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

Sponsor

UCB Biopharma S.P.R.L. (Industry)

Overall Status

Completed

CT.gov ID

NCT02354105

Collaborator

Parexel (Industry)

680

Enrollment

100

Locations

37.8

Actual Duration (Months)

6.8

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Axial Spondyloarthritis

Study Design

Study Type:

Observational

Actual Enrollment :

680 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jan 12, 2015

Actual Primary Completion Date :

Mar 9, 2018

Actual Study Completion Date :

Mar 9, 2018

Arms and Interventions

Arm	Intervention/Treatment
CZP treatment axSpA patients who have been newly prescribed Certolizumab Pegol (CZP).

Outcome Measures

Primary Outcome Measures

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 [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 Outcome Measures

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 [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.
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 [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.
Assessment of SpondyloArthritis International Society 20 % (ASAS20) response criteria in the overall axSpA population, and the AS and nr-axSpA subpopulations at Week 12 [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.
Assessment of SpondyloArthritis International Society 20 % (ASAS20) response criteria in the overall axSpA population, and the AS and nr-axSpA subpopulations at Week 24 [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.
Assessment of SpondyloArthritis International Society 20 % (ASAS20) response criteria in the overall axSpA population, and the AS and nr-axSpA subpopulations at Week 52 [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.
Assessment of SpondyloArthritis International Society 40 % (ASAS40) response criteria in the overall axSpA population, and the AS and nr-axSpA subpopulations at Week 12 [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.
Assessment of SpondyloArthritis International Society 40 % (ASAS40) response criteria in the overall axSpA population, and the AS and nr-axSpA subpopulations at Week 24 [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.
Assessment of SpondyloArthritis International Society 40 % (ASAS40) response criteria in the overall axSpA population, and the AS and nr-axSpA subpopulations at Week 52 [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.
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 [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.
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 [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.
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 [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.
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 [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'.
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 [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'.
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 [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'.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country
1	602	Bruxelles	Belgium
2	604	Edegem	Belgium
3	601	Genk	Belgium
4	603	Heusy	Belgium
5	53	Altenburg	Germany
6	18	Bayreuth	Germany
7	6	Bayreuth	Germany
8	13	Berlin	Germany
9	14	Berlin	Germany
10	16	Berlin	Germany
11	30	Berlin	Germany
12	7	Berlin	Germany
13	4	Burghausen	Germany
14	25	Chemnitz	Germany
15	50	Cottbus	Germany
16	11	Dresden	Germany
17	8	Düsseldorf	Germany
18	36	Elmshorn	Germany
19	35	Erfurt	Germany
20	19	Freiburg	Germany
21	41	Goslar	Germany
22	26	Greifswald	Germany
23	32	Halle	Germany
24	23	Hamburg	Germany
25	47	Hamburg	Germany
26	1	Hannover	Germany
27	44	Hannover	Germany
28	42	Heidelberg	Germany
29	10	Herne	Germany
30	40	Hofheim am Taunus	Germany
31	34	Hoyerswerda	Germany
32	27	Karlsruhe	Germany
33	48	Karlstadt	Germany
34	49	Karlstadt	Germany
35	21	Leipzig	Germany
36	38	Leipzig	Germany
37	9	Magdeburg	Germany
38	29	Marktredwitz	Germany
39	31	München	Germany
40	43	München	Germany
41	2	Naunhof	Germany
42	20	Planegg	Germany
43	24	Potsdam	Germany
44	15	Püttlingen	Germany
45	28	Saarbrücken	Germany
46	51	Wuppertal	Germany
47	39	Zwickau	Germany
48	202	Athens	Greece
49	210	Athens	Greece
50	211	Athens	Greece
51	212	Athens	Greece
52	207	Lárisa	Greece
53	208	Maroúsi	Greece
54	201	Patra	Greece
55	203	Thessaloniki	Greece
56	204	Thessaloniki	Greece
57	205	Thessaloniki	Greece
58	206	Thessaloníki	Greece
59	504	Firenze	Italy
60	501	Palermo	Italy
61	502	Potenza	Italy
62	505	Roma	Italy
63	500	Siena	Italy
64	503	Verona	Italy
65	116	Barcelona	Spain
66	114	Bilbao	Spain
67	122	Cartagena	Spain
68	108	Córdoba	Spain
69	120	Granada	Spain
70	107	León	Spain
71	123	Lorca	Spain
72	119	Murcia	Spain
73	101	Mérida	Spain
74	117	Salamanca	Spain
75	118	San Sebastian	Spain
76	121	Sant Joan Despi	Spain
77	112	Tarragona	Spain
78	115	Terrassa	Spain
79	416	Barnsley	United Kingdom
80	405	Basingstoke	United Kingdom
81	401	Bath	United Kingdom
82	423	Bolton	United Kingdom
83	421	Christchurch	United Kingdom
84	403	Hull	United Kingdom
85	420	Leeds	United Kingdom
86	415	Leicester	United Kingdom
87	409	Liverpool	United Kingdom
88	422	LLandudno	United Kingdom
89	411	Luton	United Kingdom
90	414	Manchester	United Kingdom
91	406	Middlesborough	United Kingdom
92	424	North Shields	United Kingdom
93	413	Norwich	United Kingdom
94	410	Preston	United Kingdom
95	412	Southampton	United Kingdom
96	419	Stevenage	United Kingdom
97	418	Sunderland	United Kingdom
98	408	Torquay	United Kingdom
99	407	Truro	United Kingdom
100	425	Wigan	United Kingdom