Phase 4
Completed N=210
Etanercept Withdrawal And Retreament Study In Subjects With Nr-ax SpA
Spondylitis, Ankylosing
Source: ClinicalTrials.gov NCT02509026 ↗
Enrolled (actual)
210
Serious AEs
1.7%
Results posted
Jun 2020
Primary outcomePrimary: Percentage of Participants Who Experienced Flare Within 40 Weeks Following Withdrawal of 24 Weeks of Etanercept Treatment — 74.8 percentage of participants
◆ Published Evidence
Emerging
6citations · ~2 / year
Etanercept Withdrawal and Retreatment in Nonradiographic Axial Spondyloarthritis: Results of RE-EMBARK, an Open-Label Phase IV Trial.
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.
Linked Publications
-
Etanercept Withdrawal and Retreatment in Nonradiographic Axial Spondyloarthritis: Results of RE-EMBARK, an Open-Label Phase IV Trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Who Experienced Flare Within 40 Weeks Following Withdrawal of 24 Weeks of Etanercept Treatment |
74.8 | — |
| SECONDARY Time to Flare Following Withdrawal of Etanercept Treatment |
16.1 | — |
| SECONDARY Percentage of Participants With Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Less Than (<)1.3: Observed Cases (OC): Period 1 |
0.5; 14.4; 27.4; 38.1; 41.9; 62.6 | — |
| SECONDARY Percentage of Participants With Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Less Than (<)1.3: Observed Cases (OC): Period 2 |
52.7; 45.2; 48.5; 42.0; 56.1; 55.9 | — |
| SECONDARY Percentage of Participants With Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Less Than (<)1.3: Observed Cases (OC): Period 3 |
53.6; 61.6; 62.4 | — |
| SECONDARY 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 |
0.5; 14.4; 27.4; 36.5; 40.4; 58.7 | — |
| SECONDARY 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 |
52.7; 39.8; 34.5; 26.5; 29.2; 24.8 | — |
| SECONDARY 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 |
52.9; 60.9; 62.1 | — |
| SECONDARY Percentage of Participants Who Achieved Assessment of Spondyloarthritis Society (ASAS 20) Response: Observed Cases (OC): Period 1 |
58.7; 68.7; 71.7; 78.1; 85.8 | — |
| SECONDARY Percentage of Participants Who Achieved Assessment of Spondyloarthritis Society (ASAS 20) Response: Observed Cases (OC): Period 2 |
86.0; 88.9; 83.1; 91.5; 91.4; 92.6 | — |
| SECONDARY Percentage of Participants Who Achieved Assessment of Spondyloarthritis Society (ASAS 20) Response: Observed Cases (OC): Period 3 |
33.3; 80.0; 81.6; 87.1 | — |
| SECONDARY Percentage of Participants Who Achieved Assessment of Spondyloarthritis Society (ASAS 20) Response: Last Observation Carried Forward (LOCF): Period 1 |
58.7; 68.8; 71.2; 76.4; 83.2 | — |
| SECONDARY Percentage of Participants Who Achieved Assessment of Spondyloarthritis Society (ASAS 20) Response: Last Observation Carried Forward (LOCF): Period 2 |
86.0; 84.3; 79.4; 79.4; 78.4; 77.5 | — |
| SECONDARY Percentage of Participants Who Achieved Assessment of Spondyloarthritis Society (ASAS 20) Response: Last Observation Carried Forward (LOCF): Period 3 |
33.3; 79.1; 81.6; 86.2 | — |
| SECONDARY Percentage of Participants Who Achieved Assessment of Spondyloarthritis Society 40 (ASAS 40) Response: Last Observation Carried Forward (LOCF): Period 1 |
34.6; 49.0; 51.0; 61.1; 71.6 | — |
| SECONDARY Percentage of Participants Who Achieved Assessment of Spondyloarthritis Society 40 (ASAS 40) Response: Last Observation Carried Forward (LOCF): Period 2 |
77.0; 72.5; 69.6; 64.7; 66.7; 62.7 | — |
| SECONDARY Percentage of Participants Who Achieved Assessment of Spondyloarthritis Society 40 (ASAS 40) Response: Last Observation Carried Forward (LOCF): Period 3 |
20.0; 67.4; 74.7; 77.0 | — |
| SECONDARY Percentage of Participants Who Achieved Assessment of Spondyloarthritis Society 40 (ASAS 40) Response: Observed Cases (OC): Period 1 |
34.6; 49.3; 52.5; 64.1; 75.8 | — |
| SECONDARY Percentage of Participants Who Achieved Assessment of Spondyloarthritis Society 40 (ASAS 40) Response: Observed Cases (OC): Period 2 |
77.0; 77.8; 74.6; 74.5; 82.9; 74.1 | — |
| SECONDARY Percentage of Participants Who Achieved Assessment of Spondyloarthritis Society 40 (ASAS 40) Response: Observed Cases (OC): Period 3 |
20.0; 68.2; 74.7; 78.8 | — |
| SECONDARY Percentage of Participants Who Achieved Assessment of Spondyloarthritis Society (ASAS) Partial Remission: Last Observation Carried Forward (LOCF): Period 1 |
19.2; 29.8; 37.0; 40.9; 58.2 | — |
| SECONDARY Percentage of Participants Who Achieved Assessment of Spondyloarthritis Society (ASAS) Partial Remission: Last Observation Carried Forward (LOCF): Period 2 |
63.0; 53.9; 48.0; 41.2; 44.1; 41.2 | — |
| SECONDARY Percentage of Participants Who Achieved Assessment of Spondyloarthritis Society (ASAS) Partial Remission: Last Observation Carried Forward (LOCF): Period 3 |
0.0; 45.3; 55.2; 52.9 | — |
| SECONDARY Percentage of Participants Who Achieved Assessment of Spondyloarthritis Society (ASAS) Partial Remission: Observed Cases (OC): Period 1 |
19.2; 30.3; 38.9; 42.7; 62.1 | — |
| SECONDARY Percentage of Participants Who Achieved Assessment of Spondyloarthritis Society (ASAS) Partial Remission: Observed Cases (OC): Period 2 |
63.0; 58.0; 59.3; 51.1; 68.6; 70.4 | — |
| SECONDARY Percentage of Participants Who Achieved Assessment of Spondyloarthritis Society (ASAS) Partial Remission: Observed Cases (OC): Period 3 |
0.0; 45.9; 55.2; 52.9 | — |
| SECONDARY Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS)-C-Reactive Protein (CRP) Score: Last Observation Carried Forward (LOCF): Period 1 |
3.54; -1.27; -1.53; -1.62; -1.77; -2.02 | — |
| SECONDARY Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS)-C-Reactive Protein (CRP) Score: Last Observation Carried Forward (LOCF): Period 2 |
0.90; -1.83; 0.66; -1.54; 0.96; -1.36 | — |
| SECONDARY Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Score: Last Observation Carried Forward (LOCF): Period 3 |
2.97; -0.44; 2.08; 0.23; -1.92; 0.67 | — |
| SECONDARY Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Score: Observed Cases (OC): Period 1 |
3.54; -1.27; -1.54; -1.66; -1.85; -2.13 | — |
| SECONDARY Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Score: Observed Cases (OC): Period 2 |
0.90; -1.83; 0.66; -1.76; 0.77; -1.65 | — |
| SECONDARY Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Score: Observed Cases (OC): Period 3 |
2.97; -0.44; 2.08; 0.23; -1.94; 0.65 | — |
| SECONDARY Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) Erythrocyte Sedimentation Rate (ESR) Score: Last Observation Carried Forward (LOCF): Period 1 |
3.59; -1.27; -1.56; -1.70; -1.81; -2.05 | — |
| SECONDARY Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS)-Erythrocyte Sedimentation Rate (ESR) Score: Last Observation Carried Forward (LOCF): Period 2 |
0.92; -1.81; 0.68; -1.58; 0.93; -1.34 | — |
| SECONDARY Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS)-Erythrocyte Sedimentation Rate (ESR) Score: Last Observation Carried Forward (LOCF): Period 3 |
3.15; -0.54; 2.05; 0.10; -1.97; 0.65 | — |
| SECONDARY Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) Erythrocyte Sedimentation Rate (ESR) Score: Observed Cases (OC): Period 1 |
3.59; -1.27; -1.57; -1.75; -1.89; -2.16 | — |
| SECONDARY Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS)-Erythrocyte Sedimentation Rate (ESR) Score: Observed Cases (OC): Period 2 |
0.92; -1.81; 0.68; -1.81; 0.70; -1.59 | — |
| SECONDARY Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS)-Erythrocyte Sedimentation Rate (ESR) Score: Observed Cases (OC): Period 3 |
3.15; -0.54; 2.05; 0.10; -1.99; 0.63 | — |
| SECONDARY Percentage of Participants Who Achieved Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Major Improvement: Last Observation Carried Forward (LOCF): Period 1 |
26.0; 32.2; 36.1; 39.9; 49.0 | — |
| SECONDARY Percentage of Participants Who Achieved Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Major Improvement: Last Observation Carried Forward (LOCF): Period 2 |
43.6; 34.5; 30.1; 25.7; 22.1; 18.6 | — |
| SECONDARY Percentage of Participants Who Achieved Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Major Improvement: Last Observation Carried Forward (LOCF): Period 3 |
6.7; 41.2; 55.2; 54.0 | — |
| SECONDARY Percentage of Participants Who Achieved Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Major Improvement: Observed Cases (OC): Period 1 |
26.0; 32.8; 38.1; 42.4; 52.6 | — |
| SECONDARY Percentage of Participants Who Achieved Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Major Improvement: Observed Cases (OC): Period 2 |
43.6; 39.8; 37.9; 34.0; 31.7; 23.5 | — |
| SECONDARY Percentage of Participants Who Achieved Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Major Improvement: Observed Cases (OC): Period 3 |
6.7; 41.7; 55.8; 55.3 | — |
| SECONDARY 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 |
55.8; 64.4; 63.9; 71.6; 77.4 | — |
| SECONDARY 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 |
74.5; 70.8; 59.3; 55.8; 54.9; 50.4 | — |
| SECONDARY 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 |
26.7; 80.0; 82.8; 79.3 | — |
| SECONDARY Percentage of Participants Who Achieved Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Clinically Important Improvement: Observed Cases (OC): Period 1 |
55.8; 64.7; 65.5; 74.3; 81.1 | — |
| SECONDARY Percentage of Participants Who Achieved Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Clinically Important Improvement: Observed Cases (OC): Period 2 |
74.5; 79.6; 68.2; 72.0; 78.0; 70.6 | — |
| SECONDARY Percentage of Participants Who Achieved Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Clinically Important Improvement: Observed Cases (OC): Period 3 |
26.7; 81.0; 83.7; 81.2 | — |
| SECONDARY Change From Baseline in Nocturnal Back Pain: Last Observation Carried Forward (LOCF): Period 1 |
5.92; -2.53; -3.10; -3.25; -3.55; -4.14 | — |
| SECONDARY Change From Baseline in Nocturnal Back Pain: Last Observation Carried Forward (LOCF): Period 2 |
0.63; -3.77; 1.08; -3.05; 1.80; -2.64 | — |
| SECONDARY Change From Baseline in Nocturnal Back Pain: Last Observation Carried Forward (LOCF): Period 3 |
5.54; -0.28; 4.35; 1.29; -4.03; 1.33 | — |
| SECONDARY Change From Baseline in Nocturnal Back Pain: Observed Cases (OC): Period 1 |
5.92; -2.53; -3.10; -3.32; -3.68; -4.32 | — |
| SECONDARY Change From Baseline in Nocturnal Back Pain: Observed Cases (OC): Period 2 |
0.63; -3.77; 1.08; -3.50; 1.33; -3.12 | — |
| SECONDARY Change From Baseline in Nocturnal Back Pain: Observed Cases (OC): Period 3 |
5.54; -0.28; 4.35; 1.29; -4.07; 1.34 | — |
| SECONDARY Change From Baseline in Total Back Pain: Last Observation Carried Forward (LOCF): Period 1 |
5.98; -2.39; -2.96; -3.15; -3.44; -4.05 | — |
| SECONDARY Change From Baseline in Total Back Pain: Last Observation Carried Forward (LOCF): Period 2 |
0.71; -3.68; 1.09; -2.92; 1.84; -2.48 | — |
| SECONDARY Change From Baseline in Total Back Pain: Last Observation Carried Forward (LOCF): Period 3 |
5.66; -0.10; 4.34; 1.07; -3.73; 1.35 | — |
| SECONDARY Change From Baseline in Total Back Pain: Observed Cases (OC): Period 1 |
5.98; -2.39; -2.97; -3.23; -3.56; -4.24 | — |
| SECONDARY Change From Baseline in Total Back Pain: Observed Cases (OC): Period 2 |
0.71; -3.68; 1.09; -3.43; 1.38; -2.97 | — |
| SECONDARY Change From Baseline in Total Back Pain: Observed Cases (OC): Period 3 |
5.66; -0.10; 4.34; 1.07; -3.76; 1.35 | — |
| SECONDARY Mean Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI): Observed Cases (OC): Period 1 |
4.66; -1.62; -2.22; -2.44; -2.73; -3.24 | — |
| SECONDARY Mean Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI): Observed Cases (OC): Period 2 |
0.59; -3.00; 0.90; -3.10; 0.88; -2.88 | — |
| SECONDARY Mean Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI): Observed Cases (OC): Period 3 |
4.14; -0.62; 3.11; 0.78; -2.99; 1.13 | — |
| SECONDARY Mean Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI): Last Observation Carried Forward (LOCF): Period 1 |
4.66; -1.62; -2.23; -2.39; -2.65; -3.10 | — |
| SECONDARY Mean Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI): Last Observation Carried Forward (LOCF): Period 2 |
0.59; -3.00; 0.90; -2.54; 1.35; -2.21 | — |
| SECONDARY Mean Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI): Last Observation Carried Forward (LOCF): Period 3 |
4.14; -0.62; 3.11; 0.78; -2.98; 1.14 | — |
| SECONDARY Mean Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Total Score: Observed Cases (OC): Period 1 |
6.41; -2.39; -3.08; -3.40; -3.91; -4.65 | — |
| SECONDARY Mean Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Total Score: Observed Cases (OC): Period 2 |
0.63; -4.10; 1.38; -4.11; 1.37; -3.77 | — |
| SECONDARY Mean Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Total Score: Observed Cases (OC): Period 3 |
5.53; -0.92; 4.63; 0.37; -4.04; 1.66 | — |
| SECONDARY Mean Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Total Score: Last Observation Carried Forward (LOCF): Period 1 |
6.41; -2.39; -3.07; -3.34; -3.74; -4.41 | — |
| SECONDARY Mean Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Total Score:Last Observation Carried Forward (LOCF): Period 2 |
0.63; -4.10; 1.38; -3.49; 1.99; -2.96 | — |
| SECONDARY Mean Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Total Score: Last Observation Carried Forward (LOCF): Period 3 |
5.53; -0.92; 4.63; 0.37; -4.01; 1.68 | — |
| SECONDARY 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 |
33.7; 50.7; 57.1; 66.7; 78.9 | — |
| SECONDARY 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 |
77.7; 77.7; 73.9; 77.4; 83.3; 76.5 | — |
| SECONDARY 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 |
20.0; 72.9; 78.2; 84.7 | — |
| SECONDARY 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 |
33.7; 50.5; 55.8; 63.9; 75.0 | — |
| SECONDARY 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 |
77.7; 67.0; 57.4; 51.3; 47.0; 41.7 | — |
| SECONDARY 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 |
20.0; 72.1; 78.2; 82.8 | — |
| SECONDARY Mean Change From Baseline in Highly Sensitive C Reactive Protein (hsCRP): Observed Cases (OC): Period 1 |
12.73; -8.72; -9.20; -8.98; -9.12; -9.73 | — |
| SECONDARY Mean Change From Baseline in Highly Sensitive C Reactive Protein (hsCRP): Observed Cases (OC): Period 2 |
1.45; -7.46; 2.60; -6.94; 4.72; -5.87 | — |
| SECONDARY Mean Change From Baseline in Highly Sensitive C Reactive Protein (hsCRP): Observed Cases (OC): Period 3 |
7.14; -2.58; 9.15; 1.61; -8.20; 0.54 | — |
| SECONDARY Mean Change From Baseline in Highly Sensitive C Reactive Protein (hsCRP): Last Observation Carried Forward (LOCF): Period 1 |
12.73; -8.72; -9.14; -8.77; -8.72; -9.28 | — |
| SECONDARY Mean Change From Baseline in Highly Sensitive C Reactive Protein (hsCRP): Last Observation Carried Forward (LOCF): Period 2 |
1.45; -7.46; 2.60; -5.86; 4.46; -5.56 | — |
| SECONDARY Mean Change From Baseline in Highly Sensitive C Reactive Protein (hsCRP): Last Observation Carried Forward (LOCF): Period 3 |
7.14; -2.58; 9.15; 1.61; -7.98; 1.53 | — |
| SECONDARY 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 |
4.3; 28.5; 50.3 | — |
| SECONDARY 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 |
43.0; 37.9; 46.3 | — |
| SECONDARY 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 |
6.7; 50.0 | — |
| SECONDARY 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 |
4.3; 28.5; 47.8 | — |
| SECONDARY 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 |
43.0; 32.4; 28.7 | — |
| SECONDARY 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 |
6.7; 50.0 | — |
| SECONDARY 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 |
70.0; 79.1 | — |
| SECONDARY 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 |
72.0; 68.2; 75.6 | — |
| SECONDARY 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 |
53.3; 82.6 | — |
| SECONDARY 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 |
70.0; 76.8 | — |
| SECONDARY 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 |
72.0; 62.0; 61.1 | — |
| SECONDARY 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 |
53.3; 82.6 | — |
| SECONDARY 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 |
32.5; 64.6; 20.6; 1.9; 37.3; 65.2 | — |
| SECONDARY 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 |
66.4; 83.2; 55.1; 28.0; 70.1; 71.2 | — |
| SECONDARY 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 |
26.7; 73.3; 26.7; 6.7; 46.7; 73.3 | — |
| SECONDARY 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 |
32.5; 64.6; 20.6; 1.9; 37.3; 65.2 | — |
| SECONDARY 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 |
66.4; 83.2; 55.1; 28.0; 70.1; 57.4 | — |
| SECONDARY 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 |
26.7; 73.3; 26.7; 6.7; 46.7; 73.3 | — |
| SECONDARY 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 |
0.42; 0.30; 0.38 | — |
| SECONDARY 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 |
0.89; 0.27; -0.15; 0.26; -0.13; 0.25 | — |
| SECONDARY 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 |
0.55; 0.17; -0.29; 0.01; 0.43; -0.06 | — |
| SECONDARY 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 |
0.42; 0.30; 0.37 | — |
| SECONDARY 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 |
0.89; 0.27; -0.15; 0.24; -0.18; 0.21 | — |
| SECONDARY 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 |
0.55; 0.17; -0.29; 0.01; 0.43; -0.06 | — |
| SECONDARY Change From Baseline in Short Form-36 (SF-36) Physical Component Score (PCS) at Week 12, 24: Observed Cases (OC): Period 1 |
33.29; 8.84; 12.90 | — |
| SECONDARY Change From Baseline in Short Form-36 (SF-36) Physical Component Score (PCS) at Week 32, 48, 64: Observed Cases (OC): Period 2 |
50.03; 9.62; -5.97; 8.02; -7.84; 9.18 | — |
| SECONDARY Change From Baseline in Short Form-36 (SF-36) Physical Component Score (PCS) at Week 64, 76: Observed Cases (OC): Period 3 |
34.39; -0.81; -16.06; -2.98; 11.76; -3.21 | — |
| SECONDARY Change From Baseline in Short Form-36 (SF-36) Physical Component Score (PCS) Week 12, 24: Last Observation Carried Forward (LOCF): Period 1 |
33.29; 8.84; 12.14 | — |
| SECONDARY 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 |
50.03; 9.62; -5.97; 6.52; -9.19; 5.52 | — |
| SECONDARY Change From Baseline in Short Form-36 (SF-36) Physical Component Score (PCS) at Week 64, 76: Last Observation Carried Forward (LOCF): Period 3 |
34.39; -0.81; -16.06; -2.98; 11.76; -3.21 | — |
| SECONDARY 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 |
73.1; 79.6 | — |
| SECONDARY 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 |
72.8; 70.3; 75.0 | — |
| SECONDARY 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 |
26.7; 80.5 | — |
| SECONDARY Percentage of Participants With >=5 Score Improvement From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 12, 24: Period 1 |
62.4; 73.7 | — |
| SECONDARY 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 |
65.0; 59.4; 62.5 | — |
| SECONDARY Percentage of Participants With >=5 Score Improvement From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 64, 76: Period 3 |
20.0; 74.4 | — |
| SECONDARY Change From Baseline in Short Form-36 (SF-36) Mental Component Score (MCS) at Week 12, 24: Observed Cases (OC): Period 1 |
44.23; 5.24; 9.23 | — |
| SECONDARY Change From Baseline in Short Form-36 (SF-36) Mental Component Score (MCS) at Week 32, 48, 64: Observed Cases (OC): Period 2 |
55.06; 5.71; -3.74; 6.36; -3.19; 4.99 | — |
| SECONDARY Change From Baseline in Short Form-36 (SF-36) Mental Component Score (MCS) at Week 64, 76: Observed Cases (OC): Period 3 |
47.95; 0.92; -7.66; 0.46; 8.81; -2.13 | — |
| SECONDARY Change From Baseline in Short Form-36 (SF-36) Mental Component Score (MCS) at Week 12, 24: Last Observation Carried Forward (LOCF): Period 1 |
44.23; 5.24; 8.39 | — |
| SECONDARY 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 |
55.06; 5.71; -3.74; 5.83; -3.99; 5.17 | — |
| SECONDARY Change From Baseline in Short Form-36 (SF-36) Mental Component Score (MCS) at Week 64, 76: Last Observation Carried Forward (LOCF): Period 3 |
47.95; 0.92; -7.66; 0.46; 8.81; -2.13 | — |
| SECONDARY 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 |
52.8; 67.2 | — |
| SECONDARY 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 |
59.2; 54.7; 60.0 | — |
| SECONDARY 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 |
26.7; 64.6 | — |
| SECONDARY 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 |
45.2; 59.7 | — |
| SECONDARY 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 |
48.5; 45.3; 40.0 | — |
| SECONDARY 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 |
6.7; 56.1 | — |
| SECONDARY Change From Baseline in Work Productivity and Activity Impairment (WPAI): Observed Cases (OC): Period 1 |
50.79; -15.19; -21.44; -21.83; -27.58; -35.08 | — |
| SECONDARY Change From Baseline in Work Productivity and Activity Impairment (WPAI): Observed Cases (OC): Period 2 |
10.11; -31.56; 6.87; -31.00; 9.70; -25.71 | — |
| SECONDARY Change From Baseline in Work Productivity and Activity Impairment (WPAI): Observed Cases (OC): Period 3 |
45.37; 8.00; 43.64; 13.00; -26.32; 13.67 | — |
| SECONDARY Change From Baseline in Work Productivity and Activity Impairment (WPAI): Last Observation Carried Forward (LOCF): Period 1 |
50.79; -15.19; -21.25; -20.44; -24.53; -29.93 | — |
| SECONDARY Change From Baseline in Work Productivity and Activity Impairment (WPAI): Last Observation Carried Forward (LOCF): Period 2 |
10.11; -31.56; 6.87; -24.94; 13.41; -19.87 | — |
| SECONDARY Change From Baseline in Work Productivity and Activity Impairment (WPAI): Last Observation Carried Forward (LOCF): Period 3 |
45.37; 8.00; 43.64; 13.00; -25.25; 14.92 | — |
| SECONDARY 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 |
8.48; -6.08 | — |
| SECONDARY 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 |
2.41; -6.04; 2.07; -6.81; 1.45 | — |
| SECONDARY 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 |
3.98; -5.17; -2.00; 4.75; -8.44; -1.41 | — |
| SECONDARY 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 |
8.48; -6.08 | — |
| SECONDARY 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 |
2.41; -6.04; 2.07; -5.96; 0.37 | — |
| SECONDARY 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 |
3.98; -5.17; -2.00; 4.75; -8.44; -1.41 | — |
| SECONDARY Time to Ankylosing Spondylitis Disease Activity Score (ASDAS) Inactive Disease After Re-treatment in Period 3 |
5.1 | — |
| SECONDARY Change From Baseline in Subject Assessment of Disease Activity (SADA) Visual Analogue Scale (VAS): Observed Cases (OC): Period 1 |
6.34; -2.48; -3.06; -3.44; -3.90; -4.72 | — |
| SECONDARY Change From Baseline in Subject Assessment of Disease Activity (SADA) Visual Analogue Scale (VAS): Observed Cases (OC): Period 2 |
0.61; -4.08; 1.46; -3.87; 1.68; -3.62 | — |
| SECONDARY Change From Baseline in Subject Assessment of Disease Activity (SADA) Visual Analogue Scale (VAS): Observed Cases (OC): Period 3 |
6.27; -0.26; 4.95; 0.67; -4.21; 1.63 | — |
| SECONDARY Change From Baseline in Subject Assessment of Disease Activity (SADA) Visual Analogue Scale (VAS): Last Observation Carried Forward (LOCF): Period 1 |
6.34; -2.48; -3.04; -3.35; -3.70; -4.45 | — |
| SECONDARY Change From Baseline in Subject Assessment of Disease Activity (SADA) Visual Analogue Scale (VAS): Last Observation Carried Forward (LOCF): Period 2 |
0.61; -4.08; 1.46; -3.24; 2.27; -2.73 | — |
| SECONDARY Change From Baseline in Subject Assessment of Disease Activity (SADA) Visual Analogue Scale (VAS): Last Observation Carried Forward (LOCF): Period 3 |
6.27; -0.26; 4.95; 0.67; -4.17; 1.66 | — |
| SECONDARY Change From Baseline in Physician Global Assessment (PGA) Visual Analogue Scale (VAS): Observed Cases (OC): Period 1 |
6.07; -2.89; -3.83; -4.16; -4.57; -4.81 | — |
| SECONDARY Change From Baseline in Physician Global Assessment (PGA) Visual Analogue Scale (VAS): Observed Cases (OC): Period 2 |
0.63; -4.65; 0.92; -4.27; 1.33; -3.98 | — |
| SECONDARY Change From Baseline in Physician Global Assessment (PGA) Visual Analogue Scale (VAS): Observed Cases (OC): Period 3 |
4.89; -2.18; 4.52; 1.88; -4.51; 1.06 | — |
| SECONDARY Change From Baseline in Physician Global Assessment (PGA) Visual Analogue Scale (VAS): Last Observation Carried Forward (LOCF): Period 1 |
6.07; -2.89; -3.76; -4.02; -4.32; -4.54 | — |
| SECONDARY Change From Baseline in Physician Global Assessment (PGA) Visual Analogue Scale (VAS): Last Observation Carried Forward (LOCF): Period 2 |
0.63; -4.65; 0.92; -3.91; 1.64; -3.31 | — |
| SECONDARY Change From Baseline in Physician Global Assessment (PGA) Visual Analogue Scale (VAS): Last Observation Carried Forward (LOCF): Period 3 |
4.89; -2.18; 4.52; 1.88; -4.46; 1.12 | — |
| SECONDARY Change From Baseline in Bath Ankylosing Spondylitis Global Index (BAS-G) Score at Week 12, 24: Last Observation Carried Forward (LOCF): Period 1 |
6.48; -2.58; -3.95 | — |
| SECONDARY Change From Baseline in Bath Ankylosing Spondylitis Global Index (BAS-G) Score) at Week 32, 48, 64: Last Observation Carried Forward (LOCF): Period 2 |
1.39; -3.78; 1.10; -3.04; 1.84; -2.64 | — |
| SECONDARY Change From Baseline in Bath Ankylosing Spondylitis Global Index (BAS-G) Score at Week 64, 76: Last Observation Carried Forward (LOCF): Period 3 |
4.74; -2.23; 2.94; 0.83; -4.35; 0.57 | — |
| SECONDARY Change From Baseline in Bath Ankylosing Spondylitis Global Index (BAS-G) Score at Week 12, 24: Observed Cases (OC): Period 1 |
6.48; -2.58; -4.11 | — |
| SECONDARY Change From Baseline in Bath Ankylosing Spondylitis Global Index (BAS-G) Score) at Week 32, 48, 64: Observed Cases (OC): Period 2 |
1.39; -3.78; 1.10; -3.54; 1.44; -3.52 | — |
| SECONDARY Change From Baseline in Bath Ankylosing Spondylitis Global Index (BAS-G) Score at Week 64, 76: Observed Cases (OC): Period 3 |
4.74; -2.23; 2.94; 0.83; -4.35; 0.57 | — |
| SECONDARY Change From Baseline in Number of Swollen Joint Count at Week 12, 24: Observed Cases (OC): Period 1 |
2.32; -1.72; -1.85 | — |
| SECONDARY Change From Baseline in Number of Swollen Joint Count at Week 32, 48, 64: Observed Cases (OC): Period 2 |
0.95; -2.69; 0.46; -1.64; -0.59; -0.82 | — |
| SECONDARY Change From Baseline in Number of Swollen Joint Count at Week 64, 76: Observed Cases (OC): Period 3 |
1.19; -0.67; 1.17; 0.33; -2.50; 0.50 | — |
| SECONDARY Change From Baseline in Number of Swollen Joint Count at Week 12, 24: Last Observation Carried Forward (LOCF): Period 1 |
2.32; -1.72; -1.92 | — |
| SECONDARY Change From Baseline in Number of Swollen Joint Count at Week 32, 48, 64: Last Observation Carried Forward (LOCF): Period 2 |
0.95; -2.69; 0.46; -2.24; -0.02; -2.00 | — |
| SECONDARY Change From Baseline in Number of Swollen Joint Count at Week 64, 76 : Last Observation Carried Forward (LOCF): Period 3 |
1.19; -0.67; 1.17; 0.33; -2.32; 0.53 | — |
| SECONDARY Change From Baseline in Number of Tender Joint Count at Week 12, 24: Observed Cases (OC): Period 1 |
5.96; -2.82; -3.67 | — |
| SECONDARY Change From Baseline in Number of Tender Joint Count at Week 32, 48, 64: Observed Cases (OC): Period 2 |
2.70; -3.27; 0.61; -2.68; -0.73; -2.27 | — |
| SECONDARY Change From Baseline in Number of Tender Joint Count at Week 64, 76: : Observed Cases (OC): Period 3 |
3.60; -0.17; 0.33; 0.00; -3.56; 0.06 | — |
| SECONDARY Change From Baseline in Number of Tender Joint Count at Week 12, 24: Last Observation Carried Forward (LOCF): Period 1 |
5.96; -2.82; -3.15 | — |
| SECONDARY Change From Baseline in Number of Tender Joint Count at Week 32, 48, 64: Last Observation Carried Forward (LOCF): Period 2 |
2.70; -3.27; 0.61; -2.88; -0.05; -2.72 | — |
| SECONDARY Change From Baseline in Number of Tender Joint Count at Week 64, 76: Last Observation Carried Forward (LOCF): Period 3 |
3.60; -0.17; 0.33; 0.00; -3.32; 0.11 | — |
| SECONDARY Change From Baseline in Dactylitis Total Score at Week 12, 24: Observed Cases (OC): Period 1 |
0.42; -0.27; -0.30 | — |
| SECONDARY Change From Baseline in Dactylitis Total Score at Week 32, 48, 64: Observed Cases (OC): Period 2 |
0.02; -0.42; 0.01; -0.36; 0.09; -0.57 | — |
| SECONDARY Change From Baseline in Dactylitis Total Score at Week 64, 76: Observed Cases (OC): Period 3 |
0.08; -0.33; 0.20; 0.25; -0.50; 0.00 | — |
| SECONDARY Change From Baseline in Dactylitis Total Score at Week 12, 24: Last Observation Carried Forward (LOCF): Period 1 |
0.42; -0.27; -0.28 | — |
| SECONDARY Change From Baseline in Dactylitis Total Score at Week 32, 48, 64: Last Observation Carried Forward (LOCF): Period 2 |
0.02; -0.42; 0.01; -0.36; 0.06; -0.39 | — |
| SECONDARY Change From Baseline in Dactylitis Total Score at Week 64, 76: Last Observation Carried Forward (LOCF): Period 3 |
0.08; -0.33; 0.20; 0.25; -0.50; 0.00 | — |
| SECONDARY Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) at Week 12, 24: Observed Cases (OC) : Period 1 |
2.86; -1.22; -1.59 | — |
| SECONDARY Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) at Week 32, 48, 64: Observed Cases (OC): Period 2 |
0.36; -1.06; 0.71; -1.50; 0.32; -1.37 | — |
| SECONDARY Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) at Week 64, 76: Observed Cases (OC): Period 3 |
1.48; -1.13; 0.67; 0.14; -1.86; -0.06 | — |
| SECONDARY Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) at Week 12, 24: Last Observation Carried Forward (LOCF): Period 1 |
2.86; -1.22; -1.55 | — |
| SECONDARY Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) at Week 32, 48, 64: Last Observation Carried Forward (LOCF): Period 2 |
0.36; -1.06; 0.71; -1.13; 0.62; -1.00 | — |
| SECONDARY Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) at Week 64, 76: Last Observation Carried Forward (LOCF): Period 3 |
1.48; -1.13; 0.67; 0.14; -1.86; -0.06 | — |
| SECONDARY Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) |
147; 37; 29; 6; 1; 0 | — |
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
Data sourced from ClinicalTrials.gov (NCT02509026) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.