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

Last updated: January 20, 2021
Sponsor: UCB Biopharma SRL
Overall Status: Completed

Phase

4

Condition

Iritis

Uveitis

Treatment

N/A

Clinical Study ID

NCT03020992
AS0007
2016-000343-14
  • Ages > 18
  • All Genders

Study 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

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 ofSpondyloArthritis 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) > upperlimit of normal (ULN) and /or current evidence of sacroiliitis on magnetic resonanceimaging (MRI) (no confirmation by central reading) as defined by ASAS criteria
  • Ankylosing spondylitis (AS) subjects must have evidence of sacroiliitis on x-raymeeting the modified New York (mNY) classification criteria according to theInvestigator
  • Subjects must have a documented history of Anterior Uveitis (AU) diagnosed by anophthalmologist and have at least 2 AU flares in the past, of which at least 1 AUflare was in the last 12 months prior to Baseline

Exclusion

Exclusion Criteria:

  • Other inflammatory arthritis
  • Secondary, noninflammatory condition that, in the Investigator's opinion, issymptomatic enough to interfere with evaluation of the effect of study drug on thesubject'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 theBaseline Visit or has had complications related to the device
  • Subject has had Retisert or Iluvien (glucocorticosteroid implant) removed within 90days 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

Study Design

Total Participants: 89
Study Start date:
December 21, 2016
Estimated Completion Date:
January 23, 2020

Connect with a study center

  • As0007 101

    Brno,
    Czechia

    Site Not Available

  • As0007 103

    Brno,
    Czechia

    Site Not Available

  • As0007 107

    Brno,
    Czechia

    Site Not Available

  • As0007 108

    Ostrava,
    Czechia

    Site Not Available

  • As0007 109

    Pardubice,
    Czechia

    Site Not Available

  • As0007 105

    Praha,
    Czechia

    Site Not Available

  • As0007 102

    Praha 2,
    Czechia

    Site Not Available

  • As0007 304

    Frankfurt,
    Germany

    Site Not Available

  • As0007 301

    Freiburg,
    Germany

    Site Not Available

  • As0007 303

    Muenster,
    Germany

    Site Not Available

  • As0007 302

    Munich,
    Germany

    Site Not Available

  • As0007 302

    München,
    Germany

    Site Not Available

  • As0007 303

    Münster,
    Germany

    Site Not Available

  • As0007 401

    Amsterdam,
    Netherlands

    Site Not Available

  • As0007 506

    Bialystok,
    Poland

    Site Not Available

  • As0007 506

    Białystok,
    Poland

    Site Not Available

  • As0007 510

    Lublin,
    Poland

    Site Not Available

  • As0007 509

    Poznan,
    Poland

    Site Not Available

  • As0007 509

    Poznań,
    Poland

    Site Not Available

  • As0007 511

    Poznań,
    Poland

    Site Not Available

  • As0007 502

    Torun,
    Poland

    Site Not Available

  • As0007 502

    Toruń,
    Poland

    Site Not Available

  • As0007 501

    Warszawa,
    Poland

    Site Not Available

  • As0007 505

    Warszawa,
    Poland

    Site Not Available

  • As0007 507

    Wroclaw,
    Poland

    Site Not Available

  • As0007 504

    Wrocław,
    Poland

    Site Not Available

  • As0007 507

    Wrocław,
    Poland

    Site Not Available

  • As0007 508

    Wrocław,
    Poland

    Site Not Available

  • As0007 604

    Barcelona,
    Spain

    Site Not Available

  • As0007 601

    Córdoba,
    Spain

    Site Not Available

  • As0007 603

    Madrid,
    Spain

    Site Not Available

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