Clinical trial NCT02509026: Etanercept Withdrawal And Retreament Study In Subjects With Nr-ax SpA
Official title: A MULTICENTER OPEN-LABEL STUDY OF ETANERCEPT WITHDRAWAL AND RETREATMENT IN SUBJECTS WITH NON-RADIOGRAPHIC AXIAL SPONDYLOARTHRITIS WHO ACHIEVED ADEQUATE 24 WEEK RESPONSE
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Spondylitis, Ankylosing
Keywords: non-radiographic axial spondyloarthritis
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2015-07-27
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed description: This multcenter, open-label, three period study will evaluate withdrawal and retreatment of etanercept in subjects with nr-ax SpA who achieved adequate response following 24 weeks of treatment.

Eligibility criteria: Inclusion Criteria:

* diagnosis of axial SpA duration of symptoms \>3 months and \<5 years back pain with a less than favorable response to NSAIDs

Exclusion Criteria:

* radiological sacroiliitis previous treatment with TNF inhibitor, biologic, immunosuppressive

Primary outcomes:
measure: Percentage of Participants Who Experienced Flare Within 40 Weeks Following Withdrawal of 24 Weeks of Etanercept Treatment
timeFrame: Within 40 weeks after Etanercept withdrawal (from Week 24 to Week 64)
Secondary outcomes:
measure: Time to Flare Following Withdrawal of Etanercept Treatment
timeFrame: Within 40 weeks after Etanercept withdrawal (from Week 24 to Week 64)
measure: Percentage of Participants With Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Less Than (<)1.3: Observed Cases (OC): Period 1
timeFrame: Baseline (Day 1 Week 1), Week 4, 8, 12, 16, 24
measure: Percentage of Participants With Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Less Than (<)1.3: Observed Cases (OC): Period 2
timeFrame: Week 28, 32, 40, 48, 56, 64
measure: Percentage of Participants With Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Less Than (<)1.3: Observed Cases (OC): Period 3
timeFrame: Week 68, 72, 76
measure: 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
timeFrame: Baseline (Day 1 Week 1), Week 4, 8, 12, 16, 24
measure: 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
timeFrame: Week 28, 32, 40, 48, 56, 64
measure: 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
timeFrame: Week 68, 72, 76
measure: Percentage of Participants Who Achieved Assessment of Spondyloarthritis Society (ASAS 20) Response: Observed Cases (OC): Period 1
timeFrame: Week 4, 8, 12, 16, 24
measure: Percentage of Participants Who Achieved Assessment of Spondyloarthritis Society (ASAS 20) Response: Observed Cases (OC): Period 2
timeFrame: Week 28, 32, 40, 48, 56, 64
measure: Percentage of Participants Who Achieved Assessment of Spondyloarthritis Society (ASAS 20) Response: Observed Cases (OC): Period 3
timeFrame: Week 64, 68, 72, 76
measure: Percentage of Participants Who Achieved Assessment of Spondyloarthritis Society (ASAS 20) Response: Last Observation Carried Forward (LOCF): Period 1
timeFrame: Week 4, 8, 12, 16, 24
measure: Percentage of Participants Who Achieved Assessment of Spondyloarthritis Society (ASAS 20) Response: Last Observation Carried Forward (LOCF): Period 2
timeFrame: Week 28, 32, 40, 48, 56, 64
measure: Percentage of Participants Who Achieved Assessment of Spondyloarthritis Society (ASAS 20) Response: Last Observation Carried Forward (LOCF): Period 3
timeFrame: Week 64, 68, 72, 76
measure: Percentage of Participants Who Achieved Assessment of Spondyloarthritis Society 40 (ASAS 40) Response: Last Observation Carried Forward (LOCF): Period 1
timeFrame: Week 4, 8, 12, 16, 24
measure: Percentage of Participants Who Achieved Assessment of Spondyloarthritis Society 40 (ASAS 40) Response: Last Observation Carried Forward (LOCF): Period 2
timeFrame: Week 28, 32, 40, 48, 56, 64
measure: Percentage of Participants Who Achieved Assessment of Spondyloarthritis Society 40 (ASAS 40) Response: Last Observation Carried Forward (LOCF): Period 3
timeFrame: Week 64, 68, 72, 76
measure: Percentage of Participants Who Achieved Assessment of Spondyloarthritis Society 40 (ASAS 40) Response: Observed Cases (OC): Period 1
timeFrame: Week 4, 8, 12, 16, 24
measure: Percentage of Participants Who Achieved Assessment of Spondyloarthritis Society 40 (ASAS 40) Response: Observed Cases (OC): Period 2
timeFrame: Week 28, 32, 40, 48, 56, 64
measure: Percentage of Participants Who Achieved Assessment of Spondyloarthritis Society 40 (ASAS 40) Response: Observed Cases (OC): Period 3
timeFrame: Week 64, 68, 72, 76
measure: Percentage of Participants Who Achieved Assessment of Spondyloarthritis Society (ASAS) Partial Remission: Last Observation Carried Forward (LOCF): Period 1
timeFrame: Week 4, 8, 12, 16, 24
measure: Percentage of Participants Who Achieved Assessment of Spondyloarthritis Society (ASAS) Partial Remission: Last Observation Carried Forward (LOCF): Period 2
timeFrame: Week 28, 32, 40, 48, 56, 64
measure: Percentage of Participants Who Achieved Assessment of Spondyloarthritis Society (ASAS) Partial Remission: Last Observation Carried Forward (LOCF): Period 3
timeFrame: Week 64, 68, 72, 76
measure: Percentage of Participants Who Achieved Assessment of Spondyloarthritis Society (ASAS) Partial Remission: Observed Cases (OC): Period 1
timeFrame: Week 4, 8, 12, 16, 24
measure: Percentage of Participants Who Achieved Assessment of Spondyloarthritis Society (ASAS) Partial Remission: Observed Cases (OC): Period 2
timeFrame: Week 28, 32, 40, 48, 56, 64
measure: Percentage of Participants Who Achieved Assessment of Spondyloarthritis Society (ASAS) Partial Remission: Observed Cases (OC): Period 3
timeFrame: Week 64, 68, 72, 76
measure: Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS)-C-Reactive Protein (CRP) Score: Last Observation Carried Forward (LOCF): Period 1
timeFrame: Baseline (Day 1 Week 1), Week 4, 8, 12, 16, 24
measure: Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS)-C-Reactive Protein (CRP) Score: Last Observation Carried Forward (LOCF): Period 2
timeFrame: Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 28, 32, 40, 48, 56, 64
measure: Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Score: Last Observation Carried Forward (LOCF): Period 3
timeFrame: 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
measure: Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Score: Observed Cases (OC): Period 1
timeFrame: Baseline (Day 1 Week 1), Week 4, 8, 12, 16, 24
measure: Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Score: Observed Cases (OC): Period 2
timeFrame: Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 28, 32, 40, 48, 56, 64
measure: Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Score: Observed Cases (OC): Period 3
timeFrame: 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
measure: Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) Erythrocyte Sedimentation Rate (ESR) Score: Last Observation Carried Forward (LOCF): Period 1
timeFrame: Baseline (Day 1 Week 1), Week 4, 8, 12, 16, 24
measure: Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS)-Erythrocyte Sedimentation Rate (ESR) Score: Last Observation Carried Forward (LOCF): Period 2
timeFrame: Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 28, 32, 40, 48, 56, 64
measure: Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS)-Erythrocyte Sedimentation Rate (ESR) Score: Last Observation Carried Forward (LOCF): Period 3
timeFrame: 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
measure: Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) Erythrocyte Sedimentation Rate (ESR) Score: Observed Cases (OC): Period 1
timeFrame: Baseline (Day 1 Week 1), Week 4, 8, 12, 16, 24
measure: Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS)-Erythrocyte Sedimentation Rate (ESR) Score: Observed Cases (OC): Period 2
timeFrame: Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 28, 32, 40, 48, 56, 64
measure: Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS)-Erythrocyte Sedimentation Rate (ESR) Score: Observed Cases (OC): Period 3
timeFrame: 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
measure: Percentage of Participants Who Achieved Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Major Improvement: Last Observation Carried Forward (LOCF): Period 1
timeFrame: Week 4, 8, 12, 16, 24
measure: Percentage of Participants Who Achieved Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Major Improvement: Last Observation Carried Forward (LOCF): Period 2
timeFrame: Week 28, 32, 40, 48, 56, 64
measure: Percentage of Participants Who Achieved Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Major Improvement: Last Observation Carried Forward (LOCF): Period 3
timeFrame: Week 64, 68, 72, 76
measure: Percentage of Participants Who Achieved Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Major Improvement: Observed Cases (OC): Period 1
timeFrame: Week 4, 8, 12, 16, 24
measure: Percentage of Participants Who Achieved Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Major Improvement: Observed Cases (OC): Period 2
timeFrame: Week 28, 32, 40, 48, 56, 64
measure: Percentage of Participants Who Achieved Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Major Improvement: Observed Cases (OC): Period 3
timeFrame: Week 64, 68, 72, 76
measure: 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
timeFrame: Week 4, 8, 12, 16, 24
measure: 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
timeFrame: Week 28, 32, 40, 48, 56, 64
measure: 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
timeFrame: Week 64, 68, 72, 76
measure: Percentage of Participants Who Achieved Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Clinically Important Improvement: Observed Cases (OC): Period 1
timeFrame: Week 4, 8, 12, 16, 24
measure: Percentage of Participants Who Achieved Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Clinically Important Improvement: Observed Cases (OC): Period 2
timeFrame: Week 28, 32, 40, 48, 56, 64
measure: Percentage of Participants Who Achieved Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Clinically Important Improvement: Observed Cases (OC): Period 3
timeFrame: Week 64, 68, 72, 76
measure: Change From Baseline in Nocturnal Back Pain: Last Observation Carried Forward (LOCF): Period 1
timeFrame: Baseline (Day 1 Week 1), Week 4, 8, 12, 16, 24
measure: Change From Baseline in Nocturnal Back Pain: Last Observation Carried Forward (LOCF): Period 2
timeFrame: Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 28, 32, 40, 48, 56, 64
measure: Change From Baseline in Nocturnal Back Pain: Last Observation Carried Forward (LOCF): Period 3
timeFrame: 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
measure: Change From Baseline in Nocturnal Back Pain: Observed Cases (OC): Period 1
timeFrame: Baseline (Day 1 Week 1), Week 4, 8, 12, 16, 24
measure: Change From Baseline in Nocturnal Back Pain: Observed Cases (OC): Period 2
timeFrame: Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 28, 32, 40, 48, 56, 64
measure: Change From Baseline in Nocturnal Back Pain: Observed Cases (OC): Period 3
timeFrame: 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
measure: Change From Baseline in Total Back Pain: Last Observation Carried Forward (LOCF): Period 1
timeFrame: Baseline (Day 1 Week 1), Week 4, 8, 12, 16, 24
measure: Change From Baseline in Total Back Pain: Last Observation Carried Forward (LOCF): Period 2
timeFrame: Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 28, 32, 40, 48, 56, 64
measure: Change From Baseline in Total Back Pain: Last Observation Carried Forward (LOCF): Period 3
timeFrame: 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
measure: Change From Baseline in Total Back Pain: Observed Cases (OC): Period 1
timeFrame: Baseline (Day 1 Week 1), Week 4, 8, 12, 16, 24
measure: Change From Baseline in Total Back Pain: Observed Cases (OC): Period 2
timeFrame: Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 28, 32, 40, 48, 56, 64
measure: Change From Baseline in Total Back Pain: Observed Cases (OC): Period 3
timeFrame: 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
measure: Mean Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI): Observed Cases (OC): Period 1
timeFrame: Baseline (Day 1 Week 1), Week 4, 8, 12, 16, 24
measure: Mean Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI): Observed Cases (OC): Period 2
timeFrame: Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 28, 32, 40, 48, 56, 64
measure: Mean Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI): Observed Cases (OC): Period 3
timeFrame: 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
measure: Mean Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI): Last Observation Carried Forward (LOCF): Period 1
timeFrame: Baseline (Day 1 Week 1), Week 4, 8, 12, 16, 24
measure: Mean Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI): Last Observation Carried Forward (LOCF): Period 2
timeFrame: Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 28, 32, 40, 48, 56, 64
measure: Mean Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI): Last Observation Carried Forward (LOCF): Period 3
timeFrame: 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
measure: Mean Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Total Score: Observed Cases (OC): Period 1
timeFrame: Baseline (Day 1 Week 1), Week 4, 8, 12, 16, 24
measure: Mean Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Total Score: Observed Cases (OC): Period 2
timeFrame: Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 28, 32, 40, 48, 56, 64
measure: Mean Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Total Score: Observed Cases (OC): Period 3
timeFrame: 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
measure: Mean Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Total Score: Last Observation Carried Forward (LOCF): Period 1
timeFrame: Baseline (Day 1 Week 1), Week 4, 8, 12, 16, 24
measure: Mean Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Total Score:Last Observation Carried Forward (LOCF): Period 2
timeFrame: Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 28, 32, 40, 48, 56, 64
measure: Mean Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Total Score: Last Observation Carried Forward (LOCF): Period 3
timeFrame: 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
measure: 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
timeFrame: Baseline (Day 1 Week 1), Week 4, 8, 12, 16, 24
measure: 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
timeFrame: Period 2 baseline (last visit before treatment withdrawal), Week 28, 32, 40, 48, 56, 64
measure: 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
timeFrame: Period 3 baseline (last visit before retreatment), Week 64, 68, 72, 76
measure: 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
timeFrame: Baseline (Day 1 Week 1), Week 4, 8, 12, 16, 24
measure: 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
timeFrame: Period 2 baseline (last visit before treatment withdrawal), Week 28, 32, 40, 48, 56, 64
measure: 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
timeFrame: Period 3 baseline (last visit before retreatment), Week 64, 68, 72, 76
measure: Mean Change From Baseline in Highly Sensitive C Reactive Protein (hsCRP): Observed Cases (OC): Period 1
timeFrame: Baseline (Day 1 Week 1), Week 4, 8, 12, 16, 24
measure: Mean Change From Baseline in Highly Sensitive C Reactive Protein (hsCRP): Observed Cases (OC): Period 2
timeFrame: Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 28, 32, 40, 48, 56, 64
measure: Mean Change From Baseline in Highly Sensitive C Reactive Protein (hsCRP): Observed Cases (OC): Period 3
timeFrame: 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
measure: Mean Change From Baseline in Highly Sensitive C Reactive Protein (hsCRP): Last Observation Carried Forward (LOCF): Period 1
timeFrame: Baseline (Day 1 Week 1), Week 4, 8, 12, 16, 24
measure: Mean Change From Baseline in Highly Sensitive C Reactive Protein (hsCRP): Last Observation Carried Forward (LOCF): Period 2
timeFrame: Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 28, 32, 40, 48, 56, 64
measure: Mean Change From Baseline in Highly Sensitive C Reactive Protein (hsCRP): Last Observation Carried Forward (LOCF): Period 3
timeFrame: 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
measure: 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
timeFrame: Baseline (Day 1 Week 1), Week 12, 24
measure: 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
timeFrame: Week 32, 48, 64
measure: 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
timeFrame: Week 64, 76
measure: 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
timeFrame: Baseline (Day 1 Week 1), Week 12, 24
measure: 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
timeFrame: Week 32, 48, 64
measure: 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
timeFrame: Week 64, 76
measure: 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
timeFrame: Week 12, 24
measure: 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
timeFrame: Week 32, 48, 64
measure: 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
timeFrame: Week 64, 76
measure: 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
timeFrame: Week 12, 24
measure: 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
timeFrame: Week 32, 48, 64
measure: 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
timeFrame: Week 64, 76
measure: 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
timeFrame: Baseline (Day 1 Week 1), Week 12, 24
measure: 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
timeFrame: Week 32, 48, 64
measure: 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
timeFrame: Week 64, 76
measure: 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
timeFrame: Baseline (Day 1 Week 1), Week 12, 24
measure: 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
timeFrame: Week 32, 48, 64
measure: 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
timeFrame: Week 64, 76
measure: 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
timeFrame: Baseline (Day 1 Week 1), Week 12, 24
measure: 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
timeFrame: Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 32, 48, 64
measure: 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
timeFrame: 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
measure: 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
timeFrame: Baseline (Day 1 Week 1), Week 12, 24
measure: 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
timeFrame: Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 32, 48, 64
measure: 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
timeFrame: 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
measure: Change From Baseline in Short Form-36 (SF-36) Physical Component Score (PCS) at Week 12, 24: Observed Cases (OC): Period 1
timeFrame: Baseline (Day 1 Week 1), Week 12, 24
measure: Change From Baseline in Short Form-36 (SF-36) Physical Component Score (PCS) at Week 32, 48, 64: Observed Cases (OC): Period 2
timeFrame: Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 32, 48, 64
measure: Change From Baseline in Short Form-36 (SF-36) Physical Component Score (PCS) at Week 64, 76: Observed Cases (OC): Period 3
timeFrame: 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
measure: Change From Baseline in Short Form-36 (SF-36) Physical Component Score (PCS) Week 12, 24: Last Observation Carried Forward (LOCF): Period 1
timeFrame: Baseline (Day 1 Week 1), Week 12, 24
measure: 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
timeFrame: Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 32, 48, 64
measure: Change From Baseline in Short Form-36 (SF-36) Physical Component Score (PCS) at Week 64, 76: Last Observation Carried Forward (LOCF): Period 3
timeFrame: 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
measure: 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
timeFrame: Baseline (Day 1 Week 1), Week 12, 24
measure: 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
timeFrame: Period 2 baseline (last visit before treatment withdrawal), Week 32, 48, 64
measure: 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
timeFrame: Period 3 baseline (last visit before retreatment), Week 64, 76
measure: Percentage of Participants With >=5 Score Improvement From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 12, 24: Period 1
timeFrame: Baseline (Day 1 Week 1), Week 12, 24
measure: 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
timeFrame: Period 2 baseline (last visit before treatment withdrawal), Week 32, 48, 64
measure: Percentage of Participants With >=5 Score Improvement From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 64, 76: Period 3
timeFrame: Period 3 baseline (last visit before retreatment), Week 64, 76
measure: Change From Baseline in Short Form-36 (SF-36) Mental Component Score (MCS) at Week 12, 24: Observed Cases (OC): Period 1
timeFrame: Baseline (Day 1 Week 1), Week 12, 24
measure: Change From Baseline in Short Form-36 (SF-36) Mental Component Score (MCS) at Week 32, 48, 64: Observed Cases (OC): Period 2
timeFrame: Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 32, 48, 64
measure: Change From Baseline in Short Form-36 (SF-36) Mental Component Score (MCS) at Week 64, 76: Observed Cases (OC): Period 3
timeFrame: 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
measure: Change From Baseline in Short Form-36 (SF-36) Mental Component Score (MCS) at Week 12, 24: Last Observation Carried Forward (LOCF): Period 1
timeFrame: Baseline (Day 1 Week 1), Week 12, 24
measure: 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
timeFrame: Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 32, 48, 64
measure: Change From Baseline in Short Form-36 (SF-36) Mental Component Score (MCS) at Week 64, 76: Last Observation Carried Forward (LOCF): Period 3
timeFrame: 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
measure: 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
timeFrame: Baseline (Day 1 Week 1), Week 12, 24
measure: 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
timeFrame: Period 2 baseline (last visit before treatment withdrawal), Week 32, 48, 64
measure: 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
timeFrame: Period 3 baseline (last visit before retreatment), Week 64, 76
measure: 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
timeFrame: Baseline (Day 1 Week 1), Week 12, 24
measure: 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
timeFrame: Period 2 baseline (last visit before treatment withdrawal), Week 32, 48, 64
measure: 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
timeFrame: Period 3 baseline (last visit before retreatment), Week 64, 76
measure: Change From Baseline in Work Productivity and Activity Impairment (WPAI): Observed Cases (OC): Period 1
timeFrame: Baseline (Day 1 Week 1), Week 4, 8, 12, 16, 24
measure: Change From Baseline in Work Productivity and Activity Impairment (WPAI): Observed Cases (OC): Period 2
timeFrame: Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 28, 32, 40, 48, 56, 64
measure: Change From Baseline in Work Productivity and Activity Impairment (WPAI): Observed Cases (OC): Period 3
timeFrame: 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
measure: Change From Baseline in Work Productivity and Activity Impairment (WPAI): Last Observation Carried Forward (LOCF): Period 1
timeFrame: Baseline (Day 1 Week 1), Week 4, 8, 12, 16, 24
measure: Change From Baseline in Work Productivity and Activity Impairment (WPAI): Last Observation Carried Forward (LOCF): Period 2
timeFrame: Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 28, 32, 40, 48, 56, 64
measure: Change From Baseline in Work Productivity and Activity Impairment (WPAI): Last Observation Carried Forward (LOCF): Period 3
timeFrame: 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
measure: 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
timeFrame: Baseline (Day 1 Week 1), Week 24
measure: 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
timeFrame: Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 48, 64
measure: 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
timeFrame: 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
measure: 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
timeFrame: Baseline (Day 1 Week 1), Week 24
measure: 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
timeFrame: Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 48, 64
measure: 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
timeFrame: 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
measure: Time to Ankylosing Spondylitis Disease Activity Score (ASDAS) Inactive Disease After Re-treatment in Period 3
timeFrame: Within 12 weeks of Period 3 (retreatment period from Week 64 to 76)
measure: Change From Baseline in Subject Assessment of Disease Activity (SADA) Visual Analogue Scale (VAS): Observed Cases (OC): Period 1
timeFrame: Baseline (Day 1 Week 1), Week 4, 8, 12, 16, 24
measure: Change From Baseline in Subject Assessment of Disease Activity (SADA) Visual Analogue Scale (VAS): Observed Cases (OC): Period 2
timeFrame: Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 28, 32, 40, 48, 56, 64
measure: Change From Baseline in Subject Assessment of Disease Activity (SADA) Visual Analogue Scale (VAS): Observed Cases (OC): Period 3
timeFrame: 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
measure: Change From Baseline in Subject Assessment of Disease Activity (SADA) Visual Analogue Scale (VAS): Last Observation Carried Forward (LOCF): Period 1
timeFrame: Baseline (Day 1 Week 1), Week 4, 8, 12, 16, 24
measure: Change From Baseline in Subject Assessment of Disease Activity (SADA) Visual Analogue Scale (VAS): Last Observation Carried Forward (LOCF): Period 2
timeFrame: Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 28, 32, 40, 48, 56, 64
measure: Change From Baseline in Subject Assessment of Disease Activity (SADA) Visual Analogue Scale (VAS): Last Observation Carried Forward (LOCF): Period 3
timeFrame: 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
measure: Change From Baseline in Physician Global Assessment (PGA) Visual Analogue Scale (VAS): Observed Cases (OC): Period 1
timeFrame: Baseline (Day 1 Week 1), Week 4, 8, 12, 16, 24
measure: Change From Baseline in Physician Global Assessment (PGA) Visual Analogue Scale (VAS): Observed Cases (OC): Period 2
timeFrame: Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 28, 32, 40, 48, 56, 64
measure: Change From Baseline in Physician Global Assessment (PGA) Visual Analogue Scale (VAS): Observed Cases (OC): Period 3
timeFrame: 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
measure: Change From Baseline in Physician Global Assessment (PGA) Visual Analogue Scale (VAS): Last Observation Carried Forward (LOCF): Period 1
timeFrame: Baseline (Day 1 Week 1), Week 4, 8, 12, 16, 24
measure: Change From Baseline in Physician Global Assessment (PGA) Visual Analogue Scale (VAS): Last Observation Carried Forward (LOCF): Period 2
timeFrame: Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 28, 32, 40, 48, 56, 64
measure: Change From Baseline in Physician Global Assessment (PGA) Visual Analogue Scale (VAS): Last Observation Carried Forward (LOCF): Period 3
timeFrame: 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
measure: Change From Baseline in Bath Ankylosing Spondylitis Global Index (BAS-G) Score at Week 12, 24: Last Observation Carried Forward (LOCF): Period 1
timeFrame: Baseline (Day 1 Week 1), Week 12, 24
measure: Change From Baseline in Bath Ankylosing Spondylitis Global Index (BAS-G) Score) at Week 32, 48, 64: Last Observation Carried Forward (LOCF): Period 2
timeFrame: Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 32, 48, 64
measure: Change From Baseline in Bath Ankylosing Spondylitis Global Index (BAS-G) Score at Week 64, 76: Last Observation Carried Forward (LOCF): Period 3
timeFrame: 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
measure: Change From Baseline in Bath Ankylosing Spondylitis Global Index (BAS-G) Score at Week 12, 24: Observed Cases (OC): Period 1
timeFrame: Baseline (Day 1 Week 1), Week 12, 24
measure: Change From Baseline in Bath Ankylosing Spondylitis Global Index (BAS-G) Score) at Week 32, 48, 64: Observed Cases (OC): Period 2
timeFrame: Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 32, 48, 64
measure: Change From Baseline in Bath Ankylosing Spondylitis Global Index (BAS-G) Score at Week 64, 76: Observed Cases (OC): Period 3
timeFrame: 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
measure: Change From Baseline in Number of Swollen Joint Count at Week 12, 24: Observed Cases (OC): Period 1
timeFrame: Baseline (Day 1 Week 1), Week 12, 24
measure: Change From Baseline in Number of Swollen Joint Count at Week 32, 48, 64: Observed Cases (OC): Period 2
timeFrame: Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 32, 48, 64
measure: Change From Baseline in Number of Swollen Joint Count at Week 64, 76: Observed Cases (OC): Period 3
timeFrame: 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
measure: Change From Baseline in Number of Swollen Joint Count at Week 12, 24: Last Observation Carried Forward (LOCF): Period 1
timeFrame: Baseline (Day 1 Week 1), Week 12, 24
measure: Change From Baseline in Number of Swollen Joint Count at Week 32, 48, 64: Last Observation Carried Forward (LOCF): Period 2
timeFrame: Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 32, 48, 64
measure: Change From Baseline in Number of Swollen Joint Count at Week 64, 76 : Last Observation Carried Forward (LOCF): Period 3
timeFrame: 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
measure: Change From Baseline in Number of Tender Joint Count at Week 12, 24: Observed Cases (OC): Period 1
timeFrame: Baseline (Day 1 Week 1), Week 12, 24
measure: Change From Baseline in Number of Tender Joint Count at Week 32, 48, 64: Observed Cases (OC): Period 2
timeFrame: Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 32, 48, 64
measure: Change From Baseline in Number of Tender Joint Count at Week 64, 76: : Observed Cases (OC): Period 3
timeFrame: 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
measure: Change From Baseline in Number of Tender Joint Count at Week 12, 24: Last Observation Carried Forward (LOCF): Period 1
timeFrame: Baseline (Day 1 Week 1), Week 12, 24
measure: Change From Baseline in Number of Tender Joint Count at Week 32, 48, 64: Last Observation Carried Forward (LOCF): Period 2
timeFrame: Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 32, 48, 64
measure: Change From Baseline in Number of Tender Joint Count at Week 64, 76: Last Observation Carried Forward (LOCF): Period 3
timeFrame: 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
measure: Change From Baseline in Dactylitis Total Score at Week 12, 24: Observed Cases (OC): Period 1
timeFrame: Baseline (Day 1 Week 1), Week 12, 24
measure: Change From Baseline in Dactylitis Total Score at Week 32, 48, 64: Observed Cases (OC): Period 2
timeFrame: Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 32, 48, 64
measure: Change From Baseline in Dactylitis Total Score at Week 64, 76: Observed Cases (OC): Period 3
timeFrame: 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
measure: Change From Baseline in Dactylitis Total Score at Week 12, 24: Last Observation Carried Forward (LOCF): Period 1
timeFrame: Baseline (Day 1 Week 1), Week 12, 24
measure: Change From Baseline in Dactylitis Total Score at Week 32, 48, 64: Last Observation Carried Forward (LOCF): Period 2
timeFrame: Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 32, 48, 64
measure: Change From Baseline in Dactylitis Total Score at Week 64, 76: Last Observation Carried Forward (LOCF): Period 3
timeFrame: 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
measure: Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) at Week 12, 24: Observed Cases (OC) : Period 1
timeFrame: Baseline (Day 1 Week 1), Week 12, 24
measure: Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) at Week 32, 48, 64: Observed Cases (OC): Period 2
timeFrame: Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 32, 48, 64
measure: Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) at Week 64, 76: Observed Cases (OC): Period 3
timeFrame: 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
measure: Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) at Week 12, 24: Last Observation Carried Forward (LOCF): Period 1
timeFrame: Baseline (Day 1 Week 1), Week 12, 24
measure: Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) at Week 32, 48, 64: Last Observation Carried Forward (LOCF): Period 2
timeFrame: Period 1 Baseline (Day 1 Week 1), Period 2: Baseline (last visit before treatment withdrawal), Week 32, 48, 64
measure: Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) at Week 64, 76: Last Observation Carried Forward (LOCF): Period 3
timeFrame: 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
measure: Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: 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)
Other outcomes:
Locations:
city: Pensacola
country: United States
facility: Gulf Region Clinical Research Institute
state: Florida
city: Chicago
country: United States
facility: Northwestern Medical Group; Division of Rheumatology
state: Illinois
city: Chicago
country: United States
facility: Northwestern Memorial Hospital
state: Illinois
city: Chicago
country: United States
facility: Northwestern University Clinical and Translational Sciences Institute (NUCATS)
state: Illinois
city: Mineola
country: United States
facility: Winthrop University Hospital, Clinical Trials Center
state: New York
city: Portland
country: United States
facility: Oregon Health and Science University Research Pharmacy
state: Oregon
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
city: Duncansville
country: United States
facility: Altoona Center for Clinical Research
state: Pennsylvania
city: Hershey
country: United States
facility: Penn State Milton S. Hershey Medical Center
state: Pennsylvania
city: Seattle
country: United States
facility: Swedish Medical Center Investigational Drug Services Pharmacy
state: Washington
city: Seattle
country: United States
facility: Seattle Rheumatology Associates
state: Washington
city: Seattle
country: United States
facility: Swedish Medical Center
state: Washington
city: Broadmeadow
country: Australia
facility: Genesis Research Services Pty Ltd
state: New South Wales
city: Cardiff
country: Australia
facility: Hunter Imaging Group
state: New South Wales
city: Maroochydore
country: Australia
facility: Pacific Radiology
state: Queensland
city: Maroochydore
country: Australia
facility: Rheumatology Research Centre
state: Queensland
city: North Adelaide
country: Australia
facility: Benson Radiology
state: South Australia
city: Woodville South
country: Australia
facility: The Queen Elizabeth Hospital
state: South Australia
city: Nedlands
country: Australia
facility: SKG Radiology Hollywood Hospital
state: Western Australia
city: Subiaco
country: Australia
facility: SKG Radiology Subiaco
state: Western Australia
city: Victoria Park
country: Australia
facility: R.K. Will Pty Ltd
state: Western Australia
city: Sint-Niklaas
country: Belgium
facility: Private Practice Rheumatology
state: OVL
city: Genk
country: Belgium
facility: Reumaclinic
city: Medellin
country: Colombia
facility: Centro Integral de Reumatologia Reumalab S.A.S.
state: Antioquia
city: Medellin
country: Colombia
facility: Hospital Pablo Tobon Uribe
state: Antioquia
city: Chía
country: Colombia
facility: Preventive Care SAS
state: Cundinamarca
city: Praha 11
country: Czechia
facility: Affidea Praha s.r.o.
city: Praha 2
country: Czechia
facility: Revmatologicky ustav
city: Uherske Hradiste
country: Czechia
facility: MEDICAL PLUS, s.r.o.
city: Uherske Hradiste
country: Czechia
facility: Uherskohradist' ska nemocnice a.s.
city: Uherske Hradiste
country: Czechia
facility: Lekarna Hradebni s.r.o.
city: Helsinki
country: Finland
facility: Helsinki University Hospital
city: Helsinki
country: Finland
facility: HYKS, Meilahden kolmiosairaala
city: Hyvinkaa
country: Finland
facility: Kiljavan Laaketutkimus Oy
city: Nancy
country: France
facility: Service d'Imagerie Guilloz
city: Paris
country: France
facility: Hopital Cochin Pavillon Hardy B4
city: Paris
country: France
facility: Pharmacie-Secteur Essais cliniques
city: Rennes
country: France
facility: CHU de Rennes, Hopital Sud
city: Toulouse cedex 9
country: France
facility: CHU PURPAN, Hopital Pierre-Paul Riquet
city: Toulouse cedex 9
country: France
facility: Pharmacie
city: Vandoeuvre les Nancy
country: France
facility: Pharmacie Essais cliniques
city: Vandoeuvre-les-Nancy cedex
country: France
facility: CHU de Nancy - Hopital de Brabois
city: Muenchen
country: Germany
facility: Medizinische Klinik und Poliklinik IV
state: Bavaria
city: Herne
country: Germany
facility: Rheumazentrum Ruhrgebiet
state: NRW
city: Berlin
country: Germany
facility: Charité Universitaetsmedizin Berlin
city: Berlin
country: Germany
facility: Apotheke am Tierpark
city: Berlin
country: Germany
facility: Charité Universitaetsmedizin Berlin
city: Berlin
country: Germany
facility: Praxis für radiologische Diagnostik
city: Berlin
country: Germany
facility: Rheumatologische Schwerpunktpraxis
city: Berlin
country: Germany
facility: Schlosspark-Klinik GmbH
city: Chemnitz
country: Germany
facility: Mvz Agilomed
city: Koeln
country: Germany
facility: Universitaetskliniken Koeln
city: Budapest
country: Hungary
facility: Qualiclinic Kft.
city: Veszprem
country: Hungary
facility: VITAL MEDICAL CENTER Orvosi es Fogorvosi Kozpont
city: Amsterdam
country: Netherlands
facility: READE
city: Leiden
country: Netherlands
facility: LUMC
city: Bydgoszcz
country: Poland
facility: Nzoz McD Voxel
city: Bydgoszcz
country: Poland
facility: Szpital Uniwersytecki nr 2 im. dr J. Biziela w Bydgoszczy, Klinika Reumatologii i Ukladowych Chorob
city: Bydgoszcz
country: Poland
facility: Zaklad Radiologii i Diagnostyki Obrazowej
city: Elblag
country: Poland
facility: Centrum Kliniczno-Badawcze J. Brzezicki, B. Gornikiewicz-Brzezicka Lekarze Spolka Partnerska
city: Koscian
country: Poland
facility: Samodzielny Publiczny Zespol Opieki Zdrowotnej
city: Lublin
country: Poland
facility: Reumed Sp z.o.o. Zespool Poradni Specjalistycznych Filia nr 1
city: Nowy Duninow
country: Poland
facility: RCMed
city: Poznan
country: Poland
facility: Diagnostic-Med Centrum Diagnostyki Radiologicznej
city: Sochaczew
country: Poland
facility: RCMed
city: Stalowa Wola
country: Poland
facility: SANUS Szpital Specjalistyczny Sp. z o.o.
city: Torun
country: Poland
facility: Nasz Lekarz Przychodnie Medyczne
city: Warszawa
country: Poland
facility: Medycyna Kliniczna
city: Warszawa
country: Poland
facility: Reumatika-Centrum Reumatologii NZOZ
city: Wrocław
country: Poland
facility: Centrum Medyczne OPOROW
city: Santiago de Compostela
country: Spain
facility: Complejo Hospitalario Universitario Santiago
state: A Coruna
city: San Cristobal de la Laguna
country: Spain
facility: Hospital Universitario de Canarias
state: Santa CRUZ DE Tenerife
city: La Coruna
country: Spain
facility: Complexo Hospitalario Universitario A Coruna
city: La Coruna
country: Spain
facility: Hospital San Rafael
city: Sevilla
country: Spain
facility: Complejo Hospitalario Regional Virgen Macarena
city: Gothenburg
country: Sweden
facility: Sahlgrenska University Hospital
city: Malmo
country: Sweden
facility: Skanes University Hospital Malmo
city: Uppsala
country: Sweden
facility: Akademiska sjukhuset
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Hospital
city: Taichung
country: Taiwan
facility: Chung Shan Medical University Hospital
city: Taichung
country: Taiwan
facility: Chung Shan Medical University
city: Taichung
country: Taiwan
facility: China Medical University Hospital
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: 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.