Phase 4
N=89
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
Axial Spondyloarthritis (axSpA) · Anterior Uveitis (AU)
Bottom Line
View on ClinicalTrials.gov: NCT03020992 ↗Enrolled (actual)
89
Serious AEs
12.4%
Results posted
Dec 2020
Primary outcome: Primary: Number of Distinct Episodes of Anterior Uveitis (AU) Flares During the Treatment Period — 1.9; 0.3 flares — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Certolizumab Pegol (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- UCB Biopharma SRL
- Primary completion
- Dec 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Distinct Episodes of Anterior Uveitis (AU) Flares During the Treatment Period |
1.9; 0.3 | <0.001 sig |
| SECONDARY 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 |
132.72; 18.56 | — |
| SECONDARY 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 |
97.51; 17.67 | — |
| SECONDARY 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 |
132.72; 18.56 | — |
| SECONDARY 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 |
97.51; 17.67 | — |
| SECONDARY Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) at Week 48 |
-1.55 | — |
| SECONDARY Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) at Week 96 |
-1.61 | — |
| SECONDARY Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 48 |
-3.2 | — |
| SECONDARY Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 96 |
-3.4 | — |
| SECONDARY Percentage of Participants Meeting Assessment of SpondyloArthritis International Society 20 % Response Criteria (ASAS20) at Week 48 |
75.6 | — |
| SECONDARY Percentage of Participants Meeting Assessment of SpondyloArthritis International Society 20 % Response Criteria (ASAS20) at Week 96 |
75.6 | — |
| SECONDARY Percentage of Participants Meeting Assessment of SpondyloArthritis International Society 40 % Response Criteria (ASAS40) at Week 48 |
53.5 | — |
| SECONDARY Percentage of Participants Meeting Assessment of SpondyloArthritis International Society 40 % Response Criteria (ASAS40) at Week 96 |
58.5 | — |
| SECONDARY Percentage of Participants Meeting Assessment of SpondyloArthritis International Society (ASAS) 5/6 Response at Week 48 |
— | — |
| SECONDARY Percentage of Participants Meeting Assessment of SpondyloArthritis International Society (ASAS) 5/6 Response at Week 96 |
— | — |
| SECONDARY Percentage of Participants With Assessment of SpondyloArthritis International Society (ASAS) Partial Remission (PR) Response at Week 48 |
31.4 | — |
| SECONDARY Percentage of Participants With Assessment of SpondyloArthritis International Society (ASAS) Partial Remission (PR) Response at Week 96 |
36.6 | — |
| SECONDARY Change From Baseline in Tender Joint Count (44 Joint Count) at Week 48 |
-4.9 | — |
| SECONDARY Change From Baseline in Tender Joint Count (44 Joint Count) at Week 96 |
-4.7 | — |
| SECONDARY Change From Baseline in Swollen Joint Count (44 Joint Count) at Week 48 |
-4.2 | — |
| SECONDARY Change From Baseline in Swollen Joint Count (44 Joint Count) at Week 96 |
-3.9 | — |
| SECONDARY Change From Baseline in Physician's Global Assessment of Disease Activity (PhGADA) at Week 48 |
-43.8 | — |
| SECONDARY Change From Baseline in Physician's Global Assessment of Disease Activity (PhGADA) at Week 96 |
-42.5 | — |
| SECONDARY Change From Baseline in Patient's Global Assessment of Disease Activity (PtGADA) at Week 48 |
-3.6 | — |
| SECONDARY Change From Baseline in Patient's Global Assessment of Disease Activity (PtGADA) at Week 96 |
-3.9 | — |
| SECONDARY Change From Baseline in Total Spinal Pain at Week 48 Assessed by Numerical Rating Scale (NRS) |
-3.8 | — |
| SECONDARY Change From Baseline in Total Spinal Pain at Week 96 Assessed by Numerical Rating Scale (NRS) |
-4.1 | — |
| SECONDARY Change From Baseline to Week 48 in the Bath Ankylosing Spondylitis Functional Index (BASFI) |
-2.23 | — |
| SECONDARY Change From Baseline to Week 96 in the Bath Ankylosing Spondylitis Functional Index (BASFI) |
-2.28 | — |
| SECONDARY 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 |
-3.7 | — |
| SECONDARY 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 |
-3.8 | — |
| SECONDARY Percentage of Participants Reporting at Least One Treatment-Emergent Adverse Events (TEAEs) During the Study |
80.9 | — |
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
Data sourced from ClinicalTrials.gov (NCT03020992). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.