N/A
Completed N=1,685
Study Evaluating The Use Of Etanercept In Patients With Ankylosing Spondylitis
Source: ClinicalTrials.gov NCT00544557 ↗Enrolled (actual)
1,685
Serious AEs
7.6%
Results posted
May 2015
Primary outcomePrimary: Percentage of Participants Achieving Partial Remission at Week 26 — 19.0 percentage of participants
Summary
This study aims to provide a holistic assessment of patients receiving etanercept in a real-world setting.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Achieving Partial Remission at Week 26 |
19.0 | — |
| PRIMARY Percentage of Participants Achieving Partial Remission at Week 52 |
23.0 | — |
| SECONDARY Percentage of Participants With Serious Adverse Events (SAEs) or Adverse Events (AEs) |
7.6; 38.2 | — |
| SECONDARY Percentage of Participants With Serious Adverse Events (SAEs) or Adverse Events (AEs) by Co-morbidity |
NA; NA | — |
| SECONDARY Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 52 |
5.327; -2.199 | — |
| SECONDARY Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 52 |
4.9; -1.7 | — |
| SECONDARY Change From Baseline in Occiput-to-Wall Distance at Week 52 |
6.7; -0.7 | — |
| SECONDARY Change From Baseline in Lateral Lumbar Flexion at Week 52 |
11.8; 1.0 | — |
| SECONDARY Change From Baseline in Patient's Global Assessment (PtGA) of Pain at Week 52 |
6.5; -3.0 | — |
| SECONDARY Change From Baseline in Patient Global Assessment (PtGA) of Disease Activity at Week 52 |
6.2; -3.1 | — |
| SECONDARY Change From Baseline in Physician Global Assessment (PGA) of Disease Activity at Week 52 |
6.4; -4.2 | — |
| SECONDARY Change From Baseline in Duration of Morning Stiffness at Week 52 |
58.6; -37.0 | — |
| SECONDARY Percentage of Participants With Significant Reduction of Morning Stiffness |
51.6; 62.1; 67.2; 68.0; 69.8; 70.6 | — |
| SECONDARY Percentage of Participants With Presence of Peripheral Arthritis |
36.8; 26.0; 22.0; 18.2; 16.7; 14.6 | — |
| SECONDARY Change From Baseline in Number of Affected Joints by Peripheral Arthritis at Week 52 |
2.2; -1.3 | — |
| SECONDARY Percentage of Participants With Presence of Enthesitis |
20.6; 14.7; 11.5; 9.5; 8.5; 7.4 | — |
| SECONDARY Change From Baseline in Number of Affected Body Parts by Enthesitis at Week 52 |
0.6; -0.4 | — |
| SECONDARY Change From Baseline in C-Reactive Protein (CRP) at Week 52 |
2.6; -1.6 | — |
| SECONDARY Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Week 52 |
26.9; -14.2 | — |
| SECONDARY Percentage of Participants With Assessment in Ankylosing Spondylitis 20 (ASAS-20) Response |
60.6; 61.6; 63.1; 63.7 | — |
| SECONDARY Percentage of Participants With Assessment in Ankylosing Spondylitis 40 (ASAS-40) Response |
44.1; 46.7; 48.6; 51.0 | — |
| SECONDARY Euro Quality of Life-5 Dimensions (EQ-5D) Time Trade Off (TTO) |
0.58; 0.80; 0.82 | — |
| SECONDARY Euro Quality of Life (EQ--5D)- Visual Analog Scale (VAS) |
54.3; 71.9; 74.2 | — |
| SECONDARY Work Productivity and Activity Impairment - Special Health Problems (WPAI:SHP) |
21.9; 48.3; 52.9; 58.1; 6.6; 27.3 | — |
| SECONDARY Healthcare Resource Utilization |
4.7; 3.7; 1.6; 0.3; 0.2; 0.0 | — |
| SECONDARY Duration of Healthcare Resources Utilization |
3.7; 3.1; 0.9; 2.0; 1.5; 0.1 | — |
| SECONDARY Percentage of Participants With Prior or Concomitant Medication Use for Treatment of Ankylosing Spondylitis |
38.4; 98.6 | — |
| SECONDARY Percentage of Participants With Discontinuation of Treatment Due to Adverse Events |
11.8 | — |
Eligibility Criteria
Inclusion Criteria
- Diagnosis of ankylosing spondylitis (AS)
Exclusion Criteria
- Hypersensitivity to etanercept
- Active infection including chronic or localised infection
- Sepsis or risk of sepsis
Data sourced from ClinicalTrials.gov (NCT00544557). 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.