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

Axial Spondyloarthritis Clinical Trial

— CIMAX  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02354105
• Other study ID #: AS0002
• Status: Completed
• Start date: January 12, 2015
• Est. completion date: March 9, 2018

Study information

• Verified date: March 2019
• Source: UCB Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 680
• Est. completion date: March 9, 2018
• Est. primary completion date: March 9, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

Related Conditions & MeSH terms

• Axial Spondyloarthritis
• Spondylarthritis

Locations

Country	Name	City	State
Belgium	602	Bruxelles
Belgium	604	Edegem
Belgium	601	Genk
Belgium	603	Heusy
Germany	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
Germany	41	Goslar
Germany	26	Greifswald
Germany	32	Halle
Germany	23	Hamburg
Germany	47	Hamburg
Germany	1	Hannover
Germany	44	Hannover
Germany	42	Heidelberg
Germany	10	Herne
Germany	40	Hofheim am Taunus
Germany	34	Hoyerswerda
Germany	27	Karlsruhe
Germany	48	Karlstadt
Germany	49	Karlstadt
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
Greece	202	Athens
Greece	210	Athens
Greece	211	Athens
Greece	212	Athens
Greece	207	Lárisa
Greece	208	Maroúsi
Greece	201	Patra
Greece	203	Thessaloniki
Greece	204	Thessaloniki
Greece	205	Thessaloniki
Greece	206	Thessaloníki
Italy	504	Firenze
Italy	501	Palermo
Italy	502	Potenza
Italy	505	Roma
Italy	500	Siena
Italy	503	Verona
Spain	116	Barcelona
Spain	114	Bilbao
Spain	122	Cartagena
Spain	108	Córdoba
Spain	120	Granada
Spain	107	León
Spain	123	Lorca
Spain	101	Mérida
Spain	119	Murcia
Spain	117	Salamanca
Spain	118	San Sebastian
Spain	121	Sant Joan Despi
Spain	112	Tarragona
Spain	115	Terrassa
United Kingdom	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	Middlesborough
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

Sponsors (2)

Lead Sponsor	Collaborator
UCB Biopharma S.P.R.L.	Parexel

Countries where clinical trial is conducted

Belgium,  Germany,  Greece,  Italy,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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.	From Baseline to Week 12
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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