Phase 3
N=490
Study of Apremilast to Treat Subjects With Active Ankylosing Spondylitis
Ankylosing Spondyloarthritis
Bottom Line
View on ClinicalTrials.gov: NCT01583374 ↗Enrolled (actual)
490
Serious AEs
6.9%
Results posted
Mar 2015
Primary outcome: Primary: Percentage of Participants Who Achieved an Assessment of SpondyloArthritis International Society 20 (ASAS 20) Response at Week 16 — 36.6; 35.0; 32.5 Percentage of Participants — p=0.4383
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Apremilast tablet 20 mg (Drug); Apremilast tablet 30 mg BID (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Amgen
- Primary completion
- Feb 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Who Achieved an Assessment of SpondyloArthritis International Society 20 (ASAS 20) Response at Week 16 |
36.6; 35.0; 32.5 | 0.4383 |
| SECONDARY Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 24 |
-0.94; -1.11; -0.99 | 0.8032 |
| SECONDARY Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 24 |
-1.21; -1.30; -1.18 | 0.8618 |
| SECONDARY Percentage of Participants Who Achieved an Assessment of SpondyloArthritis International Society 20 (ASAS) Response at Week 24 |
31.7; 36.2; 33.7 | 0.6958 |
| SECONDARY Change From Baseline in the Ankylosing Spondylitis Quality of Life (ASQoL) Summary Score at Week 24 |
-1.77; -1.50; -1.52 | 0.5126 |
| SECONDARY Change From Baseline in the Physical Component Summary Score (PCS) of Medical Outcome Study Short Form 36-Item Health Survey, Version 2 (SF-36) at Week 24 |
3.50; 3.46; 3.79 | 0.6997 |
| SECONDARY Change From Baseline in Bath Ankylosing Spondylitis Metrology Index-Linear (BASMI-Linear) at Week 24 |
-0.19; -0.16; -0.13 | 0.3307 |
| SECONDARY Change From Baseline in the Radiographic Score Using the Modified Stoke Ankylosing Spondylitis Spine Score (m-SASSS) at Week 104 and Week 260 |
0.99; 0.65; 0.98; 0.82; 1.12; 3.14 | — |
| SECONDARY Number of Participants With Treatment Emergent Adverse Events (TEAEs) During the Placebo Controlled Phase |
83; 91; 88; 24; 44; 51 | — |
| SECONDARY Number of Participants With Treatment Emergent Adverse Events During the Apremilast Exposure Period |
114; 47; 239; 5; 8; 23 | — |
Summary
Apremilast is a new, orally available, small molecule drug that specifically inhibits phosphodiesterase 4 (PDE4), an enzyme that modulates inflammatory cytokines. This clinical study tests whether apremilast can improve the signs and symptoms of ankylosing spondylitis.
Eligibility Criteria
Inclusion Criteria
- Must have a documented diagnosis of ankylosing spondylitis as defined by low back pain and stiffness, which improves with exercise, but is not relieved by rest for more than 3 months prior to screening. At the completion of screening procedures, a documented diagnosis of definite active AS, as defined by the modified New York criteria (1984) whereby both criteria, at least 1 radiographic criterion and at least 1 clinical criterion, must be met
- Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) is ≥ 4
- Total back pain is ≥ 4
- On stable dose of AS medication (or lack of medication) prior to randomization and through week 24
Exclusion Criteria
- Prior treatment with a Tumor Necrosis Factor (TNF) blocker and any biologic treatment for AS
Data sourced from ClinicalTrials.gov (NCT01583374). 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.