A Study to Assess the Effects of Certolizumab Pegol on the Reduction of Anterior Uveitis (AU) Fla… (NCT03020992) | Clinical Trial Compass
CompletedPhase 4
A Study to Assess the Effects of Certolizumab Pegol on the Reduction of Anterior Uveitis (AU) Flares in Axial Spondyloarthritis Subjects With a Documented History of AU
Czechia89 participantsStarted 2016-12-21
Plain-language summary
The purpose of the study is to demonstrate the effect of Certolizumab Pegol (CZP) treatment on the reduction of Anterior Uveitis (AU) flares in subjects with active axial Spondyloarthritis (axSpA) and a documented history of AU.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Subjects must have a documented diagnosis of adult-onset axial Spondyloarthritis (axSpA) with at least 3 months' symptom duration and meet the Assessment of SpondyloArthritis International Society (ASAS) criteria
* Subjects must have active disease at Screening as defined by
* Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score \>= 4
* Spinal pain \>= 4 on a 0 to 10 Numerical Rating Scale (NRS; from BASDAI item 2)
* Nonradiographic (Nr)-axSpA subjects must either have C-reactive protein (CRP) \> upper limit of normal (ULN) and /or current evidence of sacroiliitis on magnetic resonance imaging (MRI) (no confirmation by central reading) as defined by ASAS criteria
* Ankylosing spondylitis (AS) subjects must have evidence of sacroiliitis on x-ray meeting the modified New York (mNY) classification criteria according to the Investigator
* Subjects must have a documented history of Anterior Uveitis (AU) diagnosed by an ophthalmologist and have at least 2 AU flares in the past, of which at least 1 AU flare was in the last 12 months prior to Baseline
Exclusion Criteria:
* Other inflammatory arthritis
* Secondary, noninflammatory condition that, in the Investigator's opinion, is symptomatic enough to interfere with evaluation of the effect of study drug on the subject's primary diagnosis of axial spondyloarthritis (axSpA)
* Any history of uveitis except for Anterior Uveitis (AU) associated with axSpA
* Any condition or complicating factor that ma…
What they're measuring
1
Number of Distinct Episodes of Anterior Uveitis (AU) Flares During the Treatment Period
Timeframe: During the pre-study period and during the Treatment Period up to 96 weeks