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)
- Conditions
- anterior uveïtis flares in axial spondyloarthritiseye inflammation in spondyloarthritis1001591910023213
- Registration Number
- NL-OMON46252
- Lead Sponsor
- CB Biopharma SPR
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 10
The study population will be subjects *18 years, with a documented diagnosis of adult onset axSpA as meeting the Assessment of SpondyloArthritis International Society ([ASAS] criteria of at least 3 months* symptom duration, and with active disease defined by a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) *4, and spinal pain *4 on a 0 to 10 Numerical Rating Scale (NRS). Nonradiographic axSpA subjects must either have C Reactive Protein > upper limit of normal (ULN) and /or current evidence of sacroiliitis on Magnetic Resonance Imaging taken within 3 months prior to Baseline (no confirmation by central reading) as defined by ASAS criteria and ankylosing spondylitis subjects must have evidence of sacroiliitis on an x-ray taken within 12 months prior to Baseline meeting modified New York criteria according to the Investigator. Subjects must have a documented history of 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.
Additionally, subjects must be HLA-B27 positive (if known prior to Screening, no additional testing is to be performed; if unknown, testing is to be performed at Screening and checked at Baseline) and subjects must have been intolerant to or had an inadequate response to at least 2 Nonsteroidal Anti-inflammatory drugs (NSAIDs). Inadequate response to an NSAID is defined as lack of response to at least 14 days of continuous NSAID therapy at the highest tolerated dose of the administered NSAID.
1. The subject has previously participated in this study or has previously received CZP treatment in or outside of another clinical study. However rescreening is possible if prophylactic treatment for latent tuberculosis infection (LTBI) was to be given but the Screening Period exceeded the 12 weeks.
2. The subject has participated in another study of an investigational medicinal product (IMP) (or a medical device) within the previous 3 months or is currently participating in another study of an IMP (or a medical device).
3. The subject has a history of chronic alcohol or drug abuse.
4. The subject has any medical or psychiatric condition that, in the opinion of the Investigator, could jeopardize or would compromise the subject*s ability to participate in this study.
5. The subject has a known hypersensitivity to any components of CZP or a history of an adverse reaction to polyethylene glycol.
Axial SpA-disease related exclusions
6. Subjects must not have any other inflammatory arthritis (eg, rheumatoid arthritis, systemic lupus erythematosus, sarcoidosis, or fibromyalgia).
7. Subjects must not have a 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 axSpA.
Ophthalmic exclusion criteria
8. Any history of uveitis (eg, posterior, panuveitis) except for AU associated with axSpA.
9. Any condition or complicating factor that may interfere with the AU assessment, for example:
a. History of cataract surgery within 6 months prior to Baseline
b. Corneal or lens opacity
c. Proliferative or severe nonproliferative diabetic retinopathy or clinically significant macular edema due to diabetic retinopathy
d. Neovascular/wet age-related macular degeneration
e. History of scleritis
f. History of intraocular surgery, with the exception of phacoemulsification
10. Subject has 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 or has had complications related to removal of the device.
11. Subject has received intraocular or periocular corticosteroids within 90 days prior to the Baseline visit.
12. Subject has received Ozurdex® (dexamethasone implant) within 6 months prior to the Baseline Visit.
13. Subject on cyclophosphamide within 30 days prior to the Baseline Visit.
14. Subject has received intravitreal methotrexate within 90 days prior to the Baseline Visit.
15. Subject has received intravitreal anti-vascular endothelial growth factor therapy:
a. Within 45 days of the Baseline visit for Lucentis® (ranibizumab) or Avastin® (bevacizumab)
or
b. Within 60 days of the Baseline visit for anti-VEGF Trap Zaltrap® (aflibercept)
Prior medications exclusions
16. Subjects must not have used the following medications in the manner as detailed by the exclusion criteria in Table 6-1 (protocol page 31).
Previous clinical studies and previous biological therapy exclusions
17. Subjects must not have received any nonbiological therapy for axSpA not listed in Table 1 within or outside of a clinical study in the 3 months or within 5 half lives prior to the Baseline Visit (whichever is longer).
18. Subjects mus
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary efficacy variable:<br /><br>The primary efficacy variable will be the count of distinct episodes of AU<br /><br>flares during the Treatment Period.</p><br>
- Secondary Outcome Measures
Name Time Method