N/A
Completed N=84
Defining Remission With Etanercept in AS in Real Life Clinical Practice
Source: ClinicalTrials.gov NCT02202850 ↗Enrolled (actual)
84
Serious AEs
3.6%
Results posted
Nov 2018
Primary outcomePrimary: Percentage of Participants Who Achieved Assessment of SpondyloArthritis International Society (ASAS) Partial Remission at Month 6 and Maintained Till Month 12 — 14.7; 0.0 percentage of participants
Summary
Determine which remission criterion at Month 6 predicts remission at Month 12 the best.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Who Achieved Assessment of SpondyloArthritis International Society (ASAS) Partial Remission at Month 6 and Maintained Till Month 12 |
14.7; 0.0 | — |
| PRIMARY Percentage of Participants Who Achieved Assessment of SpondyloArthritis International Society (ASAS) 5/6 Remission Criteria at Month 6 and Maintained Till Month 12 |
43.3; 60.0 | — |
| PRIMARY Percentage of Participants Who Achieved Assessment of SpondyloArthritis International Society (ASAS) 60 Remission Criteria at Month 6 and Maintained Till Month 12 |
29.4; 0.0 | — |
| PRIMARY Percentage of Participants Who Achieved Assessment of SpondyloArthritis International Society (ASAS) 40 Remission Criteria at Month 6 and Maintained Till Month 12 |
32.4; 20.0 | — |
| PRIMARY Percentage of Participants Who Achieved the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 Remission Criteria at Month 6 and Maintained Till Month 12 |
27.8; 0.0 | — |
| PRIMARY Percentage of Participants Who Achieved the Ankylosing Spondylitis Disease Activity Score Based on C-Reactive Protein (ASDAS-CRP) Remission Criteria at Month 6 and Maintained Till Month 12 |
10.7; 0.0 | — |
| PRIMARY Percentage of Participants Who Achieved the Ankylosing Spondylitis Disease Activity Score Based on Erythrocyte Sedimentation Rate (ASDAS-ESR) Remission Criteria at Month 6 and Maintained Till Month 12 |
15.0; 0.0 | — |
| SECONDARY Percentage of Participants Who Achieved Assessment of SpondyloArthritis International Society (ASAS) Partial Remission Criteria at Month 3, 6, 9 and 12 |
12.5; 0.0; 17.7; 0.0; 16.7; 0.0 | — |
| SECONDARY Percentage of Participants Who Achieved Assessment of SpondyloArthritis International Society (ASAS) 5/6 Remission Criteria at Month 3, 6, 9 and 12 |
51.4; 20.0; 46.7; 60.0; 57.7; 33.3 | — |
| SECONDARY Percentage of Participants Who Achieved Assessment of SpondyloArthritis International Society (ASAS) 60 Remission Criteria at Month 3, 6, 9 and 12 |
30.0; 0.0; 32.4; 0.0; 33.3; 0.0 | — |
| SECONDARY Percentage of Participants Who Achieved Assessment of SpondyloArthritis International Society (ASAS) 40 Remission Criteria at Month 3, 6, 9 and 12 |
37.5; 28.6; 41.2; 20.0; 46.7; 16.7 | — |
| SECONDARY Percentage of Participants Who Achieved the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 Remission Criteria at Month 3, 6, 9 and 12 |
41.5; 14.3; 30.6; 0.0; 45.2; 0.0 | — |
| SECONDARY Percentage of Participants Who Achieved the Ankylosing Spondylitis Disease Activity Score Based on C-Reactive Protein (ASDAS-CRP) Remission Criteria at Month 3, 6, 9 and 12 |
24.2; 0.0; 17.9; 0.0; 26.1; 0.0 | — |
| SECONDARY Percentage of Participants Who Achieved the Ankylosing Spondylitis Disease Activity Score Based on Erythrocyte Sedimentation Rate (ASDAS-ESR) Remission Criteria at Month 3, 6, 9 and 12 |
16.0; 0.0; 20.0; 0.0; 15.4; 0.0 | — |
| SECONDARY Change From Baseline in Participant Global Assessment (PGA) Score at Month 6 and 12 |
7.61; 7.63; 3.62; 2.60; 3.43; 3.00 | — |
| SECONDARY Change From Baseline in Pain Score of Ankylosing Spondylitis at Month 6 and 12 |
6.40; 7.00; 2.15; 1.70; 2.60; 2.81 | — |
| SECONDARY Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) Score at Month 6 and 12 |
5.90; 7.34; 2.07; 1.90; 2.15; 2.39 | — |
| SECONDARY Change From Baseline in Inflammation Score of Ankylosing Spondylitis at Month 6 and 12 |
5.98; 6.81; 2.71; 3.40; 3.07; 2.50 | — |
| SECONDARY Change From Baseline in C-Reactive Protein (CRP) at Month 6 and 12 |
14.49; 6.06; 1.45; 5.04; 11.50; -2.03 | — |
| SECONDARY Change From Baseline in Spinal Mobility Measurement at Month 6 and 12 |
10.04; 10.80; -3.13; -0.83; -3.73; 1.08 | — |
| SECONDARY Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Month 6 and 12 |
6.45; 7.14; 2.16; 2.16; 2.62; 2.48 | — |
| SECONDARY Change From Baseline in Ankylosing Spondylitis Disease Activity Score Based on C-Reactive Protein (ASDAS-CRP) at Month 6 and 12 |
3.73; 3.54; 1.44; 1.54; 1.70; 1.17 | — |
| SECONDARY Change From Baseline in Ankylosing Spondylitis Disease Activity Score Based on Erythrocyte Sedimentation Rate (ASDAS-ESR) at Month 6 and 12 |
3.25; 3.51; 1.17; 1.11; 1.18; 1.25 | — |
Eligibility Criteria
Inclusion Criteria
- Patients with AS who start treatment with Etanercept according to prevailing reimbursement criteria and dosing in line with SmPC.
- First cohort: Etanercept is the first biological product prescribed
- Second cohort: Etanercept is the second biological product prescribed
- Capable of understanding and willing to provide signed and dated written, voluntary informed consent before any protocol-specific procedures are performed.
- 18 years of age or older at time of consent
- Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study.
Exclusion Criteria
- History of or current psychiatric illness that would interfere with the subject's ability to comply with protocol requirements or to give informed consent.
Data sourced from ClinicalTrials.gov (NCT02202850). 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.