY outcome

Timeframe: Month 3

Population: Participants with available data

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.

Outcome measures

Measure	Active Supervised Training (AST) n=2 Participants Participants were to receive active supervised and standardized training (AST).	Standard of Care (SOC) Physiotherapy Participants were to receive standard of care physiotherapy, according to the physiotherapist discretion.
Percentage of Participants With ASDAS Moderate Disease Activity	0.0 percentage of participants	—

SECONDARY outcome

Timeframe: Month 3

Population: Participants with available data

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.

Outcome measures

Measure	Active Supervised Training (AST) n=2 Participants Participants were to receive active supervised and standardized training (AST).	Standard of Care (SOC) Physiotherapy Participants were to receive standard of care physiotherapy, according to the physiotherapist discretion.
Percentage of Participants With ASDAS High Disease Activity	50.0 percentage of participants	—

SECONDARY outcome

Timeframe: Month 3

Population: Participants with available data

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.

Outcome measures

Measure	Active Supervised Training (AST) n=2 Participants Participants were to receive active supervised and standardized training (AST).	Standard of Care (SOC) Physiotherapy Participants were to receive standard of care physiotherapy, according to the physiotherapist discretion.
Percentage of Participants With ASDAS Very High Disease Activity	0.0 percentage of participants	—

SECONDARY outcome

Timeframe: Baseline and Month 3

Population: Participants with available data

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."

Outcome measures

Measure	Active Supervised Training (AST) n=2 Participants Participants were to receive active supervised and standardized training (AST).	Standard of Care (SOC) Physiotherapy Participants were to receive standard of care physiotherapy, according to the physiotherapist discretion.
Percentage of Participants Achieving ASDAS Major Improvement	0.0 percentage of participants	—

SECONDARY outcome

Timeframe: Baseline and Month 3

Population: Participants with available data

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."

Outcome measures

Measure	Active Supervised Training (AST) n=2 Participants Participants were to receive active supervised and standardized training (AST).	Standard of Care (SOC) Physiotherapy Participants were to receive standard of care physiotherapy, according to the physiotherapist discretion.
Percentage of Participants Achieving ASDAS Clinically Important Improvement	0.0 percentage of participants	—

SECONDARY outcome

Timeframe: Baseline and Month 3

Population: Participants with available data

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).

Outcome measures

Measure	Active Supervised Training (AST) n=2 Participants Participants were to receive active supervised and standardized training (AST).	Standard of Care (SOC) Physiotherapy Participants were to receive standard of care physiotherapy, according to the physiotherapist discretion.
Percentage of Participants Achieving an Assessment of Spondyloarthritis International Society (ASAS) 20 Response	0.0 percentage of participants	—

SECONDARY outcome

Timeframe: Baseline and Month 3

Population: Participants with available data

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).

Outcome measures

Measure	Active Supervised Training (AST) n=2 Participants Participants were to receive active supervised and standardized training (AST).	Standard of Care (SOC) Physiotherapy Participants were to receive standard of care physiotherapy, according to the physiotherapist discretion.
Percentage of Participants Achieving an ASAS 40 Response	0.0 percentage of participants	—

SECONDARY outcome

Timeframe: Month 3

Population: Participants with available data

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).

Outcome measures

Measure	Active Supervised Training (AST) n=2 Participants Participants were to receive active supervised and standardized training (AST).	Standard of Care (SOC) Physiotherapy Participants were to receive standard of care physiotherapy, according to the physiotherapist discretion.
Percentage of Participants Achieving ASAS Partial Remission	0.0 percentage of participants	—

SECONDARY outcome

Timeframe: Baseline and Month 3

Population: Participants with available data

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).

Outcome measures

Measure	Active Supervised Training (AST) n=2 Participants Participants were to receive active supervised and standardized training (AST).	Standard of Care (SOC) Physiotherapy Participants were to receive standard of care physiotherapy, according to the physiotherapist discretion.
Change From Baseline in Patient's Global Assessment of Pain	-0.5 scores on a scale Standard Deviation 0.7	—

SECONDARY outcome

Timeframe: Baseline and Month 3

Population: Participants with available data

The patient's assessment of total back pain was assessed on a NRS from 0 (no pain) to 10 (most severe pain).

Outcome measures

Measure	Active Supervised Training (AST) n=2 Participants Participants were to receive active supervised and standardized training (AST).	Standard of Care (SOC) Physiotherapy Participants were to receive standard of care physiotherapy, according to the physiotherapist discretion.
Change From Baseline in Patient's Assessment of Total Back Pain	0.5 scores on a scale Standard Deviation 0.7	—

SECONDARY outcome

Timeframe: Baseline and Month 3

Population: Participants with available data

The patient's assessment of nocturnal back pain was assessed on a NRS from 0 (no pain) to 10 (most severe pain).

Outcome measures

Measure	Active Supervised Training (AST) n=2 Participants Participants were to receive active supervised and standardized training (AST).	Standard of Care (SOC) Physiotherapy Participants were to receive standard of care physiotherapy, according to the physiotherapist discretion.
Change From Baseline in Patient's Assessment of Nocturnal Back Pain	-0.5 scores on a scale Standard Deviation 0.7	—

SECONDARY outcome

Timeframe: Baseline and Month 3

Population: No participants had available WAI data

This is used to assess participant's work ability.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and Month 3

Population: Participants with available data

Fatigue was assessed as Question 1 of the BASDAI, on a NRS from 0 (none) to 10 (very severe).

Outcome measures

Measure	Active Supervised Training (AST) n=2 Participants Participants were to receive active supervised and standardized training (AST).	Standard of Care (SOC) Physiotherapy Participants were to receive standard of care physiotherapy, according to the physiotherapist discretion.
Change From Baseline in Fatigue	-0.5 scores on a scale Standard Deviation 0.7	—

SECONDARY outcome

Timeframe: Baseline and Month 3

Population: Participants with available data

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).

Outcome measures

Measure	Active Supervised Training (AST) n=2 Participants Participants were to receive active supervised and standardized training (AST).	Standard of Care (SOC) Physiotherapy Participants were to receive standard of care physiotherapy, according to the physiotherapist discretion.
Change From Baseline in Severity and Duration of Morning Stiffness	-1.5 scores on a scale Standard Deviation 0.7	—

SECONDARY outcome

Timeframe: Baseline and Month 3

Population: No participants had available FABQ data

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.

Outcome measures

Outcome data not reported

Adverse Events

Active Supervised Training (AST)

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Standard of Care (SOC) Physiotherapy

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Not Randomized

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Active Supervised Training (AST) n=4 participants at risk Participants were to receive active supervised and standardized training (AST).	Standard of Care (SOC) Physiotherapy n=3 participants at risk Participants were to receive standard of care physiotherapy, according to the physiotherapist discretion.	Not Randomized n=10 participants at risk Participants who were enrolled in the study but were not randomized.
Infections and infestations Pulpitis dental	0.00% 0/4 • Up to 3 months	33.3% 1/3 • Number of events 1 • Up to 3 months	0.00% 0/10 • Up to 3 months
Infections and infestations Urinary tract infection	0.00% 0/4 • Up to 3 months	33.3% 1/3 • Number of events 1 • Up to 3 months	0.00% 0/10 • Up to 3 months
Injury, poisoning and procedural complications Road traffic accident	0.00% 0/4 • Up to 3 months	33.3% 1/3 • Number of events 1 • Up to 3 months	0.00% 0/10 • Up to 3 months
Musculoskeletal and connective tissue disorders Axial spondyloarthritis	0.00% 0/4 • Up to 3 months	0.00% 0/3 • Up to 3 months	10.0% 1/10 • Number of events 1 • Up to 3 months
Musculoskeletal and connective tissue disorders Back pain	25.0% 1/4 • Number of events 1 • Up to 3 months	0.00% 0/3 • Up to 3 months	0.00% 0/10 • Up to 3 months
Musculoskeletal and connective tissue disorders Bone lesion	0.00% 0/4 • Up to 3 months	33.3% 1/3 • Number of events 1 • Up to 3 months	0.00% 0/10 • Up to 3 months
Skin and subcutaneous tissue disorders Psoriasis	25.0% 1/4 • Number of events 1 • Up to 3 months	0.00% 0/3 • Up to 3 months	0.00% 0/10 • Up to 3 months

Additional Information

Global Medical Services

AbbVie

Phone: 800-633-9110

Email: abbvieclinicaltrials@abbvie.com

Results disclosure agreements

• Principal investigator is a sponsor employee AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
• Publication restrictions are in place

Restriction type: OTHER