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
Condition: Axial Spondyloarthritis (axSpA); Anterior Uveitis (AU)
MeSH terms: Spondylitis; Spondylarthritis; Axial Spondyloarthritis; Uveitis; Uveitis, Anterior; Iridocyclitis
Intervention: Certolizumab Pegol
Intervention description: pharmaceutical form: solution for infusion in prefilled syringe
concentration: 200 mg/mL
route of administration: subcutaneous
Intervention MeSH terms: Certolizumab Pegol
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 89.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Axial Spondyloarthritis; axSpA; Anterior Uveitis; Certolizumab Pegol; Cimzia

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.
    

Eligibility criteria:

        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 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

          -  Intravitreal anti-vascular endothelial growth factor (VEGF) therapy