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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02552212
Registration number
NCT02552212
Ethics application status
Date submitted
15/09/2015
Date registered
17/09/2015
Date last updated
18/08/2022
Titles & IDs
Public title
Multicenter Study Evaluating Certolizumab Pegol Compared to Placebo in Subjects With axSpA Without X-ray Evidence of AS
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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
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Secondary ID [1]
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2015-001894-41
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Secondary ID [2]
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AS0006
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Universal Trial Number (UTN)
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Trial acronym
C-AXSPAND
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Axial Spondyloarthritis
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Nonradiographic Axial Spondyloarthritis
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Nr-axSpA
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Condition category
Condition code
Inflammatory and Immune System
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Other inflammatory or immune system disorders
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Musculoskeletal
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Other muscular and skeletal disorders
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Inflammatory and Immune System
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Rheumatoid arthritis
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Musculoskeletal
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Osteoarthritis
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Intervention/exposure
Study type
Interventional(has expanded access)
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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
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of Subjects With Ankylosing Spondylitis Disease Activity Score Major Improvement (ASDAS-MI) Response Criteria Response at Week 52
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Assessment method [1]
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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").
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Timepoint [1]
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Week 52
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Primary outcome [2]
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Percentage of Subjects With Axial SpondyloArthritis International Society 40% Response Criteria (ASAS40) Response at Week 12
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Assessment method [2]
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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.
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Timepoint [2]
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Week 12
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Primary outcome [3]
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Certolizumab Pegol Plasma Concentration at Baseline
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Assessment method [3]
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Certolizumab pegol plasma concentration was measured at Baseline in micrograms per millilitre (µg/mL).
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Timepoint [3]
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Baseline (Week 0)
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Primary outcome [4]
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Certolizumab Pegol Plasma Concentration at Week 1
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Assessment method [4]
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Certolizumab pegol plasma concentration was measured at Week 1, in µg/mL.
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Timepoint [4]
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Week 1
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Primary outcome [5]
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Certolizumab Pegol Plasma Concentration at Week 2
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Assessment method [5]
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Certolizumab pegol plasma concentration was measured at Week 2, in µg/mL.
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Timepoint [5]
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Week 2
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Primary outcome [6]
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Certolizumab Pegol Plasma Concentration at Week 4
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Assessment method [6]
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Certolizumab pegol plasma concentration was measured at Week 4, in µg/mL.
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Timepoint [6]
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Week 4
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Primary outcome [7]
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Certolizumab Pegol Plasma Concentration at Week 12
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Assessment method [7]
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Certolizumab pegol plasma concentration was measured at Week 12, in µg/mL.
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Timepoint [7]
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Week 12
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Primary outcome [8]
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Certolizumab Pegol Plasma Concentration at Week 24
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Assessment method [8]
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Certolizumab pegol plasma concentration was measured at Week 24, in µg/mL.
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Timepoint [8]
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Week 24
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Primary outcome [9]
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Certolizumab Pegol Plasma Concentration at Week 36
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Assessment method [9]
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Certolizumab pegol plasma concentration was measured at Week 36, in µg/mL.
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Timepoint [9]
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Week 36
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Primary outcome [10]
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Certolizumab Pegol Plasma Concentration at Week 52
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Assessment method [10]
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Certolizumab pegol plasma concentration was measured at Week 52, in µg/mL.
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Timepoint [10]
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Week 52
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Primary outcome [11]
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Certolizumab Pegol Plasma Concentration at Follow-Up (FU) Visit
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Assessment method [11]
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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.
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Timepoint [11]
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Follow-up Visit (up to Week 60)
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Secondary outcome [1]
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Percentage of Subjects With Axial SpondyloArthritis International Society 40% Response Criteria (ASAS40) Response at Week 52
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Assessment method [1]
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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.
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Timepoint [1]
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Week 52
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Secondary outcome [2]
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Change From Baseline to Week 12 in the Bath Ankylosing Spondylitis Functional Index (BASFI)
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Assessment method [2]
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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.
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Timepoint [2]
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From Baseline to Week 12
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Secondary outcome [3]
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Change From Baseline to Week 52 in the Bath Ankylosing Spondylitis Functional Index (BASFI)
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Assessment method [3]
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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.
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Timepoint [3]
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From Baseline to Week 52
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Secondary outcome [4]
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Change From Baseline to Week 12 in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
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Assessment method [4]
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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.
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Timepoint [4]
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From Baseline to Week 12
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Secondary outcome [5]
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Change From Baseline to Week 52 in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
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Assessment method [5]
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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.
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Timepoint [5]
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From Baseline to Week 52
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Secondary outcome [6]
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Change From Baseline to Week 12 in Sacroiliac Spondyloarthritis Research Consortium of Canada (SI-SPARCC) Score
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Assessment method [6]
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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.
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Timepoint [6]
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From Baseline to Week 12
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Secondary outcome [7]
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Number of Subjects Without Relevant Changes to Background Medication From Baseline to Week 52
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Assessment method [7]
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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.
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Timepoint [7]
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From Baseline to Week 52
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Secondary outcome [8]
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Change From Baseline in Ankylosing Spondylitis Quality of Life (ASQoL) at Week 52
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Assessment method [8]
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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.
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Timepoint [8]
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From Baseline to Week 52
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Secondary outcome [9]
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Change From Baseline in ASQoL at Week 1
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Assessment method [9]
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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.
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Timepoint [9]
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From Baseline to Week 1
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Secondary outcome [10]
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Change From Baseline in ASQoL at Week 2
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Assessment method [10]
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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.
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Timepoint [10]
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From Baseline to Week 2
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Secondary outcome [11]
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Change From Baseline in ASQoL at Week 4
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Assessment method [11]
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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.
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Timepoint [11]
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From Baseline to Week 4
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Secondary outcome [12]
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Change From Baseline in ASQoL at Week 12
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Assessment method [12]
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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.
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Timepoint [12]
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From Baseline to Week 12
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Secondary outcome [13]
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Change From Baseline in ASQoL at Week 24
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Assessment method [13]
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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.
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Timepoint [13]
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From Baseline to Week 24
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Secondary outcome [14]
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Change From Baseline in ASQoL at Week 36
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Assessment method [14]
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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.
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Timepoint [14]
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From Baseline to Week 36
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Secondary outcome [15]
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Change From Baseline in ASQoL at Week 48
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Assessment method [15]
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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.
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Timepoint [15]
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From Baseline to Week 48
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Secondary outcome [16]
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Change From Baseline in Nocturnal Spinal Pain Numerical Rating Scale (NRS) at Week 52
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Assessment method [16]
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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.
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Timepoint [16]
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From Baseline to Week 52
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Secondary outcome [17]
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Number of Subjects With Anterior Uveitis (AU) or New AU Flares Through Week 52
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Assessment method [17]
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The number of subjects with AU or new AU flares during the study treatment period.
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Timepoint [17]
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Throughout the study conduct (up to Week 52)
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Secondary outcome [18]
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Percentage of Subjects With Treatment-Emergent Adverse Events (TEAEs) During the Study
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Assessment method [18]
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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.
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Timepoint [18]
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From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156)
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Secondary outcome [19]
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Percentage of Subjects With Serious Adverse Events (SAEs) During the Study
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Assessment method [19]
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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.
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Timepoint [19]
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From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156)
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Secondary outcome [20]
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Percentage of Subjects With Adverse Events Leading to Withdrawal From Investigational Medicinal Product (IMP) During the Study
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Assessment method [20]
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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.
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Timepoint [20]
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From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156)
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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)
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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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
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/09/2015
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/05/2020
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Sample size
Target
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Accrual to date
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Final
317
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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As0006 208 - Camperdown
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Recruitment hospital [2]
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0
As0006 210 - Coffs Harbour
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Recruitment hospital [3]
0
0
As0006 204 - Footscray
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Recruitment hospital [4]
0
0
As0006 201 - Malvern East
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Recruitment hospital [5]
0
0
As0006 209 - Maroochydore
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Recruitment hospital [6]
0
0
As0006 205 - South Hobart
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Recruitment hospital [7]
0
0
As0006 202 - Victoria Park
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Recruitment postcode(s) [1]
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0
- Camperdown
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Recruitment postcode(s) [2]
0
0
- Coffs Harbour
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Recruitment postcode(s) [3]
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0
- Footscray
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Recruitment postcode(s) [4]
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0
- Malvern East
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Recruitment postcode(s) [5]
0
0
- Maroochydore
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Recruitment postcode(s) [6]
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0
- South Hobart
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Recruitment postcode(s) [7]
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- Victoria Park
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Recruitment outside Australia
Country [1]
0
0
United States of America
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State/province [1]
0
0
Alabama
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Country [2]
0
0
United States of America
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State/province [2]
0
0
Arizona
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Country [3]
0
0
United States of America
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State/province [3]
0
0
California
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Country [4]
0
0
United States of America
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State/province [4]
0
0
Connecticut
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Country [5]
0
0
United States of America
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State/province [5]
0
0
Florida
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Country [6]
0
0
United States of America
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State/province [6]
0
0
Georgia
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Country [7]
0
0
United States of America
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State/province [7]
0
0
Idaho
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Country [8]
0
0
United States of America
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State/province [8]
0
0
Maryland
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Country [9]
0
0
United States of America
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State/province [9]
0
0
Massachusetts
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Country [10]
0
0
United States of America
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State/province [10]
0
0
Minnesota
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Country [11]
0
0
United States of America
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State/province [11]
0
0
Missouri
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Country [12]
0
0
United States of America
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State/province [12]
0
0
New York
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Country [13]
0
0
United States of America
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State/province [13]
0
0
North Carolina
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Country [14]
0
0
United States of America
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State/province [14]
0
0
Oklahoma
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Country [15]
0
0
United States of America
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State/province [15]
0
0
Oregon
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Country [16]
0
0
United States of America
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State/province [16]
0
0
Pennsylvania
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Country [17]
0
0
United States of America
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State/province [17]
0
0
South Carolina
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Country [18]
0
0
United States of America
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State/province [18]
0
0
Utah
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Country [19]
0
0
United States of America
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State/province [19]
0
0
Washington
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Country [20]
0
0
United States of America
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State/province [20]
0
0
Wisconsin
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Country [21]
0
0
Bulgaria
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State/province [21]
0
0
Plovdiv
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Country [22]
0
0
Bulgaria
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State/province [22]
0
0
Ruse
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Country [23]
0
0
Bulgaria
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State/province [23]
0
0
Sevlievo
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Country [24]
0
0
Bulgaria
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State/province [24]
0
0
Sofia
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Country [25]
0
0
Bulgaria
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State/province [25]
0
0
Varna
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Country [26]
0
0
Canada
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State/province [26]
0
0
Edmonton
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Country [27]
0
0
Canada
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State/province [27]
0
0
Victoria
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Country [28]
0
0
Czechia
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State/province [28]
0
0
Hlucín
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Ryazan'
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Tolyatti
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Taiwan
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Taipei
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Funding & Sponsors
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UCB BIOSCIENCES GmbH
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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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02552212
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UCB Cares
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1-844-599-2273 (UCB)
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Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02552212
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