At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 192 enrolled
Drug / intervention
Adalimumab +2 morebiological
Likely dose
Adalimumab 40 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multicenter Study of the Efficacy and Safety of the Human Anti-TNF Monoclonal Antibody Adalimumab in Subjects With Axial Spondyloarthritis
In Brief
A Phase 3 clinical trial evaluating Adalimumab, Placebo, and 1 other intervention for Axial Spondyloarthritis. Completed, enrolled 192 participants across 38 sites in 10 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAxial Spondyloarthritis
CountriesAustralia, Belgium, Canada, Czechia, France, Germany, Netherlands, Spain, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartJul 2009
First PostedJul 2009
Primary CompletionFeb 2011
Study CompletionAug 2013
TodayJul 2026
First PostedJul 14, 2009
Enrollment StartJul 1, 2009
Primary CompletionFeb 1, 2011
Study CompletionAug 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 17.0 years ago
Interventions
Adalimumabbiological
40 mg every other week up to Week 12
Placebobiological
Placebo every other week up to Week 12
Open-label Adalimumabbiological
40 mg every other week, Week 12 through Week 156