Reduction of signs and symptoms in patients with moderate to severely early axial
spondyloarthritis (without radiological sacroiliitis) who have had an inadequate response to
or do not tolerate NSAID therapy.
Study Objectives:Efficacy -To assess whether patients with moderate to severely active early
axial spondyloarthritis (without radiological sacroiliitis) will show response when
adalimumab is added to the pre-existing or in case of intolerance to NSAID therapy. Response
will be measured at week 12 by change of efficacy parameters compared to baseline.Safety - To
demonstrate the safety of adalimumab in study patients with moderate to severely active early
axial spondyloarthritis (without radiological sacroiliitis) in patients who have had an
inadequate response to or do not tolerate NSAID therapy.