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12日最近更新: 2020年3月18日

适应症

试验速览

暂无简介。

•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 >=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
•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 Baseline
•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

•- 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

发起方

CB Biopharma SPRL.