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.
Drug: Certolizumab Pegol
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Full eligibility criteria for NCT03020992
Ages eligible for Study
18 Years and older
Genders eligible for Study
Accepts Healthy Volunteers
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
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 may interfere with the AU assessment
Retisert® or Iluvien® (glucocorticosteroid implant) within 3 years prior to the Baseline Visit or has had complications related to the device
Subject has had Retisert or Iluvien (glucocorticosteroid implant) removed within 90 days prior to the Baseline Visit
Intraocular or periocular corticosteroids within 90 days prior to the Baseline visit
Ozurdex® (dexamethasone implant) within 6 months prior to the Baseline Visit
Cyclophosphamide within 30 days prior to the Baseline Visit
Intravitreal methotrexate (MTX) within 90 days prior to the Baseline Visit
Tris trial is registered with FDA with number: NCT03020992. The sponsor of the trial is UCB Biopharma SRL and it is looking for 89 volunteers for the current phase.
Official trial title: Multicenter, Open-Label Study to Assess the Effects of Certolizumab Pegol on the Reduction of Anterior Uveitis Flares in Axial Spondyloarthritis Subjects With a History of Anterior Uveitis (C-VIEW)
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