Axial Spondyloarthritis
Conditions
Brief summary
1. Incidence of treatment-emergent adverse events (TEAEs) during the study 2. Incidence of serious adverse events (SAEs) during the study 3. Treatment-emergent adverse events (TEAEs) leading to withdrawal from the study
Detailed description
1. Assessment of SpondyloArthritis International Society 40% response criteria (ASAS40) response at Week 28, 2. Assessment of SpondyloArthritis International Society 40% response criteria (ASAS40) response at Week 52, 3. Assessment of SpondyloArthritis International Society 40% response criteria (ASAS40) response at Week 112, 4. Assessment of SpondyloArthritis International Society 20% response criteria (ASAS20) response at Week 28, 5. Assessment of SpondyloArthritis International Society 20% response criteria (ASAS20) response at Week 52, 6. Assessment of SpondyloArthritis International Society 20% response criteria (ASAS20) response at Week 112, 7. Change from Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 28, 8. Change from Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 52, 9. Change from Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 112, 10. Assessment of SpondyloArthritis International Society partial remission (ASAS-PR) at Week 28, 11. Assessment of SpondyloArthritis International Society partial remission (ASAS-PR) at Week 52, 12. Assessment of SpondyloArthritis International Society partial remission (ASAS-PR) at Week 112, 13. Assessment of Ankylosing Spondylitis Disease Activity Score-C-reactive protein (ASDAS-CRP) at Week 28, 14. Assessment of Ankylosing Spondylitis Disease Activity Score-C-reactive protein (ASDAS-CRP) at Week 52, 15. Assessment of Ankylosing Spondylitis Disease Activity Score-C-reactive protein (ASDAS-CRP) at Week 112, 16. Assessment of SpondyloArthritis International Society (ASAS) 5/6 response at Week 28, 17. Assessment of SpondyloArthritis International Society (ASAS) 5/6 response at Week 52, 18. Assessment of SpondyloArthritis International Society (ASAS) 5/6 response at Week 112, 19. Change from Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 28, 20. Change from Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 52, 21. Change from Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 112, 22. Change from Baseline in Nocturnal Spinal Pain Numeric Rating Scale (NRS) at Week 28, 23. Change from Baseline in Nocturnal Spinal Pain Numeric Rating Scale (NRS) at Week 52, 24. Change from Baseline in Nocturnal Spinal Pain Numeric Rating Scale (NRS) at Week 112, 25. Change from Baseline in Ankylosing Spondylitis Quality of Life (ASQoL) at Week 28, 26. Change from Baseline in Ankylosing Spondylitis Quality of Life (ASQoL) at Week 52, 27. Change from Baseline in Ankylosing Spondylitis Quality of Life (ASQoL) at Week 112, 28. Change from Baseline in the Short Form 36-Item Health Survey (SF-36) physical component summary (PCS) at Week 28, 29. Change from Baseline in the Short Form 36-Item Health Survey (SF-36) physical component summary (PCS) at Week 52, 30. Change from Baseline in the Short Form 36-Item Health Survey (SF-36) physical component summary (PCS) at Week 112, 31. Change from Baseline in Bath Ankylosing Spondylitis Disease Metrology Index (BASMI) at Week 28, 32. Change from Baseline in Bath Ankylosing Spondylitis Disease Metrology Index (BASMI) at Week 52, 33. Change from Baseline in Bath Ankylosing Spondylitis Disease Metrology Index (BASMI) at Week 112, 34. Change from Baseline in the Maastricht Ankylosing Spondylitis Enthesitis (MASES) Index at Week 28, 35. Change from Baseline in the Maastricht Ankylosing Spondylitis Enthesitis (MASES) Index at Week 52, 36. Change from Baseline in the Maastricht Ankylosing Spondylitis Enthesitis (MASES) Index at Week 112
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Incidence of treatment-emergent adverse events (TEAEs) during the study 2. Incidence of serious adverse events (SAEs) during the study 3. Treatment-emergent adverse events (TEAEs) leading to withdrawal from the study | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Assessment of SpondyloArthritis International Society 40% response criteria (ASAS40) response at Week 28, 2. Assessment of SpondyloArthritis International Society 40% response criteria (ASAS40) response at Week 52, 3. Assessment of SpondyloArthritis International Society 40% response criteria (ASAS40) response at Week 112, 4. Assessment of SpondyloArthritis International Society 20% response criteria (ASAS20) response at Week 28, 5. Assessment of SpondyloArthritis International Society 20% response criteria (ASAS20) response at Week 52, 6. Assessment of SpondyloArthritis International Society 20% response criteria (ASAS20) response at Week 112, 7. Change from Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 28, 8. Change from Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 52, 9. Change from Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 112, 1 | — |
Countries
Belgium, Czechia, France, Germany, Hungary, Poland, Spain