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Multicenter Study Evaluating Certolizumab Pegol Compared to Placebo in Subjects With axSpA Without X-ray Evidence of AS (C-AXSPAND)

Primary Purpose

Axial Spondyloarthritis, Nonradiographic Axial Spondyloarthritis, Nr-axSpA

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Certolizumab Pegol
Placebo
Sponsored by
UCB BIOSCIENCES GmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Axial Spondyloarthritis focused on measuring Axial Spondyloarthritis, axSpA, Ankylosing Spondylitis, Anti TNF-alpha, Certolizumab Pegol, Nr-axSpA, Non-radiographic, Spondylarthropathies, Arthritis, Spinal Diseases, Immunosuppressive Agents

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

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

Sites / Locations

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Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Certolizumab Pegol 200 mg Q2W

Placebo

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Percentage of Subjects With Ankylosing Spondylitis Disease Activity Score Major Improvement (ASDAS-MI) Response Criteria Response at Week 52
This variable was considered as primary in all countries except for Canada (and any other country where applicable or where requested by Regulatory Authorities) where it was considered as secondary variable. ASDAS-MI was achieved when there was a reduction (improvement) >= 2.0 in the ASDAS relative to Baseline, or when the lowest possible ASDAS score (0.6) was reached. The ASDAS was 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 [ln] of the (CRP [mg/L] + 1)) Back pain, PGADA, duration of morning stiffness, peripheral pain/swelling and fatigue were all assessed on a numerical scale (0 to 10 units, where 0 is "not active" and 10 is "very active").
Percentage of Subjects With Axial SpondyloArthritis International Society 40% Response Criteria (ASAS40) Response at Week 12
This variable was 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 was 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), where 0 is "not active" and 10 is "very active" 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.
Certolizumab Pegol Plasma Concentration at Baseline
Certolizumab pegol plasma concentration was measured at Baseline in micrograms per millilitre (µg/mL).
Certolizumab Pegol Plasma Concentration at Week 1
Certolizumab pegol plasma concentration was measured at Week 1, in µg/mL.
Certolizumab Pegol Plasma Concentration at Week 2
Certolizumab pegol plasma concentration was measured at Week 2, in µg/mL.
Certolizumab Pegol Plasma Concentration at Week 4
Certolizumab pegol plasma concentration was measured at Week 4, in µg/mL.
Certolizumab Pegol Plasma Concentration at Week 12
Certolizumab pegol plasma concentration was measured at Week 12, in µg/mL.
Certolizumab Pegol Plasma Concentration at Week 24
Certolizumab pegol plasma concentration was measured at Week 24, in µg/mL.
Certolizumab Pegol Plasma Concentration at Week 36
Certolizumab pegol plasma concentration was measured at Week 36, in µg/mL.
Certolizumab Pegol Plasma Concentration at Week 52
Certolizumab pegol plasma concentration was measured at Week 52, in µg/mL.
Certolizumab Pegol Plasma Concentration at Follow-Up (FU) Visit
Certolizumab pegol plasma concentration was measured at the Follow-Up Visit, in µg/mL. Follow-Up Visit was defined as 8 weeks after Week 52 or Withdrawal (WD) visit for subjects not participating in the Safety Follow-Up Extension (SFE) Period.

Secondary Outcome Measures

Percentage of Subjects With Axial SpondyloArthritis International Society 40% Response Criteria (ASAS40) Response at Week 52
The ASAS40 response was 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), where 0 is "not active" and 10 is "very active" 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.
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 (Easy) to 10 (Impossible), with lower scores indicating better physical function. The change from Baseline is calculated, a negative value indicating improvement and a positive value worsening.
Change From Baseline to Week 52 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 (Easy) to 10 (Impossible), with lower scores indicating better physical function. The change from Baseline is calculated, a negative value indicating improvement and a positive value worsening.
Change From Baseline to Week 12 in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
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 (not active) to 10 (very active), with lower scores indicating lower disease activity. The change from Baseline is calculated, a negative value indicating improvement and a positive value worsening.
Change From Baseline to Week 52 in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
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 (not active) to 10 (very active), with lower scores indicating lower disease activity. The change from Baseline is calculated, a negative value indicating improvement and a positive value worsening.
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. The change from Baseline is calculated, a negative value indicating improvement and a positive value worsening.
Number of Subjects Without Relevant Changes to Background Medication From Baseline to Week 52
The number of subjects who did not have relevant changes to background medications during the study treatment period. A subject is without relevant changes to background medication if they do not have: the addition of a new disease-modifying antirheumatic drug (DMARD) or the change from one DMAR to another; the addition of an nonsteroidal anti-inflammatory drug (NSAID) or the change from one NSAID to another; an increased dose of chronic corticosteroids; the addition of a new chronic analgesic medication or increased dose in chronic analgesic medication; and they complete double-blind study treatment to Week 52.
Change From Baseline in Ankylosing Spondylitis Quality of Life (ASQoL) at Week 52
The ASQoL score ranged from 0 to 18 with higher score indicating worse Health-Related Quality of Life (HRQoL) and 0 indicating good HRQoL. The change from Baseline is calculated, a negative value indicating improvement and a positive value worsening.
Change From Baseline in ASQoL at Week 1
The ASQoL score ranged from 0 to 18 with higher score indicating worse Health-Related Quality of Life (HRQoL) and 0 indicating good HRQoL. The change from Baseline is calculated, a negative value indicating improvement and a positive value worsening.
Change From Baseline in ASQoL at Week 2
The ASQoL score ranged from 0 to 18 with higher score indicating worse Health-Related Quality of Life (HRQoL) and 0 indicating good HRQoL. The change from Baseline is calculated, a negative value indicating improvement and a positive value worsening.
Change From Baseline in ASQoL at Week 4
The ASQoL score ranged from 0 to 18 with higher score indicating worse Health-Related Quality of Life (HRQoL) and 0 indicating good HRQoL. The change from Baseline is calculated, a negative value indicating improvement and a positive value worsening.
Change From Baseline in ASQoL at Week 12
The ASQoL score ranged from 0 to 18 with higher score indicating worse Health-Related Quality of Life (HRQoL) and 0 indicating good HRQoL. The change from Baseline is calculated, a negative value indicating improvement and a positive value worsening.
Change From Baseline in ASQoL at Week 24
The ASQoL score ranged from 0 to 18 with higher score indicating worse Health-Related Quality of Life (HRQoL) and 0 indicating good HRQoL. The change from Baseline is calculated, a negative value indicating improvement and a positive value worsening.
Change From Baseline in ASQoL at Week 36
The ASQoL score ranged from 0 to 18 with higher score indicating worse Health-Related Quality of Life (HRQoL) and 0 indicating good HRQoL. The change from Baseline is calculated, a negative value indicating improvement and a positive value worsening.
Change From Baseline in ASQoL at Week 48
The ASQoL score ranged from 0 to 18 with higher score indicating worse Health-Related Quality of Life (HRQoL) and 0 indicating good HRQoL. The change from Baseline is calculated, a negative value indicating improvement and a positive value worsening.
Change From Baseline in Nocturnal Spinal Pain Numerical Rating Scale (NRS) at Week 52
The nocturnal spinal pain experienced by subjects due to AS was measured by following question 'How much pain of your spine due to spondylitis do you have at night?'. The NRS ranged from 0 to 10, where 0 represented 'no pain' and 10 represented 'most severe pain'. The change from Baseline is calculated, a negative value indicating improvement and a positive value worsening.
Number of Subjects With Anterior Uveitis (AU) or New AU Flares Through Week 52
The number of subjects with AU or new AU flares during the study treatment period.
Percentage of Subjects With Treatment-Emergent Adverse Events (TEAEs) During the Study
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.
Percentage of Subjects With Serious Adverse Events (SAEs) During the Study
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.
Percentage of Subjects With Adverse Events Leading to Withdrawal From Investigational Medicinal Product (IMP) During the Study
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.

Full Information

First Posted
September 15, 2015
Last Updated
August 16, 2022
Sponsor
UCB BIOSCIENCES GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT02552212
Brief Title
Multicenter Study Evaluating Certolizumab Pegol Compared to Placebo in Subjects With axSpA Without X-ray Evidence of AS
Acronym
C-AXSPAND
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
September 2015 (Actual)
Primary Completion Date
May 2018 (Actual)
Study Completion Date
May 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UCB BIOSCIENCES GmbH

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Axial Spondyloarthritis, Nonradiographic Axial Spondyloarthritis, Nr-axSpA
Keywords
Axial Spondyloarthritis, axSpA, Ankylosing Spondylitis, Anti TNF-alpha, Certolizumab Pegol, Nr-axSpA, Non-radiographic, Spondylarthropathies, Arthritis, Spinal Diseases, Immunosuppressive Agents

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
317 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Certolizumab Pegol 200 mg Q2W
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Matching placebo to Certolizumab Pegol (CZP) injections are administered every 2 weeks from Week 0 onwards.
Intervention Type
Biological
Intervention Name(s)
Certolizumab Pegol
Other Intervention Name(s)
Cimzia, CDP870
Intervention Description
Active Substance: Certolizumab Pegol Pharmaceutical Form: Prefilled syringe Concentration: 200 mg / ml Route of Administration: Subcutaneous injection
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Active Substance: Placebo Pharmaceutical Form: Prefilled syringe Concentration: 0.9 % saline Route of Administration: Subcutaneous injection
Primary Outcome Measure Information:
Title
Percentage of Subjects With Ankylosing Spondylitis Disease Activity Score Major Improvement (ASDAS-MI) Response Criteria Response at Week 52
Description
This variable was considered as primary in all countries except for Canada (and any other country where applicable or where requested by Regulatory Authorities) where it was considered as secondary variable. ASDAS-MI was achieved when there was a reduction (improvement) >= 2.0 in the ASDAS relative to Baseline, or when the lowest possible ASDAS score (0.6) was reached. The ASDAS was 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 [ln] of the (CRP [mg/L] + 1)) Back pain, PGADA, duration of morning stiffness, peripheral pain/swelling and fatigue were all assessed on a numerical scale (0 to 10 units, where 0 is "not active" and 10 is "very active").
Time Frame
Week 52
Title
Percentage of Subjects With Axial SpondyloArthritis International Society 40% Response Criteria (ASAS40) Response at Week 12
Description
This variable was 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 was 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), where 0 is "not active" and 10 is "very active" 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.
Time Frame
Week 12
Title
Certolizumab Pegol Plasma Concentration at Baseline
Description
Certolizumab pegol plasma concentration was measured at Baseline in micrograms per millilitre (µg/mL).
Time Frame
Baseline (Week 0)
Title
Certolizumab Pegol Plasma Concentration at Week 1
Description
Certolizumab pegol plasma concentration was measured at Week 1, in µg/mL.
Time Frame
Week 1
Title
Certolizumab Pegol Plasma Concentration at Week 2
Description
Certolizumab pegol plasma concentration was measured at Week 2, in µg/mL.
Time Frame
Week 2
Title
Certolizumab Pegol Plasma Concentration at Week 4
Description
Certolizumab pegol plasma concentration was measured at Week 4, in µg/mL.
Time Frame
Week 4
Title
Certolizumab Pegol Plasma Concentration at Week 12
Description
Certolizumab pegol plasma concentration was measured at Week 12, in µg/mL.
Time Frame
Week 12
Title
Certolizumab Pegol Plasma Concentration at Week 24
Description
Certolizumab pegol plasma concentration was measured at Week 24, in µg/mL.
Time Frame
Week 24
Title
Certolizumab Pegol Plasma Concentration at Week 36
Description
Certolizumab pegol plasma concentration was measured at Week 36, in µg/mL.
Time Frame
Week 36
Title
Certolizumab Pegol Plasma Concentration at Week 52
Description
Certolizumab pegol plasma concentration was measured at Week 52, in µg/mL.
Time Frame
Week 52
Title
Certolizumab Pegol Plasma Concentration at Follow-Up (FU) Visit
Description
Certolizumab pegol plasma concentration was measured at the Follow-Up Visit, in µg/mL. Follow-Up Visit was defined as 8 weeks after Week 52 or Withdrawal (WD) visit for subjects not participating in the Safety Follow-Up Extension (SFE) Period.
Time Frame
Follow-up Visit (up to Week 60)
Secondary Outcome Measure Information:
Title
Percentage of Subjects With Axial SpondyloArthritis International Society 40% Response Criteria (ASAS40) Response at Week 52
Description
The ASAS40 response was 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), where 0 is "not active" and 10 is "very active" 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.
Time Frame
Week 52
Title
Change From Baseline to Week 12 in the Bath Ankylosing Spondylitis Functional Index (BASFI)
Description
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 (Easy) to 10 (Impossible), with lower scores indicating better physical function. The change from Baseline is calculated, a negative value indicating improvement and a positive value worsening.
Time Frame
From Baseline to Week 12
Title
Change From Baseline to Week 52 in the Bath Ankylosing Spondylitis Functional Index (BASFI)
Description
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 (Easy) to 10 (Impossible), with lower scores indicating better physical function. The change from Baseline is calculated, a negative value indicating improvement and a positive value worsening.
Time Frame
From Baseline to Week 52
Title
Change From Baseline to Week 12 in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
Description
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 (not active) to 10 (very active), with lower scores indicating lower disease activity. The change from Baseline is calculated, a negative value indicating improvement and a positive value worsening.
Time Frame
From Baseline to Week 12
Title
Change From Baseline to Week 52 in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
Description
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 (not active) to 10 (very active), with lower scores indicating lower disease activity. The change from Baseline is calculated, a negative value indicating improvement and a positive value worsening.
Time Frame
From Baseline to Week 52
Title
Change From Baseline to Week 12 in Sacroiliac Spondyloarthritis Research Consortium of Canada (SI-SPARCC) Score
Description
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. The change from Baseline is calculated, a negative value indicating improvement and a positive value worsening.
Time Frame
From Baseline to Week 12
Title
Number of Subjects Without Relevant Changes to Background Medication From Baseline to Week 52
Description
The number of subjects who did not have relevant changes to background medications during the study treatment period. A subject is without relevant changes to background medication if they do not have: the addition of a new disease-modifying antirheumatic drug (DMARD) or the change from one DMAR to another; the addition of an nonsteroidal anti-inflammatory drug (NSAID) or the change from one NSAID to another; an increased dose of chronic corticosteroids; the addition of a new chronic analgesic medication or increased dose in chronic analgesic medication; and they complete double-blind study treatment to Week 52.
Time Frame
From Baseline to Week 52
Title
Change From Baseline in Ankylosing Spondylitis Quality of Life (ASQoL) at Week 52
Description
The ASQoL score ranged from 0 to 18 with higher score indicating worse Health-Related Quality of Life (HRQoL) and 0 indicating good HRQoL. The change from Baseline is calculated, a negative value indicating improvement and a positive value worsening.
Time Frame
From Baseline to Week 52
Title
Change From Baseline in ASQoL at Week 1
Description
The ASQoL score ranged from 0 to 18 with higher score indicating worse Health-Related Quality of Life (HRQoL) and 0 indicating good HRQoL. The change from Baseline is calculated, a negative value indicating improvement and a positive value worsening.
Time Frame
From Baseline to Week 1
Title
Change From Baseline in ASQoL at Week 2
Description
The ASQoL score ranged from 0 to 18 with higher score indicating worse Health-Related Quality of Life (HRQoL) and 0 indicating good HRQoL. The change from Baseline is calculated, a negative value indicating improvement and a positive value worsening.
Time Frame
From Baseline to Week 2
Title
Change From Baseline in ASQoL at Week 4
Description
The ASQoL score ranged from 0 to 18 with higher score indicating worse Health-Related Quality of Life (HRQoL) and 0 indicating good HRQoL. The change from Baseline is calculated, a negative value indicating improvement and a positive value worsening.
Time Frame
From Baseline to Week 4
Title
Change From Baseline in ASQoL at Week 12
Description
The ASQoL score ranged from 0 to 18 with higher score indicating worse Health-Related Quality of Life (HRQoL) and 0 indicating good HRQoL. The change from Baseline is calculated, a negative value indicating improvement and a positive value worsening.
Time Frame
From Baseline to Week 12
Title
Change From Baseline in ASQoL at Week 24
Description
The ASQoL score ranged from 0 to 18 with higher score indicating worse Health-Related Quality of Life (HRQoL) and 0 indicating good HRQoL. The change from Baseline is calculated, a negative value indicating improvement and a positive value worsening.
Time Frame
From Baseline to Week 24
Title
Change From Baseline in ASQoL at Week 36
Description
The ASQoL score ranged from 0 to 18 with higher score indicating worse Health-Related Quality of Life (HRQoL) and 0 indicating good HRQoL. The change from Baseline is calculated, a negative value indicating improvement and a positive value worsening.
Time Frame
From Baseline to Week 36
Title
Change From Baseline in ASQoL at Week 48
Description
The ASQoL score ranged from 0 to 18 with higher score indicating worse Health-Related Quality of Life (HRQoL) and 0 indicating good HRQoL. The change from Baseline is calculated, a negative value indicating improvement and a positive value worsening.
Time Frame
From Baseline to Week 48
Title
Change From Baseline in Nocturnal Spinal Pain Numerical Rating Scale (NRS) at Week 52
Description
The nocturnal spinal pain experienced by subjects due to AS was measured by following question 'How much pain of your spine due to spondylitis do you have at night?'. The NRS ranged from 0 to 10, where 0 represented 'no pain' and 10 represented 'most severe pain'. The change from Baseline is calculated, a negative value indicating improvement and a positive value worsening.
Time Frame
From Baseline to Week 52
Title
Number of Subjects With Anterior Uveitis (AU) or New AU Flares Through Week 52
Description
The number of subjects with AU or new AU flares during the study treatment period.
Time Frame
Throughout the study conduct (up to Week 52)
Title
Percentage of Subjects With Treatment-Emergent Adverse Events (TEAEs) During the Study
Description
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.
Time Frame
From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156)
Title
Percentage of Subjects With Serious Adverse Events (SAEs) During the Study
Description
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.
Time Frame
From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156)
Title
Percentage of Subjects With Adverse Events Leading to Withdrawal From Investigational Medicinal Product (IMP) During the Study
Description
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.
Time Frame
From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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) 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
UCB Cares
Organizational Affiliation
1-844-599-2273 (UCB)
Official's Role
Study Director
Facility Information:
Facility Name
As0006 125
City
Birmingham
State/Province
Alabama
Country
United States
Facility Name
As0006 120
City
Scottsdale
State/Province
Arizona
Country
United States
Facility Name
As0006 115
City
Tucson
State/Province
Arizona
Country
United States
Facility Name
As0006 155
City
Beverly Hills
State/Province
California
Country
United States
Facility Name
As0006 101
City
Palm Desert
State/Province
California
Country
United States
Facility Name
As0006 143
City
San Francisco
State/Province
California
Country
United States
Facility Name
As0006 160
City
New Haven
State/Province
Connecticut
Country
United States
Facility Name
As0006 117
City
Daytona Beach
State/Province
Florida
Country
United States
Facility Name
As0006 116
City
DeBary
State/Province
Florida
Country
United States
Facility Name
As0006 124
City
Fort Lauderdale
State/Province
Florida
Country
United States
Facility Name
As0006 133
City
New Port Richey
State/Province
Florida
Country
United States
Facility Name
As0006 138
City
Plantation
State/Province
Florida
Country
United States
Facility Name
As0006 134
City
Tampa
State/Province
Florida
Country
United States
Facility Name
As0006 106
City
Vero Beach
State/Province
Florida
Country
United States
Facility Name
As0006 148
City
Atlanta
State/Province
Georgia
Country
United States
Facility Name
As0006 137
City
Idaho Falls
State/Province
Idaho
Country
United States
Facility Name
As0006 102
City
Cumberland
State/Province
Maryland
Country
United States
Facility Name
As0006 141
City
Cumberland
State/Province
Maryland
Country
United States
Facility Name
As0006 111
City
Wheaton
State/Province
Maryland
Country
United States
Facility Name
As0006 127
City
Boston
State/Province
Massachusetts
Country
United States
Facility Name
As0006 147
City
Worcester
State/Province
Massachusetts
Country
United States
Facility Name
As0006 110
City
Eagan
State/Province
Minnesota
Country
United States
Facility Name
As0006 123
City
Rochester
State/Province
Minnesota
Country
United States
Facility Name
As0006 103
City
Saint Louis
State/Province
Missouri
Country
United States
Facility Name
As0006 114
City
Brooklyn
State/Province
New York
Country
United States
Facility Name
As0006 118
City
Charlotte
State/Province
North Carolina
Country
United States
Facility Name
As0006 149
City
Oklahoma City
State/Province
Oklahoma
Country
United States
Facility Name
As0006 105
City
Portland
State/Province
Oregon
Country
United States
Facility Name
As0006 108
City
Duncansville
State/Province
Pennsylvania
Country
United States
Facility Name
As0006 144
City
Philadelphia
State/Province
Pennsylvania
Country
United States
Facility Name
As0006 129
City
Wyomissing
State/Province
Pennsylvania
Country
United States
Facility Name
As0006 156
City
Orangeburg
State/Province
South Carolina
Country
United States
Facility Name
As0006 107
City
Salt Lake City
State/Province
Utah
Country
United States
Facility Name
As0006 104
City
Seattle
State/Province
Washington
Country
United States
Facility Name
As0006 158
City
Manitowoc
State/Province
Wisconsin
Country
United States
Facility Name
As0006 113
City
Onalaska
State/Province
Wisconsin
Country
United States
Facility Name
As0006 208
City
Camperdown
Country
Australia
Facility Name
As0006 210
City
Coffs Harbour
Country
Australia
Facility Name
As0006 204
City
Footscray
Country
Australia
Facility Name
As0006 201
City
Malvern East
Country
Australia
Facility Name
As0006 209
City
Maroochydore
Country
Australia
Facility Name
As0006 205
City
South Hobart
Country
Australia
Facility Name
As0006 202
City
Victoria Park
Country
Australia
Facility Name
As0006 302
City
Plovdiv
Country
Bulgaria
Facility Name
As0006 305
City
Plovdiv
Country
Bulgaria
Facility Name
As0006 304
City
Ruse
Country
Bulgaria
Facility Name
As0006 306
City
Sevlievo
Country
Bulgaria
Facility Name
As0006 300
City
Sofia
Country
Bulgaria
Facility Name
As0006 307
City
Sofia
Country
Bulgaria
Facility Name
As0006 309
City
Sofia
Country
Bulgaria
Facility Name
As0006 308
City
Varna
Country
Bulgaria
Facility Name
As0006 152
City
Edmonton
Country
Canada
Facility Name
As0006 150
City
Victoria
Country
Canada
Facility Name
As0006 326
City
Hlučín
Country
Czechia
Facility Name
As0006 324
City
Hustopeče
Country
Czechia
Facility Name
As0006 327
City
Olomouc
Country
Czechia
Facility Name
As0006 320
City
Ostrava
Country
Czechia
Facility Name
As0006 322
City
Pardubice
Country
Czechia
Facility Name
As0006 328
City
Praha 2
Country
Czechia
Facility Name
As0006 323
City
Praha
Country
Czechia
Facility Name
As0006 329
City
Praha
Country
Czechia
Facility Name
As0006 330
City
Praha
Country
Czechia
Facility Name
As0006 333
City
Příbor
Country
Czechia
Facility Name
As0006 332
City
Rychnov Nad Kněžnou
Country
Czechia
Facility Name
As0006 331
City
Zlín
Country
Czechia
Facility Name
As0006 365
City
Balatonfüred
Country
Hungary
Facility Name
As0006 362
City
Budapest
Country
Hungary
Facility Name
As0006 363
City
Budapest
Country
Hungary
Facility Name
As0006 361
City
Szekesfehervar
Country
Hungary
Facility Name
As0006 406
City
Bydgoszcz
Country
Poland
Facility Name
As0006 400
City
Elbląg
Country
Poland
Facility Name
As0006 401
City
Kraków
Country
Poland
Facility Name
As0006 402
City
Kraków
Country
Poland
Facility Name
As0006 411
City
Lublin
Country
Poland
Facility Name
As0006 403
City
Poznań
Country
Poland
Facility Name
As0006 404
City
Poznań
Country
Poland
Facility Name
As0006 405
City
Toruń
Country
Poland
Facility Name
As0006 407
City
Warszawa
Country
Poland
Facility Name
As0006 408
City
Warszawa
Country
Poland
Facility Name
As0006 409
City
Warszawa
Country
Poland
Facility Name
As0006 410
City
Warszawa
Country
Poland
Facility Name
As0006 413
City
Wrocław
Country
Poland
Facility Name
As0006 414
City
Wrocław
Country
Poland
Facility Name
As0006 461
City
Chelyabinsk
Country
Russian Federation
Facility Name
As0006 453
City
Ivanovo
Country
Russian Federation
Facility Name
As0006 450
City
Kazan
Country
Russian Federation
Facility Name
As0006 451
City
Kazan
Country
Russian Federation
Facility Name
As0006 458
City
Kemerovo
Country
Russian Federation
Facility Name
As0006 455
City
Moscow
Country
Russian Federation
Facility Name
As0006 466
City
Moscow
Country
Russian Federation
Facility Name
As0006 462
City
Orenburg
Country
Russian Federation
Facility Name
As0006 452
City
Ryazan'
Country
Russian Federation
Facility Name
As0006 459
City
Saint Petersburg
Country
Russian Federation
Facility Name
As0006 463
City
Saint Petersburg
Country
Russian Federation
Facility Name
As0006 464
City
Saint Petersburg
Country
Russian Federation
Facility Name
As0006 467
City
Saint Petersburg
Country
Russian Federation
Facility Name
As0006 465
City
Samara
Country
Russian Federation
Facility Name
As0006 454
City
Saratov
Country
Russian Federation
Facility Name
As0006 460
City
Smolensk
Country
Russian Federation
Facility Name
As0006 456
City
Tolyatti
Country
Russian Federation
Facility Name
As0006 457
City
Yaroslavl
Country
Russian Federation
Facility Name
As0006 232
City
Hualien City
Country
Taiwan
Facility Name
As0006 230
City
Taichung City
Country
Taiwan
Facility Name
As0006 233
City
Taichung City
Country
Taiwan
Facility Name
As0006 231
City
Taipei
Country
Taiwan

12. IPD Sharing Statement

Citations:
PubMed Identifier
35296532
Citation
van der Heijde D, Gensler LS, Maksymowych WP, Landewe R, Rudwaleit M, Bauer L, Kumke T, Kim M, Auteri SE, Hoepken B, Deodhar A. Long-term safety and clinical outcomes of certolizumab pegol treatment in patients with active non-radiographic axial spondyloarthritis: 3-year results from the phase 3 C-axSpAnd study. RMD Open. 2022 Mar;8(1):e002138. doi: 10.1136/rmdopen-2021-002138.
Results Reference
result
PubMed Identifier
35733363
Citation
Robinson PC, Maksymowych WP, Gensler LS, Hall S, Rudwaleit M, Hoepken B, Bauer L, Kumke T, Kim M, de Peyrecave N, Deodhar A. Certolizumab Pegol Efficacy in Patients With Non-Radiographic Axial Spondyloarthritis Stratified by Baseline MRI and C-Reactive Protein Status: An Analysis From the C-axSpAnd Study. ACR Open Rheumatol. 2022 Sep;4(9):794-801. doi: 10.1002/acr2.11469. Epub 2022 Jun 22.
Results Reference
result
PubMed Identifier
34715908
Citation
Maksymowych WP, Kumke T, Auteri SE, Hoepken B, Bauer L, Rudwaleit M. Predictors of long-term clinical response in patients with non-radiographic axial spondyloarthritis receiving certolizumab pegol. Arthritis Res Ther. 2021 Oct 29;23(1):274. doi: 10.1186/s13075-021-02650-4.
Results Reference
derived
PubMed Identifier
30848558
Citation
Deodhar A, Gensler LS, Kay J, Maksymowych WP, Haroon N, Landewe R, Rudwaleit M, Hall S, Bauer L, Hoepken B, de Peyrecave N, Kilgallen B, van der Heijde D. A Fifty-Two-Week, Randomized, Placebo-Controlled Trial of Certolizumab Pegol in Nonradiographic Axial Spondyloarthritis. Arthritis Rheumatol. 2019 Jul;71(7):1101-1111. doi: 10.1002/art.40866. Epub 2019 May 28.
Results Reference
derived
Links:
URL
http://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
Description
FDA Safety Alerts and Recalls

Learn more about this trial

Multicenter Study Evaluating Certolizumab Pegol Compared to Placebo in Subjects With axSpA Without X-ray Evidence of AS

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