EUCTR2016-000343-14-ES进行中（未招募）1 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) - C-VIEW
CB Biopharma SPRL.0 个研究点目标入组 86 人开始时间: 2016年7月15日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 86
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •1) 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
- •2) Subjects must have active disease at Screening as defined by
- •- Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score >=
- •- 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) taken within
- •3 months prior to Baseline (no confirmation by central reading) as
- •defined by ASAS criteria
- •- Ankylosing spondylitis (AS) subjects must have evidence of sacroiliitis
- •on x-ray taken within 12
- •months prior to Baseline meeting modified New York (mNY) criteria
- •according to the Investigator
- •3) 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
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 86
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
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
- •- Any condition or complicating factor that may interfere with the AU
- •- 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
- •- Intravitreal anti-vascular endothelial growth factor (VEGF) therapy
研究者
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