D2E7-Early AS

Sponsor
Charite University, Berlin, Germany
Study ID
NCT00235105
Phase
PHASE2/PHASE3
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Mar 31, 2005
Status verified
Oct 2005
Completion
Jun 30, 2007

Study Design

Enrollment
46 participants
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Primary Outcome Measure

ASAS 40 at week 12

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