Clinical trial NCT02354105: A Study to Assess the Effectiveness of Certolizumab Pegol in Patients With Axial Spondyloarthritis in Daily Life
Official title: A Noninterventional Study to Assess the Effectiveness of Certolizumab Pegol in Patients With Axial Spondyloarthritis in Daily Practice
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Axial Spondyloarthritis
Keywords: Axial Spondyloarthritis
Radiographic Axial Spondyloarthritis
Non-radiographic Axial Spondyloarthritis
Ankylosing spondylitis
Diagnosis
Cimzia
CZP
Certolizumab Pegol
CDP870
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
Collaborators: name: Parexel
First posted: 2015-02-03
Enrollment: 680
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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


Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: From Baseline to Week 52
Secondary outcomes:
measure: 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
timeFrame: From Baseline to Week 12
measure: 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
timeFrame: From Baseline to Week 24
measure: Assessment of SpondyloArthritis International Society 20 % (ASAS20) response criteria in the overall axSpA population, and the AS and nr-axSpA subpopulations at Week 12
timeFrame: At Week 12
measure: Assessment of SpondyloArthritis International Society 20 % (ASAS20) response criteria in the overall axSpA population, and the AS and nr-axSpA subpopulations at Week 24
timeFrame: At Week 24
measure: Assessment of SpondyloArthritis International Society 20 % (ASAS20) response criteria in the overall axSpA population, and the AS and nr-axSpA subpopulations at Week 52
timeFrame: At Week 52
measure: Assessment of SpondyloArthritis International Society 40 % (ASAS40) response criteria in the overall axSpA population, and the AS and nr-axSpA subpopulations at Week 12
timeFrame: At Week 12
measure: Assessment of SpondyloArthritis International Society 40 % (ASAS40) response criteria in the overall axSpA population, and the AS and nr-axSpA subpopulations at Week 24
timeFrame: At Week 24
measure: Assessment of SpondyloArthritis International Society 40 % (ASAS40) response criteria in the overall axSpA population, and the AS and nr-axSpA subpopulations at Week 52
timeFrame: At Week 52
measure: 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
timeFrame: From Baseline to Week 12
measure: 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
timeFrame: From Baseline to Week 24
measure: 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
timeFrame: From Baseline to Week 52
measure: 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
timeFrame: From Baseline to Week 12
measure: 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
timeFrame: From Baseline to Week 24
measure: 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
timeFrame: From Baseline to Week 52
Other outcomes:
Locations:
city: Bruxelles
country: Belgium
facility: 602
city: Edegem
country: Belgium
facility: 604
city: Genk
country: Belgium
facility: 601
city: Heusy
country: Belgium
facility: 603
city: Altenburg
country: Germany
facility: 53
city: Bayreuth
country: Germany
facility: 18
city: Bayreuth
country: Germany
facility: 6
city: Berlin
country: Germany
facility: 13
city: Berlin
country: Germany
facility: 14
city: Berlin
country: Germany
facility: 16
city: Berlin
country: Germany
facility: 30
city: Berlin
country: Germany
facility: 7
city: Burghausen
country: Germany
facility: 4
city: Chemnitz
country: Germany
facility: 25
city: Cottbus
country: Germany
facility: 50
city: Dresden
country: Germany
facility: 11
city: Düsseldorf
country: Germany
facility: 8
city: Elmshorn
country: Germany
facility: 36
city: Erfurt
country: Germany
facility: 35
city: Freiburg
country: Germany
facility: 19
city: Goslar
country: Germany
facility: 41
city: Greifswald
country: Germany
facility: 26
city: Halle
country: Germany
facility: 32
city: Hamburg
country: Germany
facility: 23
city: Hamburg
country: Germany
facility: 47
city: Hannover
country: Germany
facility: 1
city: Hannover
country: Germany
facility: 44
city: Heidelberg
country: Germany
facility: 42
city: Herne
country: Germany
facility: 10
city: Hofheim am Taunus
country: Germany
facility: 40
city: Hoyerswerda
country: Germany
facility: 34
city: Karlsruhe
country: Germany
facility: 27
city: Karlstadt
country: Germany
facility: 48
city: Karlstadt
country: Germany
facility: 49
city: Leipzig
country: Germany
facility: 21
city: Leipzig
country: Germany
facility: 38
city: Magdeburg
country: Germany
facility: 9
city: Marktredwitz
country: Germany
facility: 29
city: München
country: Germany
facility: 31
city: München
country: Germany
facility: 43
city: Naunhof
country: Germany
facility: 2
city: Planegg
country: Germany
facility: 20
city: Potsdam
country: Germany
facility: 24
city: Püttlingen
country: Germany
facility: 15
city: Saarbrücken
country: Germany
facility: 28
city: Wuppertal
country: Germany
facility: 51
city: Zwickau
country: Germany
facility: 39
city: Athens
country: Greece
facility: 202
city: Athens
country: Greece
facility: 210
city: Athens
country: Greece
facility: 211
city: Athens
country: Greece
facility: 212
city: Lárisa
country: Greece
facility: 207
city: Maroúsi
country: Greece
facility: 208
city: Patra
country: Greece
facility: 201
city: Thessaloniki
country: Greece
facility: 203
city: Thessaloniki
country: Greece
facility: 204
city: Thessaloniki
country: Greece
facility: 205
city: Thessaloníki
country: Greece
facility: 206
city: Firenze
country: Italy
facility: 504
city: Palermo
country: Italy
facility: 501
city: Potenza
country: Italy
facility: 502
city: Roma
country: Italy
facility: 505
city: Siena
country: Italy
facility: 500
city: Verona
country: Italy
facility: 503
city: Barcelona
country: Spain
facility: 116
city: Bilbao
country: Spain
facility: 114
city: Cartagena
country: Spain
facility: 122
city: Córdoba
country: Spain
facility: 108
city: Granada
country: Spain
facility: 120
city: León
country: Spain
facility: 107
city: Lorca
country: Spain
facility: 123
city: Murcia
country: Spain
facility: 119
city: Mérida
country: Spain
facility: 101
city: Salamanca
country: Spain
facility: 117
city: San Sebastian
country: Spain
facility: 118
city: Sant Joan Despi
country: Spain
facility: 121
city: Tarragona
country: Spain
facility: 112
city: Terrassa
country: Spain
facility: 115
city: Barnsley
country: United Kingdom
facility: 416
city: Basingstoke
country: United Kingdom
facility: 405
city: Bath
country: United Kingdom
facility: 401
city: Bolton
country: United Kingdom
facility: 423
city: Christchurch
country: United Kingdom
facility: 421
city: Hull
country: United Kingdom
facility: 403
city: Leeds
country: United Kingdom
facility: 420
city: Leicester
country: United Kingdom
facility: 415
city: Liverpool
country: United Kingdom
facility: 409
city: LLandudno
country: United Kingdom
facility: 422
city: Luton
country: United Kingdom
facility: 411
city: Manchester
country: United Kingdom
facility: 414
city: Middlesborough
country: United Kingdom
facility: 406
city: North Shields
country: United Kingdom
facility: 424
city: Norwich
country: United Kingdom
facility: 413
city: Preston
country: United Kingdom
facility: 410
city: Southampton
country: United Kingdom
facility: 412
city: Stevenage
country: United Kingdom
facility: 419
city: Sunderland
country: United Kingdom
facility: 418
city: Torquay
country: United Kingdom
facility: 408
city: Truro
country: United Kingdom
facility: 407
city: Wigan
country: United Kingdom
facility: 425
Study officials:
affiliation: +1 844 599 2273 (UCB)
name: UCB Cares
role: STUDY_DIRECTOR
References: