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Completed

NCT Number: NCT02354105

A Study to Assess the Effectiveness of Certolizumab Pegol in Patients With Axial Spondyloarthritis in Daily Life

The primary purpose is to assess the effectiveness of certolizumab pegol in patients with axial spondyloarthritis under routine clinical practice.

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Key information

Conditions

Axial Spondyloarthritis Ankylosis Arthritis Bone Diseases Disease Joint Diseases Musculoskeletal Diseases Non-Radiographic Axial Spondyloarthritis Pathologic Processes Pathological Conditions, Signs and Symptoms Spinal Diseases Spondylarthritis Spondylarthropathies Spondylitis Spondylitis, Ankylosing

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

602, Brussels, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • The patient personally signed and dated a Patient Data Consent Form (PDCF) prior to Visit 2. No data can be entered into the electronic Documentation form (eDF) prior to signature of the PDCF.
  • The patient must have a clinical diagnosis of active axial spondyloarthritis (axSpA), [ankylosing spondylitis (AS) or nonradiographic axial spondyloarthritis (nr-axSpA)] according to the diagnostic criteria used by the physician in routine clinical practice.
  • The decision to prescribe Certolizumab Pegol (CZP) is made by the physician independent of the patient's participation in the NIS.
  • The patient must be newly prescribed CZP according to local regulations or guidelines (eg, Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) >=4).
  • Treatment is according to instructions in the Summary of Product Characteristics (SmPC) for patients considered by the treating physician to be reliable and capable of adhering to the observational plan (eg, able to understand and complete questionnaires).
  • If a patient is participating in an ongoing investigational study, then he/she will not be able to take part in this study.

Exclusion criteria

N/A

Treatment and study plan

Primary outcomes

  1. Change from Baseline to Week 52 in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) in the overall axial spondyloarthritis (axSpA) population, and the ankylosing spondylitis (AS) and nonradiographic axSpA (nr-axSpA) subpopulations

    Time frame: From Baseline to Week 52

    The BASDAI is a validated self-reported instrument, which consists of six 10 unit horizontal Numeric Rating Scales to measure the disease activity of ankylosing spondylitis (AS) from the subject's perspective. It measures the severity of fatigue, spinal and peripheral joint pain and swelling, enthesitis, and morning stiffness (both severity and duration) over the last week. The final BASDAI scores ranges from 0 to 10, with lower scores indicating lower disease activity.

Secondary outcomes

  1. Change from Baseline to Week 12 in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) in the overall axSpA population, and the AS and nr-axSpA subpopulations

    Time frame: From Baseline to Week 12

    The BASDAI is a validated self-reported instrument, which consists of six 10 unit horizontal Numeric Rating Scales to measure the disease activity of ankylosing spondylitis (AS) from the subject's perspective. It measures the severity of fatigue, spinal and peripheral joint pain and swelling, enthesitis, and morning stiffness (both severity and duration) over the last week. The final BASDAI scores ranges from 0 to 10, with lower scores indicating lower disease activity.

  2. Change from Baseline to Week 24 in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) in the overall axSpA population, and the AS and nr-axSpA subpopulations

    Time frame: From Baseline to Week 24

    The BASDAI is a validated self-reported instrument, which consists of six 10 unit horizontal Numeric Rating Scales to measure the disease activity of ankylosing spondylitis (AS) from the subject's perspective. It measures the severity of fatigue, spinal and peripheral joint pain and swelling, enthesitis, and morning stiffness (both severity and duration) over the last week. The final BASDAI scores ranges from 0 to 10, with lower scores indicating lower disease activity.

  3. Assessment of SpondyloArthritis International Society 20 % (ASAS20) response criteria in the overall axSpA population, and the AS and nr-axSpA subpopulations at Week 12

    Time frame: At Week 12

    The ASAS20 response is the improvement of at least 20 % and absolute improvement of at least 1 unit on a 0 to 10 Numeric Rating Scale (NRS) in at least 3 of the 4 domains: Patient's Global Assessment of Disease Activity (PtGADA), Pain assessment (total spinal pain NRS scores), Function (Bath Ankylosing Spondylitis Functional Index (BASFI)), Inflammation (mean of Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) questions 5 and 6 concerning morning stiffness intensity and duration) and absence of deterioration in the potential remaining domain.

  4. Assessment of SpondyloArthritis International Society 20 % (ASAS20) response criteria in the overall axSpA population, and the AS and nr-axSpA subpopulations at Week 24

    Time frame: At Week 24

    The ASAS20 response is the improvement of at least 20 % and absolute improvement of at least 1 unit on a 0 to 10 Numeric Rating Scale (NRS) in at least 3 of the 4 domains: Patient's Global Assessment of Disease Activity (PtGADA), Pain assessment (total spinal pain NRS scores), Function (Bath Ankylosing Spondylitis Functional Index (BASFI)), Inflammation (mean of Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) questions 5 and 6 concerning morning stiffness intensity and duration) and absence of deterioration in the potential remaining domain.

  5. Assessment of SpondyloArthritis International Society 20 % (ASAS20) response criteria in the overall axSpA population, and the AS and nr-axSpA subpopulations at Week 52

    Time frame: At Week 52

    The ASAS20 response is the improvement of at least 20 % and absolute improvement of at least 1 unit on a 0 to 10 Numeric Rating Scale (NRS) in at least 3 of the 4 domains: Patient's Global Assessment of Disease Activity (PtGADA), Pain assessment (total spinal pain NRS scores), Function (Bath Ankylosing Spondylitis Functional Index (BASFI)), Inflammation (mean of Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) questions 5 and 6 concerning morning stiffness intensity and duration) and absence of deterioration in the potential remaining domain.

  6. Assessment of SpondyloArthritis International Society 40 % (ASAS40) response criteria in the overall axSpA population, and the AS and nr-axSpA subpopulations at Week 12

    Time frame: At Week 12

    The ASAS40 response is the relative improvement of at least 40 % and absolute improvement of at least 2 units on a 0 to 10 Numeric Rating Scale (NRS) in at least 3 of the 4 domains: Patient's Global Assessment of Disease Activity (PtGADA), Pain assessment (total spinal pain NRS scores), Function (Bath Ankylosing Spondylitis Functional Index (BASFI)), Inflammation (mean of Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) questions 5 and 6 concerning morning stiffness intensity and duration) and no worsening at all in the remaining domain.

  7. Assessment of SpondyloArthritis International Society 40 % (ASAS40) response criteria in the overall axSpA population, and the AS and nr-axSpA subpopulations at Week 24

    Time frame: At Week 24

    The ASAS40 response is the relative improvement of at least 40 % and absolute improvement of at least 2 units on a 0 to 10 Numeric Rating Scale (NRS) in at least 3 of the 4 domains: Patient's Global Assessment of Disease Activity (PtGADA), Pain assessment (total spinal pain NRS scores), Function (Bath Ankylosing Spondylitis Functional Index (BASFI)), Inflammation (mean of Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) questions 5 and 6 concerning morning stiffness intensity and duration) and no worsening at all in the remaining domain.

  8. Assessment of SpondyloArthritis International Society 40 % (ASAS40) response criteria in the overall axSpA population, and the AS and nr-axSpA subpopulations at Week 52

    Time frame: At Week 52

    The ASAS40 response is the relative improvement of at least 40 % and absolute improvement of at least 2 units on a 0 to 10 Numeric Rating Scale (NRS) in at least 3 of the 4 domains: Patient's Global Assessment of Disease Activity (PtGADA), Pain assessment (total spinal pain NRS scores), Function (Bath Ankylosing Spondylitis Functional Index (BASFI)), Inflammation (mean of Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) questions 5 and 6 concerning morning stiffness intensity and duration) and no worsening at all in the remaining domain.

  9. Change from Baseline to Week 12 in Bath Ankylosing Spondylitis Functional Index (BASFI) in the overall axSpA population, and the AS and nr-axSpA subpopulations

    Time frame: From Baseline to Week 12

    The BASFI is a validated disease-specific instrument for assessing physical function. The BASFI comprises 10 items relating to the past week. The BASFI is the mean of the 10 scores such that the total score ranges from 0 to 10, with lower scores indicating better physical function.

  10. Change from Baseline to Week 24 in Bath Ankylosing Spondylitis Functional Index (BASFI) in the overall axSpA population, and the AS and nr-axSpA subpopulations

    Time frame: From Baseline to Week 24

    The BASFI is a validated disease-specific instrument for assessing physical function. The BASFI comprises 10 items relating to the past week. The BASFI is the mean of the 10 scores such that the total score ranges from 0 to 10, with lower scores indicating better physical function.

  11. Change from Baseline to Week 52 in Bath Ankylosing Spondylitis Functional Index (BASFI) in the overall axSpA population, and the AS and nr-axSpA subpopulations

    Time frame: From Baseline to Week 52

    The BASFI is a validated disease-specific instrument for assessing physical function. The BASFI comprises 10 items relating to the past week. The BASFI is the mean of the 10 scores such that the total score ranges from 0 to 10, with lower scores indicating better physical function.

  12. Change from Baseline to Week 12 in Patient's Global Assessment of Disease Activity (PtGADA) in the overall axSpA population, and the AS and nr-axSpA subpopulations

    Time frame: From Baseline to Week 12

    Subjects will score their global assessment of their disease activity in response to the question 'how active was your spondylitis on average during the last week?' using a Numeric Rating Scale (NRS) where 0 is 'not active' and 10 is 'very active'.

  13. Change from Baseline to Week 24 in Patient's Global Assessment of Disease Activity (PtGADA) in the overall axSpA population, and the AS and nr-axSpA subpopulations

    Time frame: From Baseline to Week 24

    Subjects will score their global assessment of their disease activity in response to the question 'how active was your spondylitis on average during the last week?' using a Numeric Rating Scale (NRS) where 0 is 'not active' and 10 is 'very active'.

  14. Change from Baseline to Week 52 in Patient's Global Assessment of Disease Activity (PtGADA) in the overall axSpA population, and the AS and nr-axSpA subpopulations

    Time frame: From Baseline to Week 52

    Subjects will score their global assessment of their disease activity in response to the question 'how active was your spondylitis on average during the last week?' using a Numeric Rating Scale (NRS) where 0 is 'not active' and 10 is 'very active'.

Sponsors and collaborators

Lead sponsor

UCB Biopharma S.P.R.L.

Industry

Collaborators

  • Parexel

Registry information

Official study title

A Noninterventional Study to Assess the Effectiveness of Certolizumab Pegol in Patients With Axial Spondyloarthritis in Daily Practice

Acronym: CIMAX

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Feb 3, 2015
Registry last updated
Mar 11, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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