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A Post-Marketing-Observational Study (PMOS) to Determine the Effectiveness of Combined Adalimumab Treatment and Active Supervised Training in Patients With Axial Spondyloarthritis (axSpA) (Treat & Train)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03258814
Recruitment Status : Terminated (Low or No Enrollment)
First Posted : August 23, 2017
Results First Posted : October 2, 2019
Last Update Posted : October 2, 2019
Sponsor:
Information provided by (Responsible Party):
AbbVie

Brief Summary:
This study is a non-interventional, longitudinal and non-confirmatory study to compare an active supervised training (AST) with standard of care (SOC) physiotherapy in patients with axial spondyloarthritis and stable response to adalimumab (HUMIRA®) with respect to health-related outcomes. The primary objective is the improvement in spinal mobility after a 6 month training program.

Condition or disease Intervention/treatment
Axial Spondyloarthritis Behavioral: Active Supervised Training (AST) Behavioral: Standard of Care (SOC) Physiotherapy

Detailed Description:

Treatment of axSpA patients with adalimumab (HUMIRA®) was according to the local adalimumab product label and local standard of care. AxSpA patients who responded to newly initialized adalimumab treatment based on physicians' decision, and who were eligible for active physiotherapy were enrolled in the study. Although this was a non-interventional study, participants were randomly assigned to receive either active supervised and standardized training physiotherapy or standard of care physiotherapy in order to provide adequate numbers of participants in each comparison group.

Participants who consented to participate in the study were observed for up to 12 months from Baseline (defined as the Randomization visit where participants were assigned to one of the two physiotherapy options).

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Study Type : Observational
Actual Enrollment : 17 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Treat and Train - A Post-Marketing-Observational Study (PMOS) to Determine the Effectiveness of Combined Adalimumab Treatment and Active Supervised Training in Patients With Axial Spondyloarthritis
Actual Study Start Date : December 8, 2017
Actual Primary Completion Date : September 14, 2018
Actual Study Completion Date : September 14, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Adalimumab

Group/Cohort Intervention/treatment
Active Supervised Training (AST)
Participants with axSpA and treated with adalimumab (HUMIRA®) according to the local product label and local standard of care were to receive active supervised and standardized training (AST).
Behavioral: Active Supervised Training (AST)
The active supervised and standardized training consisted of 24 units of exercise within 20 weeks performed in certified training centers and was focused on back fitness, core strengthening and patient engagement to treat back pain and functional impairment.

Standard of Care (SOC) Physiotherapy
Participants with axSpA and treated with adalimumab (HUMIRA®) according to the local product label and local standard of care were to receive standard of care physiotherapy, according to the physiotherapist discretion.
Behavioral: Standard of Care (SOC) Physiotherapy
Standard of care physiotherapy as used in this study included active as well as passive training and massages according to the physiotherapist discretion.




Primary Outcome Measures :
  1. Change Form Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) at Month 6 [ Time Frame: Baseline and 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


Secondary Outcome Measures :
  1. Change Form Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) at Month 3 [ Time Frame: Baseline and 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.

  2. Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) [ Time Frame: Baseline and Month 3 ]
    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.

  3. Change From Baseline in Assessment of Spondyloarthritis International Society (ASAS) Health Index (HI) [ Time Frame: Baseline and Month 3 ]
    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.

  4. Change From Baseline in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) [ Time Frame: Baseline and Month 3 ]
    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.

  5. Percentage of Participants Achieving a BASDAI 50 Response [ Time Frame: Month 3 ]

    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.


  6. Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) [ Time Frame: Baseline and Month 3 ]
    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."

  7. Percentage of Participants With ASDAS Inactive Disease [ Time Frame: Month 3 ]
    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.

  8. Percentage of Participants With ASDAS Low Disease Activity [ Time Frame: Month 3 ]
    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.

  9. Percentage of Participants With ASDAS Moderate Disease Activity [ Time Frame: Month 3 ]
    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.

  10. Percentage of Participants With ASDAS High Disease Activity [ Time Frame: Month 3 ]
    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.

  11. Percentage of Participants With ASDAS Very High Disease Activity [ Time Frame: Month 3 ]
    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.

  12. Percentage of Participants Achieving ASDAS Major Improvement [ Time Frame: Baseline and Month 3 ]
    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."

  13. Percentage of Participants Achieving ASDAS Clinically Important Improvement [ Time Frame: Baseline and Month 3 ]

    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."


  14. Percentage of Participants Achieving an Assessment of Spondyloarthritis International Society (ASAS) 20 Response [ Time Frame: Baseline and Month 3 ]

    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).

  15. Percentage of Participants Achieving an ASAS 40 Response [ Time Frame: Baseline and Month 3 ]

    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).

  16. Percentage of Participants Achieving ASAS Partial Remission [ Time Frame: Month 3 ]

    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).

  17. Change From Baseline in Patient's Global Assessment of Pain [ Time Frame: Baseline and Month 3 ]
    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).

  18. Change From Baseline in Patient's Assessment of Total Back Pain [ Time Frame: Baseline and Month 3 ]
    The patient's assessment of total back pain was assessed on a NRS from 0 (no pain) to 10 (most severe pain).

  19. Change From Baseline in Patient's Assessment of Nocturnal Back Pain [ Time Frame: Baseline and Month 3 ]
    The patient's assessment of nocturnal back pain was assessed on a NRS from 0 (no pain) to 10 (most severe pain).

  20. Change From Baseline in Modified Work Ability Index (WAI) [ Time Frame: Baseline and Month 3 ]
    This is used to assess participant's work ability.

  21. Change From Baseline in Fatigue [ Time Frame: Baseline and Month 3 ]
    Fatigue was assessed as Question 1 of the BASDAI, on a NRS from 0 (none) to 10 (very severe).

  22. Change From Baseline in Severity and Duration of Morning Stiffness [ Time Frame: Baseline and Month 3 ]

    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).


  23. Change From Baseline in Fear-Avoidance Belief Questionnaire Score (FABQ) [ Time Frame: Baseline and Month 3 ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Participants with axial spondyloarthritis who received Humira® per local product label at rheumatology centers in Germany.
Criteria

Inclusion Criteria:

  • Participants diagnosed with axial spondyloarthritis (axSpA) (either ankylosing spondylitis (AS) or non-radiographic axial spondyloarthritis (nr-axSpA)), fulfilling the Assessment of Spondyloarthritis International Society (ASAS) classification, aged at least 18 years
  • Prescription of Humira® (adalimumab) for treating axSpA according to the local product label
  • Eligibility for active physiotherapy according to the rheumatologist and physiotherapist
  • Participants must have signed written informed consent before starting any study related assessments or procedures.

Exclusion Criteria:

  • Participants with total spinal ankylosis based on the investigators' assessments of available radiographs
  • Participants who are not eligible for active supervised training or active physiotherapy at the discretion of the rheumatologist and/or the physiotherapist
  • Participants with poorly controlled medical condition(s), which in the opinion of the investigator, would put the participant at risk by participation in the protocol
  • Any prior treatment with a biologic disease-modifying antirheumatic drugs (DMARD) is prohibited.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03258814


Locations
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Germany
Rheumahaus Studien GbR, Potsdam, DE /ID# 164494
Potsdam, Brandenburg, Germany, 14467
MVZ Wittenbergplatz PP Orthos /ID# 204802
Berlin, Germany, 10787
Rheumapraxis /ID# 164461
Halle, Germany, 06128
Praxis Ortho DE /ID# 204149
Hamburg, Germany, 22415
Praxis internistische Rheumato /ID# 164463
Leipzig, Germany, 04129
Krankenhaus St. Josef /ID# 164501
Wuppertal, Germany, 42105
Sponsors and Collaborators
AbbVie
Investigators
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Study Director: AbbVie Inc. AbbVie
  Study Documents (Full-Text)

Documents provided by AbbVie:
Study Protocol  [PDF] February 15, 2017
Statistical Analysis Plan  [PDF] February 14, 2019

Additional Information:
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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT03258814    
Other Study ID Numbers: P15-710
First Posted: August 23, 2017    Key Record Dates
Results First Posted: October 2, 2019
Last Update Posted: October 2, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by AbbVie:
axial spondyloarthritis
active supervised training
physical training
adalimumab
spinal mobility
physiotherapy
physical function
health-related quality of life
pain
disease activity
psychosocial risk factors
workability
Bath Ankylosing Spondylitis Metrology Index (BASMI)
Additional relevant MeSH terms:
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Spondylarthritis
Spondylitis
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Arthritis
Joint Diseases