Phase 3
N=192
Study of Adalimumab in Patients With Axial Spondyloarthritis
Axial Spondyloarthritis
Bottom Line
View on ClinicalTrials.gov: NCT00939003 ↗Enrolled (actual)
192
Serious AEs
9.7%
Results posted
Mar 2012
Primary outcome: Primary: Number of Participants Achieving an Assessment of Spondyloarthritis International Society (ASAS) 40 Response — 14; 33 participants — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Adalimumab (Biological); Placebo (Biological); Open-label Adalimumab (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- AbbVie (prior sponsor, Abbott)
- Primary completion
- Feb 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Achieving an Assessment of Spondyloarthritis International Society (ASAS) 40 Response |
14; 33 | <0.001 sig |
| SECONDARY Number of Participants Achieving an Assessment of Spondyloarthritis International Society (ASAS) 20 Response |
29; 47 | 0.004 sig |
| SECONDARY Number of Participants Achieving a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 Response |
14; 32 | 0.001 sig |
| SECONDARY Change From Baseline in Short Form-36 (SF-36) Physical Component Summary Score |
2.0; 5.5 | 0.001 sig |
| SECONDARY Number of Participants Achieving ASAS Partial Remission |
5; 15 | 0.014 sig |
| SECONDARY Number of Participants Achieving an ASAS5/6 Response |
6; 28 | <0.001 sig |
| SECONDARY Change From Baseline in Disability Index of Health Assessment Questionnaire Modified for the Spondyloarthropathies (HAQ-S) |
-0.1; -0.3 | 0.027 sig |
| SECONDARY Change From Baseline in High-Sensitivity C-Reactive Protein (hsCRP) |
-0.3; -4.7 | <0.001 sig |
| SECONDARY Change From Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Magnetic Resonance Imaging (MRI) Score for Sacroiliac Joints |
-0.6; -3.2 | 0.003 sig |
| SECONDARY Change From Baseline in SPARCC MRI Score for the Spine |
-0.2; -1.8 | 0.001 sig |
Summary
This study will evaluate how well adalimumab works in the short and long term in patients with axial spondyloarthritis who are not diagnosed as having either ankylosing spondylitis or psoriatic arthritis.
Eligibility Criteria
Inclusion Criteria
- Adult patients with inadequate response to >/= 1 non-steroidal anti-inflammatory drugs (NSAIDs)
- Chronic back pain with onset < 45 years of age
- Magnetic resonance imaging (MRI) indicating active sacroiliitis or positive human leukocyte antigen-B27 (HLA-B27) blood test in addition to meeting spondyloarthritis clinical criteria
- Negative purified protein derivative (PPD) test and chest x-ray performed at Baseline visit must be negative
- Ability to administer subcutaneous injections
- General good health otherwise
Exclusion Criteria
- Prior anti-tumor necrosis factor (TNF) therapy
- Psoriasis or psoriatic arthritis
- Fulfillment of modified New York criteria for ankylosing spondylitis
- Recent infection requiring treatment
- Significant medical events or conditions that may put patients at risk for participation
- Females who are pregnant or breast-feeding or considering becoming pregnant during the study
- History of cancer, except successfully treated skin cancer
- Recent history of drug or alcohol abuse
Data sourced from ClinicalTrials.gov (NCT00939003). 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.