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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03020992
• Date of registration: 11/01/2017
• Prospective Registration: No
• Primary sponsor: UCB Biopharma SRL
• Public title: 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
• Scientific 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)
• Date of first enrolment: December 21, 2016
• Target sample size: 89
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03020992
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 4

Countries of recruitment

Czech Republic, Czechia, Germany, Netherlands, Poland, Spain

Contacts

• Name: UCB Cares
• Affiliation: 001 844 599 2273 (UCB)

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Anterior Uveitis (AU)

Axial Spondyloarthritis (axSpA)

Intervention(s)

Drug: Certolizumab Pegol

Primary Outcome(s)

Number of distinct episodes of anterior uveitis (AU) flares during the Treatment Period [Time Frame: During the pre-study period and during the Treatment Period up to 96 weeks]

Secondary Outcome(s)

Change From Baseline in Patient's Global Assessment of Disease Activity (PtGADA) at Week 96 [Time Frame: From Baseline to Week 96]

Change from Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 96 [Time Frame: From Baseline to Week 96]

Change from Baseline in swollen joint count (44 joint count) at Week 48 [Time Frame: From Baseline to Week 48]

Change from Baseline in tender joint count (44 joint count) at Week 96 [Time Frame: From Baseline to Week 96]

Change from Baseline to Week 48 in Inflammation assessed by the mean of the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) questions 5 and 6 concerning morning stiffness and duration [Time Frame: From Baseline to Week 48]

Change from Baseline in swollen joint count (44 joint count) at Week 96 [Time Frame: From Baseline to Week 96]

Change from Baseline in total spinal pain at Week 96 assessed by Numerical Rating Scale (NRS) [Time Frame: From Baseline to Week 96]

Percentage of subjects meeting Axial Spondyloarthritis International Society (ASAS) 5/6 response at Week 48 [Time Frame: Week 48]

Number of Anterior Uveitis (AU) flares per 100 patient-years in subjects with active axial Spondyloarthritis (axSpA) and at least 1 AU episode within 12 months prior Baseline at Week 96 [Time Frame: During the pre-study period and during the Treatment Period up to 96 weeks]

Number of Anterior Uveitis (AU) flares per 100 patient-years in subjects with active axial Spondyloarthritis (axSpA) and a history of AU at Week 96 [Time Frame: During the pre-study period and during the Treatment Period up to 96 weeks]

Treatment-Emergent Adverse Events (TEAEs) during the study [Time Frame: From Baseline up to the Safety Follow-up Visit (up to Week 104)]

Percentage of subjects meeting Axial Spondyloarthritis International Society 20 % response criteria (ASAS20) at Week 48 [Time Frame: Week 48]

Number of Anterior Uveitis (AU) flares per 100 patient-years in subjects with active axial Spondyloarthritis (axSpA) and a history of AU at Week 48 [Time Frame: During the pre-study period and during the Treatment Period up to 48 weeks]

Number of Anterior Uveitis (AU) flares per 100 patient-years in subjects with active axial Spondyloarthritis (axSpA) and at least 1 AU episode within 12 months prior Baseline at Week 48 [Time Frame: During the pre-study period and during the Treatment Period up to 48 weeks]

Change from Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) at Week 96 [Time Frame: From Baseline to Week 96]

Change from Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) at Week 48 [Time Frame: From Baseline to Week 48]

Change From Baseline in Patient's Global Assessment of Disease Activity (PtGADA) at Week 48 [Time Frame: From Baseline to Week 48]

Change from Baseline to Week 96 in Inflammation assessed by the mean of the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) questions 5 and 6 concerning morning stiffness and duration [Time Frame: From Baseline to Week 96]

Change from Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 48 [Time Frame: From Baseline to Week 48]

Change from Baseline in total spinal pain at Week 48 assessed by Numerical Rating Scale (NRS) [Time Frame: From Baseline to Week 48]

Percentage of subjects with Axial Spondyloarthritis International Society (ASAS) partial remission (PR) response at Week 48 [Time Frame: Week 48]

Change From Baseline in Physician's Global Assessment of Disease Activity (PhGADA) at Week 96 [Time Frame: From Baseline to Week 96]

Change from Baseline to Week 96 in the Bath Ankylosing Spondylitis Functional Index (BASFI) [Time Frame: From Baseline to Week 96]

Change from Baseline in tender joint count (44 joint count) at Week 48 [Time Frame: From Baseline to Week 48]

Change from Baseline to Week 48 in the Bath Ankylosing Spondylitis Functional Index (BASFI) [Time Frame: From Baseline to Week 48]

Percentage of subjects meeting Axial Spondyloarthritis International Society 40 % response criteria (ASAS40) at Week 48 [Time Frame: Week 48]

Change From Baseline in Physician's Global Assessment of Disease Activity (PhGADA) at Week 48 [Time Frame: From Baseline to Week 48]

Percentage of subjects meeting Axial Spondyloarthritis International Society (ASAS) 5/6 response at Week 96 [Time Frame: Week 96]

Percentage of subjects meeting Axial Spondyloarthritis International Society 20 % response criteria (ASAS20) at Week 96 [Time Frame: Week 96]

Percentage of subjects meeting Axial Spondyloarthritis International Society 40 % response criteria (ASAS40) at Week 96 [Time Frame: Week 96]

Percentage of subjects with Axial Spondyloarthritis International Society (ASAS) partial remission (PR) response at Week 96 [Time Frame: Week 96]

Secondary ID(s)

2016-000343-14

AS0007

Source(s) of Monetary Support

Please refer to primary and secondary sponsors