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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02509026




Registration number
NCT02509026
Ethics application status
Date submitted
21/07/2015
Date registered
27/07/2015
Date last updated
16/06/2020

Titles & IDs
Public title
Etanercept Withdrawal And Retreament Study In Subjects With Nr-ax SpA
Scientific title
A MULTICENTER OPEN-LABEL STUDY OF ETANERCEPT WITHDRAWAL AND RETREATMENT IN SUBJECTS WITH NON-RADIOGRAPHIC AXIAL SPONDYLOARTHRITIS WHO ACHIEVED ADEQUATE 24 WEEK RESPONSE
Secondary ID [1] 0 0
2015-000541-24
Secondary ID [2] 0 0
B1801381
Universal Trial Number (UTN)
Trial acronym
RE-EMBARK
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Spondylitis, Ankylosing 0 0
Condition category
Condition code
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders
Musculoskeletal 0 0 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Etanercept

Experimental: Etanercept - etanercept 50 mg QW


Treatment: Other: Etanercept
50 mg subcutaneous, once weekly, 24 weeks
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants Who Experienced Flare Within 40 Weeks Following Withdrawal of 24 Weeks of Etanercept Treatment
Timepoint [1] 0 0
Within 40 weeks after Etanercept withdrawal (from Week 24 to Week 64)
Secondary outcome [1] 0 0
Time to Flare Following Withdrawal of Etanercept Treatment
Timepoint [1] 0 0
Within 40 weeks after Etanercept withdrawal (from Week 24 to Week 64)
Secondary outcome [2] 0 0
Percentage of Participants With Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Less Than (<)1.3: Observed Cases (OC): Period 1
Timepoint [2] 0 0
Baseline (Day 1 Week 1), Week 4, 8, 12, 16, 24
Secondary outcome [3] 0 0
Percentage of Participants With Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Less Than (<)1.3: Observed Cases (OC): Period 2
Timepoint [3] 0 0
Week 28, 32, 40, 48, 56, 64
Secondary outcome [4] 0 0
Percentage of Participants With Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Less Than (<)1.3: Observed Cases (OC): Period 3
Timepoint [4] 0 0
Week 68, 72, 76
Secondary outcome [5] 0 0
Percentage of Participants With Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Less Than (<) 1.3: Last Observation Carried Forward (LOCF): Period 1
Timepoint [5] 0 0
Baseline (Day 1 Week 1), Week 4, 8, 12, 16, 24
Secondary outcome [6] 0 0
Percentage of Participants With Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Less Than (<) 1.3: Last Observation Carried Forward (LOCF): Period 2
Timepoint [6] 0 0
Week 28, 32, 40, 48, 56, 64
Secondary outcome [7] 0 0
Percentage of Participants With Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Less Than (<) 1.3: Last Observation Carried Forward (LOCF): Period 3
Timepoint [7] 0 0
Week 68, 72, 76
Secondary outcome [8] 0 0
Percentage of Participants Who Achieved Assessment of Spondyloarthritis Society (ASAS 20) Response: Observed Cases (OC): Period 1
Timepoint [8] 0 0
Week 4, 8, 12, 16, 24
Secondary outcome [9] 0 0
Percentage of Participants Who Achieved Assessment of Spondyloarthritis Society (ASAS 20) Response: Observed Cases (OC): Period 2
Timepoint [9] 0 0
Week 28, 32, 40, 48, 56, 64
Secondary outcome [10] 0 0
Percentage of Participants Who Achieved Assessment of Spondyloarthritis Society (ASAS 20) Response: Observed Cases (OC): Period 3
Timepoint [10] 0 0
Week 64, 68, 72, 76
Secondary outcome [11] 0 0
Percentage of Participants Who Achieved Assessment of Spondyloarthritis Society (ASAS 20) Response: Last Observation Carried Forward (LOCF): Period 1
Timepoint [11] 0 0
Week 4, 8, 12, 16, 24
Secondary outcome [12] 0 0
Percentage of Participants Who Achieved Assessment of Spondyloarthritis Society (ASAS 20) Response: Last Observation Carried Forward (LOCF): Period 2
Timepoint [12] 0 0
Week 28, 32, 40, 48, 56, 64
Secondary outcome [13] 0 0
Percentage of Participants Who Achieved Assessment of Spondyloarthritis Society (ASAS 20) Response: Last Observation Carried Forward (LOCF): Period 3
Timepoint [13] 0 0
Week 64, 68, 72, 76
Secondary outcome [14] 0 0
Percentage of Participants Who Achieved Assessment of Spondyloarthritis Society 40 (ASAS 40) Response: Last Observation Carried Forward (LOCF): Period 1
Timepoint [14] 0 0
Week 4, 8, 12, 16, 24
Secondary outcome [15] 0 0
Percentage of Participants Who Achieved Assessment of Spondyloarthritis Society 40 (ASAS 40) Response: Last Observation Carried Forward (LOCF): Period 2
Timepoint [15] 0 0
Week 28, 32, 40, 48, 56, 64
Secondary outcome [16] 0 0
Percentage of Participants Who Achieved Assessment of Spondyloarthritis Society 40 (ASAS 40) Response: Last Observation Carried Forward (LOCF): Period 3
Timepoint [16] 0 0
Week 64, 68, 72, 76
Secondary outcome [17] 0 0
Percentage of Participants Who Achieved Assessment of Spondyloarthritis Society 40 (ASAS 40) Response: Observed Cases (OC): Period 1
Timepoint [17] 0 0
Week 4, 8, 12, 16, 24
Secondary outcome [18] 0 0
Percentage of Participants Who Achieved Assessment of Spondyloarthritis Society 40 (ASAS 40) Response: Observed Cases (OC): Period 2
Timepoint [18] 0 0
Week 28, 32, 40, 48, 56, 64
Secondary outcome [19] 0 0
Percentage of Participants Who Achieved Assessment of Spondyloarthritis Society 40 (ASAS 40) Response: Observed Cases (OC): Period 3
Timepoint [19] 0 0
Week 64, 68, 72, 76
Secondary outcome [20] 0 0
Percentage of Participants Who Achieved Assessment of Spondyloarthritis Society (ASAS) Partial Remission: Last Observation Carried Forward (LOCF): Period 1
Timepoint [20] 0 0
Week 4, 8, 12, 16, 24
Secondary outcome [21] 0 0
Percentage of Participants Who Achieved Assessment of Spondyloarthritis Society (ASAS) Partial Remission: Last Observation Carried Forward (LOCF): Period 2
Timepoint [21] 0 0
Week 28, 32, 40, 48, 56, 64
Secondary outcome [22] 0 0
Percentage of Participants Who Achieved Assessment of Spondyloarthritis Society (ASAS) Partial Remission: Last Observation Carried Forward (LOCF): Period 3
Timepoint [22] 0 0
Week 64, 68, 72, 76
Secondary outcome [23] 0 0
Percentage of Participants Who Achieved Assessment of Spondyloarthritis Society (ASAS) Partial Remission: Observed Cases (OC): Period 1
Timepoint [23] 0 0
Week 4, 8, 12, 16, 24
Secondary outcome [24] 0 0
Percentage of Participants Who Achieved Assessment of Spondyloarthritis Society (ASAS) Partial Remission: Observed Cases (OC): Period 2
Timepoint [24] 0 0
Week 28, 32, 40, 48, 56, 64
Secondary outcome [25] 0 0
Percentage of Participants Who Achieved Assessment of Spondyloarthritis Society (ASAS) Partial Remission: Observed Cases (OC): Period 3
Timepoint [25] 0 0
Week 64, 68, 72, 76
Secondary outcome [26] 0 0
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS)-C-Reactive Protein (CRP) Score: Last Observation Carried Forward (LOCF): Period 1
Timepoint [26] 0 0
Baseline (Day 1 Week 1), Week 4, 8, 12, 16, 24
Secondary outcome [27] 0 0
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS)-C-Reactive Protein (CRP) Score: Last Observation Carried Forward (LOCF): Period 2
Timepoint [27] 0 0
Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 28, 32, 40, 48, 56, 64
Secondary outcome [28] 0 0
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Score: Last Observation Carried Forward (LOCF): Period 3
Timepoint [28] 0 0
Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Period 3: Baseline (last visit before retreatment), Week 64, 68, 72, 76
Secondary outcome [29] 0 0
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Score: Observed Cases (OC): Period 1
Timepoint [29] 0 0
Baseline (Day 1 Week 1), Week 4, 8, 12, 16, 24
Secondary outcome [30] 0 0
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Score: Observed Cases (OC): Period 2
Timepoint [30] 0 0
Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 28, 32, 40, 48, 56, 64
Secondary outcome [31] 0 0
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Score: Observed Cases (OC): Period 3
Timepoint [31] 0 0
Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Period 3 Baseline (last visit before retreatment), Week 64, 68, 72, 76
Secondary outcome [32] 0 0
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) Erythrocyte Sedimentation Rate (ESR) Score: Last Observation Carried Forward (LOCF): Period 1
Timepoint [32] 0 0
Baseline (Day 1 Week 1), Week 4, 8, 12, 16, 24
Secondary outcome [33] 0 0
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS)-Erythrocyte Sedimentation Rate (ESR) Score: Last Observation Carried Forward (LOCF): Period 2
Timepoint [33] 0 0
Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 28, 32, 40, 48, 56, 64
Secondary outcome [34] 0 0
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS)-Erythrocyte Sedimentation Rate (ESR) Score: Last Observation Carried Forward (LOCF): Period 3
Timepoint [34] 0 0
Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Period 3 Baseline (last visit before retreatment), Week 64, 68, 72, 76
Secondary outcome [35] 0 0
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) Erythrocyte Sedimentation Rate (ESR) Score: Observed Cases (OC): Period 1
Timepoint [35] 0 0
Baseline (Day 1 Week 1), Week 4, 8, 12, 16, 24
Secondary outcome [36] 0 0
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS)-Erythrocyte Sedimentation Rate (ESR) Score: Observed Cases (OC): Period 2
Timepoint [36] 0 0
Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 28, 32, 40, 48, 56, 64
Secondary outcome [37] 0 0
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS)-Erythrocyte Sedimentation Rate (ESR) Score: Observed Cases (OC): Period 3
Timepoint [37] 0 0
Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Period 3 Baseline (last visit before retreatment), Week 64, 68, 72, 76
Secondary outcome [38] 0 0
Percentage of Participants Who Achieved Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Major Improvement: Last Observation Carried Forward (LOCF): Period 1
Timepoint [38] 0 0
Week 4, 8, 12, 16, 24
Secondary outcome [39] 0 0
Percentage of Participants Who Achieved Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Major Improvement: Last Observation Carried Forward (LOCF): Period 2
Timepoint [39] 0 0
Week 28, 32, 40, 48, 56, 64
Secondary outcome [40] 0 0
Percentage of Participants Who Achieved Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Major Improvement: Last Observation Carried Forward (LOCF): Period 3
Timepoint [40] 0 0
Week 64, 68, 72, 76
Secondary outcome [41] 0 0
Percentage of Participants Who Achieved Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Major Improvement: Observed Cases (OC): Period 1
Timepoint [41] 0 0
Week 4, 8, 12, 16, 24
Secondary outcome [42] 0 0
Percentage of Participants Who Achieved Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Major Improvement: Observed Cases (OC): Period 2
Timepoint [42] 0 0
Week 28, 32, 40, 48, 56, 64
Secondary outcome [43] 0 0
Percentage of Participants Who Achieved Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Major Improvement: Observed Cases (OC): Period 3
Timepoint [43] 0 0
Week 64, 68, 72, 76
Secondary outcome [44] 0 0
Percentage of Participants Who Achieved Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Clinically Important Improvement: Last Observation Carried Forward (LOCF): Period 1
Timepoint [44] 0 0
Week 4, 8, 12, 16, 24
Secondary outcome [45] 0 0
Percentage of Participants Who Achieved Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Clinically Important Improvement: Last Observation Carried Forward (LOCF): Period 2
Timepoint [45] 0 0
Week 28, 32, 40, 48, 56, 64
Secondary outcome [46] 0 0
Percentage of Participants Who Achieved Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Clinically Important Improvement: Last Observation Carried Forward (LOCF): Period 3
Timepoint [46] 0 0
Week 64, 68, 72, 76
Secondary outcome [47] 0 0
Percentage of Participants Who Achieved Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Clinically Important Improvement: Observed Cases (OC): Period 1
Timepoint [47] 0 0
Week 4, 8, 12, 16, 24
Secondary outcome [48] 0 0
Percentage of Participants Who Achieved Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Clinically Important Improvement: Observed Cases (OC): Period 2
Timepoint [48] 0 0
Week 28, 32, 40, 48, 56, 64
Secondary outcome [49] 0 0
Percentage of Participants Who Achieved Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Clinically Important Improvement: Observed Cases (OC): Period 3
Timepoint [49] 0 0
Week 64, 68, 72, 76
Secondary outcome [50] 0 0
Change From Baseline in Nocturnal Back Pain: Last Observation Carried Forward (LOCF): Period 1
Timepoint [50] 0 0
Baseline (Day 1 Week 1), Week 4, 8, 12, 16, 24
Secondary outcome [51] 0 0
Change From Baseline in Nocturnal Back Pain: Last Observation Carried Forward (LOCF): Period 2
Timepoint [51] 0 0
Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 28, 32, 40, 48, 56, 64
Secondary outcome [52] 0 0
Change From Baseline in Nocturnal Back Pain: Last Observation Carried Forward (LOCF): Period 3
Timepoint [52] 0 0
Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Period 3 Baseline (last visit before retreatment), Week 64, 68, 72, 76
Secondary outcome [53] 0 0
Change From Baseline in Nocturnal Back Pain: Observed Cases (OC): Period 1
Timepoint [53] 0 0
Baseline (Day 1 Week 1), Week 4, 8, 12, 16, 24
Secondary outcome [54] 0 0
Change From Baseline in Nocturnal Back Pain: Observed Cases (OC): Period 2
Timepoint [54] 0 0
Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 28, 32, 40, 48, 56, 64
Secondary outcome [55] 0 0
Change From Baseline in Nocturnal Back Pain: Observed Cases (OC): Period 3
Timepoint [55] 0 0
Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Period 3 Baseline (last visit before retreatment), Week 64, 68, 72, 76
Secondary outcome [56] 0 0
Change From Baseline in Total Back Pain: Last Observation Carried Forward (LOCF): Period 1
Timepoint [56] 0 0
Baseline (Day 1 Week 1), Week 4, 8, 12, 16, 24
Secondary outcome [57] 0 0
Change From Baseline in Total Back Pain: Last Observation Carried Forward (LOCF): Period 2
Timepoint [57] 0 0
Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 28, 32, 40, 48, 56, 64
Secondary outcome [58] 0 0
Change From Baseline in Total Back Pain: Last Observation Carried Forward (LOCF): Period 3
Timepoint [58] 0 0
Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Period 3 Baseline (last visit before retreatment), Week 64, 68, 72, 76
Secondary outcome [59] 0 0
Change From Baseline in Total Back Pain: Observed Cases (OC): Period 1
Timepoint [59] 0 0
Baseline (Day 1 Week 1), Week 4, 8, 12, 16, 24
Secondary outcome [60] 0 0
Change From Baseline in Total Back Pain: Observed Cases (OC): Period 2
Timepoint [60] 0 0
Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 28, 32, 40, 48, 56, 64
Secondary outcome [61] 0 0
Change From Baseline in Total Back Pain: Observed Cases (OC): Period 3
Timepoint [61] 0 0
Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Period 3 Baseline (last visit before retreatment), Week 64, 68, 72, 76
Secondary outcome [62] 0 0
Mean Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI): Observed Cases (OC): Period 1
Timepoint [62] 0 0
Baseline (Day 1 Week 1), Week 4, 8, 12, 16, 24
Secondary outcome [63] 0 0
Mean Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI): Observed Cases (OC): Period 2
Timepoint [63] 0 0
Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 28, 32, 40, 48, 56, 64
Secondary outcome [64] 0 0
Mean Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI): Observed Cases (OC): Period 3
Timepoint [64] 0 0
Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Period 3 Baseline (last visit before retreatment), Week 64, 68, 72, 76
Secondary outcome [65] 0 0
Mean Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI): Last Observation Carried Forward (LOCF): Period 1
Timepoint [65] 0 0
Baseline (Day 1 Week 1), Week 4, 8, 12, 16, 24
Secondary outcome [66] 0 0
Mean Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI): Last Observation Carried Forward (LOCF): Period 2
Timepoint [66] 0 0
Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 28, 32, 40, 48, 56, 64
Secondary outcome [67] 0 0
Mean Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI): Last Observation Carried Forward (LOCF): Period 3
Timepoint [67] 0 0
Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Period 3 Baseline (last visit before retreatment), Week 64, 68, 72, 76
Secondary outcome [68] 0 0
Mean Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Total Score: Observed Cases (OC): Period 1
Timepoint [68] 0 0
Baseline (Day 1 Week 1), Week 4, 8, 12, 16, 24
Secondary outcome [69] 0 0
Mean Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Total Score: Observed Cases (OC): Period 2
Timepoint [69] 0 0
Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 28, 32, 40, 48, 56, 64
Secondary outcome [70] 0 0
Mean Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Total Score: Observed Cases (OC): Period 3
Timepoint [70] 0 0
Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Period 3 Baseline (last visit before retreatment), Week 64, 68, 72, 76
Secondary outcome [71] 0 0
Mean Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Total Score: Last Observation Carried Forward (LOCF): Period 1
Timepoint [71] 0 0
Baseline (Day 1 Week 1), Week 4, 8, 12, 16, 24
Secondary outcome [72] 0 0
Mean Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Total Score:Last Observation Carried Forward (LOCF): Period 2
Timepoint [72] 0 0
Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 28, 32, 40, 48, 56, 64
Secondary outcome [73] 0 0
Mean Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Total Score: Last Observation Carried Forward (LOCF): Period 3
Timepoint [73] 0 0
Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Period 3 Baseline (last visit before retreatment), Week 64, 68, 72, 76
Secondary outcome [74] 0 0
Percentage of Participants Who Achieved at Least 50% Improvement From Baseline in Disease Activity According to Bath Ankylosing Spondylitis Disease Activity Index (BASDAI): Observed Cases (OC): Period 1
Timepoint [74] 0 0
Baseline (Day 1 Week 1), Week 4, 8, 12, 16, 24
Secondary outcome [75] 0 0
Percentage of Participants Who Achieved at Least 50% Improvement From Baseline in Disease Activity According to Bath Ankylosing Spondylitis Disease Activity Index (BASDAI): Observed Cases (OC): Period 2
Timepoint [75] 0 0
Period 2 baseline (last visit before treatment withdrawal), Week 28, 32, 40, 48, 56, 64
Secondary outcome [76] 0 0
Percentage of Participants Who Achieved at Least 50% Improvement From Baseline in Disease Activity According to Bath Ankylosing Spondylitis Disease Activity Index (BASDAI): Observed Cases (OC): Period 3
Timepoint [76] 0 0
Period 3 baseline (last visit before retreatment), Week 64, 68, 72, 76
Secondary outcome [77] 0 0
Percentage of Participants Who Achieved at Least 50% Improvement From Baseline in Disease Activity According to Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) :Last Observation Carried Forward (LOCF): Period 1
Timepoint [77] 0 0
Baseline (Day 1 Week 1), Week 4, 8, 12, 16, 24
Secondary outcome [78] 0 0
Percentage of Participants Who Achieved at Least 50% Improvement From Baseline in Disease Activity According to Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) :Last Observation Carried Forward (LOCF): Period 2
Timepoint [78] 0 0
Period 2 baseline (last visit before treatment withdrawal), Week 28, 32, 40, 48, 56, 64
Secondary outcome [79] 0 0
Percentage of Participants Who Achieved at Least 50% Improvement From Baseline in Disease Activity According to Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) :Last Observation Carried Forward (LOCF): Period 3
Timepoint [79] 0 0
Period 3 baseline (last visit before retreatment), Week 64, 68, 72, 76
Secondary outcome [80] 0 0
Mean Change From Baseline in Highly Sensitive C Reactive Protein (hsCRP): Observed Cases (OC): Period 1
Timepoint [80] 0 0
Baseline (Day 1 Week 1), Week 4, 8, 12, 16, 24
Secondary outcome [81] 0 0
Mean Change From Baseline in Highly Sensitive C Reactive Protein (hsCRP): Observed Cases (OC): Period 2
Timepoint [81] 0 0
Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 28, 32, 40, 48, 56, 64
Secondary outcome [82] 0 0
Mean Change From Baseline in Highly Sensitive C Reactive Protein (hsCRP): Observed Cases (OC): Period 3
Timepoint [82] 0 0
Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Period 3 Baseline (last visit before retreatment), Week 64, 68, 72, 76
Secondary outcome [83] 0 0
Mean Change From Baseline in Highly Sensitive C Reactive Protein (hsCRP): Last Observation Carried Forward (LOCF): Period 1
Timepoint [83] 0 0
Baseline (Day 1 Week 1), Week 4, 8, 12, 16, 24
Secondary outcome [84] 0 0
Mean Change From Baseline in Highly Sensitive C Reactive Protein (hsCRP): Last Observation Carried Forward (LOCF): Period 2
Timepoint [84] 0 0
Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 28, 32, 40, 48, 56, 64
Secondary outcome [85] 0 0
Mean Change From Baseline in Highly Sensitive C Reactive Protein (hsCRP): Last Observation Carried Forward (LOCF): Period 3
Timepoint [85] 0 0
Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Period 3 Baseline (last visit before retreatment), Week 64, 68, 72, 76
Secondary outcome [86] 0 0
Percentage of Participants Who Achieved an European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) VAS Score > 82 at Week 12, 24: Observed Cases (OC): Period 1
Timepoint [86] 0 0
Baseline (Day 1 Week 1), Week 12, 24
Secondary outcome [87] 0 0
Percentage of Participants Who Achieved an European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) VAS Score > 82 at Week 32, 48, 64: Observed Cases (OC): Period 2
Timepoint [87] 0 0
Week 32, 48, 64
Secondary outcome [88] 0 0
Percentage of Participants Who Achieved an European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) VAS Score > 82 at Week 64, 76: Observed Cases (OC): Period 3
Timepoint [88] 0 0
Week 64, 76
Secondary outcome [89] 0 0
Percentage of Participants Who Achieved an European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) VAS Score > 82 at Week 12, 24: Last Observation Carried Forward (LOCF): Period 1
Timepoint [89] 0 0
Baseline (Day 1 Week 1), Week 12, 24
Secondary outcome [90] 0 0
Percentage of Participants Who Achieved an European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) VAS Score > 82 at Week 32, 48, 64: Last Observation Carried Forward (LOCF): Period 2
Timepoint [90] 0 0
Week 32, 48, 64
Secondary outcome [91] 0 0
Percentage of Participants Who Achieved an European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) VAS Score > 82 at Week 64, 76: Last Observation Carried Forward (LOCF): Period 3
Timepoint [91] 0 0
Week 64, 76
Secondary outcome [92] 0 0
Percentage of Participants With >=0.05 Score Increase From Baseline in European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Index Score at Week 12, 24: Observed Cases (OC): Period 1
Timepoint [92] 0 0
Week 12, 24
Secondary outcome [93] 0 0
Percentage of Participants With >=0.05 Score Increase From Baseline in European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Index Score at Week 32, 48, 64: Observed Cases (OC): Period 2
Timepoint [93] 0 0
Week 32, 48, 64
Secondary outcome [94] 0 0
Percentage of Participants With >=0.05 Score Increase From Baseline in European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Index Score at Week 64, 76: Observed Cases (OC): Period 3
Timepoint [94] 0 0
Week 64, 76
Secondary outcome [95] 0 0
Percentage of Participants With >=0.05 Score Increase From Baseline in European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Index Score at Week 12, 24: Last Observation Carried Forward (LOCF): Period 1
Timepoint [95] 0 0
Week 12, 24
Secondary outcome [96] 0 0
Percentage of Participants With >=0.05 Score Increase From Baseline in European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Index Score at Week 32, 48, 64: Last Observation Carried Forward (LOCF): Period 2
Timepoint [96] 0 0
Week 32, 48, 64
Secondary outcome [97] 0 0
Percentage of Participants With >=0.05 Score Increase From Baseline in European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Index Score at Week 64, 76: Last Observation Carried Forward (LOCF): Period 3
Timepoint [97] 0 0
Week 64, 76
Secondary outcome [98] 0 0
Percentage of Participants Who Achieved an European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Score of 1 at Week 12, 24: Observed Cases (OC): Period 1
Timepoint [98] 0 0
Baseline (Day 1 Week 1), Week 12, 24
Secondary outcome [99] 0 0
Percentage of Participants Who Achieved an European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Score of 1 at Week 32, 48, 64: Observed Cases (OC): Period 2
Timepoint [99] 0 0
Week 32, 48, 64
Secondary outcome [100] 0 0
Percentage of Participants Who Achieved an European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Score of 1 at Week 64, 76: Observed Cases (OC): Period 3
Timepoint [100] 0 0
Week 64, 76
Secondary outcome [101] 0 0
Percentage of Participants Who Achieved an European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Score of 1 at Week 12, 24: Last Observation Carried Forward (LOCF): Period 1
Timepoint [101] 0 0
Baseline (Day 1 Week 1), Week 12, 24
Secondary outcome [102] 0 0
Percentage of Participants Who Achieved an European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Score of 1 at Week 32, 48, 64: Last Observation Carried Forward (LOCF): Period 2
Timepoint [102] 0 0
Week 32, 48, 64
Secondary outcome [103] 0 0
Percentage of Participants Who Achieved an European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Score of 1 at Week 64, 76: Last Observation Carried Forward (LOCF): Period 3
Timepoint [103] 0 0
Week 64, 76
Secondary outcome [104] 0 0
Change From Baseline in European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Index Scores at Week 12, 24: Observed Cases (OC): Period 1
Timepoint [104] 0 0
Baseline (Day 1 Week 1), Week 12, 24
Secondary outcome [105] 0 0
Change From Baseline in European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Index Scores at Week 32, 48, 64: Observed Cases (OC): Period 2
Timepoint [105] 0 0
Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 32, 48, 64
Secondary outcome [106] 0 0
Change From Baseline in European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Index Scores at Week 64, 76: Observed Cases (OC): Period 3
Timepoint [106] 0 0
Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Period 3 Baseline (last visit before retreatment), Week 64, 76
Secondary outcome [107] 0 0
Change From Baseline in European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Index Scores at Week 12, 24: Last Observation Carried Forward (LOCF): Period 1
Timepoint [107] 0 0
Baseline (Day 1 Week 1), Week 12, 24
Secondary outcome [108] 0 0
Change From Baseline in European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Index Scores at Week 32, 48, 64: Last Observation Carried Forward (LOCF): Period 2
Timepoint [108] 0 0
Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 32, 48, 64
Secondary outcome [109] 0 0
Change From Baseline in European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Index Scores at Week 64, 76: Last Observation Carried Forward (LOCF): Period 3
Timepoint [109] 0 0
Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Period 3 Baseline (last visit before retreatment), Week 64, 76
Secondary outcome [110] 0 0
Change From Baseline in Short Form-36 (SF-36) Physical Component Score (PCS) at Week 12, 24: Observed Cases (OC): Period 1
Timepoint [110] 0 0
Baseline (Day 1 Week 1), Week 12, 24
Secondary outcome [111] 0 0
Change From Baseline in Short Form-36 (SF-36) Physical Component Score (PCS) at Week 32, 48, 64: Observed Cases (OC): Period 2
Timepoint [111] 0 0
Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 32, 48, 64
Secondary outcome [112] 0 0
Change From Baseline in Short Form-36 (SF-36) Physical Component Score (PCS) at Week 64, 76: Observed Cases (OC): Period 3
Timepoint [112] 0 0
Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Period 3 Baseline (last visit before retreatment), Week 64, 76
Secondary outcome [113] 0 0
Change From Baseline in Short Form-36 (SF-36) Physical Component Score (PCS) Week 12, 24: Last Observation Carried Forward (LOCF): Period 1
Timepoint [113] 0 0
Baseline (Day 1 Week 1), Week 12, 24
Secondary outcome [114] 0 0
Change From Baseline in Short Form-36 (SF-36) Physical Component Score (PCS) at Week 32, 48, 64: Last Observation Carried Forward (LOCF): Period 2
Timepoint [114] 0 0
Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 32, 48, 64
Secondary outcome [115] 0 0
Change From Baseline in Short Form-36 (SF-36) Physical Component Score (PCS) at Week 64, 76: Last Observation Carried Forward (LOCF): Period 3
Timepoint [115] 0 0
Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Period 3 Baseline (last visit before retreatment), Week 64, 76
Secondary outcome [116] 0 0
Percentage of Participants With >=2.5 Score Improvement From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 12, 24: Period 1
Timepoint [116] 0 0
Baseline (Day 1 Week 1), Week 12, 24
Secondary outcome [117] 0 0
Percentage of Participants With >=2.5 Score Improvement From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 32, 48, 64: Period 2
Timepoint [117] 0 0
Period 2 baseline (last visit before treatment withdrawal), Week 32, 48, 64
Secondary outcome [118] 0 0
Percentage of Participants With >=2.5 Score Improvement From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 64, 76: Period 3
Timepoint [118] 0 0
Period 3 baseline (last visit before retreatment), Week 64, 76
Secondary outcome [119] 0 0
Percentage of Participants With >=5 Score Improvement From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 12, 24: Period 1
Timepoint [119] 0 0
Baseline (Day 1 Week 1), Week 12, 24
Secondary outcome [120] 0 0
Percentage of Participants With >=5 Score Improvement From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 32, 48, 64: Period 2
Timepoint [120] 0 0
Period 2 baseline (last visit before treatment withdrawal), Week 32, 48, 64
Secondary outcome [121] 0 0
Percentage of Participants With >=5 Score Improvement From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 64, 76: Period 3
Timepoint [121] 0 0
Period 3 baseline (last visit before retreatment), Week 64, 76
Secondary outcome [122] 0 0
Change From Baseline in Short Form-36 (SF-36) Mental Component Score (MCS) at Week 12, 24: Observed Cases (OC): Period 1
Timepoint [122] 0 0
Baseline (Day 1 Week 1), Week 12, 24
Secondary outcome [123] 0 0
Change From Baseline in Short Form-36 (SF-36) Mental Component Score (MCS) at Week 32, 48, 64: Observed Cases (OC): Period 2
Timepoint [123] 0 0
Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 32, 48, 64
Secondary outcome [124] 0 0
Change From Baseline in Short Form-36 (SF-36) Mental Component Score (MCS) at Week 64, 76: Observed Cases (OC): Period 3
Timepoint [124] 0 0
Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Period 3 Baseline (last visit before retreatment), Week 64, 76
Secondary outcome [125] 0 0
Change From Baseline in Short Form-36 (SF-36) Mental Component Score (MCS) at Week 12, 24: Last Observation Carried Forward (LOCF): Period 1
Timepoint [125] 0 0
Baseline (Day 1 Week 1), Week 12, 24
Secondary outcome [126] 0 0
Change From Baseline in Short Form-36 (SF-36) Mental Component Score (MCS) at Week 32, 48, 64: Last Observation Carried Forward (LOCF): Period 2
Timepoint [126] 0 0
Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 32, 48, 64
Secondary outcome [127] 0 0
Change From Baseline in Short Form-36 (SF-36) Mental Component Score (MCS) at Week 64, 76: Last Observation Carried Forward (LOCF): Period 3
Timepoint [127] 0 0
Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Period 3 Baseline (last visit before retreatment), Week 64, 76
Secondary outcome [128] 0 0
Percentage of Participants With >=2.5 Score Improvement From Baseline in Short Form-36 (SF-36) Mental Component Score (MCS) at Week 12, 24: Period 1
Timepoint [128] 0 0
Baseline (Day 1 Week 1), Week 12, 24
Secondary outcome [129] 0 0
Percentage of Participants With >=2.5 Score Improvement From Baseline in Short Form-36 (SF-36) Mental Component Score (MCS) at Week 32, 48, 64: Period 2
Timepoint [129] 0 0
Period 2 baseline (last visit before treatment withdrawal), Week 32, 48, 64
Secondary outcome [130] 0 0
Percentage of Participants With >=2.5 Score Improvement From Baseline in Short Form-36 (SF-36) Mental Component Score (MCS) at Week 64, 76: Period 3
Timepoint [130] 0 0
Period 3 baseline (last visit before retreatment), Week 64, 76
Secondary outcome [131] 0 0
Percentage of Participants With >=5 Score Improvement From Baseline in Short Form-36 (SF-36) Mental Component Score (MCS) at Week 12, 24: Period 1
Timepoint [131] 0 0
Baseline (Day 1 Week 1), Week 12, 24
Secondary outcome [132] 0 0
Percentage of Participants With >=5 Score Improvement From Baseline in Short Form-36 (SF-36) Mental Component Score (MCS) at Week 32, 48, 64: Period 2
Timepoint [132] 0 0
Period 2 baseline (last visit before treatment withdrawal), Week 32, 48, 64
Secondary outcome [133] 0 0
Percentage of Participants With >=5 Score Improvement From Baseline in Short Form-36 (SF-36) Mental Component Score (MCS) at Week 64, 76: Period 3
Timepoint [133] 0 0
Period 3 baseline (last visit before retreatment), Week 64, 76
Secondary outcome [134] 0 0
Change From Baseline in Work Productivity and Activity Impairment (WPAI): Observed Cases (OC): Period 1
Timepoint [134] 0 0
Baseline (Day 1 Week 1), Week 4, 8, 12, 16, 24
Secondary outcome [135] 0 0
Change From Baseline in Work Productivity and Activity Impairment (WPAI): Observed Cases (OC): Period 2
Timepoint [135] 0 0
Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 28, 32, 40, 48, 56, 64
Secondary outcome [136] 0 0
Change From Baseline in Work Productivity and Activity Impairment (WPAI): Observed Cases (OC): Period 3
Timepoint [136] 0 0
Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Period 3 Baseline (last visit before retreatment), Week 64, 68, 72, 76
Secondary outcome [137] 0 0
Change From Baseline in Work Productivity and Activity Impairment (WPAI): Last Observation Carried Forward (LOCF): Period 1
Timepoint [137] 0 0
Baseline (Day 1 Week 1), Week 4, 8, 12, 16, 24
Secondary outcome [138] 0 0
Change From Baseline in Work Productivity and Activity Impairment (WPAI): Last Observation Carried Forward (LOCF): Period 2
Timepoint [138] 0 0
Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 28, 32, 40, 48, 56, 64
Secondary outcome [139] 0 0
Change From Baseline in Work Productivity and Activity Impairment (WPAI): Last Observation Carried Forward (LOCF): Period 3
Timepoint [139] 0 0
Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Period 3 Baseline (last visit before retreatment), Week 64, 68, 72, 76
Secondary outcome [140] 0 0
Change From Baseline in Magnetic Resonance Imaging (MRI) of the Spine (Spondyloarthritis Research Consortium of Canada [SPARCC] Score) at Week 24: Last Observation Carried Forward (LOCF): Period 1
Timepoint [140] 0 0
Baseline (Day 1 Week 1), Week 24
Secondary outcome [141] 0 0
Change From Baseline in Magnetic Resonance Imaging (MRI) of the Spine (Spondyloarthritis Research Consortium of Canada [SPARCC] Score) at Week 48, 64: Last Observation Carried Forward (LOCF): Period 2
Timepoint [141] 0 0
Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 48, 64
Secondary outcome [142] 0 0
Change From Baseline in Magnetic Resonance Imaging (MRI) of the Spine (Spondyloarthritis Research Consortium of Canada [SPARCC] Score) at Week 64, 76: Last Observation Carried Forward (LOCF): Period 3
Timepoint [142] 0 0
Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Period 3 Baseline (last visit before retreatment), Week 64, 76
Secondary outcome [143] 0 0
Change From Baseline in Magnetic Resonance Imaging (MRI) of the Spine (Spondyloarthritis Research Consortium of Canada [SPARCC] Score) at Week 24: Observed Cases (OC): Period 1
Timepoint [143] 0 0
Baseline (Day 1 Week 1), Week 24
Secondary outcome [144] 0 0
Change From Baseline in Magnetic Resonance Imaging (MRI) of the Spine (Spondyloarthritis Research Consortium of Canada [SPARCC] Score) at Week 48, 64: Observed Cases (OC): Period 2
Timepoint [144] 0 0
Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 48, 64
Secondary outcome [145] 0 0
Change From Baseline in Magnetic Resonance Imaging (MRI) of the Spine (Spondyloarthritis Research Consortium of Canada [SPARCC] Score) at Week 64, 76: Observed Cases (OC): Period 3
Timepoint [145] 0 0
Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Period 3 Baseline (last visit before retreatment), Week 64, 76
Secondary outcome [146] 0 0
Time to Ankylosing Spondylitis Disease Activity Score (ASDAS) Inactive Disease After Re-treatment in Period 3
Timepoint [146] 0 0
Within 12 weeks of Period 3 (retreatment period from Week 64 to 76)
Secondary outcome [147] 0 0
Change From Baseline in Subject Assessment of Disease Activity (SADA) Visual Analogue Scale (VAS): Observed Cases (OC): Period 1
Timepoint [147] 0 0
Baseline (Day 1 Week 1), Week 4, 8, 12, 16, 24
Secondary outcome [148] 0 0
Change From Baseline in Subject Assessment of Disease Activity (SADA) Visual Analogue Scale (VAS): Observed Cases (OC): Period 2
Timepoint [148] 0 0
Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 28, 32, 40, 48, 56, 64
Secondary outcome [149] 0 0
Change From Baseline in Subject Assessment of Disease Activity (SADA) Visual Analogue Scale (VAS): Observed Cases (OC): Period 3
Timepoint [149] 0 0
Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Period 3 Baseline (last visit before retreatment), Week 64, 68, 72, 76
Secondary outcome [150] 0 0
Change From Baseline in Subject Assessment of Disease Activity (SADA) Visual Analogue Scale (VAS): Last Observation Carried Forward (LOCF): Period 1
Timepoint [150] 0 0
Baseline (Day 1 Week 1), Week 4, 8, 12, 16, 24
Secondary outcome [151] 0 0
Change From Baseline in Subject Assessment of Disease Activity (SADA) Visual Analogue Scale (VAS): Last Observation Carried Forward (LOCF): Period 2
Timepoint [151] 0 0
Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 28, 32, 40, 48, 56, 64
Secondary outcome [152] 0 0
Change From Baseline in Subject Assessment of Disease Activity (SADA) Visual Analogue Scale (VAS): Last Observation Carried Forward (LOCF): Period 3
Timepoint [152] 0 0
Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Period 3 Baseline (last visit before retreatment), Week 64, 68, 72, 76
Secondary outcome [153] 0 0
Change From Baseline in Physician Global Assessment (PGA) Visual Analogue Scale (VAS): Observed Cases (OC): Period 1
Timepoint [153] 0 0
Baseline (Day 1 Week 1), Week 4, 8, 12, 16, 24
Secondary outcome [154] 0 0
Change From Baseline in Physician Global Assessment (PGA) Visual Analogue Scale (VAS): Observed Cases (OC): Period 2
Timepoint [154] 0 0
Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 28, 32, 40, 48, 56, 64
Secondary outcome [155] 0 0
Change From Baseline in Physician Global Assessment (PGA) Visual Analogue Scale (VAS): Observed Cases (OC): Period 3
Timepoint [155] 0 0
Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Period 3 Baseline (last visit before retreatment), Week 64, 68, 72, 76
Secondary outcome [156] 0 0
Change From Baseline in Physician Global Assessment (PGA) Visual Analogue Scale (VAS): Last Observation Carried Forward (LOCF): Period 1
Timepoint [156] 0 0
Baseline (Day 1 Week 1), Week 4, 8, 12, 16, 24
Secondary outcome [157] 0 0
Change From Baseline in Physician Global Assessment (PGA) Visual Analogue Scale (VAS): Last Observation Carried Forward (LOCF): Period 2
Timepoint [157] 0 0
Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 28, 32, 40, 48, 56, 64
Secondary outcome [158] 0 0
Change From Baseline in Physician Global Assessment (PGA) Visual Analogue Scale (VAS): Last Observation Carried Forward (LOCF): Period 3
Timepoint [158] 0 0
Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Period 3 Baseline (last visit before retreatment), Week 64, 68, 72, 76
Secondary outcome [159] 0 0
Change From Baseline in Bath Ankylosing Spondylitis Global Index (BAS-G) Score at Week 12, 24: Last Observation Carried Forward (LOCF): Period 1
Timepoint [159] 0 0
Baseline (Day 1 Week 1), Week 12, 24
Secondary outcome [160] 0 0
Change From Baseline in Bath Ankylosing Spondylitis Global Index (BAS-G) Score) at Week 32, 48, 64: Last Observation Carried Forward (LOCF): Period 2
Timepoint [160] 0 0
Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 32, 48, 64
Secondary outcome [161] 0 0
Change From Baseline in Bath Ankylosing Spondylitis Global Index (BAS-G) Score at Week 64, 76: Last Observation Carried Forward (LOCF): Period 3
Timepoint [161] 0 0
Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Period 3 Baseline (last visit before retreatment), Week 64, 76
Secondary outcome [162] 0 0
Change From Baseline in Bath Ankylosing Spondylitis Global Index (BAS-G) Score at Week 12, 24: Observed Cases (OC): Period 1
Timepoint [162] 0 0
Baseline (Day 1 Week 1), Week 12, 24
Secondary outcome [163] 0 0
Change From Baseline in Bath Ankylosing Spondylitis Global Index (BAS-G) Score) at Week 32, 48, 64: Observed Cases (OC): Period 2
Timepoint [163] 0 0
Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 32, 48, 64
Secondary outcome [164] 0 0
Change From Baseline in Bath Ankylosing Spondylitis Global Index (BAS-G) Score at Week 64, 76: Observed Cases (OC): Period 3
Timepoint [164] 0 0
Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Period 3 Baseline (last visit before retreatment), Week 64, 76
Secondary outcome [165] 0 0
Change From Baseline in Number of Swollen Joint Count at Week 12, 24: Observed Cases (OC): Period 1
Timepoint [165] 0 0
Baseline (Day 1 Week 1), Week 12, 24
Secondary outcome [166] 0 0
Change From Baseline in Number of Swollen Joint Count at Week 32, 48, 64: Observed Cases (OC): Period 2
Timepoint [166] 0 0
Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 32, 48, 64
Secondary outcome [167] 0 0
Change From Baseline in Number of Swollen Joint Count at Week 64, 76: Observed Cases (OC): Period 3
Timepoint [167] 0 0
Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Period 3 Baseline (last visit before retreatment), Week 64, 76
Secondary outcome [168] 0 0
Change From Baseline in Number of Swollen Joint Count at Week 12, 24: Last Observation Carried Forward (LOCF): Period 1
Timepoint [168] 0 0
Baseline (Day 1 Week 1), Week 12, 24
Secondary outcome [169] 0 0
Change From Baseline in Number of Swollen Joint Count at Week 32, 48, 64: Last Observation Carried Forward (LOCF): Period 2
Timepoint [169] 0 0
Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 32, 48, 64
Secondary outcome [170] 0 0
Change From Baseline in Number of Swollen Joint Count at Week 64, 76 : Last Observation Carried Forward (LOCF): Period 3
Timepoint [170] 0 0
Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Period 3 Baseline (last visit before retreatment), Week 64, 76
Secondary outcome [171] 0 0
Change From Baseline in Number of Tender Joint Count at Week 12, 24: Observed Cases (OC): Period 1
Timepoint [171] 0 0
Baseline (Day 1 Week 1), Week 12, 24
Secondary outcome [172] 0 0
Change From Baseline in Number of Tender Joint Count at Week 32, 48, 64: Observed Cases (OC): Period 2
Timepoint [172] 0 0
Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 32, 48, 64
Secondary outcome [173] 0 0
Change From Baseline in Number of Tender Joint Count at Week 64, 76: : Observed Cases (OC): Period 3
Timepoint [173] 0 0
Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Period 3 Baseline (last visit before retreatment), Week 64, 76
Secondary outcome [174] 0 0
Change From Baseline in Number of Tender Joint Count at Week 12, 24: Last Observation Carried Forward (LOCF): Period 1
Timepoint [174] 0 0
Baseline (Day 1 Week 1), Week 12, 24
Secondary outcome [175] 0 0
Change From Baseline in Number of Tender Joint Count at Week 32, 48, 64: Last Observation Carried Forward (LOCF): Period 2
Timepoint [175] 0 0
Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 32, 48, 64
Secondary outcome [176] 0 0
Change From Baseline in Number of Tender Joint Count at Week 64, 76: Last Observation Carried Forward (LOCF): Period 3
Timepoint [176] 0 0
Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Period 3 Baseline (last visit before retreatment), Week 64, 76
Secondary outcome [177] 0 0
Change From Baseline in Dactylitis Total Score at Week 12, 24: Observed Cases (OC): Period 1
Timepoint [177] 0 0
Baseline (Day 1 Week 1), Week 12, 24
Secondary outcome [178] 0 0
Change From Baseline in Dactylitis Total Score at Week 32, 48, 64: Observed Cases (OC): Period 2
Timepoint [178] 0 0
Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 32, 48, 64
Secondary outcome [179] 0 0
Change From Baseline in Dactylitis Total Score at Week 64, 76: Observed Cases (OC): Period 3
Timepoint [179] 0 0
Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Period 3 Baseline (last visit before retreatment), Week 64, 76
Secondary outcome [180] 0 0
Change From Baseline in Dactylitis Total Score at Week 12, 24: Last Observation Carried Forward (LOCF): Period 1
Timepoint [180] 0 0
Baseline (Day 1 Week 1), Week 12, 24
Secondary outcome [181] 0 0
Change From Baseline in Dactylitis Total Score at Week 32, 48, 64: Last Observation Carried Forward (LOCF): Period 2
Timepoint [181] 0 0
Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 32, 48, 64
Secondary outcome [182] 0 0
Change From Baseline in Dactylitis Total Score at Week 64, 76: Last Observation Carried Forward (LOCF): Period 3
Timepoint [182] 0 0
Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Period 3 Baseline (last visit before retreatment), Week 64, 76
Secondary outcome [183] 0 0
Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) at Week 12, 24: Observed Cases (OC) : Period 1
Timepoint [183] 0 0
Baseline (Day 1 Week 1), Week 12, 24
Secondary outcome [184] 0 0
Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) at Week 32, 48, 64: Observed Cases (OC): Period 2
Timepoint [184] 0 0
Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 32, 48, 64
Secondary outcome [185] 0 0
Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) at Week 64, 76: Observed Cases (OC): Period 3
Timepoint [185] 0 0
Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Period 3 Baseline (last visit before retreatment), Week 64, 76
Secondary outcome [186] 0 0
Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) at Week 12, 24: Last Observation Carried Forward (LOCF): Period 1
Timepoint [186] 0 0
Baseline (Day 1 Week 1), Week 12, 24
Secondary outcome [187] 0 0
Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) at Week 32, 48, 64: Last Observation Carried Forward (LOCF): Period 2
Timepoint [187] 0 0
Period 1 Baseline (Day 1 Week 1), Period 2: Baseline (last visit before treatment withdrawal), Week 32, 48, 64
Secondary outcome [188] 0 0
Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) at Week 64, 76: Last Observation Carried Forward (LOCF): Period 3
Timepoint [188] 0 0
Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Period 3 Baseline (last visit before retreatment), Week 64, 76
Secondary outcome [189] 0 0
Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Timepoint [189] 0 0
Baseline (Day 1) up to 28 days after last dose of study drug (for period 1: maximum up to 28 weeks, for period 2: maximum up to 68 weeks, period 3: maximum up to 80 weeks)

Eligibility
Key inclusion criteria
* diagnosis of axial SpA duration of symptoms >3 months and <5 years back pain with a less than favorable response to NSAIDs
Minimum age
18 Years
Maximum age
49 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* radiological sacroiliitis previous treatment with TNF inhibitor, biologic, immunosuppressive

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
24/09/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
6/09/2019
Sample size
Target
Accrual to date
Final
210
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,WA
Recruitment hospital [1] 0 0
Genesis Research Services Pty Ltd - Broadmeadow
Recruitment hospital [2] 0 0
Hunter Imaging Group - Cardiff
Recruitment hospital [3] 0 0
Pacific Radiology - Maroochydore
Recruitment hospital [4] 0 0
Rheumatology Research Centre - Maroochydore
Recruitment hospital [5] 0 0
Benson Radiology - North Adelaide
Recruitment hospital [6] 0 0
The Queen Elizabeth Hospital - Woodville South
Recruitment hospital [7] 0 0
SKG Radiology Hollywood Hospital - Nedlands
Recruitment hospital [8] 0 0
SKG Radiology Subiaco - Subiaco
Recruitment hospital [9] 0 0
R.K. Will Pty Ltd - Victoria Park
Recruitment postcode(s) [1] 0 0
2292 - Broadmeadow
Recruitment postcode(s) [2] 0 0
2285 - Cardiff
Recruitment postcode(s) [3] 0 0
4558 - Maroochydore
Recruitment postcode(s) [4] 0 0
5006 - North Adelaide
Recruitment postcode(s) [5] 0 0
5011 - Woodville South
Recruitment postcode(s) [6] 0 0
6009 - Nedlands
Recruitment postcode(s) [7] 0 0
6008 - Subiaco
Recruitment postcode(s) [8] 0 0
6100 - Victoria Park
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Florida
Country [2] 0 0
United States of America
State/province [2] 0 0
Illinois
Country [3] 0 0
United States of America
State/province [3] 0 0
New York
Country [4] 0 0
United States of America
State/province [4] 0 0
Oregon
Country [5] 0 0
United States of America
State/province [5] 0 0
Pennsylvania
Country [6] 0 0
United States of America
State/province [6] 0 0
Washington
Country [7] 0 0
Belgium
State/province [7] 0 0
OVL
Country [8] 0 0
Belgium
State/province [8] 0 0
Genk
Country [9] 0 0
Colombia
State/province [9] 0 0
Antioquia
Country [10] 0 0
Colombia
State/province [10] 0 0
Cundinamarca
Country [11] 0 0
Czechia
State/province [11] 0 0
Praha 11
Country [12] 0 0
Czechia
State/province [12] 0 0
Praha 2
Country [13] 0 0
Czechia
State/province [13] 0 0
Uherske Hradiste
Country [14] 0 0
Finland
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Taichung

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Pfizer
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to study the benefits and risks of etanercept withdrawal in patients who have achieved a significant clinical response.
Trial website
https://clinicaltrials.gov/study/NCT02509026
Trial related presentations / publications
Van den Bosch F, Wei JC, Nash P, Blanco FJ, Graham D, Zang C, Arthur E, Borlenghi C, Tsekouras V, Vlahos B, Deodhar A. Etanercept Withdrawal and Retreatment in Nonradiographic Axial Spondyloarthritis: Results of RE-EMBARK, an Open-Label Phase IV Trial. J Rheumatol. 2023 Apr;50(4):478-487. doi: 10.3899/jrheum.220353. Epub 2022 Nov 15.
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
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

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02509026