Please note that the ANZCTR website will be unavailable from 9am until 9.30am (AEST) on Monday 22nd July for website maintenance. Please be sure to log out of the system in order to avoid any loss of data. Thank you and apologies for any inconvenience caused.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02552212




Registration number
NCT02552212
Ethics application status
Date submitted
15/09/2015
Date registered
17/09/2015
Date last updated
3/04/2019

Titles & IDs
Public title
Multicenter Study Evaluating Certolizumab Pegol Compared to Placebo in Subjects With axSpA Without X-ray Evidence of AS
Scientific title
Phase 3, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate Efficacy and Safety of Certolizumab Pegol in Subjects With Active Axial Spondyloarthritis (axSpA) Without X-Ray Evidence of Ankylosing Spondylitis (AS) and Objective Signs of Inflammation
Secondary ID [1] 0 0
2015-001894-41
Secondary ID [2] 0 0
AS0006
Universal Trial Number (UTN)
Trial acronym
C-AXSPAND
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Axial Spondyloarthritis 0 0
Nonradiographic Axial Spondyloarthritis 0 0
Nr-axSpA 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders
Inflammatory and Immune System 0 0 0 0
Rheumatoid arthritis
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional(has expanded access)
Description of intervention(s) / exposure
Other interventions - Certolizumab Pegol
Other interventions - Placebo

Experimental: Certolizumab Pegol 200 mg Q2W - 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 onwards.

Placebo Comparator: Placebo - Matching placebo to Certolizumab Pegol (CZP) injections are administered every 2 weeks from Week 0 onwards.


Other interventions: Certolizumab Pegol
Active Substance: Certolizumab Pegol
Pharmaceutical Form: Prefilled syringe
Concentration: 200 mg / ml
Route of Administration: Subcutaneous injection

Other interventions: Placebo
Active Substance: Placebo
Pharmaceutical Form: Prefilled syringe
Concentration: 0.9 % saline
Route of Administration: Subcutaneous injection

Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Ankylosing Spondylitis Disease Activity Score major improvement (ASDAS-MI) response criteria response at Week 52 - This variable is considered as primary in all countries except for Canada (and any other country where applicable or where requested by Regulatory Authorities) where it is considered as secondary variable.
ASDAS-MI is achieved when there is a reduction (improvement) >= 2.0 in the ASDAS relative to Baseline.
The ASDAS 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 × Patient's Global Assessment of Disease Activity (PGADA) 0.073 × Peripheral pain/swelling (BASDAI Q3 result) 0.579 × (natural logarithm of the C-reactive protein (CRP) [mg/L] + 1) Back pain, PGADA, duration of morning stiffness, peripheral pain/swelling and fatigue are all assessed on a numerical scale (0 to 10 units).
Timepoint [1] 0 0
Week 52
Primary outcome [2] 0 0
Axial SpondyloArthritis International Society 40% response criteria (ASAS40) response at Week 12 - This variable is considered as primary for Canada (and any other country where applicable or where requested by Regulatory Authorities) and as secondary variable in all other countries.
The ASAS40 response is defined as relative improvements 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 (PGADA), 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.
Timepoint [2] 0 0
Week 12
Primary outcome [3] 0 0
Certolizumab pegol plasma concentration at Baseline - Certolizumab pegol plasma concentration will be measured at Baseline.
Timepoint [3] 0 0
Baseline (Week 0)
Primary outcome [4] 0 0
Certolizumab pegol plasma concentration at Week 1 - Certolizumab pegol plasma concentration will be measured at Week 1.
Timepoint [4] 0 0
Week 1
Primary outcome [5] 0 0
Certolizumab pegol plasma concentration at Week 2 - Certolizumab pegol plasma concentration will be measured at Week 2.
Timepoint [5] 0 0
Week 2
Primary outcome [6] 0 0
Certolizumab pegol plasma concentration at Week 4 - Certolizumab pegol plasma concentration will be measured at Week 4.
Timepoint [6] 0 0
Week 4
Primary outcome [7] 0 0
Certolizumab pegol plasma concentration at Week 12 - Certolizumab pegol plasma concentration will be measured at Week 12.
Timepoint [7] 0 0
Week 12
Primary outcome [8] 0 0
Certolizumab pegol plasma concentration at Week 24 - Certolizumab pegol plasma concentration will be measured at Week 24.
Timepoint [8] 0 0
Week 24
Primary outcome [9] 0 0
Certolizumab pegol plasma concentration at Week 36 - Certolizumab pegol plasma concentration will be measured at Week 36.
Timepoint [9] 0 0
Week 36
Primary outcome [10] 0 0
Certolizumab pegol plasma concentration at Week 52 - Certolizumab pegol plasma concentration will be measured at Week 52.
Timepoint [10] 0 0
Week 52
Primary outcome [11] 0 0
Certolizumab pegol plasma concentration at Follow-Up (FU) Visit - Certolizumab pegol plasma concentration will be measured at the Follow-Up Visit.
Timepoint [11] 0 0
Follow-Up Visit (8 weeks after the Week 52)
Secondary outcome [1] 0 0
Axial SpondyloArthritis International Society 40% response criteria (ASAS40) response at Week 52 - The ASAS40 response is defined as relative improvements 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 (PGADA), 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.
Timepoint [1] 0 0
Week 52
Secondary outcome [2] 0 0
Change from Baseline to Week 12 in the Bath ankylosing spondylitis functional index (BASFI) - 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.
Timepoint [2] 0 0
From Baseline to Week 12
Secondary outcome [3] 0 0
Change from Baseline to Week 52 in the Bath ankylosing spondylitis functional index (BASFI) - The Bath ankylosing spondylitis functional index (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.
Timepoint [3] 0 0
From Baseline to Week 52
Secondary outcome [4] 0 0
Change from Baseline to Week 12 in the Bath ankylosing spondylitis disease activity index (BASDAI) - The Bath ankylosing spondylitis disease activity index (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.
Timepoint [4] 0 0
From Baseline to Week 12
Secondary outcome [5] 0 0
Change from Baseline to Week 52 in the Bath ankylosing spondylitis disease activity index (BASDAI) - The Bath ankylosing spondylitis disease activity index (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.
Timepoint [5] 0 0
From Baseline to Week 52
Secondary outcome [6] 0 0
Change from Baseline to Week 12 in sacroiliac Spondyloarthritis Research Consortium of Canada (SI-SPARCC) score - The Spondyloarthritis Research Consortium of Canada (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.
Timepoint [6] 0 0
From Baseline to Week 12
Secondary outcome [7] 0 0
Relevant changes to background medication from Baseline to Week 52 - The percentage of subjects who do not have relevant changes to background medications during the study treatment period.
Timepoint [7] 0 0
From Baseline to Week 52
Secondary outcome [8] 0 0
Change from Baseline in Ankylosing Spondylitis Quality of Life (ASQoL) at Week 52 - The ASQoL score ranges from 0 to 18 with higher score indicating worse health-related quality of life (HRQoL).
Timepoint [8] 0 0
From Baseline to Week 52
Secondary outcome [9] 0 0
Change from Baseline in ASQoL at Week 1 - The ASQoL score ranges from 0 to 18 with higher score indicating worse HRQoL.
Timepoint [9] 0 0
From Baseline to Week 1
Secondary outcome [10] 0 0
Change from Baseline in ASQoL at Week 2 - The ASQoL score ranges from 0 to 18 with higher score indicating worse HRQoL.
Timepoint [10] 0 0
From Baseline to Week 2
Secondary outcome [11] 0 0
Change from Baseline in ASQoL at Week 4 - The ASQoL score ranges from 0 to 18 with higher score indicating worse HRQoL.
Timepoint [11] 0 0
From Baseline to Week 4
Secondary outcome [12] 0 0
Change from Baseline in ASQoL at Week 12 - The ASQoL score ranges from 0 to 18 with higher score indicating worse HRQoL.
Timepoint [12] 0 0
From Baseline to Week 12
Secondary outcome [13] 0 0
Change from Baseline in ASQoL at Week 24 - The ASQoL score ranges from 0 to 18 with higher score indicating worse HRQoL.
Timepoint [13] 0 0
From Baseline to Week 24
Secondary outcome [14] 0 0
Change from Baseline in ASQoL at Week 36 - The ASQoL score ranges from 0 to 18 with higher score indicating worse HRQoL.
Timepoint [14] 0 0
From Baseline to Week 36
Secondary outcome [15] 0 0
Change from Baseline in ASQoL at Week 48 - The ASQoL score ranges from 0 to 18 with higher score indicating worse HRQoL.
Timepoint [15] 0 0
From Baseline to Week 48
Secondary outcome [16] 0 0
Change from Baseline in nocturnal spinal pain Numerical Rating Scale (NRS) at Week 52 - The nocturnal pain experienced subjects due to AS will be measured by following question 'How much pain of your spine due to spondylitis do you have at night?'. The NRS will be from 1 to 10 with a higher score indicating worse pain.
Timepoint [16] 0 0
From Baseline to Week 52
Secondary outcome [17] 0 0
Occurence of anterior uveitis (AU) or new AU flares through Week 52 - The percentage of subjects with AU or new AU flares during the study treatment period.
Timepoint [17] 0 0
Throughout the study conduct (up to Week 52)
Secondary outcome [18] 0 0
Incidence of treatment-emergent adverse events (TEAEs) during the study - Subjects not participating in the SFE will be assessed at Follow-Up at Week 60. An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Timepoint [18] 0 0
From Baseline until Follow-Up (FU)/Safety Follow-Up Extension (SFE) (up to Week 60/156)
Secondary outcome [19] 0 0
Incidence of serious adverse events (SAEs) during the study - Subjects not participating in the SFE will be assessed at Follow-Up at Week 60.
A serious adverse event (SAE) is any untoward medical occurrence that at any dose:
Results in death
Is life-threatening
Requires in patient hospitalization or prolongation of existing hospitalization
Is a congenital anomaly or birth defect
Is an infection that requires treatment parenteral antibiotics
Other important medical events which based on medical or scientific judgement may jeopardize the patients, or may require medical or surgical intervention to prevent any of the above
Timepoint [19] 0 0
From Baseline until Follow-Up (FU)/Safety Follow-Up Extension (SFE) (up to Week 60/156)
Secondary outcome [20] 0 0
Adverse events leading to withdrawal from investigational medicinal product (IMP) during the study - Subjects not participating in the SFE will be assessed at Follow-Up at Week 60. An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Timepoint [20] 0 0
From Baseline until Follow-Up (FU)/Safety Follow-Up Extension (SFE) (up to Week 60/156)

Eligibility
Key inclusion criteria
- At least 18 years old at the start of Screening Visit

- A documented diagnosis of adult-onset axial SpondyloArthritis (axSpA) and meet the
Assessment of SpondyloArthritis International Society (ASAS) criteria for axSpA

- Subjects must have had back pain for at least 12 months before Screening

- No sacroiliitis defined by Modified New York (mNY) criteria on sacroiliac (SI) x-rays

- Active disease at Screening as defined by

- Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score >= 4

- Spinal pain >= 4 on a 0 to 10 Numerical Rating Scale (NRS)

- Inadequate response to, have a contraindication to, or have been intolerant to at
least 2 Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Diagnosis of AS or any other Inflammatory Arthritis

- Prior treatment with any experimental biological agents for treatment of Axial
SpondyloArthritis (SpA)

- Exposure to more than 1 tumor necrosis factor (TNF)-antagonist or primary failure to
TNF antagonist therapy

- History of or current chronic or recurrent infections

- Subjects with known Tuberculosis (TB) infection, at high risk of acquiring TB
infection, or latent Tuberculosis (LTB)

- 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
As0006 208 - Camperdown
Recruitment hospital [2] 0 0
As0006 210 - Coffs Harbour
Recruitment hospital [3] 0 0
As0006 204 - Footscray
Recruitment hospital [4] 0 0
As0006 201 - Malvern East
Recruitment hospital [5] 0 0
As0006 209 - Maroochydore
Recruitment hospital [6] 0 0
As0006 205 - South Hobart
Recruitment hospital [7] 0 0
As0006 202 - Victoria Park
Recruitment postcode(s) [1] 0 0
- Camperdown
Recruitment postcode(s) [2] 0 0
- Coffs Harbour
Recruitment postcode(s) [3] 0 0
- Footscray
Recruitment postcode(s) [4] 0 0
- Malvern East
Recruitment postcode(s) [5] 0 0
- Maroochydore
Recruitment postcode(s) [6] 0 0
- South Hobart
Recruitment postcode(s) [7] 0 0
- Victoria Park
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Connecticut
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Georgia
Country [7] 0 0
United States of America
State/province [7] 0 0
Idaho
Country [8] 0 0
United States of America
State/province [8] 0 0
Maryland
Country [9] 0 0
United States of America
State/province [9] 0 0
Massachusetts
Country [10] 0 0
United States of America
State/province [10] 0 0
Minnesota
Country [11] 0 0
United States of America
State/province [11] 0 0
Missouri
Country [12] 0 0
United States of America
State/province [12] 0 0
New York
Country [13] 0 0
United States of America
State/province [13] 0 0
North Carolina
Country [14] 0 0
United States of America
State/province [14] 0 0
Oklahoma
Country [15] 0 0
United States of America
State/province [15] 0 0
Oregon
Country [16] 0 0
United States of America
State/province [16] 0 0
Pennsylvania
Country [17] 0 0
United States of America
State/province [17] 0 0
South Carolina
Country [18] 0 0
United States of America
State/province [18] 0 0
Utah
Country [19] 0 0
United States of America
State/province [19] 0 0
Washington
Country [20] 0 0
United States of America
State/province [20] 0 0
Wisconsin
Country [21] 0 0
Bulgaria
State/province [21] 0 0
Plovdiv
Country [22] 0 0
Bulgaria
State/province [22] 0 0
Ruse
Country [23] 0 0
Bulgaria
State/province [23] 0 0
Sevlievo
Country [24] 0 0
Bulgaria
State/province [24] 0 0
Sofia
Country [25] 0 0
Bulgaria
State/province [25] 0 0
Varna
Country [26] 0 0
Canada
State/province [26] 0 0
Edmonton
Country [27] 0 0
Canada
State/province [27] 0 0
Victoria
Country [28] 0 0
Czechia
State/province [28] 0 0
Hlucín
Country [29] 0 0
Czechia
State/province [29] 0 0
Hustopece
Country [30] 0 0
Czechia
State/province [30] 0 0
Olomouc
Country [31] 0 0
Czechia
State/province [31] 0 0
Ostrava
Country [32] 0 0
Czechia
State/province [32] 0 0
Pardubice
Country [33] 0 0
Czechia
State/province [33] 0 0
Praha 2
Country [34] 0 0
Czechia
State/province [34] 0 0
Praha
Country [35] 0 0
Czechia
State/province [35] 0 0
Príbor
Country [36] 0 0
Czechia
State/province [36] 0 0
Rychnov Nad KneĹžnou
Country [37] 0 0
Czechia
State/province [37] 0 0
Zlín
Country [38] 0 0
Hungary
State/province [38] 0 0
Balatonfüred
Country [39] 0 0
Hungary
State/province [39] 0 0
Budapest
Country [40] 0 0
Hungary
State/province [40] 0 0
Szekesfehervar
Country [41] 0 0
Poland
State/province [41] 0 0
Bydgoszcz
Country [42] 0 0
Poland
State/province [42] 0 0
Elblag
Country [43] 0 0
Poland
State/province [43] 0 0
Kraków
Country [44] 0 0
Poland
State/province [44] 0 0
Lublin
Country [45] 0 0
Poland
State/province [45] 0 0
Poznan
Country [46] 0 0
Poland
State/province [46] 0 0
Torun
Country [47] 0 0
Poland
State/province [47] 0 0
Warszawa
Country [48] 0 0
Poland
State/province [48] 0 0
Wroclaw
Country [49] 0 0
Russian Federation
State/province [49] 0 0
Chelyabinsk
Country [50] 0 0
Russian Federation
State/province [50] 0 0
Ivanovo
Country [51] 0 0
Russian Federation
State/province [51] 0 0
Kazan
Country [52] 0 0
Russian Federation
State/province [52] 0 0
Kemerovo
Country [53] 0 0
Russian Federation
State/province [53] 0 0
Moscow
Country [54] 0 0
Russian Federation
State/province [54] 0 0
Orenburg
Country [55] 0 0
Russian Federation
State/province [55] 0 0
Ryazan'
Country [56] 0 0
Russian Federation
State/province [56] 0 0
Saint Petersburg
Country [57] 0 0
Russian Federation
State/province [57] 0 0
Samara
Country [58] 0 0
Russian Federation
State/province [58] 0 0
Saratov
Country [59] 0 0
Russian Federation
State/province [59] 0 0
Smolensk
Country [60] 0 0
Russian Federation
State/province [60] 0 0
Tolyatti
Country [61] 0 0
Russian Federation
State/province [61] 0 0
Yaroslavl
Country [62] 0 0
Taiwan
State/province [62] 0 0
Hualien City
Country [63] 0 0
Taiwan
State/province [63] 0 0
Taichung City
Country [64] 0 0
Taiwan
State/province [64] 0 0
Taipei

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
UCB BIOSCIENCES GmbH
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Patients with active Axial Spondyloarthritis without x-ray evidence of Ankylosing Spondylitis
and with signs of inflammation will be randomly assigned to receive certolizumab pegol (CZP)
200 mg every two weeks or placebo. The primary objective is to demonstrate the efficacy of
CZP in these patients.
Trial website
https://clinicaltrials.gov/show/NCT02552212
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
UCB Cares
Address 0 0
1-844-599-2273 (UCB)
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications