Phase 3
N=165
Study of Adalimumab in Participants With Peripheral Spondyloarthritis (SpA)
Peripheral Spondyloarthritis
Bottom Line
View on ClinicalTrials.gov: NCT01064856 ↗Enrolled (actual)
165
Serious AEs
7.9%
Results posted
Nov 2016
Primary outcome: Primary: Percentage of Responders According to the Composite Peripheral SpA Response Criteria (PSpARC 40) at Week 12 — 39.3; 19.8; 60.7; 80.2 percentage of participants — p=0.006
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Adalimumab (Biological); Placebo (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- AbbVie (prior sponsor, Abbott)
- Primary completion
- Aug 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Responders According to the Composite Peripheral SpA Response Criteria (PSpARC 40) at Week 12 |
39.3; 19.8; 60.7; 80.2 | 0.006 sig |
| PRIMARY Number of Participants With Adverse Events |
47; 45; 1; 1; 3; 0 | — |
| SECONDARY Change From Baseline in Physician Global Assessment (PGA) of Disease Activity at Week 12 |
-32.2; -18.2 | <0.001 sig |
| SECONDARY Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 12 |
-2.1; -1 | 0.003 sig |
| SECONDARY Change From Baseline in Health Assessment Questionnaire Modified for the Spondyloarthropathies (HAQ-S) Total at Week 12 |
-0.3; -0.2 | 0.051 |
| SECONDARY Change From Baseline in Short Form-36 Health Status Survey™ Version 2 (SF-36™V2) Physical Component Score (PCS) at Week 12 |
6.7; 2.4 | — |
| SECONDARY Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) at Week 12 |
-1.2; -0.8 | — |
| SECONDARY Change From Baseline in Leeds Enthesitis Index at Week 12 |
-0.8; -0.1 | — |
| SECONDARY Change From Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Score at Week 12 |
-1.7; -0.7 | — |
| SECONDARY Change From Baseline in Dactylitis at Week 12 |
-0.2; 0.3 | — |
| SECONDARY Change From Baseline in Tender Joint Count (TJC) at Week 12 |
-5.9; -1.8 | — |
| SECONDARY Change From Baseline in Swollen Joint Count (SJC) at Week 12 |
-3.6; -3.1 | — |
| SECONDARY Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) at Week 12 |
-1.0; -0.5 | — |
Summary
The objective of this study was to evaluate the efficacy and safety of adalimumab 40 mg administered every other week (eow) subcutaneously (SC) compared to placebo for 12 weeks followed by open label (OL) safety and efficacy assessments in participants with non-ankylosing spondylitis (AS), non-psoriatic arthritis (PsA) active peripheral spondyloarthritis (SpA) who have had an inadequate response to >= 2 non-steroidal anti-inflammatory drugs (NSAIDs), or are intolerant to, or have a contraindication for, NSAIDs.
Eligibility Criteria
Inclusion Criteria
- Adult participants who had inadequate response to >= 2 non-steroidal anti-inflammatories (NSAIDs)
- Participants who had arthritis or enthesitis or dactylitis plus: met spondyloarthritis clinical criteria
- Negative purified protein derivative (PPD) test and Chest X-Ray performed at Baseline Visit were Negative
- Ability to administer subcutaneous injections
- General good health
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 had put patients at risk for participation
- Female participants who were 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 (NCT01064856). 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.