Phase 4
N=90
A Study to Evaluate the NSAIDS Sparing Effect of Etanercept in Subjects With Axial Spondyloarthritis
Axial Spondyloarthritis
Bottom Line
View on ClinicalTrials.gov: NCT01298531 ↗Enrolled (actual)
90
Serious AEs
3.3%
Results posted
Jul 2014
Primary outcome: Primary: Change From Baseline in Non Steroidal Anti Inflammatory Drug (NSAID) Assessment of the SpondyloArthritis International Society (ASAS) Score at Week 8. — -63.90; -36.63 Scores on a scale — p=0.0019
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- etanercept (Drug); placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Jan 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Non Steroidal Anti Inflammatory Drug (NSAID) Assessment of the SpondyloArthritis International Society (ASAS) Score at Week 8. |
-63.90; -36.63 | 0.0019 sig |
| SECONDARY Total NSAID ASAS [Area Under Curve (AUC)] Score From Baseline to Week 8. |
45.24; 65.02 | 0.0115 sig |
| SECONDARY Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 4. |
-1.50; -0.56 | 0.0153 sig |
| SECONDARY Change From Baseline in BASDAI at Week 8 |
-2.01; -1.13 | 0.0510 |
| SECONDARY Change From Baseline in BASDAI Score at Weeks 12 and 16. |
-2.5; -2.6; -2.6; -3.0 | — |
| SECONDARY Number of Participants Using NSAIDs at Week 8. |
17; 32 | 0.0066 sig |
| SECONDARY Change From Baseline in Mini BASDAI at Week 8 (AUC). |
275.68; 329.37 | 0.0053 sig |
| SECONDARY Number of Participants Achieved BASDAI 50 at Week 8. |
16; 8 | 0.0324 sig |
| SECONDARY Number of Participants Achieved BASDAI 50 at Weeks 4, 12 and 16. |
10; 3; 17; 19; 15; 18 | — |
| SECONDARY Number of Participants Achieving ASAS 20 (Assessment of the Spondylo Arthritis International Society 20) at Weeks 4, 12 and 16 |
14; 5; 17; 21; 18; 23 | — |
| SECONDARY Number of Participants Achieving ASAS 20 at Week 8 |
16; 10 | 0.0501 |
| SECONDARY Number of Participants Achieving ASAS 40 at Weeks 4, 12 and 16. |
9; 3; 17; 20; 16; 20 | — |
| SECONDARY Number of Participants Achieving ASAS 40 at Week 8 |
16; 9 | 0.0284 sig |
| SECONDARY Number of Participants Achieving ASAS 70 at Weeks 4, 12 and 16. |
2; 1; 8; 7; 5; 11 | — |
| SECONDARY Number of Participants Achieving ASAS 70 at Week 8 |
5; 3 | 0.3291 |
| SECONDARY Change From Baseline in ASDAS CRP (Ankylosing Spondylitis Disease Activity Score-C Reactive Protein) Score at Week 4. |
-0.94; -0.16 | <0.0001 sig |
| SECONDARY Change From Baseline in ASDAS CRP Score at Week 8. |
-1.21; -0.53 | 0.0011 sig |
| SECONDARY Change From Baseline in ASDAS CRP Score at Weeks 12 and 16. |
-1.4; -1.2; -1.6; -1.5 | — |
| SECONDARY Change From Baseline in ASDAS ESR (Ankylosing Spondylitis Disease Activity Score-Erythrocyte Sedimentation Rate) Score at Week 4. |
-0.76; -0.19 | 0.0011 sig |
| SECONDARY Change From Baseline in ASDAS ESR Score at Week 8. |
-1.05; -0.38 | 0.0037 sig |
| SECONDARY Change From Baseline in ASDAS ESR Score at Weeks 12 and 16. |
-1.0; -1.0; -1.3; -1.3 | — |
| SECONDARY Change in NSAID ASAS Score From Baseline to Week 16 (ETN Arm Only) |
-65.93 | — |
| SECONDARY Change in NSAID ASAS Score From Week 8 to Week 16 (Placebo Only) |
-39.22 | — |
| SECONDARY Change From Baseline in BASDAI Level of Morning Stiffness-related Scores at Week 8 |
-2.74; -1.59 | 0.0344 sig |
Summary
This study will compare the Non Steroidal Anti-Inflammatory Drugs (NSAIDs) sparing effect of etanercept with that of placebo in adult subjects with axial Spondyloarthritis.
Eligibility Criteria
Inclusion Criteria
- Male and female subjects aged 18 years and over at the time of consent to the study.
- Diagnosis of SpA, as defined by the ASAS criteria for axial SpA
- Axial involvement refractory to previous or current intake of NSAIDs, defined as at least 2 NSAIDs at maximum tolerated dose determined from past medical history taken for a duration of > 1 month (for both NSAIDs combined) before the Screening visit.
- Active axial involvement defined by mini BASDAI
Exclusion Criteria
- Subjects who are investigational site staff members or subjects who are Pfizer employees directly involved in the conduct of the trial.
- Subjects who have received any previous treatment with etanercept or other TNFα inhibitors or biologic agents.
- Subjects with a known or expected allergy, contraindication, or hypersensitivity to etanercept or its excipients.
Data sourced from ClinicalTrials.gov (NCT01298531). 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.