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 (C-VIEW)

UCB

Status and phase: Completed; Phase 4

Conditions: Axial Spondyloarthritis (axSpA); Anterior Uveitis (AU)

Treatments: Drug: Certolizumab Pegol

Study type: Interventional

Funder types: Industry

Identifiers

NCT03020992

AS0007

2016-000343-14 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 89 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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89 participants in 1 patient group

Certolizumab Pegol

Experimental group

Description:

Subjects will receive a loading dose of Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) administered at Baseline, Week 2, and Week 4 followed by CZP 200 mg sc every two Weeks

Treatment:

Drug: Certolizumab Pegol