NCT03020992已完成4 期
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)
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 89
- 试验地点
- 35
- 主要终点
- Number of Distinct Episodes of Anterior Uveitis (AU) Flares During the Treatment Period
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Certolizumab Pegol
Experimental
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
干预措施: Certolizumab Pegol (Drug)
结局指标
主要结局
Number of Distinct Episodes of Anterior Uveitis (AU) Flares During the Treatment Period
时间窗: During the pre-study period and during the Treatment Period up to 96 weeks
A flare was defined as being a new episode of Anterior Uveitis (AU) that, based on the judgment of an ophthalmologist, required specific treatment. A flare was considered a new episode if a gap of at least 3 months occurred between 2 flares.
次要结局
- Change From Baseline in Physician's Global Assessment of Disease Activity (PhGADA) at Week 48(From Baseline to Week 48)
- Change From Baseline in Physician's Global Assessment of Disease Activity (PhGADA) at Week 96(From Baseline to Week 96)
- Change From Baseline in Patient's Global Assessment of Disease Activity (PtGADA) at Week 48(From Baseline to Week 48)
- 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(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(From Baseline to Week 96)
- Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 48(From Baseline to Week 48)
- Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 96(From Baseline to Week 96)
- Change From Baseline in Patient's Global Assessment of Disease Activity (PtGADA) at Week 96(From Baseline to Week 96)
- 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(During the pre-study period and during the Treatment Period up to 48 weeks)
- Change From Baseline in Total Spinal Pain at Week 48 Assessed by Numerical Rating Scale (NRS)(From Baseline to Week 48)
- Change From Baseline in Total Spinal Pain at Week 96 Assessed by Numerical Rating Scale (NRS)(From Baseline to Week 96)
- Change From Baseline to Week 48 in the Bath Ankylosing Spondylitis Functional Index (BASFI)(From Baseline to Week 48)
- Change From Baseline to Week 96 in the Bath Ankylosing Spondylitis Functional Index (BASFI)(From Baseline to Week 96)
- 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(During the pre-study period and during the Treatment Period up to 96 weeks)
- 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(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(From Baseline to Week 96)
- Percentage of Participants Reporting at Least One Treatment-Emergent Adverse Events (TEAEs) During the Study(From Baseline up to the Safety Follow-up Visit (up to Week 104))
- 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(During the pre-study period and during the Treatment Period up to 96 weeks)
- Percentage of Participants With Assessment of SpondyloArthritis International Society (ASAS) Partial Remission (PR) Response at Week 96(Week 96)
- Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) at Week 48(From Baseline to Week 48)
- Percentage of Participants Meeting Assessment of SpondyloArthritis International Society 20 % Response Criteria (ASAS20) at Week 48(Week 48)
- Percentage of Participants Meeting Assessment of SpondyloArthritis International Society 20 % Response Criteria (ASAS20) at Week 96(Week 96)
- Percentage of Participants Meeting Assessment of SpondyloArthritis International Society 40 % Response Criteria (ASAS40) at Week 48(Week 48)
- Percentage of Participants Meeting Assessment of SpondyloArthritis International Society 40 % Response Criteria (ASAS40) at Week 96(Week 96)
- Percentage of Participants Meeting Assessment of SpondyloArthritis International Society (ASAS) 5/6 Response at Week 96(Week 96)
- Percentage of Participants With Assessment of SpondyloArthritis International Society (ASAS) Partial Remission (PR) Response at Week 48(Week 48)
- Percentage of Participants Meeting Assessment of SpondyloArthritis International Society (ASAS) 5/6 Response at Week 48(Week 48)
- Change From Baseline in Tender Joint Count (44 Joint Count) at Week 48(From Baseline to Week 48)
- Change From Baseline in Tender Joint Count (44 Joint Count) at Week 96(From Baseline to Week 96)
- Change From Baseline in Swollen Joint Count (44 Joint Count) at Week 48(From Baseline to Week 48)
- Change From Baseline in Swollen Joint Count (44 Joint Count) at Week 96(From Baseline to Week 96)
研究者
研究点 (35)
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