Clinical trial NCT03020992: 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
Official 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Axial Spondyloarthritis (axSpA)
Anterior Uveitis (AU)
Keywords: Axial Spondyloarthritis
axSpA
Anterior Uveitis
Certolizumab Pegol
Cimzia
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2017-01-13
Enrollment: 89
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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

Primary outcomes:
measure: Number of Distinct Episodes of Anterior Uveitis (AU) Flares During the Treatment Period
timeFrame: During the pre-study period and during the Treatment Period up to 96 weeks
Secondary outcomes:
measure: Number of Anterior Uveitis (AU) Flares Per 100 Patient-years in Participants With Active Axial SpondyloArthritis (axSpA) and a History of AU at Week 48
timeFrame: During the pre-study period and during the Treatment Period up to 48 weeks
measure: Number of Anterior Uveitis (AU) Flares Per 100 Patient-years in Participants With Active Axial SpondyloArthritis (axSpA) and a History of AU at Week 96
timeFrame: During the pre-study period and during the Treatment Period up to 96 weeks
measure: Number of Anterior Uveitis (AU) Flares Per 100 Patient-years in Participants With Active Axial SpondyloArthritis (axSpA) and at Least 1 AU Episode Within 12 Months Prior Baseline at Week 48
timeFrame: During the pre-study period and during the Treatment Period up to 48 weeks
measure: Number of Anterior Uveitis (AU) Flares Per 100 Patient-years in Participants With Active Axial SpondyloArthritis (axSpA) and at Least 1 AU Episode Within 12 Months Prior Baseline at Week 96
timeFrame: During the pre-study period and during the Treatment Period up to 96 weeks
measure: Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) at Week 48
timeFrame: From Baseline to Week 48
measure: Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) at Week 96
timeFrame: From Baseline to Week 96
measure: Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 48
timeFrame: From Baseline to Week 48
measure: Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 96
timeFrame: From Baseline to Week 96
measure: Percentage of Participants Meeting Assessment of SpondyloArthritis International Society 20 % Response Criteria (ASAS20) at Week 48
timeFrame: Week 48
measure: Percentage of Participants Meeting Assessment of SpondyloArthritis International Society 20 % Response Criteria (ASAS20) at Week 96
timeFrame: Week 96
measure: Percentage of Participants Meeting Assessment of SpondyloArthritis International Society 40 % Response Criteria (ASAS40) at Week 48
timeFrame: Week 48
measure: Percentage of Participants Meeting Assessment of SpondyloArthritis International Society 40 % Response Criteria (ASAS40) at Week 96
timeFrame: Week 96
measure: Percentage of Participants Meeting Assessment of SpondyloArthritis International Society (ASAS) 5/6 Response at Week 48
timeFrame: Week 48
measure: Percentage of Participants Meeting Assessment of SpondyloArthritis International Society (ASAS) 5/6 Response at Week 96
timeFrame: Week 96
measure: Percentage of Participants With Assessment of SpondyloArthritis International Society (ASAS) Partial Remission (PR) Response at Week 48
timeFrame: Week 48
measure: Percentage of Participants With Assessment of SpondyloArthritis International Society (ASAS) Partial Remission (PR) Response at Week 96
timeFrame: Week 96
measure: Change From Baseline in Tender Joint Count (44 Joint Count) at Week 48
timeFrame: From Baseline to Week 48
measure: Change From Baseline in Tender Joint Count (44 Joint Count) at Week 96
timeFrame: From Baseline to Week 96
measure: Change From Baseline in Swollen Joint Count (44 Joint Count) at Week 48
timeFrame: From Baseline to Week 48
measure: Change From Baseline in Swollen Joint Count (44 Joint Count) at Week 96
timeFrame: From Baseline to Week 96
measure: Change From Baseline in Physician's Global Assessment of Disease Activity (PhGADA) at Week 48
timeFrame: From Baseline to Week 48
measure: Change From Baseline in Physician's Global Assessment of Disease Activity (PhGADA) at Week 96
timeFrame: From Baseline to Week 96
measure: Change From Baseline in Patient's Global Assessment of Disease Activity (PtGADA) at Week 48
timeFrame: From Baseline to Week 48
measure: Change From Baseline in Patient's Global Assessment of Disease Activity (PtGADA) at Week 96
timeFrame: From Baseline to Week 96
measure: Change From Baseline in Total Spinal Pain at Week 48 Assessed by Numerical Rating Scale (NRS)
timeFrame: From Baseline to Week 48
measure: Change From Baseline in Total Spinal Pain at Week 96 Assessed by Numerical Rating Scale (NRS)
timeFrame: From Baseline to Week 96
measure: Change From Baseline to Week 48 in the Bath Ankylosing Spondylitis Functional Index (BASFI)
timeFrame: From Baseline to Week 48
measure: Change From Baseline to Week 96 in the Bath Ankylosing Spondylitis Functional Index (BASFI)
timeFrame: From Baseline to Week 96
measure: 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
timeFrame: From Baseline to Week 48
measure: 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
timeFrame: From Baseline to Week 96
measure: Percentage of Participants Reporting at Least One Treatment-Emergent Adverse Events (TEAEs) During the Study
timeFrame: From Baseline up to the Safety Follow-up Visit (up to Week 104)
Other outcomes:
Locations:
city: Brno
country: Czechia
facility: As0007 101
city: Brno
country: Czechia
facility: As0007 103
city: Brno
country: Czechia
facility: As0007 107
city: Ostrava
country: Czechia
facility: As0007 108
city: Pardubice
country: Czechia
facility: As0007 109
city: Praha 2
country: Czechia
facility: As0007 102
city: Praha
country: Czechia
facility: As0007 105
city: Freiburg
country: Germany
facility: As0007 301
city: München
country: Germany
facility: As0007 302
city: Münster
country: Germany
facility: As0007 303
city: Amsterdam
country: Netherlands
facility: As0007 401
city: Białystok
country: Poland
facility: As0007 506
city: Lublin
country: Poland
facility: As0007 510
city: Poznań
country: Poland
facility: As0007 509
city: Poznań
country: Poland
facility: As0007 511
city: Toruń
country: Poland
facility: As0007 502
city: Warszawa
country: Poland
facility: As0007 501
city: Warszawa
country: Poland
facility: As0007 505
city: Wrocław
country: Poland
facility: As0007 504
city: Wrocław
country: Poland
facility: As0007 507
city: Wrocław
country: Poland
facility: As0007 508
city: Barcelona
country: Spain
facility: As0007 604
city: Córdoba
country: Spain
facility: As0007 601
Study officials:
affiliation: 001 844 599 2273 (UCB)
name: UCB Cares
role: STUDY_DIRECTOR
References:
citation: van der Horst-Bruinsma IE, van Bentum RE, Verbraak FD, Deodhar A, Rath T, Hoepken B, Irvin-Sellers O, Thomas K, Bauer L, Rudwaleit M. Reduction of anterior uveitis flares in patients with axial spondyloarthritis on certolizumab pegol treatment: final 2-year results from the multicenter phase IV C-VIEW study. Ther Adv Musculoskelet Dis. 2021 Mar 29;13:1759720X211003803. doi: 10.1177/1759720X211003803. eCollection 2021.