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Study to Evaluate Maintenance of Sustained Remission of axSpA With CZP Compared to Placebo (C-OPTIMISE)

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ClinicalTrials.gov Identifier: NCT02505542
Recruitment Status : Active, not recruiting
First Posted : July 22, 2015
Last Update Posted : December 7, 2018
Sponsor:
Collaborator:
Parexel
Information provided by (Responsible Party):
UCB Pharma ( UCB BIOSCIENCES GmbH )

Brief Summary:
Patients receive study drug for one year (Part A). If, after the initial run-in phase, a sustained remission is reached they will be randomly split into one of three dose groups for another year (Part B). The maintenance of the sustained remission will be analyzed.

Condition or disease Intervention/treatment Phase
Axial Spondyloarthrithis Ankylosing Spondylitis Biological: Certolizumab Pegol Other: Placebo Phase 3

Expanded Access : An investigational treatment associated with this study is available outside the clinical trial.   More info ...

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 736 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Multicenter, Open-label (Part A) Followed by a Randomized, Double-blind, Parallel-group, Placebo Controlled Study (Part B) to Evaluate Maintenance of Remission in Subjects With Active Axial Spondyloarthritis (axSpA) Receiving Either Certolizumab Pegol 200 mg Q2W or 200 mg Q4W as Compared to Placebo
Actual Study Start Date : July 2015
Estimated Primary Completion Date : February 2019
Estimated Study Completion Date : April 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Open-label Certolizumab Pegol
Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W) from Week 6 to Week 48 (Part A). Subjects in sustained remission at Week 48 are eligible for randomization into Part B.
Biological: Certolizumab Pegol
  • Active substance: Certolizumab Pegol
  • Pharmaceutical form: Prefilled syringe
  • Concentration: 200 mg / ml
  • Route of Administration: Subcutaneous injection
Other Names:
  • Cimzia
  • CDP870

Experimental: Double-blind Certolizumab Pegol 200 mg Q2W
Certolizumab Pegol (CZP) 200 mg subcutaneous (sc) every 2 weeks (Q2W) from Week 48 onwards.
Biological: Certolizumab Pegol
  • Active substance: Certolizumab Pegol
  • Pharmaceutical form: Prefilled syringe
  • Concentration: 200 mg / ml
  • Route of Administration: Subcutaneous injection
Other Names:
  • Cimzia
  • CDP870

Experimental: Double-blind Certolizumab Pegol 200 mg Q4W

Certolizumab Pegol (CZP) 200 mg subcutaneous (sc) every 4 weeks (Q4W) from Week 48 onwards.

At visits where CZP is not received, subjects receive one injection of Placebo to maintain the study blind.

Biological: Certolizumab Pegol
  • Active substance: Certolizumab Pegol
  • Pharmaceutical form: Prefilled syringe
  • Concentration: 200 mg / ml
  • Route of Administration: Subcutaneous injection
Other Names:
  • Cimzia
  • CDP870

Other: Placebo
  • Active substance: Placebo
  • Pharmaceutical form: Prefilled syringe
  • Concentration: 0.9 % Saline
  • Route of Administration: Subcutaneous injection

Placebo Comparator: Placebo
One placebo injection is administered every 2 weeks from Week 48 onwards.
Other: Placebo
  • Active substance: Placebo
  • Pharmaceutical form: Prefilled syringe
  • Concentration: 0.9 % Saline
  • Route of Administration: Subcutaneous injection

Placebo to CZP 200 mg Q2W escape
Subjects randomized to Placebo who meet flare criteria receive CZP 400 mg subcutaneous (sc) every 2 weeks (Q2W) for the first 3 visits after flare has been confirmed. After that, CZP 200 mg is given every 2 weeks in open-label fashion.
Biological: Certolizumab Pegol
  • Active substance: Certolizumab Pegol
  • Pharmaceutical form: Prefilled syringe
  • Concentration: 200 mg / ml
  • Route of Administration: Subcutaneous injection
Other Names:
  • Cimzia
  • CDP870

Other: Placebo
  • Active substance: Placebo
  • Pharmaceutical form: Prefilled syringe
  • Concentration: 0.9 % Saline
  • Route of Administration: Subcutaneous injection

CZP 200 mg Q4W to CZP 200 mg Q2W escape
Subjects randomized to CZP 200 mg Q4W who meet flare criteria receive CZP 200 mg subcutaneous (sc) every 2 weeks (Q2W) for all visits after flare has been confirmed. At the first 3 visits after flare has been confirmed, subjects receive one injection of 200 mg CZP and one injection of Placebo to maintain the study blind.
Biological: Certolizumab Pegol
  • Active substance: Certolizumab Pegol
  • Pharmaceutical form: Prefilled syringe
  • Concentration: 200 mg / ml
  • Route of Administration: Subcutaneous injection
Other Names:
  • Cimzia
  • CDP870

Other: Placebo
  • Active substance: Placebo
  • Pharmaceutical form: Prefilled syringe
  • Concentration: 0.9 % Saline
  • Route of Administration: Subcutaneous injection

CZP 200 mg Q2W to CZP 200 mg Q2W escape
Subjects randomized to CZP 200 mg Q2W who meet flare criteria receive CZP 200 mg subcutaneous (sc) every 2 weeks (Q2W) for all visits after flare has been confirmed. At the first 3 visits after flare has been confirmed, subjects receive one injection of 200 mg CZP and one injection of Placebo to maintain the study blind.
Biological: Certolizumab Pegol
  • Active substance: Certolizumab Pegol
  • Pharmaceutical form: Prefilled syringe
  • Concentration: 200 mg / ml
  • Route of Administration: Subcutaneous injection
Other Names:
  • Cimzia
  • CDP870

Other: Placebo
  • Active substance: Placebo
  • Pharmaceutical form: Prefilled syringe
  • Concentration: 0.9 % Saline
  • Route of Administration: Subcutaneous injection




Primary Outcome Measures :
  1. Percentage of subjects in Part B who do not experience a flare [ Time Frame: From Week 48 to Week 96 ]
    A flare occurs when a subject has an Ankylosing spondylitis disease activity score (ASDAS) ≥ 2.1 at 2 consecutive visits or ASDAS > 3.5 at any visit during Part B. A subject qualifies for Part B only if in sustained remission after 48 weeks of open-label Certolizumab Pegol (CZP) treatment. Sustained remission is achieved when a subject has an ASDAS < 1.3 at Week 32 or Week 36 (if ASDAS < 1.3 at Week 32, it must be < 2.1 at Week 36 [or vice versa]) and at Week 48.


Secondary Outcome Measures :
  1. Percentage of subjects achieving sustained remission in Part A [ Time Frame: Week 48 ]
    Sustained remission is achieved when a subject has an ASDAS < 1.3 at Week 32 or Week 36 (if ASDAS < 1.3 at Week 32, it must be < 2.1 at Week 36 [or vice versa]) and at Week 48.

  2. Percentage of subjects in Ankylosing Spondylitis Disease Activity Score (ASDAS) disease activity categories in Part A [ Time Frame: Week 48 ]

    ASDAS-Inactive Disease (ASDAS-ID): ASDAS < 1.3

    ASDAS-Moderate Disease (ASDAS-MD): ASDAS ≥ 1.3, < 2.1

    ASDAS-High Disease activity (ASDAS-HD): ASDAS ≥ 2.1, ≤ 3.5

    ASDAS-very High Disease activity (ASDAS-vHD): ASDAS > 3.5


  3. Percentage of subjects in Ankylosing Spondylitis Disease Activity Score (ASDAS) clinical improvement categories in Part A [ Time Frame: Week 48 ]

    ASDAS-CII: ASDAS reduction (improvement) of ≥ 1.1 relative to Baseline

    ASDAS-MI: ASDAS reduction (improvement) of ≥ 2.0 relative to Baseline


  4. Time to flare in Part B [ Time Frame: From Week 48 to Week 96 ]
    For those who meet the criteria for flare (see primary efficacy variable), the time to flare is the length in days from randomization in Part B until the visit at which the criteria for flare were met. Subjects who discontinue the study without meeting the criteria for flare will be censored at the time of their last study visit. Subjects who complete the study without meeting the criteria for flare will be censored at their Week 96 visit.

  5. Percentage of subjects in Ankylosing Spondylitis Disease Activity Score (ASDAS) disease activity categories in Part B [ Time Frame: Week 96 ]

    ASDAS-Inactive Disease (ASDAS-ID): ASDAS < 1.3

    ASDAS-Moderate Disease (ASDAS-MD): ASDAS ≥ 1.3, < 2.1

    ASDAS-High Disease activity (ASDAS-HD): ASDAS ≥ 2.1, ≤ 3.5

    ASDAS-very High Disease activity (ASDAS-vHD): ASDAS > 3.5


  6. Percentage of subjects in Ankylosing Spondylitis Disease Activity Score (ASDAS) clinical improvement categories in Part B [ Time Frame: Week 96 ]

    ASDAS-CII: ASDAS reduction (improvement) of ≥ 1.1 relative to Baseline

    ASDAS-MI: ASDAS reduction (improvement) of ≥ 2.0 relative to Baseline


  7. Percentage of subjects with Axial SpondyloArthritis International Society 20 % response criteria (ASAS20) in Part B [ Time Frame: Week 96 ]
    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.

  8. Percentage of subjects with Axial SpondyloArthritis International Society 40 % response criteria (ASAS40) in Part B [ Time Frame: Week 96 ]
    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. Percentage of subjects with Axial SpondyloArthritis International Society (ASAS) 5/6 response in Part B [ Time Frame: Week 96 ]
    The ASAS 5/6 response is defined as achieving at least 20 % improvement in 5 of 6 domains, including the 4 domains defined for ASAS20 as well as spinal mobility (lateral spinal flexion) and C-reactive Protein (CRP).

  10. Percentage of subjects with Axial SpondyloArthritis International Society (ASAS) partial remission (PR) response in Part B [ Time Frame: Week 96 ]
    The ASAS partial remission (PR) response is defined as a score of ≤ 2 units on a 0 to 10 unit scale in all 4 domains listed for ASAS20.

  11. Change from Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) in Part B [ Time Frame: From Week 48 to Week 96 ]

    The ASDAS score is calculated as the sum of the following components:

    0.121 × Back pain (BASDAI Q2 result)

    0.058 × Duration of morning stiffness (BASDAI Q6 result)

    0.110 × PtGADA

    0.073 × Peripheral pain/swelling (BASDAI Q3 result)

    0.579 × (natural logarithm of the CRP [mg/L] + 1)

    Back pain, PtGADA, duration of morning stiffness, peripheral pain/swelling and fatigue are all assessed on a numerical scale (0 to 10 units).


  12. Change from Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) in Part B [ Time Frame: From Week 48 to Week 96 ]
    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.

  13. Change from Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) in Part B [ Time Frame: From Week 48 to Week 96 ]
    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.

  14. Change from Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) in Part B [ Time Frame: From Week 48 to Week 96 ]
    The BASMI is a disease-specific measure consisting of 5 clinical measures to reflect subject axial status: cervical rotation; tragus to wall distance; lateral lumbar flexion; lumbar flexion (modified Schober test); intermalleolar distance. According to the linear definition of the BASMI a score of 0 to 10 is calculated for each item based on the measurement. The mean of the sum of the 5 scores provides the BASMI score. The higher the BASMI score the more severe the patient's limitation of movement due to their axial spondyloarthritis (axSpA).

  15. Percentage of subjects with Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 response in Part B [ Time Frame: Week 96 ]
    The BASDAI50 response is defined as an improvement of at least 50 % in the BASDAI score relative to Baseline.

  16. Change from Baseline in sacroiliac Spondyloarthritis Research Consortium of Canada (SPARCC) score in Part B [ Time Frame: From Week 48 to Week 96 ]
    The SPARCC scoring method for lesions found on the Magnetic Resonance Imaging (MRI) is based on an abnormal increased signal on the Short-Tau-Inversion Recovery (STIR) sequence, representing bone marrow edema. Total Sacroiliac (SI) joint SPARCC score can range from 0 to 72 with higher scores indicating higher joint inflammation.

  17. Change from Baseline in spine Ankylosing Spondylitis spine Magnetic Resonance Imaging Score for Disease activity (ASspIMRI-a) in the Berlin modification score in Part B [ Time Frame: From Week 48 to Week 96 ]
    The Berlin modification of the ASspiMRI-a is a scoring system with a concentration on Short-Tau-Inversion Recovery (STIR) sequences without other fat saturation techniques. It quantifies changes in 23 Vertebral Units (VU) of the spine. Active inflammation is scored by grading the degree of bone marrow edema from 0 to 3 in 1 dimension on 1 or more consecutive slices that represent the highest level of inflammation in a particular VU.

  18. Percentage of subjects in Ankylosing Spondylitis Disease Activity Score (ASDAS) disease activity categories for subjects who experience a flare in Part B [ Time Frame: Week 96 ]

    ASDAS-Inactive Disease (ASDAS-ID): ASDAS < 1.3

    ASDAS-Moderate Disease (ASDAS-MD): ASDAS ≥ 1.3, < 2.1

    ASDAS-High Disease activity (ASDAS-HD): ASDAS ≥ 2.1, ≤ 3.5

    ASDAS-very High Disease activity (ASDAS-vHD): ASDAS > 3.5


  19. Percentage of subjects in Ankylosing Spondylitis Disease Activity Score (ASDAS) clinical improvement categories for subjects who experience a flare in Part B [ Time Frame: Week 96 ]

    ASDAS-CII: ASDAS reduction (improvement) of ≥ 1.1 relative to Baseline

    ASDAS-MI: ASDAS reduction (improvement) of ≥ 2.0 relative to Baseline


  20. Percentage of subjects with Axial SpondyloArthritis International Society 20 % response criteria (ASAS20) for subjects who experience a flare in Part B [ Time Frame: Week 96 ]
    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.

  21. Percentage of subjects with Axial SpondyloArthritis International Society 40 % response criteria (ASAS40) for subjects who experience a flare in Part B [ Time Frame: Week 96 ]
    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.

  22. Percentage of subjects with Axial SpondyloArthritis International Society (ASAS) 5/6 response for subjects who experience a flare in Part B [ Time Frame: Week 96 ]
    The ASAS 5/6 response is defined as achieving at least 20 % improvement in 5 of 6 domains, including the 4 domains defined for ASAS20 as well as spinal mobility (lateral spinal flexion) and C-reactive Protein (CRP).

  23. Percentage of subjects with Axial SpondyloArthritis International Society (ASAS) partial remission (PR) response for subjects who experience a flare in Part B [ Time Frame: Week 96 ]
    The ASAS partial remission (PR) response is defined as a score of ≤ 2 units on a 0 to 10 unit scale in all 4 domains listed for ASAS20.

  24. Change from Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) for subjects who experience a flare in Part B [ Time Frame: From time of flare to Week 96 ]

    The ASDAS score is calculated as the sum of the following components:

    0.121 × Back pain (BASDAI Q2 result)

    0.058 × Duration of morning stiffness (BASDAI Q6 result)

    0.110 × PtGADA

    0.073 × Peripheral pain/swelling (BASDAI Q3 result)

    0.579 × (natural logarithm of the CRP [mg/L] + 1)

    Back pain, PtGADA, duration of morning stiffness, peripheral pain/swelling and fatigue are all assessed on a numerical scale (0 to 10 units).


  25. Change from Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) for subjects who experience a flare in Part B [ Time Frame: From time of flare to Week 96 ]
    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.

  26. Change from Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) for subjects who experience a flare in Part B [ Time Frame: From time of flare to Week 96 ]
    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.

  27. Change from Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) for subjects who experience a flare in Part B [ Time Frame: From time of flare to Week 96 ]
    The BASMI is a disease-specific measure consisting of 5 clinical measures to reflect subject axial status: cervical rotation; tragus to wall distance; lateral lumbar flexion; lumbar flexion (modified Schober test); intermalleolar distance. According to the linear definition of the BASMI a score of 0 to 10 is calculated for each item based on the measurement. The mean of the sum of the 5 scores provides the BASMI score. The higher the BASMI score the more severe the patient's limitation of movement due to their axial spondyloarthritis (axSpA).

  28. Change from Baseline in sacroiliac Spondyloarthritis Research Consortium of Canada (SPARCC) score for subjects who experience a flare in Part B [ Time Frame: From time of flare to Week 96 ]
    The SPARCC scoring method for lesions found on the Magnetic Resonance Imaging (MRI) is based on an abnormal increased signal on the Short-Tau-Inversion Recovery (STIR) sequence, representing bone marrow edema. Total Sacroiliac (SI) joint SPARCC score can range from 0 to 72 with higher scores indicating higher joint inflammation.

  29. Change from Baseline in spine Ankylosing Spondylitis spine Magnetic Resonance Imaging Score for activity (ASspIMRI-a) in the Berlin modification score for subjects who experience a flare in Part B [ Time Frame: From time of flare to Week 96 ]
    The Berlin modification of the ASspiMRI-a is a scoring system with a concentration on Short-Tau-Inversion Recovery (STIR) sequences without other fat saturation techniques. It quantifies changes in 23 Vertebral Units (VU) of the spine. Active inflammation is scored by grading the degree of bone marrow edema from 0 to 3 in 1 dimension on 1 or more consecutive slices that represent the highest level of inflammation in a particular VU.



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.


Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Documented diagnosis of adult-onset axial SpondyloArthritis (axSpA) with at least 3 months' symptom duration and meet the Assessment of SpondyloArthritis International Society (ASAS) criteria for axSpA and symptom duration of less than 5 years prior to the participation of this study
  • Active disease at Screening as defined by

    • Ankylosing Spondylitis Disease Activity Score (ASDAS) ≥ 2.1
    • Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score ≥ 4
    • Spinal pain > 4 on a 0 to 10 Numerical Rating Scale (NRS) (from BASDAI Item 2)
    • for modified New York (mNY) -negative subjects only: C-reactive Protein (CRP) > upper limit of normal (ULN) and/or current evidence for sacroiliitis on the Screening Magnetic Resonance Imaging (MRI)
  • Inadequate response to, or contraindication to, or intolerant to at least 2 Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)

Exclusion Criteria:

  • Presence of total Spinal Ankylosis ('bamboo spine')
  • Diagnosis of any other Inflammatory Arthritis
  • Prior treatment with any experimental biological agents for treatment of Axial SpondyloArthritis (SpA)
  • Exposure to more than 1 TNF-antagonist or primary failure to TNF antagonist therapy
  • History of or current chronic or recurrent infections
  • High risk of infection
  • Recent live vaccination
  • Concurrent malignancy or a history of malignancy
  • Class III or IV congestive heart failure - New York Heart Association (NYHA)
  • Demyelinating disease of the central nervous system
  • Female subjects who are breastfeeding, pregnant or plan to become pregnant during the study or within 3 months following the last dose of the investigational product
  • Subjects with any other condition which, in the investigator's judgment, would make the subject unsuitable for inclusion in the study

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): NCT02505542


  Show 108 Study Locations
Sponsors and Collaborators
UCB BIOSCIENCES GmbH
Parexel
Investigators
Study Director: UCB Cares +1 844 599 2273(UCB)

Responsible Party: UCB BIOSCIENCES GmbH
ClinicalTrials.gov Identifier: NCT02505542     History of Changes
Other Study ID Numbers: AS0005
2015-000339-34 ( EudraCT Number )
First Posted: July 22, 2015    Key Record Dates
Last Update Posted: December 7, 2018
Last Verified: December 2018

Keywords provided by UCB Pharma ( UCB BIOSCIENCES GmbH ):
Axial Spondyloarthritis
axSpA
Ankylosing Spondylitis
Anti TNF-alpha
Certolizumab Pegol
Remission
Spondylarthropathies
Arthritis
Spinal Diseases
Immunosuppressive Agents

Additional relevant MeSH terms:
Spondylitis
Spondylitis, Ankylosing
Bone Diseases, Infectious
Infection
Bone Diseases
Musculoskeletal Diseases
Spinal Diseases
Spondylarthropathies
Spondylarthritis
Ankylosis
Joint Diseases
Arthritis
Certolizumab Pegol
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents