A study to assess the effects of Certolizumab Pegol on the Reduction ofAnterior Uveitis (AU) Flares in Axial Spondyloarthritis Subjects with adocumented history of A
- Conditions
- Anterior Uveitis in subjects with Axial Spondyloarthritis (axSpA) and a history of AU.MedDRA version: 20.0Level: SOCClassification code 10028395Term: Musculoskeletal and connective tissue disordersSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersTherapeutic area: Diseases [C] - Immune System Diseases [C20]
- Registration Number
- EUCTR2016-000343-14-DE
- Lead Sponsor
- CB Biopharma SPRL.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 86
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: 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;Secondary Objective: - To assess the effect of Certolizumab Pegol (CZP) treatment on the reduction of Anterior Uveitis (AU) flares in subjects with active Axial Spondyloarthritis (axSpA) having at least 1 documented history of AU within 12 months prior to Baseline<br>- To assess the effect of Certolizumab Pegol (CZP) treatment on axSpA disease activity;Primary end point(s): Number of distinct episodes of anterior uveitis (AU) flares during the Treatment Period;Timepoint(s) of evaluation of this end point: During the Treatment Period up to 96 weeks
- Secondary Outcome Measures
Name Time Method