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| Name | Class |
|---|---|
| Parexel | INDUSTRY |
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The primary purpose is to assess the effectiveness of certolizumab pegol in patients with axial spondyloarthritis under routine clinical practice.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CZP treatment | axSpA patients who have been newly prescribed Certolizumab Pegol (CZP). |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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. | From Baseline to Week 52 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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. |
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Inclusion Criteria:
Exclusion Criteria:
N/A
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Patients with axial spondyloarthritis (axSpA) (including both ankylosing spondylitis (AS) and nonradiographic axial spondyloarthritis (nr-axSpA)) who have been newly prescribed Certolizumab Pegol (CZP) by the treating physician in regular course of practice.
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| Name | Affiliation | Role |
|---|---|---|
| UCB Cares | +1 844 599 2273 (UCB) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 602 | Brussels | Belgium | ||||
| 604 |
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| From Baseline to Week 12 |
| 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 | 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. | From Baseline to Week 24 |
| Assessment of SpondyloArthritis International Society 20 % (ASAS20) response criteria in the overall axSpA population, and the AS and nr-axSpA subpopulations 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. | At Week 12 |
| Assessment of SpondyloArthritis International Society 20 % (ASAS20) response criteria in the overall axSpA population, and the AS and nr-axSpA subpopulations 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. | At Week 24 |
| Assessment of SpondyloArthritis International Society 20 % (ASAS20) response criteria in the overall axSpA population, and the AS and nr-axSpA subpopulations 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. | At Week 52 |
| Assessment of SpondyloArthritis International Society 40 % (ASAS40) response criteria in the overall axSpA population, and the AS and nr-axSpA subpopulations 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. | At Week 12 |
| Assessment of SpondyloArthritis International Society 40 % (ASAS40) response criteria in the overall axSpA population, and the AS and nr-axSpA subpopulations 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. | At Week 24 |
| Assessment of SpondyloArthritis International Society 40 % (ASAS40) response criteria in the overall axSpA population, and the AS and nr-axSpA subpopulations 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. | At Week 52 |
| 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 | 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. | From Baseline to Week 12 |
| 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 | 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. | From Baseline to Week 24 |
| 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 | 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. | From Baseline to Week 52 |
| 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 | 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'. | From Baseline to Week 12 |
| 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 | 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'. | From Baseline to Week 24 |
| 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 | 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'. | From Baseline to Week 52 |
| Edegem |
| Belgium |
| 601 | Genk | Belgium |
| 603 | Heusy | Belgium |
| 53 | Altenburg | Germany |
| 18 | Bayreuth | Germany |
| 6 | Bayreuth | Germany |
| 13 | Berlin | Germany |
| 14 | Berlin | Germany |
| 16 | Berlin | Germany |
| 30 | Berlin | Germany |
| 7 | Berlin | Germany |
| 4 | Burghausen | Germany |
| 25 | Chemnitz | Germany |
| 50 | Cottbus | Germany |
| 11 | Dresden | Germany |
| 8 | Düsseldorf | Germany |
| 36 | Elmshorn | Germany |
| 35 | Erfurt | Germany |
| 19 | Freiburg im Breisgau | Germany |
| 41 | Goslar | Germany |
| 26 | Greifswald | Germany |
| 32 | Halle | Germany |
| 23 | Hamburg | Germany |
| 47 | Hamburg | Germany |
| 1 | Hanover | Germany |
| 44 | Hanover | Germany |
| 42 | Heidelberg | Germany |
| 10 | Herne | Germany |
| 40 | Hofheim am Taunus | Germany |
| 34 | Hoyerswerda | Germany |
| 27 | Karlsruhe | Germany |
| 48 | Karlstadt am Main | Germany |
| 49 | Karlstadt am Main | Germany |
| 21 | Leipzig | Germany |
| 38 | Leipzig | Germany |
| 9 | Magdeburg | Germany |
| 29 | Marktredwitz | Germany |
| 31 | München | Germany |
| 43 | München | Germany |
| 2 | Naunhof | Germany |
| 20 | Planegg | Germany |
| 24 | Potsdam | Germany |
| 15 | Püttlingen | Germany |
| 28 | Saarbrücken | Germany |
| 51 | Wuppertal | Germany |
| 39 | Zwickau | Germany |
| 202 | Athens | Greece |
| 210 | Athens | Greece |
| 211 | Athens | Greece |
| 212 | Athens | Greece |
| 207 | Larissa | Greece |
| 208 | Marousi | Greece |
| 201 | Pátrai | Greece |
| 203 | Thessaloniki | Greece |
| 204 | Thessaloniki | Greece |
| 205 | Thessaloniki | Greece |
| 206 | Thessaloniki | Greece |
| 504 | Florence | Italy |
| 501 | Palermo | Italy |
| 502 | Potenza | Italy |
| 505 | Roma | Italy |
| 500 | Siena | Italy |
| 503 | Verona | Italy |
| 116 | Barcelona | Spain |
| 114 | Bilbao | Spain |
| 122 | Cartagena | Spain |
| 108 | Córdoba | Spain |
| 118 | Donostia / San Sebastian | Spain |
| 120 | Granada | Spain |
| 107 | León | Spain |
| 123 | Lorca | Spain |
| 101 | Mérida | Spain |
| 119 | Murcia | Spain |
| 117 | Salamanca | Spain |
| 121 | Sant Joan Despí | Spain |
| 112 | Tarragona | Spain |
| 115 | Terrassa | Spain |
| 416 | Barnsley | United Kingdom |
| 405 | Basingstoke | United Kingdom |
| 401 | Bath | United Kingdom |
| 423 | Bolton | United Kingdom |
| 421 | Christchurch | United Kingdom |
| 403 | Hull | United Kingdom |
| 420 | Leeds | United Kingdom |
| 415 | Leicester | United Kingdom |
| 409 | Liverpool | United Kingdom |
| 422 | Llandudno | United Kingdom |
| 411 | Luton | United Kingdom |
| 414 | Manchester | United Kingdom |
| 406 | Middlesbrough | United Kingdom |
| 424 | North Shields | United Kingdom |
| 413 | Norwich | United Kingdom |
| 410 | Preston | United Kingdom |
| 412 | Southampton | United Kingdom |
| 419 | Stevenage | United Kingdom |
| 418 | Sunderland | United Kingdom |
| 408 | Torquay | United Kingdom |
| 407 | Truro | United Kingdom |
| 425 | Wigan | United Kingdom |
| ID | Term |
|---|---|
| D000089183 | Axial Spondyloarthritis |
| D000089202 | Non-Radiographic Axial Spondyloarthritis |
| D013167 | Spondylitis, Ankylosing |
| D004194 | Disease |
| ID | Term |
|---|---|
| D025242 | Spondylarthropathies |
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D000844 | Ankylosis |
| D007592 | Joint Diseases |
| D001168 | Arthritis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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